| October 2007
October
31, 2007
Download print version
Microsoft to acquire healthcare technology and
assets from Global Care Solutions
Chinese chemicals flow unchecked to world drug
market
774 arrests in China
over safety
New cancer recommendations; Diet,
weight, alcohol and red meat
consumption all implicated in cancer risk
Kimberly-Clark Professional video contest is truly
out of this world
Targeted cleaning of hand-touch surfaces
could reduce
MRSA transmission in hospitals
Targeting hand-touch surfaces in hospitals that are likely to be
contaminated by meticillin-resistant Staphylococcus aureus (MRSA), rather
than a focus on removing visible dirt, is a feasible short-term strategy for
tackling the transmission of MRSA, according to a Review in The Lancet
Infectious Diseases to be published Online, October 31. Further, this
additional cleaning would be easier to implement than improvements in
hand-hygiene compliance. The public associate visibly dirty wards with
increasing rates of MRSA, but there is little evidence for the effectiveness
of basic cleaning on reducing the risk of acquiring MRSA in health-care
institutions. Furthermore, hospital hygiene is usually assessed visually,
but this does not necessarily correlate with microbiological risk and fails
to recognise that microorganisms, including human pathogens such as MRSA,
are invisible to the naked eye.
However, the current standards for assessing hospital hygiene use visible
cleanliness as a performance criterion. Dr. Stephanie Dancer (South
General Hospital, Glasgow, UK) presents a robust case for targeted hospital
cleaning as a strategy for controlling MRSA by reviewing the evidence for
the potential impact of cleaning on each stage of the staphylococcal
transmission cycle between patients, staff, and their environment. The
author notes that cleaning is already accepted as an important factor in the
control of other hardy environmental pathogens, such as Clostridium
difficile, vancomycin-resistant enterococci, norovirus, and Acinetobacter
spp, but argues that the role of near-patient hand-touch sites, such as door
handles, bed rails, infusion pumps, and switches, in the transmission of
MRSA and other pathogens, has not been given the priority it deserves.
According Dr. Dancer, in the
UK, ward
cleaners work to a set specification that gives emphasis to the cleaning of
floors and toilets, and yet the evidence for MRSA contamination of a huge
variety of hospital items, and particularly hand-touch sites is
overwhelming. Indeed, the author notes that these hand-touch sites, which
might harbor and transmit microbial pathogens, are poorly cleaned. The
author concludes: “There can be no doubt that prioritizing hand hygiene is
the single most beneficial intervention in the control of MRSA…[but] even if
everyone does wash their hands properly, the effects of exemplary hand
hygiene are eroded if the environment is heavily contaminated by MRSA”. She
adds: “The increasing prevalence of MRSA and other multi-drug-resistant
bacteria in UK hospitals support prioritization of cleaning and other
control measures before definitive validation”. For more information see
THIS LINK

HHS
announces project to help 3.6 million consumers reap benefits of electronic
health records
HHS Secretary Mike Leavitt announced a five-year demonstration project that
will encourage small to medium-sized physician practices to adopt electronic
health records (EHRs). “This demonstration is designed to show that
streamlining health care management with electronic health records will
reduce medical errors and improve quality of care for 3.6 million
Americans. By linking higher payment to use of EHRs to meet quality
measures, we will encourage adoption of health information technology at the
community level, where 60 percent of patients receive care,” Secretary
Leavitt said. “We also anticipate that EHRs will produce significant savings
for Medicare over time by improving quality of care. This is another step in
our ongoing effort to become a smart purchaser of healthcare; paying for
better, rather than simply paying for more.”
Conducted by the Centers for Medicare & Medicaid Services (CMS),
the demonstration would be open to participation by up to 1,200 physician
practices beginning in the spring. Over a five-year period, the program will
provide financial incentives to physician groups using certified EHRs to
meet certain clinical quality measures. A bonus will be provided each year
based on a physician group’s score on a standardized survey that assesses
the specific EHR functions a group employs to support the delivery of care.
Under the CMS demonstration, all participating practices will be required to
use a certified EHR system to perform specific functions that can positively
affect patient care processes, such as clinical documentation and ordering
prescriptions. The system, which must be in place by the end of the second
year, must also be approved by a certification body officially recognized by
HHS. The core incentive payment to practices will be based on performance on
the quality measures, with an enhanced bonus based on the how well
integrated the EHR is in helping manage patient care. During the five-year
project, it is estimated that 3.6 million consumers will be directly
affected as their primary care physicians adopt certified EHRs in their
practices. In order to amplify the effect of this demonstration project, CMS
is encouraging private insurers to offer similar incentives for EHR
adoption.

Microsoft to acquire healthcare technology and assets from Global Care
Solutions
Microsoft Corp. has agreed to acquire software, intellectual property and
other assets from Global Care Solutions (GCS), a privately held company
based in Bangkok, Thailand, that develops enterprise-class health
information systems. The acquisition complements Microsoft’s portfolio of
health solutions and will provide hospitals across international markets
with a new alternative to achieve improved workflow and patient safety
through information technology. GCS employees will join Microsoft’s Health
Solutions Group, which will manage product development and delivery.
Financial terms were not disclosed.
Global Care Solutions designed and developed its end-to-end system in
collaboration with Bumrungrad International hospital, an internationally
accredited facility based in Bangkok. The hospital, which treats more than
1.2 million patients from 190 countries each year, uses the GCS solution to
efficiently manage clinical workflow, billing, regulatory compliance and
medical records. Microsoft will continue to work closely with Bumrungrad to
further build out the functionality and features of the GCS technology. “We
have a diverse patient population at Bumrungrad, with over 400,000 foreign
patients every year; half of the 3,200 patients we see each day arrive
without appointments,” said Mack Banner, the chief executive officer of the
hospital. “The GCS solution has allowed us to manage scheduling demands,
multiple languages and medical records so efficiently that the average
waiting time to see a doctor is only 17 minutes. The GCS software is a key
to our service delivery, medical quality and financial performance, and we
look forward to collaborating with Microsoft on extending its applications
across our organization.”
Global Care Solution's system is a fully integrated suite of 50 clinical and
back-office application modules designed and optimized to run all hospital
clinical and administrative operations on Microsoft Windows Server 2003 and
Microsoft SQL Server 2005. The new Microsoft offering based on the GCS
technology will complement the company's current Azyxxi solution, which
provides a data integration capability for hospitals with legacy systems
already in place.

Chinese
chemicals flow unchecked to world drug market
In January, Honor International Pharmtech was accused of shipping
counterfeit drugs into the
United States.
Even so, the Chinese chemical company, whose motto is “Thinking Much of
Honor”, was openly marketing its products in October to thousands of buyers
in Milan at the world’s biggest trade show for pharmaceutical ingredients.
Other Chinese chemical companies made the journey to the annual show as
well, including one manufacturer recently accused by American authorities of
supplying steroids to illegal underground labs and another whose
representative was arrested at the 2006 trade show for patent violations.
Also attending were two exporters owned by China’s government that had sold
poison mislabeled as a drug ingredient, which killed nearly 200 people and
injured countless others in Haiti and in Panama. Yet another chemical
company, Orient Pacific International, reserved an exhibition booth in
Milan, but its owner, Kevin Xu, could not attend. He was in a
Houston
jail on charges of selling counterfeit medicine for schizophrenia, prostate
cancer, blood clots and Alzheimer’s disease, among other maladies.
While these companies hardly represent all of the nearly 500
Chinese exhibitors, more than from any other country, they do point to a
deeper problem: Pharmaceutical ingredients exported from China are often
made by chemical companies that are neither certified nor inspected by
Chinese drug regulators, The New York Times has found. Because the
chemical companies are not required to meet even minimal drug-manufacturing
standards, there is little to stop them from exporting unapproved,
adulterated or counterfeit ingredients. The substandard formulations made
from those ingredients often end up in pharmacies in developing countries
and for sale on the Internet, where more Americans are turning for cheap
medicine.
In Milan, The Times identified at least 82 Chinese chemical companies
that said they made and exported pharmaceutical ingredients, yet not one was
certified by the State
Food and Drug
Administration in China, records show. Nonetheless, the companies
were negotiating deals at the pharmaceutical show. One of them was the Wuxi
Hexia Chemical Company. When The Times showed Yan Jiangying, a top
Chinese drug regulator, a list of 186 products being advertised by the
company, including active pharmaceutical ingredients and finished drugs, Yan
said, “This is definitely against the law.” Yet in
China,
chemical manufacturers that sell drug ingredients fall into a regulatory
hole. Pharmaceutical companies are regulated by the food and drug agency.
Chemical companies that make products as varied as fertilizer and industrial
solvents are overseen by other agencies. The problem arises when chemical
companies cross over into drug ingredients. “We have never investigated a
chemical company,” said Yan, deputy director of policy and regulation at the
State Food and Drug Administration. “We don’t have jurisdiction.”
China
has an estimated 80,000 chemical companies, and the United States Food and
Drug Administration does not know how many sell ingredients used in drugs
consumed by Americans. A House hearing on F.D.A. oversight of foreign drug
manufacturers is scheduled for Thursday. (The New York Times) For the
complete story see
THIS LINK

774 arrests in China over safety
The Chinese government revealed that it had arrested 774 people over the
last two months as part of a nationwide crackdown on the production and sale
of tainted food, drugs and agricultural products. Government regulators
hailed the arrests as a major step forward for food and drug safety, and
said the “criminal suspects” were detained during nationwide inspections of
thousands of restaurants, food and drug production plants and wholesale food
markets. Determined to counter accusations that it has been producing and
also exporting tainted goods, China has vowed to revamp its food and drug
safety regulations and to close illegal manufacturers and exporters. In the
summer, the government even executed the former head of the nation’s food
and drug administration,
Zheng Xiaoyu,
after he was convicted of accepting bribes and failing to properly supervise
food and drug companies, some of which had sold counterfeit drugs. But the
government also acknowledged that problems remain.
In its announcement, it said that this month only 82 percent of food tested
in medium and large cities in China met safety standards, and nearly 30
percent of the restaurants surveyed by regulators had failed food safety
inspections. The announcement of the arrests offered few details about the
nature and seriousness of the food and drug safety violations involved, or,
indeed, who had been arrested or the size of their businesses. The
government said only that it had investigated 626 criminal cases. The
arrests came after nearly a year of high-profile recalls involving
everything from tainted pet food ingredients to problem toys, and after
repeated promises on the part of government regulators to crack down on
tainted goods and restore confidence in the Made in China label. As part of
its effort, the government is also trying to counter widespread concerns
that the quality and safety of the food and drugs sold to its own citizens
is far worse than the products it exports. In fact, China acknowledged this
year that while it believes 99 percent of its food exports meet safety
standards, only about 80 percent of food sold domestically has passed
inspections. Today, the government said that a four-month campaign to root
out bad food and drug producers and sellers was paying dividends.
In a separate announcement, the Ministry of Agriculture said that it was
revoking the registration of 11 highly toxic pesticides because of food
safety concerns. The government also said this week that since July,
inspectors working at Chinese ports have destroyed or recalled over 1,000
tons of fake products. China is also working with American and European
regulators to cooperate on product safety and to put into place new methods
to detect harmful products. (The New York Times) For the complete article
see
THIS LINK

New cancer recommendations; Diet, weight, alcohol and red
meat
consumption all implicated in cancer risk
A team of top scientists from around the world spent five years reviewing
7,000 medical studies and concluded that diet and weight directly affect
whether you'll get cancer. The landmark study also linked consumption of
alcohol, red meat and processed meat to an increased risk of cancer. ABC
News medical editor Dr. Tim Johnson broke down the new recommendations. You
can also find more information at
www.dietandcancerreport.org.
Recommendations include: Limit body fat. Your body mass index
should be between 18.5 to 24.9. Weight around the waist is most dangerous.
Limit red meat to 2.5 ounces a day. An additional 1.7 ounces a day increases
cancer risk by 15 percent. That means an 8 ounce steak or a quarter-pound
hamburger would be the limit for a week. Limit alcohol to two drinks a day
for men, one drink a day for women. Limit salt intake to 2 grams a day.
That’s about a teaspoon a day, instead of the teaspoon and a half that most
people eat. To give you an idea of how much salt is in food, just one cup of
cottage cheese has half the salt you should eat in a day: half a teaspoon.
Processed foods are almost always higher in salt. Get nutrients from whole
foods, not vitamin supplements. Mothers should breast-feed children. (ABC
News) See THIS
LINK

Kimberly-Clark Professional video contest is truly out of this world
After boldly going where
no health and hygiene company had gone before with its launch of the first
electronic touchless bath tissue dispenser, Kimberly-Clark Professional is
now set to enter alien territory. And this time the public is invited to
travel along, through a contest being announced today at
www.aliendroppings.com.
To enter, contestants must first
view a quirky two-part video of a hapless earthling’s encounter with a
superior life form inside a men’s room stall. The brief vignettes depict
what happens when an alien competes with a human for access to a new
restroom technology. The contest challenge is to watch both videos and
create a three-minute script treatment for the duo’s close encounter of the
third time. The grand prize winner will have their video produced and will
also receive a SONY HD video camera. Additional prizes will be awarded for
first and second place. Full contest rules and prize information are
available at
http://www.aliendroppings.com/welcome.html.
The first video installment surfaces today. The second will materialize in
late November. Contest entries must be received by January 31, 2008.

October
30, 2007
Download print version
Fire-related patient load lands on UCSD’s
Hillcrest burn unit
Participants left
uninformed in some halted medical trials
FDA issues early communication about an ongoing safety
review of Aprotinin injection
Influx of medical students creates concern;
Enrollment increase
means resident training needs to expand
Getinge contracts with GE Healthcare and Premier
More
than 700 healthcare facilities respond to Cardinal Health
patient safety grant challenge
Fire-related patient load lands on UCSD’s Hillcrest
burn unit
The
tenacity with which the 18-bed the burn unit at the University
of California, San Diego (UCSD) Medical Center in Hillcrest
(CA) has tackled the strains of an unprecedented fire
emergency has once again made the hospital a hub of media
attention, this time for treating victims of the devastating
fires this week. Recognized as the only specialized burn unit
in the San Diego and Imperial counties, the hospital has
treated many of the area’s fire victims. To date, the unit has
treated 47 fire-related injuries due to surface or inhalation
burns. Currently, there are eight patients in critical
condition and 10 in rehabilitation. Nineteen out of the 20
other patients that were previously in critical care have been
upgraded to the hospital’s general ward. Laura Everett, an
administrative assistant, described last week in the burn unit
as “chaotic, but in control.” Burn Unit Charge Nurse Janine
Dubina, like all of the staff, underwent a harrowing week
dealing with crisis conditions in the unit. Living between
Lakeside and Ramona, she had to evacuate early in the week,
but still came to work ready and able. Most patients came in
during the first two days of the fire, and while new cases
have tapered off for the moment, Dubina said she expects the
number of patients to increase as the weeks progress. She said
that more people will likely start trickling in now that the
fires have died down and residents are returning to their
normal routines like after 2003’s Cedar Fires, the disaster
that put the burn unit in the national spotlight.
The current patients’ burn degrees range from 20-90 percent, some of them
being treated for inhalation as well as surface burns. Although response
efforts brought victims in quickly enough to be intubated before any
internal swelling choked off their airways, some patients’ bodies have
swelled so much internally that removal of intubation tubes is now
impossible. Dubina said that one of the major health concerns from the fires
is smoke inhalation. Having burned through many commercial and residential
developments, smoke is rife with plastics, paint and other chemical
pollutants that can cause lung damage. Smaller particles in the air farther
away from the fires can be more hazardous than the smoke and ash closer to
the fires themselves. In order to protect patients and staff from the
outside air, high-efficiency particulate air filters are stationed near the
unit’s doors, and indoor air quality is checked daily to ensure a sterile
environment.
Lasting impressions from the Cedar Fires pushed the county to make sure that
the same mistakes would not be repeated. For instance, the implementation of
a reverse-911 program saved many more lives last week, allowing people to
evacuate properly and be informed ahead of time of the disaster. The
hospital also now has a better-developed relationship with Cal Fire,
allowing for stronger lines of communication, Dubina said. “For everyone
that complains about UCSD running disaster drills, this is the reason we
knew what to do,” she said. The staff prides itself on a strong sense of
camaraderie, a bond that staff members said helped strengthen their team’s
efficiency when patients began to piling up at the burn unit. Many nurses
and doctors ignored orders to evacuate their homes, instead coming in to
work 12-hour shifts and occasionally overtime, just to make sure the unit
wasn’t left short-handed. On Oct. 21, the unit was graced with extra nurses,
according to registered nurse Jami Lewellen. “Night shift nurses stepped
outside and smelled smoke on the air, they just knew to come in,” she said.
Even students from UCSD who normally volunteer at the hospital came to help,
retrieving any extra equipment or blood that was needed, even though campus
had shut down for the week. (UCSD Guardian) To read the original article see
THIS LINK

City hospital in
Brooklyn reviews care of a boy, 12
Officials at
Kings
County Hospital Center said yesterday that they were “closely examining” why
doctors
there failed to detect a drug-resistant staph infection in a 12-year-old
Brooklyn boy who died this month. The boy, Omar Rivera, was given only
allergy medication at the hospital and was then sent home, a lawyer for the
boy’s family said yesterday. A hospital spokeswoman, Hope Mason, confirmed
that Omar was treated at the hospital shortly after midnight on Oct. 13. She
said that the hospital would look into “what more could have been done to
detect the infection at that time.” Omar was pronounced dead at Brookdale
University Hospital and Medical Center in Brooklyn at
10:25 a.m. on Oct. 14, city officials said. School
officials have said that Omar, a student at Intermediate School 211 in
Canarsie, was sick and stayed home from school on Oct. 9. On Oct. 9 or 10,
his mother, Aileen Rivera, took him to a clinic, First Medcare, on Flatlands
Avenue in Canarsie, said the family’s lawyer, Paul B. Weitz.
At First Medcare, Weitz said, doctors noted that Omar had one or two
pus-filled
boils on
his buttocks, diagnosed an infection and prescribed an
antibiotic,
amoxicillin, along with ibuprofen. A manager at First Medcare said she could
not comment on the case because of privacy laws. Late on Oct. 12, Weitz
said, Omar still had a high
fever, so
his mother took him to the emergency room at
Kings
County, a city-run hospital in
East Flatbush, with one of the city’s busiest emergency
rooms. Mason said she was not allowed to disclose who had treated Omar.
Whoever it was, said Weitz, decided that Omar had an allergic reaction to
ibuprofen and gave him Benadryl. Weitz’s account of Omar’s treatment at
Kings County was reported yesterday in The New York Post. Blood tests
done after Omar’s death determined that he was infected with the bacterium
methicillin-resistant Staphylococcus aureus, or MRSA, health officials said.
A determination on whether MRSA caused Omar’s death is not expected for
several weeks. A student at another school in the metropolitan region,
Trinity
Elementary School, in
New
Rochelle, came down with an MRSA infection, but school officials said
yesterday that the child was recovering. Custodians at the school were doing
special cleaning before today’s classes, the officials said. (The New York
Times)

Participants left
uninformed in some halted medical trials
When Congress passed a bill last month requiring makers of
drugs and medical devices to disclose the results of clinical
trials for all approved products, advocates of greater study
disclosure applauded the move. But a provision that would have
mandated disclosures for another group of products never made
it into the final version of the bill. It would have covered
products tested on patients, but dropped before marketing.
“Trial sponsors can still choose to keep information about
some trials confidential, creating serious ethical concerns,”
said Dr. Deborah A. Zarin, the director of
ClinicalTrials.gov, a Web site run by the National
Library of Medicine. Many experts said the recent
Congressional debate underscored a troubling fact: some
patients in clinical studies never learn about test results.
The problem may be particularly relevant to those implanted
with medical devices that stay with them long after a trial is
over. For manufacturers and researchers alike, “there is a
tremendous incentive to go on, to forget about the old and
move on to the new,” said Drummond Rennie, a deputy editor at
The Journal of the
American Medical Association.
There are no data available for the number of patients who
participate in studies of drugs and medical devices that never
make it to the marketplace, though it is likely that the
number runs into the thousands. A product may not reach the
market for a variety of reasons; it may not perform well in
trials, for example, or it may be rejected by regulators.
Although researchers conducting clinical studies are not
required to disclose test results to study participants, they
must alert patients taking part in a test to emerging product
dangers. Companies also have to keep promises made to
regulators at the time a trial began, like agreements to
follow the health of study patients. Such promises are often
required to get approval to begin trials in the first place.
But researchers and manufacturers do not always fulfill even
those minimal requirements. And such failing may be
particularly acute in trials of implanted devices, since those
products remain inside patients. In August, for example, the
Food and Drug Administration sent a warning to Boston Scientific after
investigators discovered the company’s diligence in following up with
patients faltered around the time it dropped a product under development.
The product being tested was an experimental stent intended to prevent the
rupturing of an aneurysm in the major abdominal artery. Among other things,
agency investigators found that Boston Scientific, which halted development
of the stent last year after a study showed it frequently fractured, had
neglected to tell patients in that trial about the problem’s scope.
Because of loopholes in the recently passed
Congressional bill, device makers like Boston Scientific will
still have discretion whether to publicly reveal the results
of studies like that of the failed stent. Under the law,
device producers will have to report such “premarketing”
studies and their results to the F.D.A. But that data will
remain in a confidential “black box” until a product is
approved; if a device is rejected or dropped, a company will
not have to disclose those results or even publicly
acknowledge that the trials occurred. Device makers lobbied
against mandating disclosure for failed products, arguing that
releasing such data would be confusing to patients and would
give away valuable information to a company’s competitors
about devices under development that might succeed in
subsequent trials. “Such disclosures could have the unintended
consequence of eliminating many small device makers from the
marketplace,” Stephen J. Ubl, chief executive of the Advanced
Medical Technology Association trade group, testified before
Congress in June.
The new bill does allow for a mechanism under which
the secretary of the
Health
and Human Services Department could release trial
data about unapproved products if a public health issue
exists, but such moves would be argued case by case. “This was
a disappointment,” said Dr. Steven E. Nissen, the chairman of
the cardiology department at the Cleveland Clinic, who helped
draft the House version of the bill. (The
New York Times) To read the original article
see
THIS LINK

FDA issues early communication about an ongoing
safety review of Aprotinin injection
The U.S. Food and Drug Administration (FDA) issued an Early Communication
about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol),
a drug used to control bleeding during heart surgery.
Last week, FDA was notified that a Canadian research group
stopped a study on Trasylol because the drug appeared to increase the risk
for death compared to the other antifibrinolytic drugs used in the study.
Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent
excessive bleeding. The data also suggested that fewer patients receiving
the drug experienced serious bleeding events.
This most recent data support the results from other comparison studies of
Trasylol. The comparison studies were discussed at a September 2007 joint
meeting of FDA’s Cardiovascular and Renal Drugs and Drug Safety and Risk
Management Advisory Committees. FDA anticipates further review of the risk
and benefits of Trasylol, which may result in additional labeling or other
regulatory action. FDA will work with the sponsor of the recently terminated
study to evaluate the data fully. In the meantime, FDA recommends that
healthcare providers review the risks and benefits of Trasylol outlined in
the label and in the Early Communication about an Ongoing Safety Review, and
discuss the information with their patients. In 2006, FDA revised the
labeling for Trasylol to strengthen its safety warning and limit its
approved usage to patients at an increased risk for blood loss and blood
transfusion during coronary bypass graft surgery. Trasylol is marketed by
Bayer Pharmaceuticals Corp.,
Leverkusen, Germany. Full text of the Early Communication about an Ongoing
Safety Review can be found at
http://www.fda.gov/cder/drug/early_comm/aprotinin.htm.

Influx of
medical students creates concern;
Enrollment increase
means resident training needs to expand
Enrollment is increasing sharply at medical schools across the country, a
trend that’s expected to help the nation combat a worsening shortage of
physicians. But it’s also focusing attention on the need to expand the other
half of the physician pipeline: residency programs. “If you don’t increase
the second stage of the education process, you don’t end up with more
practicing physicians,” said Edward Salsberg, director of the Association of
American Medical Colleges’ center for workforce studies. A record number of
students enrolled at medical schools this fall, including those in Houston,
Salsberg’s group reported recently. But the higher numbers also mean more
training positions in hospitals will be needed after those students graduate
in four years. The enrollment jump was largely in response to the AAMC’s
appeal to the nation’s 126 medical schools last year to increase class size
by nearly one-third by 2015. This year’s increase to about 17,800 first-year
students represents an 8 percent increase since 2002, the group’s benchmark
year. Medical schools in Houston are contributing to that increase.
The University of Texas Medical School at Houston enrolled 230 first-year
students this fall, up 12 percent from 206 students in 2002. And Baylor
College of Medicine plans to increase its first-year class to 200 by 2011, a
19 percent increase over the 168 students in 2002. “We think the gradual
increase will allow us to accommodate people and not affect their
education,” said Dr. Stephen Greenberg, Baylor’s dean of medical education.
Because the UT Medical School has added seats in recent years, enrollment
will remain stable for the next few years, said Dr. Judianne Kellaway,
assistant dean of admissions. But the number of applicants, which already
has outpaced the increase in class size, is expected to continue to rise.
Nearly 3,700 aspiring physicians applied this year, 5 percent more than last
year. Though medical school enrollment is on the rise, increasing the number
of residency positions is arguably more difficult. That’s mainly because
programs in most states depend largely on funding from the federal
government through Medicare, and that funding has remained static for the
past few years. State funding in Texas, however, is improving. The
Legislature this year approved an increase to $63 million for residency
programs, the highest level ever and more than double the $25 million
appropriated last year. Some state money could go toward a new neurology
residency program at the UT Medical School here. Dr. Dong Kim, chairman of
the department of neurosurgery, said seven positions could be approved by
January. Until then, the university offers residency in every specialty
except neurology, he said.
Like the rest of the country, Texas does not have enough physicians to keep
up with a growing population that demands more specialty services. It ranked
42nd in the country for its patient-to-resident ratio in 2005, with 194
patient-care physicians per 100,000 residents, according to the American
Medical Association. Lately, however, more doctors have applied for licenses
in Texas, likely because of new limits in medical malpractice lawsuits that
make it more appealing for physicians to practice here. The number of
residency positions available in Texas climbed to 7,260 slots during the
2005-06 school year, an increase of about 4 percent in two years, according
to the Accreditation Council for Graduate Medical Education. That’s far
fewer slots than other populous states; New York, for example, had more than
twice as many residents that year, partly because the state secured
nongovernmental funding. Without enough positions for its graduates, Texas
could lose physicians-in-training to other states. Nationwide, the number
of residency slots is increasing at a similar rate. About 115,100 positions
were available across the country during the 2005-06 school year, the ACGME
reported. There's good reason to keep graduates in Texas for training,
according to the Texas Medical Association, which represents physicians and
medical students. The group reported that physicians who complete both
medical school and residency here are nearly three times more likely to stay
in the state to practice. (Houston
Chronicle) To read the original article see
THIS LINK

Getinge contracts with GE Healthcare and Premier
Getinge USA,
Rochester, NY, has entered into an agreement with GE Healthcare to service
GETINGE washer/disinfectors and steam sterilizers in more than 200
facilities that contract with GE Healthcare to provide a host of asset
management services, the company has announced. Getinge USA also has been
awarded a contract with Premier Inc., one of the nation’s largest healthcare
purchasing networks, to offer detergents and cleaners to 1,700 hospitals and
more than 47,000 other healthcare sites. Getinge AB is a manufacturer and
distributor of advanced infection control equipment, medical systems and
extended care products for OR, ED, ICU, sterile processing and life science
applications. For more information, see
THIS LINK.

More
than 700 healthcare facilities respond to Cardinal Health patient safety
grant challenge
More than
10 percent of the nation’s healthcare facilities are seeking grants from
Cardinal Health through a $1 million fund set up by the company to help
improve patient safety. Company officials said more than 700 hospitals,
health systems and community health clinics responded to their announcement
in August about the grant program, which is the largest and first of its
kind in the private sector. To support initiatives that enhance patient
safety and quality of care, Cardinal Health will grant up to $50,000 per
facility to fund new and innovative programs that establish or implement
creative and replicable methods to address challenges in providing quality
patient care and to help drive improvements. The company expects to fund up
to 40 of the 730 grant requests.
In selecting grant recipients, Cardinal Health’s selection
committee will look for: projects that respond to a clearly identified, high
priority safety issue; projects that apply new thinking and approaches to
development of solutions; collaborative programs; demonstrable and
sustainable measures to assure that improvements hold up over time; model
programs that can be replicated at other organizations. To be eligible for
funding, facilities must be designated as 501(c)(3) by the IRS and were
required to submit a letter of intent to submit a proposal by October 12.
Approximately 100 to 150 institutions will be asked to submit a full
proposal, with grants announced in March 2008.

October
29, 2007
Download print version
3M and Zargis announce global marketing
alliance
Universal flu vaccine recommendation may be coming
WHO update: Avian influenza situation in
Indonesia
Pediatricians urge autism screening
Cancer patients not getting live-saving flu and
pneumonia shots
Health officials try to calm parents about staph
3M and Zargis announce global marketing
alliance
3M and Zargis Medical Corp., a spin-off from Siemens Corporate Research and
a majority-owned subsidiary of Speedus Corp. announced an exclusive
multi-year marketing agreement involving Zargis’ heart sound analysis
software and 3M Littmann’s next-generation electronic stethoscope. Under the
agreement, Zargis will support 3M in its efforts to develop a
next-generation stethoscope that will be compatible with Zargis’ heart sound
analysis software. The date on which Zargis’ software will become available
for use with a Littmann stethoscope has not yet been announced.
In addition, the alliance
provides Zargis with a wide-range of marketing and promotional opportunities
along with exclusive rights to sell its heart sound analysis software
through the global distribution network of the Littmann brand. The agreement
grants 3M a minority equity position in Zargis, following the first sale of
Zargis’ software through the 3M distribution channel, and a seat on Zargis’
board of directors.

State fines 9 hospitals; Under new law,
California
hospitals
penalized for putting the lives of patients at risk
State health officials fined nine California hospitals Thursday for
infractions that put patients at imminent risk of injury or death, including
a notorious case at Martin Luther King Jr.-Harbor Hospital in May in which a
woman died after writhing unattended on the floor of the emergency room
lobby. Glendale Memorial Hospital and Health Center, Garden Grove Hospital
and Medical Center, and Kaiser Foundation Hospital Santa Clara were among
the hospitals fined. King-Harbor and one other hospital, Feather River
Hospital in Paradise, were fined for two infractions each. Each fine is for
$25,000, the most allowed under the first phase of a law that went into
effect Jan. 1. The hospitals have 10 days to file a notice of appeal. The
fines are the first the state has levied against hospitals. And the
penalties will bring hospitals in line with nursing homes and health plans,
which already had been subject to fines.
Hospital
industry representatives had managed until last year’s legislative session
to resist fines, but their opposition was undermined by a series of
transplant fiascoes in recent years and by the long history of lapses at
King-Harbor, formerly known as King-Drew. The new law is intended to give
state regulators more teeth, said Kathleen Billingsley, deputy director of
the Center for Healthcare Quality at the California Department of Public
Health. With fines, she said, “There is a sense of immediacy and
responsiveness on the part of the provider to correct or modify the
processes that have led to these quality problems.” Glenn Melnick, a health
economist for Rand Corp., agreed, even though the fine in question, which
can reach $50,000 as the law is phased in, is half the amount that can be
levied against nursing homes. “The dollar amount of the fine is only one
potential source of leverage,” he said. “What is the impact on the
hospital’s reputation in the community? What’s the impact on the staff and
the people who work there? If they take it seriously, that could be much
more important than a $25,000 fine.” In a statement, Glendale Memorial
Hospital and Health Center, which was fined for failing to follow policies
and procedures for the safe administration of medication, said that hospital
officials were taking the matter “very seriously.” “In collaboration with
the California Department of Public Health, we have conducted a thorough
investigation of this incident and taken appropriate action to protect all
patients’ safety while in our facility,” the statement said.
Garden Grove
Hospital
and Medical Center, which was fined for being unaware of a drug’s possible
adverse effects, issued a statement that said, “The state notified the
hospital late in the day on March 20. . . that its practices did not conform
with Medicare standards of participation. Overnight, the hospital developed
a plan of corrective action which was accepted by the state the next morning
at 9 a.m.” As for King-Harbor, the Los Angeles County-owned hospital closed
its emergency room and in-patient beds in August after failing a string of
federal inspections and losing federal funding. It now offers urgent care
and out-patient clinics but no hospital services. “Both of the incidents
described are unacceptable and do not reflect the department’s commitment to
operate our hospitals in a manner that meets state and federal standards,”
said Bruce Chernof, director and chief medical officer of the county
Department of Health Services. The second incident involved a 38-year-old
man with a headache and swelling in the brain who languished in the
emergency room for four days in February before his family drove him to
another hospital, where he received emergency surgery. (Los Angeles Times)

Universal flu vaccine recommendation may be coming
The
time may soon come when doctors recommend that every American man, woman and
child be vaccinated every year for influenza, an idea offered Wednesday by a
leading expert in vaccines and preventive medicine. Dr. Gregory Poland,
director of the Vaccine Research Group at the Mayo Clinic in Rochester, MN,
testified Wednesday at a meeting of the Advisory Committee on Immunization
Practices (ACIP), the subcommittee at the Centers for Disease Control and
Prevention that issues federal recommendations for the use of vaccines in
the United States. In his testimony, Poland recommended that the United
States should move to a so-called “universal recommendation” for vaccination
against influenza, the virus that causes the flu. A universal recommendation
would make official that Americans of all ages should receive an influenza
vaccination every year. The testimony came at a time when the committee is
considering a smaller step of recommending that all school-age children
receive a yearly vaccine. “I think it’s a good idea to expand [vaccination]
to all school-age children,” Poland said. “But a better idea is to say,
‘let’s not just go age group by age group; let’s just recommend that
everybody get it.’”
Review of recent changes in the CDC recommendations shows that
ACIP has been steadily increasing the indications for a flu vaccine for
several years. Current estimates are that more than 70 percent of the U.S.
population now meets one of the 15 published criteria for recommendation of
a yearly flu vaccine. “We’ve changed the recommendation every year or two
since ‘97,” Poland said. “It’s sort of a creeping incrementalism.” Instead
of marking out ever-increasing numbers of groups that should get the flu
vaccine yearly, Poland espoused a universal recommendation that all
Americans should be getting the shot, with particular emphasis on vulnerable
groups. “Let’s just make a universal recommendation, that all Americans
should get vaccinated. But then note that there are particular high-risk
groups that should be particularly recommended to get the vaccine.”
Such
a move would not come without difficulty. Currently, less than 40 percent of
America’s
300 million people receive yearly flu shots, and many of those for whom it
is recommended do not receive their immunizations. Other vaccine experts
pointed out that any effort to vaccinate all Americans would face many
logistical hurdles. Concerns included the availability of enough flu vaccine
for the entire American population and the lack of a public health
infrastructure to deliver that many vaccines. A move to vaccinate everyone
could also face significant financial hurdles. “Who is going to pay for all
of this?” asked Dr. William Schaffner, chair of the department of preventive
medicine at Vanderbilt University. “For example, we know that there are 40
million people who don’t have medical insurance. Who is going to get the
vaccine to those people?” According to Poland, though, vaccine supplies have
been increasing steadily since the widely publicized vaccine shortages from
several years ago. “This year, manufacturers are going to make 130 million
doses in America. Last year and we threw away about 12 million doses,” he
said.
According to Poland, there could be a very important hidden benefit to
addressing these issues now: Americans would learn how to be prepared in
case of a bioterrorist attack or a pandemic infectious disease. “Once you’ve
made a recommendation and then implement the recommendations, you go a long
way towards figuring out the ways to operationalize the ways to administer
these things to all Americans,” Poland said. “You can’t make that happen in
the middle of an emergency.” Schaffner agreed that the development of such
public health infrastructure could be a critically important step for the
future. “If we undertook to vaccinate a very substantial proportion of the
U.S. population each year, you'd have to organize everything from vaccine
development to production to delivery,” he said. “It’d be like a training
session or a fire drill that we'd conduct each year. So if we had to do it
in any kind of emergent situation, for example, anthrax, smallpox vaccine,
delivering cipro [antibiotics], we’d have a trained provider network and a
trained public,” he said.
“It may be something that could lay the groundwork for something
looming down the line in the form of an avian flu pandemic,” said Dr. Peter
Hotez, chair of the Department of Microbiology, Immunology and Tropical
Medicine at The George Washington University. “By getting this
infrastructure into place by vaccinating the whole population against
[seasonal] flu, you lay the groundwork to combat deadly avian influenza.”
But according to Poland, this type of recommendation would likely need some
advance warning to allow for the infrastructure to be built. “I suggest we
make the recommendation in advance,” Poland said. “For example, something
like ‘starting next year, we’ll be recommending all Americans get a flu
vaccine.’” (ABC News)

WHO update: Avian influenza situation in
Indonesia
According to the World Health Organization, the Ministry of Health of
Indonesia has announced a new case of human infection of H5N1 avian
influenza. A 5-year-old female from the Tangerang District, Banten Province
developed symptoms on October 14, was hospitalized on October 20 and died in
an AI referral hospital on October 22. The investigation found that there
were poultry deaths in the case’s neighborhood in the two weeks prior to her
onset of symptoms. Of the 110 cases confirmed to date in Indonesia, 89 have
been fatal.

Pediatricians urge autism screening
The
country’s leading pediatricians group is making its strongest push yet to
have all children screened for autism twice by age 2, warning of symptoms
such as babies who don’t babble at 9 months and 1-year-olds who don’t point
to toys. The advice is meant to help both parents and doctors spot autism
sooner. There is no cure for the disorder, but experts say that early
therapy can lessen its severity. Symptoms to watch for and the call for
early screening come in two new reports. They are being released by the
American Academy of Pediatrics on Monday at its annual meeting in
San Francisco
and will appear in the November issue of the journal Pediatrics and
on the group’s Web site,
http://www.aap.org/.
The reports list numerous warning signs, such as a 4-month-old not smiling
at the sound of Mom or Dad’s voice, or the loss of language or social skills
at any age. Experts say one in 150 U.S. children have the troubling
developmental disorder. “Parents come into your office now saying ‘I’m
worried about autism.’ Ten years ago, they didn’t know what it was,” said
Dr. Chris Johnson of the University of Texas Health Science Center in San
Antonio. She co-authored the reports.
The academy’s renewed effort reflects growing awareness since its
first autism guidelines in 2001. A 2006 policy statement urged autism
screening for all children at their regular doctor visits at age 18 months
and 24 months. The authors caution that not all children who display a few
of these symptoms are autistic and they said parents shouldn't overreact to
quirky behavior. Just because a child likes to line up toy cars or has
temper tantrums “doesn't mean you need to have concern, if they're also
interacting socially and also pretending with toys and communicating well,”
said co-author Dr. Scott Myers, a neurodevelopmental pediatrician in
Danville, PA. “With awareness comes concern when there doesn’t always need
to be,” he said. “These resources will help educate the reader as to which
things you really need to be concerned about.”
Another educational tool, a Web site that debuted in mid-October, offers
dozens of video clips of autistic kids contrasted with unaffected children's
behavior. That Web site,
http://www.autismspeaks.org/, is sponsored by two nonprofit
advocacy groups: Autism Speaks and First Signs. They hope the site will
promote early diagnosis and treatment to help children with autism lead more
normal lives. The two new reports say children with suspected autism should
start treatment even before a formal diagnosis. They also warn parents about
the special diets and alternative treatments endorsed by celebrities, saying
there’s no proof those work. Recommended treatment should include at least
25 hours a week of intensive behavior-based therapy, including educational
activities and speech therapy, according to the reports. They list several
specific approaches that have been shown to help. For very young children,
therapy typically involves fun activities, such as bouncing balls back and
forth or sharing toys to develop social skills; there is repeated praise for
eye contact and other behavior autistic children often avoid. (The
Associated Press) For more information see
THIS LINK or see
THIS LINK

Cancer patients not getting live-saving flu and pneumonia
shots
Although flu and pneumonia can be lethal for cancer patients, more than one
quarter of patients undergoing radiation therapy are not complying with
national guidelines to be vaccinated against these potentially
life-threatening yet preventable illnesses, according to a study presented
October 28, at the American Society for Therapeutic Radiology and Oncology’s
49th Annual Meeting in Los Angeles. While Centers for Disease Control and
Prevention guidelines and the Joint Commission recommend an annual flu
(influenza) vaccine for cancer patients aged 50 years or older, 25 percent
of patients 50 years or older reported never having received the flu
vaccine. Similarly, the pneumonia (pneumococcus) vaccine is recommended to
all cancer patients 65 year or older; however, over one-third (36 percent)
of cancer patients in this age range reported never having received the
vaccine. Cancer patients are at a higher risk of acquiring and dying from
these illnesses due to a weaker immune system, among other factors.
Three reasons accounted for almost 80 percent of why patients didn’t receive
either vaccine: Patients either believed they didn’t need the vaccines, they
didn’t know about the recommended vaccination guidelines or their physicians
didn’t recommend the vaccines. While 44 percent of patients who received
either vaccine reported that they were asked or informed about these
vaccines by their family physicians or internists, only seven percent
reported being asked or informed by their oncologists. “People undergoing
cancer treatment and their loved ones should ask their oncologists about
these vaccines. They are a very simple, yet very effective, way for people
living with cancer to extend their lives,” said Neha Vapiwala, M.D., a study
author and a radiation oncologist at the Hospital of the
University
of Pennsylvania in Philadelphia. “Oncologists have the opportunity to talk
to patients about recommended vaccines during their frequent interactions
with patients, whether it be before, during, or after cancer therapy. This
discussion could result in better cancer care and ultimately save lives.”
This was the first study done to find out whether cancer patients receiving
radiation therapy complied with national vaccination guidelines.

Health
officials try to calm parents about staph
Some angry and nervous parents kept their children out of a Brooklyn (NY)
middle school, after learning about the death of a student who had been
infected with a virulent, drug-resistant strain of bacteria. But school and
health officials tried to assure parents that all the proper procedures had
been followed and that there was no cause for panic. The city’s health
commissioner, Dr.
Thomas R. Frieden,
said yesterday that the bacteria was the probable cause of the death of the
boy, Omar Rivera, 12. But he added, speaking at a news conference at health
department headquarters in Manhattan, that it would be impossible to know
for certain whether the bacteria had caused the death until an autopsy was
complete, which could take several weeks. Omar had been absent from school
since Oct. 9, Schools Chancellor Joel I.Klein told reporters at the news
conference. After the boy died on Oct. 14, the principal notified health
officials, who determined that the boy had been infected with the bacteria,
methicillin-resistant Staphylococcus aureus, or MRSA. Dr. Frieden said that
because the boy had not been involved in any organized team sport at school,
there was no need to screen every student. He emphasized that the most
important precaution was for students to wash their hands and not share
personal items like towels and sports uniforms.
Officials at the school, Intermediate School 211 in Canarsie, notified
parents of the boy’s death in a letter sent home with students on Thursday.
In the letter, parents were told that the school would remain open and that
health officials were available to answer questions. A complete wash-down of
the school began on Wednesday and was completed on Thursday, school
officials said. Over the last month, several schools in the New York region
and in other states have reported cases of students infected with the MRSA
bacteria. Health officials cautioned again that it was unclear whether there
had been more cases, or simply more reports in the news media. Some parents
at I.S. 211 expressed frustration that they had not been told sooner of the
boy’s death, or had a personal phone call from school officials. Joel
Lonergan, the head of school facilities at I.S. 211, said that in their
wash-down of the school, custodians wiped off all flat surfaces with a
disinfecting solution. The cleaning was completed Thursday night. A complete
cleaning is done about three or four times a year, Lonergan said. Dr.
Frieden commented: “Just please remember that cleaning of the environment is
very unlikely to make any difference in the spread of infection. It’s
something that’s done so people feel better, but this isn’t what’s going to
reduce the spread of bacteria.”
School and health officials said they did not plan a scrub at
other schools. Several students said soap at the school was often difficult
or impossible to find. Lonergan said that soap dispensers were checked each
morning and that there should be soap readily available. “It’s a custodial
issue,” he said. “We inspect the schools on a regular basis, unannounced. So
we would pick that up. But it could have been that a child was in there
before and emptied the soap dispensers.” Across the region, health and
education officials are scrambling to keep better track of MRSA cases in
schools, and to educate teachers, students and parents on how to prevent the
infection’s spread. Yesterday the Connecticut governor,
M. Jodi Rell,
authorized a new program that will enable the state health lab to pinpoint
MRSA outbreaks more quickly by using DNA to determine whether bacteria from
different patients are related. In some cases, school districts have learned
about the infections only after the fact. (The New York Times) To read the
original article see
THIS LINK

October
26, 2007
Download print version
Maryland, DC schools report seven new MRSA
cases
New watchdog for hospital superbugs in UK
Virus outbreak at British superbug hospital
Hospital association changes position on reporting
medical errors
D.C. troubled by rise in avoidable
hospitalizations
VHA Inc. study reveals hospitals planning to make
major OR
and imaging equipment purchases in 2008
Masimo’s technologies the focus of multiple
clinical studies
at ASA annual meeting
Maryland, DC schools report seven new MRSA
cases
New drug-resistant staph infections have been reported this week in public
schools in
Montgomery County,
MD, and in two charter schools in the District, bringing the total number of
cases among students and educators in the region to at least 55. The total
includes cases in
Anne Arundel
and Howard counties in
Maryland
and in
Alexandria
and
Fairfax,
Loudoun
and
Prince William
counties in
Virginia.
In
Montgomery,
school officials said that eight cases of methicillin-resistant
Staphylococcus aureus (MRSA) have been reported since Thursday, for a total
of 22.
Montgomery officials said 10 students are receiving treatment, and 12 others
have recovered. The cases span at least 13 schools. In a memo to its 58
member schools, the
D.C. Public Charter
School Board said that it knows of two staph cases: one at the
SEED public charter school in Southeast, and another at the Arts and
Technology Academy in Northeast. Both schools were closed for cleaning and
are expected to reopen Thursday, a board spokesman said. The charter board
said it was waiting for more guidance from the city health department, but
in the meantime, “regular hand-washing and otherwise good hygiene practices
should be practiced in schools.” The charter board recommended that schools
contact the board and talk to city health officials before deciding to close
a school building. In Virginia, cases were also reported this week at C.D.
Hylton High School and Old Bridge Elementary schools in Prince William
County. The two students with the infection have been successfully treated,
officials said. (Washington Post)

Knowledge is key weapon in fight against ‘superbug’
More than a dozen cases of methicillin-resistant Staphylococcus aureus
infections were reported in Indiana. But the infection is not new. “It’s
something to be aware about, not to be afraid about,” said Dr. Christopher
Belcher, a pediatric infectious disease specialist at Peyton Manning
Children’s Hospital at St. Vincent (Indianapolis). “This has been a problem
that’s been increasing in prevalence over the last seven to 10 years,’’
Belcher said. “What’s new here is the public awareness of it.” Ronald
Sokolow, a fourth-grade substitute teacher in Indianapolis Public Schools,
thought he had been bitten on the ankle by a mosquito last week. It was
actually MRSA. He has no idea where he contracted the infection, which
appeared as a painful lesion that developed into a boil. In an effort to
notify parents at the school, Sokolow, 58, contacted the media. “I wanted to
protect the kids,” he said. “I wanted their parents to know immediately.”
Sokolow’s was not the only school-related case to surface this week. At
least 14 such cases were reported across the state of Indiana in the wake of
the CDC report. Parents in the affected schools have been notified, and
classrooms that housed infected individuals have been disinfected and
cleaned, she said. Two school football players in Southern Indiana recently
were diagnosed with MRSA, as were two high school students in the Fort Wayne
area. In an effort to stem hospital MRSA infections, a pilot project in
Indianapolis is reinforcing the importance of hand hygiene in the hospital
and screening of intensive-care patients for the bug. (The Indianapolis
Star) To read the full article see
THIS LINK

New watchdog for hospital superbugs in
UK
Inspectors will be able to close dirty hospitals to protect patients from
infections as part of the British Government’s drive on superbugs. A health
and social care regulator will be set up with powers to close wards,
services or whole hospitals, sack bosses and issue warning notices and
fines. Legislation to set up the Care Quality Commission will be included in
the Queen’s Speech next month. Ministers are keen to be seen tackling
superbugs after the deaths of 90 patients from Clostridium difficile at
Maidstone and Tunbridge Wells NHS Trust over two-and-a-half years. The bug
contributed to the deaths of 255 other patients. The regulator will also be
responsible for care homes, GP surgeries and private hospitals. It will
replace the Healthcare Commission, which was set up in 2004, and will take
over the Social Care Inspectorate and the Mental Health Act Commission. The
CQC will also regulate clinical performance, finances and patient safety.
Alan Johnson, the Health Secretary, said the body would take “rapid and
appropriate action” against any organization putting patients at risk.
Dr. Hamish Meldrum, chairman of the British Medical Association, said:
"While we recognize some of the arguments for rationalizing the process of
regulation, the BMA is concerned that, only a few years after the Healthcare
Commission was set up, it is about to be abolished to make way for yet
another, new regulatory body. The NHS has been suffering from too much
reorganization and, it appears that, as soon as doctors and managers start
getting used to one system, it’s all change.” (Telegrah.co.uk) To read the
original article see
THIS LINK

Virus outbreak at British superbug
hospital
The hospital at the center of Britain’s deadliest superbug outbreak admitted
it has been forced to close a ward after an outbreak of a vomiting virus.
The outbreak of norovirus has affected 16 patients
at
Maidstone hospital in Kent, one of three hospitals run by Maidstone and
Tunbridge Wells NHS trust, where 90 people died in two outbreaks of the
Clostridium difficile bug last year.
A damning report by
the Healthcare Commission this month accused the trust of “significant
failings in infection control” after it found its hospitals had filthy wards
and elderly patients were left to lie in their own feces.
A trust spokesman said it had improved infection
control measures since the C difficile outbreak, in which 1,100 patients
were infected, and denied the ward closure was evidence that it was still
failing to meet proper hygiene standards. “Ten of the 16 patients who
contracted norovirus while on the same ward at
Maidstone hospital have now recovered from their symptoms,” he said. “The
other six patients’ symptoms are subsiding. No new cases of norovirus have
been seen on the ward since the outbreak started on Monday night. The
affected ward will remain closed to new admissions until all patients have
recovered from the illness. Additional cleaning measures are in place on the
ward and it will be deep cleaned before being reopened to the public. Staff
are monitoring four further patients for norovirus today as a precautionary
measure.”
Healthcare campaigners said they knew of another four trusts across the UK
that had been hit by norovirus outbreaks in the past two weeks. The group
Health Emergency warned outbreaks would undermine efforts to tackle
stretched hospital capacity at a time when the NHS is struggling to cope
with the continuing pressures of MRSA and C difficile. Hairmyres hospital in
East Kilbride has closed 13 wards in the past two weeks; Pilgrim hospital in
Boston, Lincolnshire, has closed one ward this week; and Royal Manchester
Children’s hospital and Bridport Community hospital, Dorset, have also been
hit by norovirus outbreaks. A spokeswoman for NHS Lanarkshire said 13 wards
had to be closed at Hairmyres hospital two weeks ago after an outbreak of
norovirus. She said only one ward remained closed and a “very small” number
of staff and patients were still affected. Geoff Martin, head of campaigns
at Health Emergency, said: “Norovirus is only a killer in very extreme
circumstances but it is a virulent bug that can knock out whole wards
overnight, putting massive pressure on beds and piling up the risk of other
cross infections. With the ongoing severe problems with MRSA and C difficile
we need a surge in norovirus like we need a hole in the head. As the virus
gets a foot hold, large chunks of the NHS bed capacity could be put out of
action with severe consequences for the fight against the other killer
bugs.” (Guardian
Unlimited)
To read the original article see
THIS
LINK

Hospital association changes position on reporting
medical errors
The Washington State Hospital Association has reversed its position on the
reporting of hospital mistakes after a public uproar over its efforts to
keep such details from being released by the state. The association’s
efforts to prevent disclosure were detailed in a front-page story Tuesday in
The Seattle Times. Cassie Sauer, spokeswoman for the association,
said the group now favors the disclosure of errors, which include operating
on the wrong body part and other dangerous incidents, as long as the reports
also include context, such as how many patients, and what types of patients,
each hospital serves, what the hospital has done about the mistakes, and how
it plans to prevent future problems. “We had a lot of discussion about your
(The Seattle Times’) article, and a lot of calls,” Sauer said. “There’s been
a lot of reaction to this, more than we expected. ... Your article made us
realize that people really do want the information.”
Since 2000, hospitals have reported
so-called “adverse events”, also including doing the wrong surgery or
leaving foreign objects in a patient’s body, to the state Health Department,
which has routinely disclosed the hospital-specific information. The
hospital association had succeeded in arguing that a law passed last
Legislative session now prevents such disclosure. Despite the reversal this
week, Sauer said, the association can’t “unring the bell,” now that they’ve
told the state Department of Health why the law passed last year prevents
disclosure. Sauer said the association still believes its interpretation of
the current law is correct. “We don’t have the power to tell them it’s OK to
violate the law,” she said. So now the association will work with state
lawmakers to change the law so that disclosure, along with needed context,
can be released. (Seattle
Times) To read the original article see
THIS LINK

D.C. troubled by rise in avoidable hospitalizations
The
District is seeing more avoidable hospitalizations among children and
middle-aged adults, a puzzling trend that includes insured and uninsured
groups and raises complex issues of healthcare access, quality and capacity.
Statistics released by Rand, an independent research organization, show that
the rate of these hospitalizations, which could have been averted through
good primary care, climbed from 39.1 per 1,000 adults ages 40-64 in 2004 to
43.4 in 2006. Among children through age 17, the rate jumped from 8.9 to
12.1. Health officials said they cannot fully explain what is causing the
increase. They began to see a rise in 2005 and tied most of it to skin
infections involving MRSA, the antibiotic-resistant staph bacteria that has
attracted attention recently because of diagnoses in school districts across
the region. The 2006 numbers suggest that far more is to blame, including a
primary care system that is overloaded, packed emergency rooms and
potentially sicker patients. Higher rates of asthma among children in
certain areas of the city appear to be a potential factor, too.
Whatever the reasons, officials described the trend as troublesome. “It’s a
problem for all of us,” said Nicole Lurie, a physician and senior scientist
at Rand. “These things are not headed in the right direction.” The
Rand analysis of healthcare patterns in the District was
presented at the annual meeting of the D.C. Primary Care Association. At the
association’s request,
Rand has looked for several years at healthcare needs,
especially as they relate to chronic disease, low-income residents and
hospital use. The data released yesterday will soon become part of a $1.5
million study commissioned by the
D.C. Council.
By late December, officials said, they will have the fullest picture ever of
the utilization of city emergency services, hospital overcrowding and, as
Lurie put it, “who's getting what care where.” That information is supposed
to guide the council in deciding how $116 million in tobacco settlement
funds should be spent. Council members originally intended the money for a
sophisticated health complex on the grounds of the former
D.C. General Hospital in
Southeast and several state-of-the-art community clinics that would bolster
services in Wards 7 and 8. An additional $80 million was to go toward urgent
or emergency care improvements, most likely at
Greater Southeast
Community Hospital and
Howard University
Hospital. The
Rand study was to direct that allocation, too. But this
week, the financial crisis that pushed Greater Southeast to the verge of
closure prompted the council to agree to spend virtually all of the
remaining tobacco money to help sell the facility and support an extensive
rehabilitation. Yesterday's report is
Rand’s most comprehensive on the subject because all
District hospitals participated. (The
Washington Post)

VHA Inc. study reveals hospitals planning to make major
OR and imaging equipment purchases in 2008
VHA Inc., a
national healthcare alliance, conducted research on 1,250 of its member
hospitals to determine their capital equipment purchase plans for 2008. The
study of operating room and radiology directors shows that VHA hospitals
plan to purchase more than 5,500 pieces of equipment for use in operating
rooms over the next 18 months and more than 1,400 pieces of imaging
equipment over the same period. This represents $500 million in purchases,
with high-end imaging equipment representing 65 percent of the total. In
addition, only 20 percent of those that participated in the research said
they have picked the manufacturer of the products, and 60 percent said that
they plan to purchase these items using their GPO contracts.
This study was the
first of two annual research studies of member hospitals that VHA conducts
on a yearly basis. Each study represents approximately 5,000 hours of market
research and includes interviews with multiple people at each hospital. VHA
uses this data to support its Group Buy and construction support programs.
Major movables and imaging equipment, such as CT scanners,
hospital beds and laboratory instruments, is defined as equipment that has a
depreciable life of three or more years. According to the study, the most
popular items hospitals will purchase will be scopes, OR lights and
stretchers.
“Hospitals
have to keep pace with new equipment, and this is exactly what is fueling
hospitals’ appetite for big spending in capital equipment, especially when
it comes to keeping competition alive with other regional health care
organizations,” said Nik Fincher,
senior director of
capital asset services at VHA Inc. According to the study, imaging continues
to be an area where hospitals are investing, with the majority of hospitals
intending to purchase: CT scanners, mammography units, C-Arms, ultrasounds
and digital radiography equipment in the coming year.
The
following factors were listed as the most important decision criteria for
purchasing movable capital equipment purchases: Product Superiority (42.2
percent); Standardization (28.5 percent); Price (13.9 percent). The study
also showed that only 4.5 percent of the research participants said
physician preference was a top priority in making these purchasing
decisions.

Masimo’s technologies the focus of multiple clinical studies at ASA annual
meeting
Masimo reported that multiple independent and objective clinical studies and
a case study were presented last week at the 2007 American Society of
Anesthesiology (ASA) Annual Meeting in San Francisco focused on the unique
benefits of Masimo’s noninvasive patient monitoring technologies in helping
clinicians provide improved patient care. These new studies add to the more
than 100 independent and objective studies demonstrating the superiority of
Masimo SET pulse oximetry, as well as adding to the growing body of research
proving the efficacy of Masimo Rainbow SET in providing accurate, reliable
physiological measurements of multiple blood constituents that previously
required invasive procedures. Built on Masimo SET Read-Through Motion and
Low Perfusion technology, Masimo Rainbow SET is the first and only
upgradeable technology platform capable of continuously and noninvasively
measuring carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pleth
variability index (PVI), in addition to oxyhemoglobin (SpO2), perfusion
index (PI) and pulse rate.
The studies included: “New Generation and Old Generation Pulse Oximeters in
Children with Cyanotic Congenital Heart Disease”, “New Pulse Oximetry
Sensors with Low Saturation Accuracy Claims - A Clinical Evaluation”,
“Rad-57 Rainbow CO-Oximeter in Detecting Methemoglobin during Upper GI
Endoscopy - A Case Report”, “Clinical Analyses of 429 Cases of Acute CO
Poisoning,” “A Comparison of Finger, Ear and Forehead SpO2 on Detecting
Oxygen Desaturation in Healthy Volunteers,” and “New Algorithm for Automatic
Estimation of the Respiratory Variations in the Pulse Oximeter Waveform” For
more information on the studies see
THIS LINK

October
25, 2007
Download print version
AIDS
vaccine volunteers among recipients who may be at higher risk
of contracting virus
Drug eluting balloons show promise as a
potential alternative
to drug eluting stents used in the treatment of
coronary artery disease
Hospitals adopt STERIS Advanced Room
Sterilization Technology
in the fight against ‘Superbugs’
Steris Corporation wins U.S. EPA SmartWay
Environmental Excellence award
Healthcare Supply
Chain Standards Coalition endorses standards
for organizational and product
identifiers
Large avian flu outbreaks more likely to
involve duck meat industry, experts find
AIDS vaccine volunteers among recipients
who may be at higher risk of contracting virus
South African
AIDS researchers have begun warning hundreds of volunteers that a highly
touted experimental vaccine they received in recent months might make them
more, not less, likely to contract HIV in the midst of one of the world's
most rampant epidemics. The move stems from the discovery last month that an
AIDS vaccine developed by Merck & Co. might have led to more infections than
it averted among study subjects in the United States and other countries.
Among those who received at least two doses of the vaccine, 19 contracted
HIV compared with 11 of those given placebos.
Researchers shut down the trial on the grounds that the vaccine was proving
ineffective, but the surge in infection among vaccinated volunteers prompted
intense scientific debate and anxiety among researchers. The failure of the
Merck vaccine is the latest in a series of disappointing results for
research projects aimed at curbing AIDS.
Researchers in
Soweto,
Cape Town,
Durban and
two other sites began contacting South Africa's 801 trial participants on
Tuesday, mainly by cellphone text message. The goal is to tell each one
individually whether they had received a placebo or the vaccine, a process
called "unblinding" the trial. Researchers are telling the roughly half who
received the vaccine that it might have increased their risk of contracting
HIV. Merck developed the vaccine in conjunction with the
U.S. National
Institutes of Health, and until September's announcement,
researchers worldwide considered it the most promising candidate yet in a
multibillion-dollar quest for an AIDS vaccine dating to the 1980s.
Scientists crafted the vaccine by genetically altering a common virus to
include elements of HIV. They hoped that it would trigger an immune response
that would make recipients less likely to contract HIV, or at least delay
the onset of full-blown AIDS.
The vaccine could not have caused infection, researchers say, but it could
have caused immunological changes that made it easier for the virus to take
hold during a later exposure. The Merck vaccine trials took place in 15
cities in the United States, including
Boston,
Los Angeles
and
New York,
and three in
Canada.
There also were sites in
Peru,
Brazil,
Australia,
Haiti, the
Dominican Republic
and
Jamaica.
Those trials began in December 2004 and included 3,000 participants, mostly
gay men.
In South Africa -- where an estimated 5.5 million people are infected with
HIV, more than in any other country -- the study used the same vaccine but
was administered separately. The trial here started later, with the first
injections this year, and had its own ethics oversight board. Most of the
subjects were heterosexual. The ethics oversight board in the United States,
which monitored the trial everywhere but in South Africa, has not decided
whether to tell participants if they received the placebo or the vaccine,
said Mark Feinberg, vice president for medical affairs and policy for Merck.
Continuing research could be compromised, he said,if participants were told
immediately whether they received the placebo or the vaccine. Vaccine
researchers are scheduled to meet in
Seattle on
Nov. 7. He added that individual participants who want to know whether they
received the vaccine will be told. Researchers also are counseling all study
participants that the vaccine may have increased HIV risk for those who
received it.
Other AIDS studies also have had unexpected results. Trials of two vaginal
microbicide gels to prevent HIV led to more infections among those using the
products instead of placebos. A massive study in
Zimbabwe
of the ability of HIV counseling and testing to prevent the spread of the
epidemic found more infections among those with expanded access to testing.
For the complete story, see
THIS LINK.
Drug eluting balloons show promise as a potential
alternative to drug eluting stents used in the treatment of coronary artery
disease
Drug eluting balloons could offer a viable alternative to drug eluting
stents (DES) in the treatment of coronary artery disease. Research results
from two studies presented at the Late Breaking Trials sessions during the
Cardiovascular Research Foundation’s (CRF) Nineteenth Annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.,
support conducting further studies of the use of this potential therapeutic
alternative. One of the studies marked the first direct comparison between
DES and drug eluting balloons. Used to open atherosclerotic arteries, DES
have come under intense scrutiny over the last several years, prompting the
U.S. Food and Drug Administration (FDA) to form a special advisory board to
investigate claims of complications. Recent studies have suggested that the
polymer coating of these stents might be implicated in the reported
complications.
The “SeQuent Please” drug eluting balloon catheter from B. Braun Melsungen
AG in Germany delivers drugs directly to the lesion during angioplasty. A
pilot study published last year in the New England Journal of Medicine
first shed light on this potential treatment option.
In the PEPCAD II study, Dr. Martin Unverdorben (Rotenburg, Germany) directly
compared “SeQuent Please” to another manufacturer’s DES in 131 patients over
six months. The team evaluated restenosis, the re-closing or narrowing of
the artery after a cardiac procedure, and the rate of major adverse cardiac
events (MACE) such as heart attack, bypass, repeat stenosis, or death.
Proving patients treated with the drug eluting balloons experienced only 3.7
percent restenosis and 4.8 percent MACE, as compared to patients with DES,
wherein restenosis was 20.8 percent with 22.0 percent MACE rate. Further
supporting these results, a separate study by Unverdorben evaluated the use
of drug eluting balloons for the treatment of small vessel disease in 120
patients. PEPCAD I is the first study to investigate the use of drug eluting
balloons in “native” lesions – those who have not already been treated by
DES or bare metal stents.
After six months, native lesions treated solely with “SeQuent Please” showed
only a 5.5 percent binary restenosis rate and 6.1 percent MACE. These
results compare quite favorably with previously published results using
drug-eluting stents for the treatment of small vessel disease with 31.2
percent restenosis and 18.9 percent MACE. The development of “SeQuent
Please” for the treatment of coronary artery disease is made possible
through B. Braun Melsungen AG agreement with Charité Hospital in Berlin,
Germany. The product features a unique matrix coating which is fully
bioabsorbable and polymer-free, enhancing the drug transfer into vascular
tissue.
Hospitals adopt STERIS Advanced Room Sterilization Technology in the fight
against ‘Superbugs’
STERIS Corporation announced it has received the first orders for its
VaproSure Room Sterilizer from several U.S. hospitals. The VaproSure Room
Sterilizer incorporates STERIS patented technologies and is the first
product of its kind for the healthcare market. Since being introduced in
June of this year, systems have been ordered by Wellmont Health System (VA,
TN, KY) Lake Hospital System (OH), and the VA Boston Healthcare System (MA).
These hospitals are demonstrating leadership in patient safety and infection
control and will use their VaproSure Room Sterilizers to sterilize all the
exposed surfaces in critical hospital rooms. As highlighted in recent
national news media reports, the persistent spread of germs and infections
in healthcare facilities is a significant challenge for patient safety and
compromises the ability for hospitals to deliver economically efficient
healthcare services.
With the VaproSure Room Sterilizer, it is now possible to sterilize all of
the exposed pre-cleaned surfaces within a sealed room. STERIS is the only
company to offer a complete hygiene solution to hospitals as a way to
enhance their infection control programs and improve the efficiency of their
operations. The VaproSure Room Sterilizer utilizes Vaprox Sterilant (EPA
Registration No. 58779-4) to create a dry sterilization vapor that
inactivates the full spectrum of biological contaminates on dry,
pre-cleaned, exposed, porous and non-porous surfaces within a sealed
hospital room. The chemistry is recognized as sporicidal, bacteriacidal,
fungicidal and virucidal. Additionally, the technology is environmentally
friendly, reducing to water vapor and oxygen at the conclusion of the cycle.
Steris
Corporation wins U.S. EPA SmartWay Environmental Excellence award
STERIS Corporation has
received the U.S. Environmental Protection Agency’s SmartWay Transport
Partnership Environmental Excellence Award for its leadership in conserving
energy and lowering greenhouse gas emissions from its transportation and
freight activities. The awards were announced earlier this week at the
annual conference of the Council of Supply Chain Management Professionals in
Philadelphia, PA. STERIS was officially recognized by the U.S. EPA as a
SmartWay Partner in January 2006. It achieved this distinction by using the
highest possible percentage of SmartWay member carriers for the transport of
STERIS materials and by instituting fuel-saving strategies for transport
vehicles. SmartWay was introduced by the EPA and a select group of 15
shipping and business leaders in 2004 as an innovative, market-based
partnership to reduce fuel use, greenhouse gas emissions, and air pollutants
from the freight sector. Today, more than 600 businesses and organizations
have joined the Partnership, including companies of all sizes, from Fortune
500 companies to family-owned businesses, each working to improve their
environmental performance. Together, these companies, including STERIS, are
conserving more than 600 million gallons of diesel fuel per year, saving the
trucking industry nearly $2 billion in annual fuel costs, and eliminating
nearly 7 million metric tons of carbon dioxide emissions. By 2012, the EPA
estimates that its SmartWay program will achieve annual savings of 3.3 to
6.6 billion gallons of diesel fuel, eliminating 33-66 million metric tons of
carbon dioxide emissions and almost 200,000 tons of nitrogen oxide
emissions.
The companies receiving
2007 U.S. EPA SmartWay Environmental Excellence Awards by partner category
are: IBM Corporation; Johnson & Johnson Sales & Logistics Company, LLC;
JCPenney; Kimberly-Clark Corporation; Lowe's Companies Inc.; Michelin North
America, Inc.; Office Depot; Sharp Electronics Corporation; and STERIS
Corporation.
For more information
about SmartWay visit:
THIS LINK.
Healthcare Supply Chain Standards Coalition endorses standards for
organizational and product identifiers
In a major step aimed
at making healthcare more affordable while strengthening patient safety and
outcomes, the Healthcare Supply Chain Standards Coalition (Standards
Coalition) is calling for industry-wide adoption of organizational and
product identifiers from GS1, an international organization dedicated to
designing and implementing supply chain standards. Specifically, the
Standards Coalition, a collaborative of 28 organizations representing the
entire healthcare supply chain, is endorsing GS1.s Global Location Number (GLN)
for organizational identification and its Global Trade Identification Number
(GTIN) for product identification. “We have the opportunity, and truly, the
obligation, as an industry, to transform how we do business,” said Joseph
Dudas, Standards Coalition co-chairman and Mayo Clinic’s director of
accounting and supply chain informatics. “With universal standards, every
supply chain participant will be able to identify every organization and
every product the same way. This is a monumental step forward from our
current state, where trading partners record organizational and product
information differently and often manually, leading to tremendous
inefficiency, waste, and inaccuracy, as well as countless opportunities for
error.”
To reach its
endorsements, the Standards Coalition spent the past year scoping the
business problems, collecting industry input about identifiers, and
evaluating standards options. As part of this effort, it conducted a survey
that found 69 percent of 129 respondents were considering adopting an
organizational identifier. Almost two-thirds said they were considering
adopting GS1’s GLN. “After much work and consideration by the Standards
Coalition subcommittees, we concluded that GS1’s standards offered the best
solutions for the industry,” said Stephen D. Christian, Standards Coalition
co-chairman. “GS1 offered a viable global approach, which is essential
today, and healthcare organizations in other countries have already begun
using its GLN and GTIN standards. GS1 has a successful track record that
dates back to the universal product code (UPC) that was adopted by the
retail and grocery industries over 30 years ago. We are working with GS1
standards to bring that measure of success to healthcare and streamline
transactions and information across the entire supply chain.”
To aggressively move the industry toward adoption, the Standards Coalition
is actively working with GS1 to enhance its standards to meet healthcare’s
needs. The Standards Coalition is also recommending GS1.s Global Data
Synchronization Network (GDSN) serve as the healthcare industry’s system for
registering, validating, disseminating, and synchronizing product
identification information. Additionally, the
Standards Coalition plans to shortly introduce implementation roadmaps for
supply chain participants, including providers, manufacturers, distributors,
and group purchasing organizations. In addition, the Standards Coalition
has launched a website,
www.hscsc.org,
for healthcare organizations to learn more about the standards and other
industry and government initiatives related to standards adoption and
implementation.
Members of the Standard’s Coalition Oversight Committee are: Abbott,
American Hospital Association, Amerinet, Ascension Health, Association for
Healthcare Resource & Materials Management (AHRMM), BD, Cardinal Health,
Coalition for Healthcare eStandards (CHeS), Consorta Catholic Resource
Partners, U.S. Department of Defense, U.S. Food and Drug Administration
(FDA), Geisinger Health System Foundation, GHX, HCA, Inland Northwest Health
Services, Intermountain Healthcare, Johnson & Johnson Med. Devices &
Diagnostics, Lawson, Mayo Clinic, McKesson Corporation, MedAssets, Mercy
Health Systems ROI, Owens & Minor, Novation, Premier Inc., Sentara
Healthcare, Strategic Marketplace Initiative (SMI) and University Hospitals.
More Info: www.gs1.com.
6
Sigma decreases mortality in hospitalized patients; Performance improvement
initiative
decreases hospital stay and costs
Although Six Sigma practices are widely used in the manufacturing industry,
the performance improvement system also may provide significant benefits for
hospitals, medical professionals, and patients. A new study presented at
CHEST 2007, the 73rd annual international scientific assembly of the
American College of Chest Physicians (ACCP), shows that Six Sigma
performance improvement practices may help hospitals decrease in-patient
mortality, length of hospital stay, and healthcare costs, and also improve
compliance with Joint Commission (JCAHO) Core Measures as they relate to
community-acquired pneumonia (CAP). “Although national guidelines for CAP
care existed, they were not being followed consistently throughout our
organization and percentages of patients with core measures met were lower
than best practice hospitals,” said study author Karen Gamerdinger, RN, MSN,
Mercy Medical Center, Des Moines, IA. “By implementing Six Sigma practices,
we showed that a quality improvement project can lead to benefits, not only
to the patients in decreased mortality, but also to physicians and nurses by
making it easier for them to provide the best, evidence-based,
guideline-directed care possible, and to the hospital itself with decreased
lengths of stay and decreased costs.”
Six Sigma is used the same way in healthcare as it is in technology and auto
industries: to eliminate non value-added steps in processes and reduce
defects and variation resulting in more efficient processes. “The focus is
still on identifying defects and improving processes to reduce variation,
whether that is improving how a patient navigates through the healthcare
system or whether it is looking at how parts are assembled in an automobile
factory,” said Gamerdinger. “This leads to improved quality care and
cost-savings in healthcare organizations.” In a retrospective study,
Gamerdinger and colleagues from Mercy Medical Center evaluated the outcomes
of a Six Sigma performance improvement project focused on compliance with
JCAHO CAP Core Measures to ensure that each measure of care was met.
Utilizing Six Sigma methodology, researchers identified critical processes
and key stakeholders in patient care and utilized specific tools for process
flow, cause/effect matrices, and outcomes analysis.
The hospital also dedicated several full-time positions to the new
methodology and trained more than 100 individuals in the Six Sigma program.
When deviations from the Six Sigma protocol occurred, timely feedback was
provided to care providers. After program implementation, researchers
collected and analyzed data related to core measures, length of stay, and
mortality in 1,550 patients with CAP admitted to the hospital during the
study period. Results indicated that compliance scores for each JCAHO Core
Measure improved from 70% to over 90%. CAP order usage improved from 40 %to
73%, yielding an 82.5% increase. Mean length of stay was reduced from 5.9
days to 5.1 days, a 13.56% reduction, which was associated with over
$300,000 in cost savings. By the end of the study period, in-hospital
mortality rates also decreased from 6.7% to 3.5%, a 47.8% reduction.
Although researchers specifically measured outcomes related to CAP, the
hospital has applied Six Sigma to other in-patient populations, including
patients with cardiac conditions, and to system-wide issues, such as delays
in medical imaging, home medical equipment projects, and reducing patient
registration times for in-patients.
Large avian flu outbreaks more likely to involve duck
meat industry, experts find
Scientists at the University of Liverpool have found that 73% of avian flu
outbreaks in the UK would not spread beyond the initial infected farm, but
larger outbreaks are more likely to involve the duck meat industry. A team
from the University’s Faculty of Veterinary Science and Department of
Mathematical Sciences were approached by the Department of Environment, Food
and Rural Affairs (DEFRA) to produce an avian flu model based on unique
levels of detail including contact points between farms.
The studies team believes that duck meat is more likely to cause large
outbreaks of avian flu because ducks often do not show signs of the disease
and as such delays diagnosis and control of the infection. Scientists used a
computer model to simulate millions of outbreaks of avian flu, so that even
rare outbreak scenarios could be observed in order to further understanding
of how the disease might spread across the UK.
Dr. Rob Christley from the University’s Faculty of Veterinary Science,
explains: “Our model is unique in the level of detail regarding contact
points between farms. We modelled four contact routes: local transmission,
where infection is spread in the area due to wind and wild animals;
transmission via delivery of feed where lorries may pick up the virus at one
farm and carry it to another; transmission via slaughterhouse lorries and
transmission via company workers, where personnel from a company may carry
the virus to other farms within the same company as they go about their
daily work. The model also provides analysis of government policy, such as
the implementation of control zones. This strategy aims to limit the
movement of birds as well as trace potential contacts where transmission of
the disease is more likely. The team found that this strategy was beneficial
in reducing the chance of very large outbreaks to almost zero. 
October
24, 2007
Download print version
Smoke in air driving more to
seek help in hospitals
Pioneer heart patient marks medical field’s
30-year history
Study sees Medicare savings from drug-coated
stents
2 carotid artery stenting studies show results
comparable to AHA guidelines
Breast cancer chemo raises heart risks
FDA approves Ixempra for advanced breast
cancer patients
Septic survival; Boys with blood infection
suffer more severely than girls
Last Call - “Best of AHRMM” seminar is
heading to
Chicago
Smoke in air driving more to
seek help in hospitals
As smoke from multiple wildfires has engulfed
Southern California, health officials said Tuesday they have
seen a dramatic increase in the number of people going to
hospitals with asthma attacks and other respiratory problems.
“We are seeing a real spike, a several-fold increase, in
people coming in with respiratory complaints, particularly
wheezing, coughing, tightness in the chest and difficulty
breathing,” said Los Angeles County Public Health Officer Dr.
Jonathan E. Fielding. Smoke and ash, along with dust raised by
gusting winds, have exaserbated air quality in at least four
counties, according to the South Coast Air Quality Management
District. “It will affect everyone in some way because it’s a
substantial exposure,” said Dr. Chand Khanna, pulmonologist at
Henry Mayo Newhall Hospital. Overwhelming amounts of
particulate matter can cause irritation and chest pain, which
can lead to coughing and shortness of breath, Khanna said. And
the poor air quality could linger, said Sam Atwood, AQMD
spokesman.
Although the
Santa Ana
winds are expected to decrease today, particulate matter blown
out to the ocean can blow back. The result will be an increase
in breathing problems. Local physicians also caution that
particulate matter can affect the heart. “Small particles are
extremely dangerous for the lungs, but also extremely
dangerous for the heart,” said Dr. Lisa Matzer, director of
the outpatient center at Glendale Adventist Hospital. “We’re
seeing earlier signs of heart disease, and we're seeing more
firemen coming in complaining of chest pains,” she said. “My
message out there is, everybody should worry about your heart
this week.” (LA Daily News)
For information from the CDC on wildfire safety see
THIS
LINK

Pioneer heart patient marks medical field’s 30-year
history
Few
of the doctors in the crowded ballroom had ever met him, but Adolph Bachman
was the patient who needed no introduction at this cardiology conference in
Washington. Thirty years ago in Zurich he became the first person to have a
blockage in a heart artery cleared without undergoing traumatic surgery, a
procedure known as angioplasty that gave rise to an entire field of medicine
in which doctors known as interventional cardiologists now specialize. More
than 15 million patients have followed the trail Bachman blazed. “I feel
compelled to give you all a big hug,” Bachman, 68, said to doctors here in a
short talk. He recalled his angioplasty and Dr. Andreas Gruentzig, the
charismatic doctor who invented the procedure and taught it to thousands of
others before dying in a plane crash in 1985.
Bachman’s gratitude was a welcome balm for the doctors at the Transcatheter
Cardiovascular Therapeutics conference, an annual gathering for the
interventional cardiology field. Their specialty has been clouded in the
last year by debate about whether some innovations, like
stents are
being overused and may even be compromising some patients’ health. The
number of angioplasties performed fell 10 percent last year because of the
“climate of calamity,” according to Dr. Martin Leon, a conference organizer.
The meeting began Saturday with scientific sessions and will run through
Thursday. The biggest priority for many in attendance, who include device
makers and their investors, has been to overcome the staggering impact of
safety questions about the most widely used devices: stents coated with
drugs that are meant to deter subsequent blockages.
In session after session, speakers here are dwelling on the small
number of deaths associated with the safety issue, a reported tendency for
deadly clots to form in the stents long after they are implanted. Various
studies show that the clot risk is slight, 0.2 percent to 0.6 percent
annually, or a handful of patients among every 1,000, and that overall death
rates are no different than for patients who use older bare-metal stents.
Many of the sessions have questioned the reliability of the studies that
raised the safety issues. Dr. Leon and Dr. Gregg Stone, another conference
organizer, voiced a caution in a joint introductory session at the
conference. They said that no clinical trials in the field had been big
enough to clarify the safety profiles of all the different stents or to
truly gauge angioplasty’s advantages in various types of patients. As a
result, they said, no single study should govern doctors’ recommendations to
patients. (The
New York Times) To read the original article see
THIS LINK

Study sees Medicare savings from drug-coated stents
Depending on whose interpretation one wants to believe,
Medicare
may, or may not, have saved money since the introduction of drug-coated
heart
stents in
2003. Researchers who analyzed Medicare data on a sampling of patients from
2001 and 2004 said today that the government spent 5.4 percent less,
adjusted for inflation, in the more recent period for each patient who
received treatment to reopen blocked coronary arteries. The more recent
figure was $29,663, compared with $31,343 in 2001. That conclusion might
seem to contradict the common wisdom that new drugs and devices are leading
to higher, rather than lower, spending on healthcare. But it comes with
several caveats, starting with the fact that the study was sponsored by
Cordis, the stent-making subsidiary of
Johnson & Johnson.
Moreover, one of the main reasons for the savings appeared to be a decline
in the percentage of patients receiving heart bypass surgery to treat
blocked arteries, compared with the rising use of balloon
angioplasty
and stenting.
Nearly one-third of the Medicare patients received bypass surgery
in 2001. By 2004 that figure had fallen to just below one-fourth of
patients. Because the study followed spending on the patients for only 13
months after their initial procedures, however, it was too short to examine
one of bypass surgery’s supposed cost advantages, that although bypass costs
more initially, it keeps arteries open far longer and so reduces spending on
repeat procedures. “The surgeons would probably be screaming,” conceded Dr,
Jason Ryan, a cardiologist at Beth Israel Deaconess Medical Center in
Boston, who presented the data this morning. He said the authors were trying
to get the paper published in a peer-reviewed journal, after which they
would consider analyzing the data over a longer period.
Beyond cost savings from surgeries avoided, the other supposed
cost benefit came from fewer repeat stenting procedures in the 2004 group.
That gain apparently reflected the main advantage of drug-coated stents over
the bare-metal versions used in the 2001 patients: the drug coatings are
meant to deter arteries from becoming blocked again. The benefits were not
only economic, according to the study. Death and heart attack rates were
also lower in 2004. Numerous factors may have been involved, including
improvements in stenting, better surgical techniques and the wider use of
additional drugs like statins and beta-blockers on the patients. The
Medicare data did not include spending on drug therapies. Since patients
receiving drug-coated stents are currently also given Plavix, a blood
thinner, for at least a year, the author’s estimated Plavix’s cost impact.
That reduced the Medicare savings to $776 per patient, Dr. Cohen said.
At least one Medicare official expressed skepticism about the
study. Stephen E. Phurrough, the director of coverage and analysis at the
Centers for Medicare and
Medicaid
Services, the agency that oversees Medicare, said that it missed the main
question: How many patients received stents or surgery at Medicare’s expense
who might have fared just as well without those treatments? “That seemed to
be the message of Courage,” Phurrough said. He was referring to a clinical
trial, known as Courage, which earlier this year concluded that many
patients with chest pains who receive stents are no better off after five
years than those who take the best available drugs and follow healthy
lifestyles. (The New York Times)

2 carotid artery stenting studies show
results comparable to AHA guidelines
Two carotid stenting trials examining patient outcomes demonstrated results
that are comparable to guidelines established by the American Heart
Association (AHA) for patients treated with carotid artery surgery. The
results of these studies were presented at the Cardiovascular Research
Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT)
scientific symposium by William A. Gray, M.D., FACC, associate professor of
clinical medicine at Columbia University College of Physicians and Surgeons
and director of Endovascular Services at the Center for Interventional
Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University
Medical Center in New York. Dr. Gray is the director of Endovascular
Services at the Cardiovascular Research Foundation.
An interim analysis of patients treated with carotid stents in Abbott’s
CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare
Events) and EXACT (Emboshield and Xact Post Approval Carotid Stent Trial)
post-marketing trials, which enrolled 4,111 patients in over 150 sites,
demonstrated 30 day patient outcome results consistent with longstanding AHA
guidelines for patients with a severe carotid stenosis but who do not have
symptoms. These guidelines recommend that rates of complications for carotid
artery surgery to prevent stroke be less than 3 percent for patients without
symptoms of stroke (asymptomatic) and 6 percent for patients with symptoms
of stroke (symptomatic).
“In these two well-conducted carotid artery stenting studies, carotid
stenting has achieved outcomes comparable guidelines established for
patients who undergo carotid surgery, and has done so in a population of
patients who are at high risk for experiencing adverse events from surgery,”
said Dr. Gray. “This is a significant report because this is the first time
that these guidelines have been achieved by any revascularization therapy in
a large, multi-center examination of such patients, and although the
guidelines were established for surgery (before stenting was practiced),
there are no comparable surgical results in this group of patients.”

Breast cancer chemo raises heart risks
A study
published in the October 9 issue of the Journal of the American College
of Cardiology has found certain treatments that cured breast cancer made
women more susceptible to heart disease. “We always felt the benefit of
savings lives outweighed the risks and were just part of the accepted cost,”
said Pamela S. Douglas, M.D., chief of cardiology at
Duke
University and co-author of the JACC paper. But with the success of
treatment and growing survivor numbers, Douglas and her colleagues are
urging doctors to take the long view when deciding on a woman's breast
cancer treatment. First treat the cancer, but don’t forget about
cardiovascular health down the road.
The spike in heart disease risk comes from a variety of sources. Chest
radiation, lack of exercise during treatments and stress are all part of the
heart-hurting connection. But according to Douglas, the greatest damage
comes from a
breast cancer
treatment mainstay, chemotherapy. Specifically, researchers are looking at
chemotherapy medicines called anthracyclines. These compounds are used to
treat a variety of cancers, including leukemia, lymphomas, uterine, ovarian
and breast cancer. They are also known to harbor a well-known risk: They
weaken some women’s hearts. “There are other drugs that are less harmful,
and we know a little bit about how to lower the doses,” said Douglas, but
it’s too soon to start completely overhauling breast cancer therapy, she
said.
Instead, doctors and organizations including the National Breast Cancer
Coalition are calling for more research into cancer treatments to see
whether other drugs might yield the same result without the added long-term
risk. Douglas also stresses that it is important to look at all the factors
surrounding a woman's condition, as patients are “taking hits from multiple
places.” While the cancer therapy might be one source of added
cardiovascular risk, diet, weight and family history also play a major role.
Her advice to patients who learn they have breast cancer, “First get cured!”
But she adds: “Take seriously the consequences that dieting and regular
exercise can have for your health while taking something that is not
necessarily heart healthy.” (CNN)

FDA approves Ixempra for advanced breast cancer
patients
The U.S. Food and Drug Administration has approved Ixempra (ixabepilone), a
new anti-cancer treatment, for use in patients with metastatic or locally
advanced breast cancer who have not responded to certain other cancer drugs.
The FDA evaluated Ixempra under priority review, completing its assessment
of the drug’s safety and effectiveness in six months. Ixempra was approved
for use in combination with another cancer drug, capecitabine, in patients
who no longer benefit from two other chemotherapy treatments. These prior
treatments included an anthracycline (such as doxorubicin or epirubicin) and
a taxane (such as paclitaxel or docetaxel). Ixempra was also approved for
use alone in patients who no longer benefit from an anthracycline, a taxane
and capecitabine. Metastatic breast cancer is the most advanced stage of
breast cancer and has the potential to spread to almost any region of the
body. Ixempra has been shown to bind to cancer cell microtubules, which are
structures within cells that help to support and shape them. Microtubules
also play a role in cell division.
The safety and efficacy of Ixempra in combination with capecitabine were
evaluated in 752 patients in a randomized clinical trial comparing the
combination to capecitabine alone. This combination therapy demonstrated
improvements in delaying cancer progression or death compared to
capecitabine alone. The safety and efficacy of Ixempra administered alone
were evaluated in a study of 126 patients. Clinically significant tumor
shrinkage occurred in 12 percent of the patients. Ixempra’s significant side
effects included peripheral neuropathy (numbness, tingling or burning in the
hands or feet) and bone marrow suppression. Women taking Ixempra should
avoid taking drugs that are strong inhibitors of CYP3A4, one of the enzymes
that metabolizes Ixempra. Ixempra should not be taken by women who have had
severe allergic reactions to drugs that contain Cremophor or its
derivatives, or by women who have baseline bone marrow suppression
determined by low white blood cell or platelet count. The combination of
Ixempra and capecitabine should not be given to patients with moderate or
severe liver impairment due to the increased risk of toxicity and death.
Ixempra is administered by intravenous infusion. It is distributed by
Bristol-Meyers Squibb Company,
Princeton, NJ.

Septic survival; Boys with blood
infection suffer more severely than girls
While survival rates for sepsis have increased over the past two decades,
children under four and those in adolescence remain highly susceptible to
the condition. Researchers in The Netherlands have now demonstrated that age
and to a lesser extent, gender, are critical factors in whether or not a
child sufferer will develop a more severe disease state and survive or not.
These findings could help to improve the treatment of sepsis and improve
survival rates further still. Writing in the online open access journal
Critical Care, Jan Hazelzet and colleagues at the Erasmus MC-Sophia
Paediatric Intensive Care Unit (PICU) in
Rotterdam describe their study of almost 300 children admitted with sepsis
and purpura (red patches caused by bleeding under the skin) between 1988 and
2006.
The results showed that the fatality rate
from sepsis and purpura was 15.7%. However, during the study period, they
observed a marked improvement in the numbers of children surviving sepsis.
Nevertheless, they found that younger children were affected more severely
and fatality rate was higher (4.3 times) for those under the age of three
years. They found no difference in fatality rates between boys and girls,
but boys were admitted to the PICU for longer periods and had more severe
symptoms. The team found that the course of sepsis and purpura was not
related to a child’s ethnic origin. In almost all cases, the infection that
led to sepsis was Neisseria meningitidis, the bacterium commonly known as
meningococcus. The team also reports how the drugs used to treat sepsis
changed during the course of the study. There has been a marked reduction in
the use of dopamine and a concomitant increase in the use of dobutamine,
norepinephrine and corticosteroids to treat sepsis. “The finding of the
important influence of young age and to a lesser extent gender can lead to a
better understanding of the disease, which in turn can lead to better
therapy”, said Jan Hazelzet.

Last Call - “Best
of AHRMM” seminar is heading to
Chicago
Did you or your staff
miss out on AHRMM’s 45th Annual Conference & Exhibition in San Diego?
Don’t worry, AHRMM’s “Passport to Success” is heading to the
Midwest. Join us on November 2 at the Hyatt Regency O’Hare and attend some
of the best Learning Lab sessions to come out this year’s AHRMM Conference.
It’s a complete day of exceptional education close to home! The “Best of
AHRMM” gives materials managers the unique opportunity to participate in
five of this year’s most highly anticipated and well-attended presentations
as well as network with other healthcare supply chain professionals located
in the Midwest region. Sessions cover three key areas:
distribution, strategic planning, and purchasing. Registration costs
$299 for AHRMM members and $399 for non-members and includes: five
educational sessions, dedicated
face-to-face networking time, CEUs, presentation handouts, and continental
breakfast, lunch, and two refreshment breaks. For complete information and
registration, see
THIS LINK

October
23, 2007
Download print version
WSJ: Putting superbugs on the defensive;
hospitals begin to tout ability
to control infection; mining the available
data
Stopping the spread of super bug
How has MRSA affected your community or
hospital?
Tell us what you think on HPN Blogline
Scarce pandemic vaccine to be given in order
WHO launches hand hygiene initiative aimed at
decreasing
healthcare-associated infection in developing
countries
High numbers of men and
women are overweight, obese
and have abdominal fat, worldwide
Hologic and Cytyc complete
merger
WSJ: Putting superbugs on the defensive;
hospitals begin to tout ability
to control infection; mining the available data
Hospitals
are prime breeding grounds for antibiotic-resistant
“superbugs” that kill tens of thousands of Americans each
year. But most people have had no way of knowing how well
their hospital keeps these bacteria, and infections in
general, under control, reported The Wall Street Journal.
That is starting to change. Nineteen states have adopted laws
in recent years requiring hospitals to report overall
infection rates publicly, with more likely to follow suit. And
Thursday, nearly two dozen federal lawmakers, headed by
Pennsylvania Rep. Tim Murphy, proposed legislation requiring
nationwide public reporting. So far, just four states have
published some infection rates for individual hospitals, and
only one state, Pennsylvania, breaks out different types of
infections. But even where patients can’t find state-mandated
infection reports, they can increasingly get information from
their local hospital about practices to prevent superbugs and
other infections. Some hospitals have found a marketing
opportunity in infection prevention: They are pushing overall
infection rates toward zero, and advertising it. They are
trumpeting prevention efforts, such as campaigns to improve
hand washing. And some are tracking patients who have been
infected with superbugs such as methicillin-resistant
Staphylococcus aureus, or MRSA, and monitoring them to prevent
the spread. “This is one of those cases where quality is also
the best business case,” said Jonathan Perlin, chief medical
officer at hospital chain HCA Inc., which has enlisted
staffers and visitors alike in its own campaign to keep germs
away from patients.
Among the four states that have published infection rates,
Missouri and Vermont let consumers learn the number of blood
infections related to central lines and how that compares with
state or national averages. Pennsylvania provides multiple
reports on different kinds of infections, and lets consumers
look up infection-related mortality, length-of-stay and cost
data for several kinds of infections. A Web site from
Consumers Union, www.stophospitalinfections.org, has links to
reports from each state, including
Florida,
according to Lisa McGiffert, director of the Stop Hospital
Infections Campaign. Information from Florida is nearly two
years old, and Missouri’s dates to December 2006. But the
information released so far is an important start, say
public-health experts, since most of the hospital-infection
reports mandated by the new state laws won’t be available
before about 2009.
Nashville, TN-based HCA has been putting up posters
exhorting doctors to wash their hands, and is even
distributing a card to visitors that explains the importance
of hand washing when coming in contact with patients. The
company says its purchases of hand-sanitizing alcohol gel,
available from dispensers throughout its hospitals, have risen
600% since early this year. (Company officials say they didn’t
measure infection rates at the start of the campaign and so
don’t know how much infections have fallen.) Other hospitals
say they have pushed antibiotic-resistant-infection rates down
sharply through a combination of techniques. The University of
Pittsburgh Medical Center, for example, has cut MRSA infection
rates in half at its main hospital since 2001 in part by
screening all intensive-care patients to see if they are
carrying the bug; it is now expanding use of the tests. To
reduce certain kinds of bloodstream infections, the
19-hospital system bundles sterile material needed to insert
central lines and has stepped up training; central-line
associated blood-infection rates have fallen by 80% since
2002, to fewer than one per thousand such procedures. It also
has taken steps to deal with the emergence of a different
strain of bacteria that can cause potentially fatal diarrhea.
The hospital lets nurses order tests for the bug; requires
longer isolation periods for those infected with it; gives
their rooms an additional cleaning with bleach; and requires
physicians to get approval from an antibiotic-management team
when using certain high-powered antimicrobials that could
affect the body’s natural defenses against the bacteria.
UPMC’s infection rates for the organism, Clostridium difficile,
have fallen two-thirds since a spike in 2000.
Intermountain Healthcare, a Salt Lake City-based chain of 21
hospitals, keeps a database of every patient who has been
infected with MRSA. Those who return to the hospital for some
other reason are immediately monitored by an infection-control
nurse and tested to see if they are carrying the bacteria.
Together with a concerted campaign to improve hand-washing,
the database has helped stop an increase in the number of MRSA
infections at the hospital over the past year. Some states are
also beginning to mandate broader testing specifically for
MRSA, since patients can carry the bug and spread it without
showing signs of infection. Pennsylvania will soon require
hospitals to test high-risk patients, including those admitted
from nursing homes. In August,
New Jersey and
Illinois
adopted legislation requiring hospitals to identify patients
carrying MRSA and isolate them, among other provisions. Some
hospitals have been turning to a variety of new technologies
to try to cut down on infections, particularly superbugs,
ranging from antibiotic-coated catheters to work surfaces made
of copper, which has antimicrobial properties, as well as
software. (The Wall Street Journal) To read the original
article see
THIS LINK

Stopping the spread of super bug
It
can start with a wound as small as a scratch or pinprick that goes unnoticed
but then bubbles up into a tiny boil. It looks like a spider bite, and many
people infected with methicillin-resistant Staphylococcus aureus, or MRSA,
think it is and make the dangerous mistake of ignoring it. Often within 24
hours, the tiny wound grows into a deep and painful abscess, a sign that
tissue destruction that comes with a MRSA infection is well under way.
Waiting longer to visit a doctor could lead to the infection burrowing deep
into the body and causing bone and blood infections and affecting the heart
valves and lungs. Studies show that nationally, MRSA infections are up from
3 percent of cultured infections in 2001 to 60 percent today. And the story
is no different locally in Sarasota, FL.
Officials at Sarasota
Memorial
Hospital noticed an increase in MRSA-related infections about three years
ago and began culturing all abscessed wounds. The hospital found that the
spread of MRSA in Sarasota is up from an estimated 3 percent in 2001 to 30
or 40 percent three years ago and rising, said Dr. William Colgate, medical
director, Sarasota Memorial emergency care center. Statistics from
Manatee
Memorial
Hospital
and Fawcett Memorial Hospital in Charlotte County are similar, officials
said. “It has doubled especially in the ER in the last six months,” said
Cassie Molina, infection control coordinator for Manatee Memorial Hospital.
Increasing numbers of the infections at Manatee Memorial's pediatric unit
mirror those from the emergency room, Molina said. “If we see an increase in
the ER, we know we are going to see one in pediatrics,” she said. Melanie
Hall, who heads infection control at Fawcett in
Punta Gorda,
FL, said she has also seen dramatic increases in MRSA
coming into the hospital, even among people who do not know they are
infected. Hall said the hospital decided in May to screen a variety of
patients coming in for MRSA, including those who were there for joint
replacement surgery, anyone coming in from a nursing home or prison, and
people with a history of having MRSA infections or kidney dialysis. Among
those, Hall has seen the numbers jump in just a few months. “The people I
have had to start putting in isolation, the numbers have gone up 40
percent,” she said. For the rest of the hospital, the numbers are similar,
with a 50 percent increase in the number of patients having
community-acquired MRSA since 2004. “And it is continuing on an upward
trend,” Hall said. “It has not leveled off.”
Hospitals report seeing the fastest growth in community-acquired MRSA.
“People come in to the emergency room and think they have a bug bite,” said
Cassie Molina, infection control coordinator for Manatee Memorial Hospital.
“But it never is.” Though the infections can be difficult to treat, they are
less so when caught early. “You keep it dry, do warm compresses,” said Scott
Pritchard, Sarasota County epidemiologist. “Some doctors will cut it open if
it’s a bigger infection.” MRSA getting into the bloodstream ups the ante and
requires more aggressive treatment, including potent antibiotics. But those
cases are “fairly rare,” Pritchard said.
Every health official had the same information for people wanting
to avoid community-acquired MRSA: do not touch your face when out in public,
thoroughly wash your hands frequently and consider all surfaces that other
people touch contaminated. Because of the increased incidence of MRSA
infections, police and sheriff's deputies in the region are wearing gloves,
wiping down their cars and gear with disinfectant and treating every
encounter with the public as a doorway for the bacteria. Among the most
vulnerable to MRSA are the homeless because they share personal items and
have limited access to clean facilities where they can shower and launder
their clothes, authorities say. Officer Scott Patrick, transient coordinator
for the Sarasota Police Department, said he has seen a marked increase in
the infections among the people he works with. Officials at the Sarasota
County Jail say they have so far not seen any cases of the skin infection,
but they have procedures in place to catch anyone who might be infected
before they enter the general jail population. (Sarasota Herald Tribune) To
read the original article see
THIS LINK
For
a related Q&A feature from The New York Times, “Drug-resistant staph:
What you need to know”, see
THIS LINK
And for another related article from The Wall Street Journal, “Wash
Your Hands, and Don't Shave Your Legs: Advice to Avoid Infection”, see
THIS LINK

How has MRSA affected your community or hospital? Tell us
what you think on HPN Blogline
Superbugs such as MRSA are in the spotlight around the country. Tell us how
MRSA is affecting your community. What is your hospital doing to fight back?
Share your stories and post comments on our Blog at
THIS LINK

Scarce pandemic vaccine to be given in order
In
the early weeks of a flu pandemic, the first to receive scarce supplies of
vaccine will include the military, medical and emergency workers, pregnant
women and babies, nearly 23 million people, under a draft federal plan to be
outlined Tuesday in Washington. At the back of the pack, in a pandemic of
the sort that killed 500,000 Americans in 1918, would be 74 million sick and
elderly adults and 122 million healthy people ages 19-64. The plan was
developed by a government working group that met with scientists and
business and community representatives over several months. It provides
guidelines for pandemic planners and offers a glimpse into some agonizing
decisions that could be necessary in the context of a swift-moving
infectious disease and a shortage of protective vaccine. “Once a pandemic
starts, vaccine will come rolling off the line in lots, so there has to be a
priority scheme on who would receive it first,” said William Raub, science
adviser to Health and Human Services Secretary Michael Leavitt. “The
committee tried to identify those who would be critical to national and
homeland security, critical to fighting the flu itself, and critical to
maintaining a functioning society.”
In meetings, the working group and other participants highlighted pregnant
women and children as a priority, the report says. This also is an efficient
use of vaccine, it says, because immunizing pregnant women protects their
newborns, too, and children need lower doses, stretching limited supplies.
Jeffrey Levi of Trust for America’s Health, an advocacy group, says the
report, being presented at a meeting of the National Vaccine Advisory
Committee, is “logical,” but more discussion is needed to refine how vaccine
will be distributed and used in different populations. The plan provides for
changes based on local needs and severity. In mild pandemics, which cause
fewer deaths among the young and healthy, it makes sense to move those at
risk of serious illness, such as the elderly and people with chronic
illnesses, higher on the list, Raub said. For instance, the plan doesn’t
target such groups as banking, food and agriculture, postal or chemical
workers in a mild or moderate pandemic. But in a severe pandemic, those
groups are in the third tier for vaccination, just behind electricity,
natural gas, communications and water personnel and essential government
workers. ”The
more severe the pandemic, the more aggressive people would be in trying to
protect critical workers,” Raub said. “But if it’s at the milder end,
critical workers would be a smaller group, so there would be more emphasis
on getting everyone vaccinated. The disruption of society wouldn’t be the
same.” (USA Today) To read the original article see
THIS LINK

WHO launches hand hygiene initiative aimed at decreasing
healthcare-associated infection in developing countries
An open-access commentary in the December 2007 issue of Infection Control
and Hospital Epidemiology examines a recently launched a global
initiative by the World Health Organization (WHO) to combat
healthcare-associated infection by improving hand hygiene in healthcare. The
commentary is part of the Global Theme Issue on Poverty and Human
Development. An international collaboration organized by the Council of
Science Editors of simultaneously published research from more than 200
medical and scientific journals, the Global Theme Issue aims to raise
awareness of the relationship between poverty and human development. Authors
Benedetta Allegranzi, MD (World Alliance for Patient Safety, World Health
Organization), and Didier Pittet, MD, MS (Infection Control Program,
University of Geneva Hospitals, Geneva), note that healthcare-associated
infection is a major patient safety problem found in every hospital,
healthcare system, and country.
The risk of healthcare-associated infection is 2 to 20 times higher for
patients in developing countries than for patients in industrialized
countries. A complex array of factors contribute to that increased risk,
including lack of resources, inappropriate use of antibiotics, use of
counterfeit drugs, understaffing and lack of training of health care
professionals, and governments that are overwhelmed with larger health
issues and cannot commit to infection control procedures and standards. The
WHO recently launched the First Global Patient Safety Challenge, “Clean Care
is Safer Care,” to reduce healthcare-associated infection worldwide. “The
First Global Patient Safety Challenge represents an unprecedented initiative
to improve infection control practices and procedures in any healthcare
setting, regardless of the level of economic development,” explained Dr.
Pittet. “Never before in the history of infection control has there been
such an opportunity to improve the health of so many millions of individuals
by promoting basic but essential practices through the powerful channels of
the WHO, which allow the involvement of governments and influence their
healthcare systems.”
The ministries of health from 43 countries have already signed the pledge to
reduce healthcare-associated infection and another 20 are expected to join
by the end of 2007. The WHO developed guidelines on hand hygiene in
healthcare based on scientific evidence and international expertise. A
multimodel implementation strategy will turn the guidelines into practice
and will suggest feasible ways to induce changes that will result in
increased hand hygiene compliance and reduced morbidity and mortality due to
healthcare-associated infection. Part of the effort is to make the
indications for hand hygiene universally understandable and not open to
interpretation. It focuses on only five points when hand hygiene is required
when providing healthcare. A worldwide pilot test of the strategy and tools
is under way to evaluate the feasibility, sustainability, cost-effectiveness
and cultural adaptation of a multimodel strategy for hand hygiene
improvement. For more information see
THIS
LINK.

High numbers of men and
women are overweight,
obese and have abdominal fat, worldwide
A new global study revealed that 40 percent of men and 30 percent of women
are overweight, while 24 percent of men and 27 percent of women are obese,
researchers reported in Circulation: Journal of the American Heart
Association. In the study, 168,159 people (69,409 men, 98,750 women)
from 18 to 80 years old (average age 48) in 63 countries across five
continents were evaluated by their primary care
physicians. “This is the largest study to assess the frequency of adiposity
(body fat) in the clinic, providing a snapshot of patients worldwide,” said
study lead author Beverley Balkau, Ph.D., director of research at INSERM in
Villejuif, France. (INSERM is the French equivalent of the U.S. National
Institutes of Health.)
The International Day for Evaluation of Abdominal Obesity (IDEA)
was a cross-sectional, epidemiological study conducted on two pre-specified
half-days by randomly selected physicians, representative of urban and rural
areas of individual countries. “The study results show that excess body
weight is pandemic, with one-half to two-thirds of the overall study
population being overweight or obese,” Balkau said. “Central adiposity adds
significantly to the risk of developing heart disease and particularly of
developing diabetes.” Physicians recorded age, gender, presence of heart
disease or diabetes and measured waist circumference (WC). Weight and height
were measured and body mass index (BMI) was calculated. “WC is a more
powerful clinical marker of heart disease and diabetes than BMI,” Balkau
said. “Visceral fat is an important determinant of cardiovascular disease
and diabetes, and the WC is closely related with visceral fat as evaluated
by CT scans. The WC is so easy to measure in the clinic.” Being overweight
or obese has health consequences, but abdominal obesity has even worse
consequences, she added.
As measured by WC using International Diabetes Federation
Caucasian criteria, more than half the study population, 56 percent of men
and 71 percent of women, had abdominal adiposity. “Overall there’s a
significant increase in the frequency of heart disease and diabetes with
increasing waist circumference,” Balkau said. “For men, each increase of
approximately 5.5 inches means an increased frequency of about 35 percent
for heart disease and for women an increase of approximately six inches
equates to a 40 percent increase for heart disease. Even in people who are
lean, an increasing waist circumference means increasing risk for heart
disease and diabetes.” As measured by BMI, more than 60 percent of men and
50 percent of women were either overweight or obese, with a BMI of 25 kg/m2
or more. The overall frequency of overweight was 40 percent in men and 30
percent in women, with similar frequency across geographical regions. The
frequency of obesity, a BMI of 30 kg/m2 or more, differed between regions
and ranged from a low of 7 percent in both men and women in South and East
Asia, to 36 percent in Canadian men and women.
The study showed the overall frequency of heart disease was 16 percent in
men and 13 percent in women, higher in men than in women. There was a high
frequency of heart disease in Eastern European men, 27 percent, and women,
24 percent, in contrast to Canada where the frequency in women was 8
percent, and in men 16 percent. The frequency of diabetes varied more across
regions than CVD. Overall, 13 percent of men and 11 percent of women were
diagnosed with diabetes. Both diabetes and heart disease were more common in
men than women. Balkau called upon governments to take more preventive
measures to stem the tide of obesity and overweight, such as providing more
access to physical activity and encouraging people to exercise.

Hologic and Cytyc
complete merger
Hologic Inc. and Cytyc Corporation announced the completion of the
combination of the two companies, creating one of the largest companies in
the world focused on advanced technology in women’s health.
Under the terms of the merger agreement, Cytyc shareholders received 0.52
shares of Hologic common stock and $16.50 in cash for each share of Cytyc
common stock held by them, with aggregate consideration paid to Cytyc
shareholders totaling approximately $6.2 billion, payable in approximately
65,800,000 shares of Hologic common stock and approximately $2.1 billion in
cash. Hologic will continue to trade on the NASDAQ Global Select Market
under the symbol “HOLX” while Cytyc will become a wholly-owned subsidiary of
Hologic and will cease trading on the NASDAQ as of the close of trading on
October 22, 2007.

October
22, 2007
Download print version
Tests reveal high chemical levels in kids’
bodies
FDA expands age range for use of bacterial
meningitis vaccine
Internists endorse 2007-08 adult immunization
schedule
and publish in Annals of Internal Medicine
Breast cancer calculator clarifying the
unknown
The asterisk on cancer deaths
Exposure to sunlight may decrease risk of
advanced breast cancer by half
Nationwide survey findings underscore
challenges, identify actions
in addressing healthcare-associated infections
Tests reveal high chemical levels in kids’
bodies
Michelle Hammond and Jeremiah Holland were
intrigued when a friend at the Oakland Tribune asked
them and their two young children to take part in a
cutting-edge study to measure the industrial chemicals in
their bodies. Fascination soon changed to fear, as tests
revealed that their children, Rowan, then 18 months, and
Mikaela, then 5, had chemical exposure levels up to seven
times those of their parents. “[Rowan's] been on this planet
for 18 months, and he’s loaded with a chemical I’ve never
heard of,”
Holland
said. “He had two to three times the level of flame retardants
in his body that’s been known to cause thyroid dysfunction in
lab rats.” The technology to test for these flame retardants,
known as polybrominated diphenyl ethers (PBDEs), and other
industrial chemicals is less than 10 years old.
Environmentalists call it “body burden” testing, an allusion
to the chemical “burden”, or legacy of toxins, running through
our bloodstream. Scientists refer to this testing as “biomonitoring”.
Most Americans haven't heard of body
burden testing, but it’s a hot topic among environmentalists
and public health experts who warn that the industrial
chemicals we come into contact with every day are accumulating
in our bodies and endangering our health in ways we have yet
to understand. “We are the humans in a dangerous and unnatural
experiment in the
United States,
and I think it’s unconscionable,” said Dr. Leo Trasande,
assistant director of the Center for Children’s Health and the
Environment at the Mount Sinai Medical Center in New York
City. Dr. Trasande said that industrial toxins could be
leading to more childhood disease and disorders. “We are in an
epidemic of environmentally mediated disease among American
children today,” he said. “Rates of asthma, childhood
cancers,
birth defects and developmental disorders have exponentially
increased, and it can't be explained by changes in the human
genome. So what has changed? All the chemicals we’re being
exposed to.” Elizabeth Whelan, president of the American
Council on Science and Health, a public health advocacy group,
disagrees. “My concern about this trend about measuring
chemicals in the blood is it’s leading people to believe that
the mere ability to detect chemicals is the same as proving a
hazard, that if you have this chemical, you are at risk of a
disease, and that is false,” she said. Whelan contends that
trace levels of industrial chemicals in our bodies do not
necessarily pose health risks.
In 2004, the
Hollands
became the first intact nuclear family in the United States to undergo body
burden testing. Rowan, at just 1½ years old, became the youngest child in
the U.S. to be tested for chemical exposure with this method. Rowan’s
extraordinarily high levels of PBDEs frightened his parents and left them
with a looming question: If PBDEs are causing neurological damage to lab
rats, could they be doing the same thing to Rowan? The answer is that no one
knows for sure. In the three years since he was tested, no developmental
problems have been found in Rowan’s neurological system. Dr. Trasande said
children up to six years old are most at risk because their vital organs and
immune system are still developing and because they depend more heavily on
their environments than adults do. “Pound for pound, they eat more food,
they drink more water, they breathe in more air,” he said. Studies on the
health effects of PBDEs are only just beginning, but many countries have
heeded the warning signs they see in animal studies. (CNN) For more
information see
THIS LINK

FDA expands age range
for use of bacterial meningitis vaccine
The U.S. Food and Drug Administration expanded the approved age range for
Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10
years. Menactra was first approved by FDA in January 2005 for people ages 11
to 55 years. Previously, Menomune was the only meningococcal vaccine
available in the United States for use in children, ages 2 years and older.
Both products are manufactured by sanofi pasteur Inc. of Swiftwater, PA.
Both vaccines offer protection against four groups of Neisseria meningitidis,
the bacterium that can cause meningitis.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP) currently recommends meningococcal vaccination
for children ages 2 to 10 years who are at increased risk of developing
meningococcal disease, such as those who have had their spleen removed or
whose spleen is not functioning; those with a medical condition called
terminal complement component deficiency which makes it difficult to fight
infection; and those who expect to travel to areas outside of the United
States where the disease is common. Vaccination also is used to control
outbreaks of bacterial meningitis.

Internists endorse 2007-08 adult
immunization schedule
and publish in Annals of Internal Medicine
The American College of Physicians (ACP), with membership of 124,000
internal medicine physicians (internists), related subspecialists, and
medical students, endorses the Centers for Disease Control’s (CDC) adult
immunization schedule for 2007-2008 and publishes the recommendations on the
Web site of its flagship journal, Annals of Internal Medicine, on
October 18. This is the first time the journal has published the
recommendations. The CDC has released the Recommended Adult Immunization
Schedule each year since 2002 to guide physicians and other clinicians about
the appropriate vaccines for their adult patients. The schedule does not
include travel-related vaccines. “Vaccines and immunizations are not just
for kids,” said Sandra Fryhofer, MD, a member of the ACP Adult Immunization
Advisory Board and an
Atlanta
physician in private practice. “And flu shots aren’t the only vaccines
adults should get.” New information in this year’s adult immunization
schedule: Vaccination for varicella (chickenpox) is now recommended for all
adults with no evidence of immunity to varicella; Vaccination for zoster
(shingles) has been added to the list of vaccines for adults age 60 or
older, regardless of whether they report having a prior episode of shingles.
“Physicians should be aware of the
schedule, know that it has been recently updated and advise their patients
of the appropriate vaccines. Patients should ask their physician about adult
immunization and what vaccines are appropriate for them,” said Dr. Fryhofer.
To reinforce the importance of the adult immunization guidelines, ACP will
notify its members of the guidelines through its monthly magazine, ACP
Observer. The organization hopes to make the full text of the guidelines and
chart available at Internal Medicine 2008, ACP’s annual scientific meeting,
in
Washington, DC. In an accompanying editorial, Gregory A. Poland, MD, and
William Schaffner, MD, also members of ACP’s Adult Immunization Advisory
Board, point out the almost 50,000 Americans die of vaccine-preventable
diseases each year and that 99 percent of them are adults. They say that it
will be difficult to achieve the same level of success in adult immunization
as the U.S. childhood immunization program, but actions such as endorsement
by the American College of Physicians and publication in Annals of
Internal Medicine are “an important step.” The new schedule,
“Recommended Adult Immunization Schedule. United States October
2007-September 2008,” appears online at the Web site of Annals of Internal
Medicine
www.annals.org.
It will be published in the
Nov. 20, 2007,
print edition of the journal.

Breast cancer calculator clarifying the
unknown
A new service is available to help women work out
whether they have an increased risk of getting breast cancer. It is an
online calculator and its aim is to give women earlier diagnosis and
treatment. The increase in the incidence of breast cancer has been blamed on
everything from stress to underarm deodorant. Dr Helen Zorbas of the
National Breast Cancer Centre says many women are confused about what puts
them at risk of developing the illness. “One in three women think that a
knock or bump to the breast increases their risk significantly yet they
don’t believe that alcohol poses any risk for breast cancer,” she said.
At today’s annual pink ribbon breakfast, the National Breast
Cancer Centre launched a new interactive risk calculator. Women are asked
about a range of factors including age, family history, alcohol intake and
use of hormones. While nothing can be done about some risk factors, 15
percent of breast cancers could be avoided by reducing alcohol intake and
boosting exercising. The calculator is being run by the national breast
cancer center on their web site, www.nbcc.org.au. Meanwhile, scientists say
a new research collaboration could see survival rates for many cancers
increase. Michelle Haber from the Children’s Cancer Institute says the Lowy
Cancer Centre is an Australian first, bringing childhood and adult cancer
research together at the one site. “The vision of the Institute is to work
to curing 100 percent of children diagnosed with cancer,” she said. The
facility will be one of the largest research centers in the southern
hemisphere. (ABC News)

The asterisk on cancer deaths
There was good news about
cancer
last week, a report that death rates in the United States have begun falling
by 2.1 percent a year, nearly twice the rate of previous declines. But the
same report, by the
American Cancer
Society and other groups, also said certain cancers seem to be
becoming more common, not hugely so, but noticeable. Among those increasing
in men and women are myeloma and cancers of the thyroid and kidney. In
women, melanoma and cancers of the bladder have increased; in men so have
cancers of the liver and esophagus. Why? Experts point to a mixed bag of
facts, theories and educated guesses. One overarching culprit may be
America’s level of
obesity,
which has been linked to increased risk of several types of cancer,
including tumors of the kidney, liver and esophagus.
But
there are much stronger risk factors for liver cancer. The major ones are
the viruses that cause
hepatitis
B and C. In some people, those infections turn chronic and gradually lead to
tumors. A vaccine that can prevent hepatitis B is used routinely in the
United States. But not every country uses it, and liver cancer here may be
rising in part because of cases among immigrants. Hepatitis C is more of a
homegrown problem. There is no vaccine, and infections surged in the 1960s
and 1970s among drug users who shared needles. The virus then spread into
the blood supply and may have infected tens of thousands of transfusion
recipients before a test was developed to screen donated blood. Liver cancer
is still turning up in people infected decades ago. When it comes to thyroid
cancer, researchers do not know whether the incidence of the disease is
actually increasing, or simply being diagnosed more often because of
improved tests. But it is a cause for concern. Increases in kidney cancer
can probably be traced mostly to increased detection. As for melanoma, the
increases probably come from both better detection and a real rise in cases
due to sun exposure, researchers said.
Smoking
raises the risk of bladder cancer. Rates in women may be rising because they
started smoking, and quitting, later than men did, said Elizabeth Ward,
director of cancer surveillance for the American Cancer Society. There has
been a similar trend with lung cancer. But over all, men have much higher
rates of bladder cancer, possibly due to higher smoking rates and chemical
exposures on the job. Trends in myeloma, a bone marrow cancer, have
researchers puzzled. “It could be improvements in diagnosis,” Dr. Ward said.
“It bears looking into, though, because it is more common in blacks than
whites, and I don’t think we have a huge amount of knowledge about risk
factors.” (The New York Times) To read the original article see
THIS LINK

Exposure to sunlight may decrease risk
of advanced breast cancer by half
A
research team from the Northern California Cancer Center, the University of
Southern California, and Wake Forest University School of Medicine has found
that increased exposure to sunlight, which increases levels of vitamin D in
the body, may decrease the risk of advanced breast cancer. In a study
reported online in the American Journal of Epidemiology, the
researchers found that women with high sun exposure had half the risk of
developing advanced breast cancer, which is cancer that has spread beyond
the breast, compared to women with low sun exposure. These findings were
observed only for women with naturally light skin color. The study defined
high sun exposure as having dark skin on the forehead, an area that is
usually exposed to sunlight.
The scientists used a portable reflectometer to measure skin color
on the underarm, an area that is usually not directly exposed to sunlight.
Based on these measurements, they classified the women as having light,
medium or dark natural skin color. Researchers then compared sun exposure
between women with breast cancer and those without breast cancer. Sun
exposure was measured as the difference in skin color between the underarm
and the forehead. In women with naturally light skin pigmentation, the group
without breast cancer had significantly more sun exposure than the group
with breast cancer. The fact that this difference occurred only in one group
suggests that the effect was due to differences in vitamin D production, and
wasn’t just because the women were sick and unable to go outdoors. In
addition, the effect held true regardless of whether the cancer was
diagnosed in the summer or in the winter. The difference was seen only in
women with advanced disease, suggesting that vitamin D may be important in
slowing the growth of breast cancer cells. “We believe that sunlight helps
to reduce women’s risk of breast cancer because the body manufactures the
active form of vitamin D from exposure to sunlight,” said Esther John,
Ph.D., lead researcher on the study from the Northern California Cancer
Center. “It is possible that these effects were observed only among light-
skinned women because sun exposure produces less vitamin D among women with
naturally darker pigmentation.”
These new findings about breast cancer risk and sun exposure based on skin
color measurements are consistent with previous research by John and
colleagues that had shown that women who reported frequent sun exposure had
a lower risk of developing breast cancer than women with infrequent sun
exposure. The researchers stressed that sunlight is not the only source of
vitamin D, which can be obtained from multivitamins, fatty fish and
fortified foods such as milk, certain cereals and fruit juices. Women should
not try to reduce their risk of breast cancer by sunbathing because of the
risks of sun-induced skin cancer, they said. “If future studies continue to
show reductions in breast cancer risk associated with sun exposure,
increasing vitamin D intake from diet and supplements may be the safest
solution to achieve adequate levels of vitamin D,” said Gary Schwartz,
Ph.D., a co-researcher from the Comprehensive Cancer Center at Wake Forest
University School of Medicine. “Since many risk factors for breast cancer
are not modifiable, our finding that a modifiable factor, vitamin D, may
reduce risk is important,” said Sue Ingles, Ph.D., a co-researcher from
University of Southern California Keck School of Medicine.

Nationwide survey findings underscore challenges,
identify actions in addressing healthcare-associated infections
Hospital professionals identified tracking infections across the entire
hospital, and the control of resistant organisms, as their top challenges
related to managing healthcare-associated infections (HAIs), according to a
survey of over 800 hospital clinicians involved in infection prevention. (To
access survey results, please visit
www.premierinc.com/quality-safety/tools-services/safety/news/).
Survey respondents, which include quality, safety, risk management and
infection control professionals representing all sizes of hospitals, also
identified measuring compliance with hand hygiene and state mandated public
reporting as major challenges.
Respondents cited catheter-associated urinary tract infections (49 percent)
and pressure ulcers (30 percent) as the most challenging to prevent among
infections identified by the Centers for Medicare and Medicaid Services
(CMS) for non-payment in 2008. Under current payment rules, CMS typically
pays hospitals more for treating a patient who develops an infection. CMS
announced that, beginning October 1, 2008, it will no longer reimburse
hospitals for treating certain preventable conditions, including errors,
injuries and infections that occur in hospitals. “This is an important
assessment of what infection control and quality experts see as their
greatest clinical challenges in managing hospital-acquired conditions,” said
Premier Safety Institute Vice President Gina Pugliese. “The Premier
healthcare alliance will be using this information to continue working with
experts in hospitals on steps and best practices to address all causes of
infection.”
The survey also found inadequate staffing for infection prevention (47
percent) and funding and budget constraints (34 percent) to be the most
significant issues their hospitals face in meeting current infection
prevention challenges. “This finding underscores that healthcare
professionals are dealing with a variety of competing demands in working to
prevent healthcare-associated infections,” said Blair Childs, Premier’s
senior vice president of Public Affairs. “To date, 26 states have public
reporting requirements that are placing new demands on hospitals, the new
‘present on admission’ coding system mandated by CMS needs to be
implemented, and there are new reporting requirements from government and
accreditation organizations. These demands are complicating what is already
a significant task of monitoring and preventing HAIs.”
Hospitals are clearly turning to technology as a way to manage these
demands. More than 22 percent of respondents currently utilize an automated
surveillance system, up from 13 percent in February. An additional 47
percent of respondents are actively considering implementing this
technology, shown to make surveillance more efficient and to free up time
for prevention activities. “More and more hospitals are starting to use
automated surveillance systems to accomplish timely and efficient tracking
of HAIs across the entire patient population,” said Dan Peterson, M.D.,
M.P.H., medical advisor for Premier. “Such systems are also key to meeting
the ever increasing regulatory, reporting, and accreditation requirements
around infection prevention.”

October
19, 2007
Download print version
HPN
to recognize “Supply Chain-Focused CEOs”
WSJ: Heart wires may pose more risk for the
young
AHRMM Launches a Salary Compensation Survey
Grading
New York
City’s public hospitals
HPV test beats Pap in detecting cervical
cancer
Alarming MRSA infection rates underscore need
for public reporting
of hospital-acquired infections
Billions per year lost in empty hospital beds,
research shows
HPN to recognize “Supply Chain-Focused CEOs”
Many industries outside of healthcare recognize and respect the
value that effective and efficient supply chain management
contributes to the top and bottom lines. Among healthcare
providers, such recognition and support is growing, slowly but
surely, from the top post in the executive suite. That’s why
Healthcare Purchasing News
launched its yearly search for “supply chain focused CEOs"
three years ago. We wanted to locate forward-thinking men and
women to share their insights with you, and you’ve helped us
do that. In fact, we’ve profiled of 10 of them already since
January 2005.
Well, it’s that time of the year again – time to nominate
noteworthy hospital presidents/CEOs for HPN’s fourth annual “S.U.R.E.
Award for Supply Chain Focused CEOs” award. We’re looking to recognize chief
executives who support, understand, recognize and
empower the materials management department to do what needs to be done
to achieve bottom-line savings and top-line revenue. We ask you, our
dedicated readers, to recommend worthy candidates for recognition in our
January 2008 edition by e-mailing us reasons how and why they deserve the
spotlight – no more than a couple of paragraphs are needed for each of the
four S.U.R.E. categories listed above that comprise the “SURE” acronym.
For your nomination to qualify, please be sure to comply with the
following rules:
1. Any nomination must be original and exclusive to HPN and
not have been submitted, either original or edited, to any other publication
or online media outlet currently or within the previous year.
2. GPO and distributor support is commendable, but we’re looking
for internally driven details beyond GPO- and distributor-driven
contributions.
3. Any nominated executive (or nominator) must be willing to share
relevant basic financial details with our readers, including annual
revenues, annual expenses and annual purchasing volume.
Help us share the stories of these remarkable CEOs in our January
2008 edition so that the industry may learn from them and be inspired.
Thanks in advance.
E-mail us your nominations
by Wednesday, November 14,
to
editor@hpnonline.com.

WSJ: Heart wires may pose more risk for the young
The defibrillator leads pulled off the market this week by Medtronic Inc.
may pose a higher risk of fracture in younger adults and children, a
population for whom the devices were particularly popular in part because of
their small diameter. Children make up a relatively small share of patients
who receive the implanted devices. But leads tend to come under greater
stress in more-active people, including kids, adolescents and younger
adults. Monday, Medtronic, based in
Minneapolis,
announced it would stop selling its Sprint Fidelis leads because of a risk
of fractures that could erroneously dispatch jolts of electricity. The
company said that of the 268,000 Sprint Fidelis leads implanted, 2,085 were
in patients under the age of 21. About 235,000 patients still have the
leads, and the company said the fractures may have contributed to five
deaths. The deceased patients’ ages haven’t been made public. Preliminary
data from physicians at 32 institutions who specialize in treating pediatric
patients and adults with congenital heart disease showed a fracture rate of
6.7% among 569 patients with Sprint Fidelis leads over 30 months. The “vast
majority” of the patients are likely to be under the age of 21, given the
physicians involved, said Wayne H. Franklin, an associate professor at
Northwestern
University’s Feinberg School of Medicine, who gathered the physician
reports.
Medtronic has reported a lower failure
rate, 2.3% after 30 months, for all patients implanted with one particular
Sprint Fidelis model. For that same model, Dr. Franklin saw a fracture rate
of 4.9% among 304 patients in his survey. The real difference may be
slightly greater, because the failure rate from Medtronic includes more than
just fractures. “It’s fairly concerning,” said Dr. Franklin, a pediatric
cardiac electrophysiologist. He began gathering the data from colleagues
belonging to a society of similar specialists after leads in two of his own
young patients fractured, leading to shocks. He and other doctors say that
despite the potentially higher risk for young people, they aren’t currently
suggesting patients replace the wires pre-emptively, which involves surgery
that can carry more risk than that of a lead's fracturing. They said they
will urge young patients to monitor their leads closely. They also say they
don't have pediatric data for other leads; all lead models tend to have
higher fracture rates in young patients. If a lead is found to be fractured,
patients can have the lead extracted or a new lead may be able to be
threaded through the same vein.
“To actually remove one of these things is not just difficult, but
can be dangerous,” said George Van Hare, a professor at Stanford Medical
School who knows of two fractures among 40 pediatric patients who got Sprint
Fidelis leads at his center. The center gets some research and training
funding from Medtronic, and he consults for one rival device maker. When a
lead fractures, patients can get unnecessary and massive shocks, or not get
the shock when they need it to save their lives after cardiac arrest. Dr.
Franklin's data add to those released Monday by Medtronic. Doctors say the
Sprint Fidelis leads were especially useful in children, adolescents and
young adults because of their narrow girth, which made them easier to thread
into small veins. They also left space for replacement leads as patients
needed updates over time. A lead prone to fracture might break more often in
younger, more active people, whose hearts beat faster and place more stress
on the leads. Even at rest, children’s hearts tend to beat more quickly than
those of adults. (Source: The Wall Street Journal) To read the original
article see
THIS LINK

AHRMM launches a Salary Compensation Survey
The
Association for Healthcare Resource & Materials Management (AHRMM) is
conducting a Salary Compensation Survey designed specifically for the
healthcare supply chain. The survey will help professionals measure,
identify, and compare current industry trends and demographics to better
determine their fair market value. To participate in AHRMM’s Salary
Compensation Survey, please click on the link below. The entire survey
should only take about 10 minutes to complete. Note: information gathered
is strictly confidential. Data will be reported in aggregate, not
individually.
http://www.surveymonkey.com/s.aspx?sm=Bxb4Hxb0UDPp6hgmeakuEg_3d_3d
Once
AHRMM has compiled the data, the association will generate both general and
customized reports of the findings, including a professional's market value
when compared to like facilities, job titles, geographical areas,
responsibilities, and more. General salary survey reports will be available
to AHRMM members for free and to non-members for $49.95. Customized reports,
based on selecting specific variables, will be available to AHRMM members
for $49.95 and to non-members for $79.95. Instructions for ordering both
reports will come from AHRMM in early 2008. To complete the survey see
THIS LINK

Grading
New York City’s
public hospitals
New York City
is a world of infinite decisions: Japanese or Vietnamese, a ball game or the
opera and the subway or a cab. Some decisions, though, involve more serious
matters. Selecting a hospital is one. But now New Yorkers trying to decide
whether to go to
Coney Island
Hospital or Kings County Hospital Center have a little more information to
guide them. Last month on its Web site, the city’s Health and Hospitals
Corporation voluntarily released infection and mortality rates for each of
its 11 public hospitals. It was the first hospital system in the state to do
so, said the corporation’s chief executive officer and president, Alan D.
Aviles. The data, which is accessible at
THIS LINK, compares the corporation’s facilities with regional and
national averages and allows New Yorkers to analyze and compare hospital
against hospital. Hailed by healthcare advocates for casting light on a
secretive industry, the release of this data has shifted attention to the
perception of public hospitals and their ability to provide quality care in
all five boroughs. Although the corporation’s acute care facilities score
above state and national averages, a familiar discrepancy emerges within its
own network: Hospitals in lower income areas tend to do worse than those in
higher income areas.
Although most of the information the
corporation has posted on its Web site is regurgitated from either the state
or federal hospital reporting system (which are also available online
federally and on the
state level),
the corporation added specific mortality data on each hospital and
statistics on infections acquired in hospitals. Since the corporation took
this step last month, another
New York
hospital–North
Shore Long Island Jewish Health System, has already followed its
lead.
New York
State began releasing
hospital mortality data
on coronary bypass surgery in the late 1980s. Then, the public information
movement stalled. In 2005, the state
legislature approved more rigorous reporting standards, which
would result in the release of hospital report cards and hospital-related
infection rates in 2009. Those regulations are currently being rolled out.
The Health and Hospitals Corporation’s voluntary release of its data puts it
a step ahead of the state statute.
Overall, the corporation’s hospitals have
average mortality rates that are better than state, regional and federal
averages. However, its average mortality rate following heart attacks is
slightly worse than the statewide figure, the corporation had 15.8 patients
die within 30 days of a heart attack from July 2005 to June 2006, while the
statewide average is 15.6. For heart failure, based on the same 30-day
measure in the same time period, the corporation scored better than the
statewide average, 10.6 compared to 11. Data on the death rates from heart
failure and heart attacks were provided by the federal Centers for Medicare
and Medicaid Services, which take into account only Medicare patients. Those
patients, said
Aviles,
comprise just 15 percent of the corporation’s patient base. When comparing
the corporation’s 11 hospitals, a familiar outcome is apparent: Facilities
in the outer boroughs and in more impoverished neighborhoods have higher
mortality rates than those in Manhattan. “Quite frankly, we’re talking about
the hospitals in the outer boroughs and the health of the communities is
often poorer,” said Aviles. “There are more patients with low incomes, that
are uninsured,” he added. For
hospital wide mortality
rates, the lowest ranking facilities, Coney Island Hospital in
Brooklyn at 3.14 percent, Kings County Hospital Center in Brooklyn at 1.72
percent and Elmhurst Hospital Center in Queens at 1.64 percent, are all
located in the outer boroughs. The hospital wide mortality rates are not
risk adjusted,
Aviles
said, and so do not take into account the types of patients or trauma seen
at each location. (Gotham Gazette) To read the original article see
THIS
LINK

HPV test beats Pap in detecting cervical cancer
A new
study led by
McGill
University researchers shows that the human papillomavirus (HPV) screening
test is far more accurate than the traditional Pap test in detecting
cervical cancer. The first round of the Canadian Cervical Cancer Screening
Trial (CCCaST), led by Dr. Eduardo Franco, Director of the Division of
Cancer Epidemiology at McGill's Faculty of Medicine, concluded that the HPV
test's ability to accurately detect pre-cancerous lesions without generating
false negatives was 94.6%, as opposed to 55.4% for the Pap test. The results
of the study, first-authored by Dr. Franco’s former McGill PhD student Dr.
Marie-Hélène Mayrand of the Centre hospitalier de l'Université de Montréal
(CHUM), with colleagues from McGill, Université de Montréal, the
Newfoundland and Labrador Public Health Laboratory and
McMaster
University, are published in the October 18 issue of The New England
Journal of Medicine.
CCCaST is
the first randomized controlled trial in North America of HPV testing as a
stand-alone screening test for cervical cancer. The first round followed
10,154 women aged 30 to 69 in
Montreal,
Quebec and St. John’s, Newfoundland who were enrolled in the study from 2002
to 2005. The study was funded by a grant from the Canadian Institutes of
Health Research (CIHR). The study concluded that while the HPV test's
sensitivity was nearly 40% greater than the Pap test’s, the Pap did,
however, slightly edge out HPV for accuracy on the specificity scale, its
ability to accurately detect pre-cancerous lesions without generating false
positives, at 96.8% versus 94.1%. “We already knew before conducting this
study that the sensitivity of Pap left a lot to be desired,” said Dr.
Franco, James McGill Professor in the Departments of Oncology and
Epidemiology and Biostatistics, and Director of the Division of Cancer
Epidemiology at McGill University's Faculty of Medicine. “However, 55.4%
accuracy is only slightly above chance. Flipping a coin gives you 50%.”
Though the
results of the CCCaST study might have a bearing on the ongoing debate about
vaccinating young women against HPV, Dr. Franco stressed that the two issues
should be considered separately. “Vaccination is primary prevention; this
study is about secondary prevention, which refers to screening. Even women
who take the vaccine will still need to be screened, because the vaccines
that are available now only prevent about 70% of all cervical cancers, and
they're primarily for young women. The HPV test may be ideal for vaccinated
women once they reach screening age, because it gives us an opportunity to
monitor the protection that the vaccine is supposed to give them.” Dr.
Franco added that, while the HPV screening test is now more expensive than a
Pap test, that will likely change over time. “Moreover, because of its
higher sensitivity and only slightly lower specificity, patients would only
require an HPV test once every three years instead of annually, as is
necessary with the Pap test.”

Alarming MRSA infection rates underscore need for public
reporting
of hospital-acquired infections
A new study that estimates nearly 19,000 Americans died in 2005
from a virulent, antibiotic-resistant infection acquired mostly in the
hospital underscores the need for Congress to require public reporting of
patient infection rates, according to Consumers Union, the nonprofit
publisher of Consumer Reports. The study by researchers at the Centers for
Disease Control and Prevention (CDC) concluded that almost 95,000 people
developed Methicillin-resistant Staphylococcus aureus (MRSA) infections that
year, and that 85 percent of the infections were acquired in health care
settings. “Every day, fifty Americans die from MRSA because hospitals aren't
doing enough to protect patients from these deadly infections,” said Lisa
McGiffert, Director of Consumers Union’s Stop Hospital Infections campaign (http://www.StopHospitalInfections.org).
“The public deserves to know which hospitals are doing a good job preventing
infections and keeping patients safe.”
HR 1174, a bipartisan measure sponsored by Rep. Tim Murphy, R-PA,
would require the public reporting by hospitals and surgical centers of one
or more types of healthcare-acquired infections. Under the bill, the
Secretary of Health and Human Services would determine which of the major
types of infections would need to be reported. HHS would submit an annual
report to Congress on steps being taken to reduce infections, and there
would be a pilot program to assist certain hospitals in developing
anti-infection programs. “By making infection rates public, HR 1174 will
encourage hospitals to improve patient care and ultimately save lives and
dollars,” said McGiffert. Earlier this week, Consumers Union called on
hospitals nationwide to disclose their hand hygiene compliance rates. For
more information see
THIS LINK or THIS
LINK

Billions per year lost in empty hospital beds, research
shows
The average 300-bed hospital can net $10 million a year in new
revenue by adding just 12 turnovers per bed, a healthcare industry
researcher told a record 200 U.S and Canadian attendees during a
TeleTracking Technologies international client conference last week in
Naples, FL. Other items which came to light during the conference: The
average hospital can treat more than 3,500 additional patients by
eliminating ‘lost bed days’ through more efficient management of bed turns;
the impact of overcrowding on patient safety is becoming increasingly
important to hospitals; patient flow technology is playing a greater role in
disaster planning.
Keynote speaker Erik Johnson, managing director of The Advisory
Board Company’s IT Insights Division, showed detailed research on the
potential return on investment delivered by improved patient flow. Johnson
said increasing the turnovers of each bed from 49.7 per year (the 40th
percentile ranking nationally) to 61 per year (the 75th percentile) can
increase revenue potential in a 300-bed hospital by over $10 million per
year and allow 3,500 more admissions without adding more beds. While the
financial impact is compelling, said TeleTracking CEO Anthony M. Sanzo,
better patient flow more importantly means better patient care. “Unless we
are willing to make improved patient flow a top industry priority, we cannot
say that we are committed to delivering the highest possible care to the
communities we serve,” Sanzo said.

October
18, 2007
Download print version
As cases arise, schools act to ward off virulent
staph
Staph infections hit
Florida high
school
Tests of heart devices to get review
FDA approves new HIV drug; Raltegravir tablets
used in combination with other antiretroviral
agents
Malaria vaccine is safe, immunogenic and
efficacious in young infants
FDA approves new drug to treat complicated
urinary tract and intra-abdominal infections
B. Braun and Premier renew agreement for
Introcan Safety IV Catheter
As cases arise, schools act to ward off
virulent staph
As national
estimates focus on an increase in serious infections caused by
an antibiotic-resistant germ, officials in the Washington,
D.C., region have identified more than a dozen cases among
students and are organizing extensive cleanups of numerous
schools, reported The Washington Post. The confluence
of circumstances, highlighted by the death of a teenager this
week in
Bedford
County,
VA, has put
administrators and parents on edge and pushed the superbug,
methicillin-resistant staphylococcus aureus, into the
forefront of public attention. As of yesterday,
Montgomery County,
MD, schools
had 14 cases, and lab results were pending in two dozen
suspected cases.
Anne
Arundel County schools have recorded one MRSA
infection and have received 57 reports from parents about
possible cases. Two cases have been confirmed at
Wilde
Lake High School in
Howard
County.
Administrators in several jurisdictions have sent notices to
parents about steps that school systems are taking. Some have
adopted policies that include requiring gym equipment to be
wiped down after use. In
Arlington County, school nurses are giving
information to students about how to care for cuts. Just
beyond
Northern Virginia, the Rappahannock County school
system recently finished a comprehensive cleaning of its two
campuses. One of that system’s two MRSA cases involved a high
school athlete who was hospitalized after his diagnosis.
Rappahannock hired a company to clean locker and weight rooms
and sent all football equipment to
Philadelphia to be professionally washed.
Rappahannock Superintendent Bob Chappell said school employees
also followed a local hospital’s advice to mop hallways and
classrooms with a bleach solution. The cost of the cleanup:
more than $10,000.
“What’s clear to us is that this bacteria is coming
into our schools from the community because the cases are so
widespread, and there appears to be no pattern,” said
Montgomery schools spokesman
Brian
Edwards. All 14
Montgomery students with confirmed infections have been treated and
are doing well, county Health Officer Ulder Tillman said. The
first of those cases occurred in June with a member of the
Sherwood High School football team; in August, diagnoses were
confirmed in six of his teammates. The remaining students
attend four other high schools and three elementary schools.
With the sudden rise in cases, Tillman and
Superintendent Jerry D. Weast sent a letter
yesterday to Montgomery parents outlining the problem and
steps they can take to prevent infection.
School officials in
Prince
George’s County said they have had no confirmed
cases of MRSA. Because of reports in other jurisdictions, they
have begun cleaning locker rooms and showers with a
hospital-grade disinfectant. A
D.C.
Health Department epidemiologist said no MRSA cases
have been identified in the city’s public schools this fall.
But officials are counting cases diagnosed in District
hospitals. Five facilities, including Children’s Hospital,
logged more than 1,300 confirmed cases between December and
September. “They come in from all over,” said Nalini Singh,
chief of the infectious diseases division at Children’s
Hospital.
Few jurisdictions mandate MRSA reporting, although
Maryland is working on a system to track and
publicly disclose infections in hospitals and other healthcare
institutions. An advisory committee is to release its report
on implementation in November, and the collection of data from
hospitals is expected to begin next year. By then, more than
three dozen facilities in Maryland, the District and Northern
Virginia will be involved in a national project to encourage
common-sense approaches to block MRSA in institutional
settings. Some surprising measures are being put into
practice. Clergy visiting patients are covering their Bibles
with surgical caps, and housekeeping employees are testing
their thoroughness with glow-in-the-dark chemicals.
(Washington Post) To read the complete article see
THIS LINK

Staph infections hit
Florida high
school
Florida Department of Health workers have told
staff and students at
Hardee
High School in Wauchula to be on alert. Five junior varsity football players
have been diagnosed with staph infections, and one of the players was left
fighting for his life. ABC 7 spoke with the family of Jonathon Kelly
Wednesday night. They said this has been a very scary experience for them,
and it started with a scab on Jonathon's elbow that wouldn’t heal. It wasn’t
long after that he was rushed by ambulance to the hospital. Five JV football
players at Hardee High School diagnosed with staph infections, one of the
players girlfriend’s, and now maybe a family member of one of the players.
But 15-year-old Jonathon Kelly’s case is the worst so far. He was diagnosed
first with a staph infection, then MRSA. Then he had an allergic reaction to
the antibiotics, causing Stevens Johnson’s Syndrome, and put his life on the
line. “His staph infection triggered that which made his whole body break
out into lesions. He had sores all up and down his arms and legs and it was
really difficult for him to breathe because the mucus linings of his lungs
and trachea got attacked.”
Jonathon's older brother James says he was taken by ambulance to
the intensive care unit at children's hospital in
St.
Petersburg. “He couldn’t open his eyes. It hurt him to talk. He couldn’t
move without being in pain.” The CDC in
Atlanta
has contacted the Kelly family to track what appears to be the latest in a
nationwide spike in staph infections. In the meantime, the Florida
Department of Health is urging everyone at
Hardee
High School to practice good hygiene, properly cover all cuts and abrasions,
and seek medical treatment for any wounds that appear infected. Advice the
Kelly family wishes Jonathon had before. Jonathon's family says he is
getting better, but they don’t know when he'll be released from the
hospital. But even after that, doctors tell them Jonathon’s immune system is
too weak to return to school for at least two months. (My Suncoast.Com) See
THIS LINK

Tests of heart devices to get review
The
Food and Drug
Administration is likely to study whether to require more
extensive tests of critical heart-device components before they are sold, as
a result of
Medtronic’s
recent problems with such a product, an agency official said yesterday. “We
are going to be looking at this to see whether the failure can help us
design better tests,” said the official, Megan Moynahan. Moynahan, a branch
chief at the F.D.A.’s Center for Devices and Radiological Health, said the
agency would examine whether the stress tests it currently required were
sufficient to catch problems with the leads. On Sunday, Medtronic urged
doctors to stop using a family of leads called Sprint Fidelis because they
were prone to cracking, with potentially life-threatening consequences like
firing repeatedly and unnecessarily, or not sending a jolt when needed. The
company has said it thinks at least five patients might have died because of
the flaw and that 4,000 to 5,000 patients would encounter problems with the
leads, which would force them to undergo potentially risky replacement
procedures. An estimated 235,000 patients are thought to have Sprint Fidelis
leads.
Questions have been raised both about whether Medtronic acted quickly enough
in stopping use of the leads and about whether the agency sufficiently
scrutinized the Sprint Fidelis before approving it in 2004 and after it
reached the market. Late Tuesday, Senator
Charles E. Grassley,
Republican of Iowa, sent letters to officials at Medtronic and the agency
that he wanted them to meet with members of his staff to discuss their
handling of the situation. “What I found troubling is that Medtronic took
months to stop the sales of the faulty lead, even though the problem had
been reported in a peer-reviewed journal months prior,” he wrote to
Medtronic. Officials of Medtronic, which is based in Minneapolis, have
insisted that they acted prudently and halted sales of the product even
though they said the data they had about the product’s fracture rate was
equivocal.
Dr. Robert J. Myerburg, a professor of medicine at the
University of Miami
who headed an outside panel that issued a report in 2006 that was highly
critical of Guidant’s handling of problems related to defibrillators, said
it was difficult to judge how Medtronic handled the issue without knowing
more information. For example, Dr. Myerburg said he would want to know how
the company’s anticipated rate of failure for the Sprint Fidelis compared
with the reality. A Medtronic spokesman has said it anticipated that the
Sprint Fidelis would perform at least as well as older leads. As for the
F.D.A., Moynahan said that although the agency had required Medtronic to
test an earlier version of a defibrillator lead in patients before approval,
it had not required the company to do so for the Sprint Fidelis. That was
because it the agency had determined that the Sprint Fidelis was not a
significant, or “generational,” change in product design, she said.
The Sprint Fidelis lead is thinner than the earlier version, the
Sprint Quattro, which has performed very well. Several experts have said the
thinner design of the Fidelis model is probably what makes it less durable
and more prone to fracturing. Before approving it, the agency did not require clinical testing of the Fidelis.
Moynahan said she believed that clinical tests would not have identified the
problem, because the number of patients in the study group would have been
too small and because the fracture problems developed well after
implantation. Instead, the F.D.A. required the product to pass only tests
intended to identify design flaws. Those were principally mechanical stress
tests meant to recreate the pressures in the body. Because the Fidelis
passed those tests, Moynahan said, the agency must review why the tests did
not pick up the problem. (The New York Times) To read the original article
see
THIS LINK

FDA approves new HIV drug; Raltegravir tablets
used in combination with other antiretroviral agents
The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets
for treatment of Human Immunodeficiency Virus (HIV)-1 infection in
combination with other antiretroviral agents in treatment-experienced adult
patients who have evidence of viral replication and HIV-1 strains resistant
to multiple antiretroviral agents. Raltegravir is the first agent of the
pharmacological class known as HIV integrase strand transfer inhibitors,
designed to interfere with the enzyme that HIV-1 needs to multiply.
Raltegravir, sold under the trade name Isentress, received a priority review
by the FDA. “This is an important new product for many HIV-infected patients
whose infections are not being controlled by currently available
medications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for
scientific and medical programs, chief medical officer and acting director,
Center for Drug Evaluation and Research.
When used with other anti-HIV medicines, raltegravir may reduce the amount
of HIV in the blood and may increase white blood cells, called CD4+ (T)
cells, that help fight off other infections. FDA’s approval of raltegravir
is based on data from two double-blind, placebo-controlled studies in 699
HIV-1 infected adult patients with histories of extensive antiretroviral
use. A greater proportion of the patients who received raltegravir in
combination with other anti-HIV drugs experienced reductions in the amount
of HIV in the blood, compared with patients who received placebo in
combination with other anti-HIV drugs. Caution is advised when using
raltegravir in patients at increased risk for certain types of muscle
problems, including those who use other medications that can cause muscle
problems. Patients taking raltegravir may still develop infections,
including opportunistic infections or other conditions that may develop in
patients living with HIV-1 infection. The long-term effects of raltegravir
are not known, and its safety and effectiveness in children less than 16
years of age has not been studied. Raltegravir also has not been studied in
pregnant women.

Malaria vaccine is safe, immunogenic and efficacious in
young infants
Initial
findings from studies to test a malaria vaccine in African infants are
promising, conclude authors of an Article published early Online and in an
upcoming edition of The Lancet. Dr Pedro Alonso, Manhica Health
Research Centre, Mozambique, amd Hospital Clinic of the Universitat de
Barcelona, Spain, and colleagues, did a double-blind trial of 214 infants in
Mozambique to test the safety, immunogenicity, and efficacy of the malaria
vaccine RTS,S/AS02D. Children were randomly assigned to received three doses
of the vaccine or hepatitis B vaccine Energix-B (as a control) at ages 10
weeks, 14 weeks and 18 weeks, as well as routine immunisation vaccines given
at eight, 12, and 16 weeks of age. They found that the vaccine was safe (the
primary purpose of the trial), since there were no vaccine-related serious
adverse events in either the vaccine or control groups, nor an imbalance in
unsolicited adverse events between the two groups. Further, they found that
for children vaccinated, the risk of new contracting new malaria infections
reduced by 65%, compared with a previous efficacy of 45% reported in a trial
of children aged one to four years.
The authors point out that all study participants were provided with
free-insecticide-treated bednets and their homes were sprayed with
insecticide twice. They say: “The trial was undertaken in an area of high
transmission, but in the context of renewed and intense malaria control
activities; the future use and deployment of a malaria vaccine should be
seen in the context of comprehensive malaria control programmes.” They
conclude that the study provides evidence of a strong association between
vaccine induced antibodies and reduction of risk of malaria infection. They
say: “This is of great significance because up until now, immunogenicity was
a marker of response with no clearly proven relation to protection, which in
turn could only be established with a clinical trial. This finding needs to
be corroborated further in other trials, but this observation might be
important in the clinical development plan of this vaccine.”

FDA approves new drug to
treat complicated urinary tract and intra-abdominal infections
The U.S. Food and Drug Administration has approved doripenem injection, 500
mg intravenous infusion, for the treatment of complicated urinary tract and
intra-abdominal infections. Doripenem injection, sold under the trade name
Doribax, has been shown to be active against several strains of bacteria.
“This is a significant new drug in the treatment of hospitalized patients
with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy
commissioner for scientific and medical programs, chief medical officer and
acting director, Center for Drug Evaluation and Research. In several
multi-center, multinational studies, doripenem was shown to have a cure rate
comparable to the currently prescribed medications levofloxacin, for
complicated urinary tract infections, and meropenem, for complicated
intra-abdominal infections. The safety and effectiveness of doripenem
injection in pediatric patients have not been established. Doripenem has not
been studied in pregnant women, and the drug should be used during pregnancy
only if clearly needed. Doripenem injection is manufactured by Johnson and
Johnson Pharmaceutical Research and Development, LLC,
Raritan, NJ.

B. Braun and Premier renew agreement for Introcan Safety
IV Catheter
In a move to increase healthcare worker safety, B. Braun Medical Inc.
recently announced Premier Purchasing Partners, LP, the healthcare
purchasing unit of Premier, Inc., has renewed its agreement for B. Braun’s
line of safety IV catheters. B. Braun’s Introcan Safety IV Catheters are
designed with passive-safety features that automatically activate to help
minimize accidental needle-stick injury. The three-year contract went into
effect on October 1, 2007 and will complement Premier’s existing five-year
agreement encompassing all major B. Braun safe solutions. The passive
Introcan Safety IV Catheter is designed to minimize accidental needle-sticks
without requiring user activation – less stress, less injuries. A stainless
steel clip shields the needle tip. This passive design eliminates the risk
of inadvertent activation while offering a short learning curve with minimal
in-service training. Along with Introcan Safety IV Catheters, Premier
members will have access to B. Braun's safety-engineered infusion products
including the Outlook Safety Infusion System, ULTRASITE Needle-Free IV
System, Excel PVC-Free/DEHP-Free IV Containers, and DUPLEX Drug Delivery
System. For more information see THIS
LINK.

October
17, 2007
Download print version
CDC estimates 94,000 invasive drug-resistant staph
infections
occurred in the U.S. in 2005
Recent death, new research, point to community
presence
of invasive strains
California Governor vetoes hospital disclosure
proposal
Bacterial strain that causes ear infections
emerges;
resistant to antibiotics, pneumococcal vaccine
Financial relationships between industry and
medical schools,
teaching hospitals highly prevalent
Cefotetan available in ready-to-use IV
container;
B. Braun adds new antibiotics to DUPLEX System
CDC estimates 94,000 invasive
drug-resistant staph infections
occurred in the U.S. in 2005
Methicillin–resistant staph aureus (MRSA) caused more than
94,000 life–threatening infections and nearly 19,000 deaths in
the United States in 2005, most of them associated with
healthcare settings, according to the most thorough study of
life–threatening infections caused by these bacteria, experts
with the Centers for Disease Control and Prevention (CDC)
report. The study in the Oct. 17 edition of the Journal of
American Medical Association (JAMA) establishes the first
national baseline by which to assess future trends in invasive
MRSA infections. MRSA infections can range from mild skin
infections to more severe infections of the bloodstream, lungs
and at surgical sites.
The study found about 85 percent of all invasive MRSA
infections were associated with healthcare settings, of which
two–thirds surfaced in the community among people who were
hospitalized, underwent a medical procedure or resided in a
long–term care facility within the previous year. In contrast,
about 15 percent of reported infections were considered to be
community–associated, which means that the infection occurred
in people without documented healthcare risk factors. The 2005
rates of invasive infection were highest among people 65 years
of age or older. African Americans were affected at twice the
rate of
Caucasians,
which could be due to higher rates of chronic illness among
African Americans.
“Healthcare facilities need to make MRSA prevention a greater
priority. The closer we get to 100 percent compliance with CDC
recommendations, the greater the impact on patient health and
safety,” said Denise Cardo, M.D., director of CDC′s Division
of Healthcare Quality Promotion. Experts arrived at the new
national estimate by projecting from the number of invasive
MRSA cases from nine U.S. sites. The sites included the state
of Connecticut; the Atlanta metropolitan area; the San
Francisco Bay area; the Denver metropolitan area; the
Portland, OR, metropolitan area; Monroe County, NY; Baltimore
City, MD; Davidson County, TN; and Ramsey County, MN. In
healthcare settings, MRSA occurs most frequently among
patients who undergo invasive medical procedures or who have
weakened immune systems and are being treated in hospitals and
healthcare facilities such as nursing homes and dialysis
centers. For more information on CDC′s guidelines for the
prevention of MRSA in healthcare settings, see
THIS LINK.
To view the JAMA article see
THIS LINK

Recent death, new research, point to community presence
of invasive strains
After a weeklong hospitalization, Ashton Bonds, a high school student from
Bedford, VA, died Monday after a mysterious infection had spread to his
kidneys, liver, lungs and the muscles around his heart. The infection turned
out to be a drug-defying bug called methicillin-resistant staphylococcus
aureus, otherwise known as MRSA. What makes this case shocking is the fact
that Bonds was seemingly healthy just weeks ago. And the case seems to
underscore another concern about the deadly infection, once only a
hospital-based concern, MRSA has spread its wings within the community
setting as well. Disease experts say anyone can be affected by the disease.
“I have seen children with severe and fatal pneumonia from presumed, or
known, community-acquired MRSA,” said Dr. Jerome Klein, professor of
pediatrics at the Boston University School of Medicine. “Although children
and adults with underlying diseases are at risk, much of the
community-acquired MRSA disease occurs in children without known risk
factors.”
Traditionally, staphylococcus aureus has been considered to be primarily a
skin infection. However, the new research shows that the invasive form of
the bug, the one that enters the body and wreaks havoc within, is becoming a
bigger threat. “We are in the middle of something explosive,” said Dr.
Stuart Levy, professor of medicine and microbiology at the Tufts University
School of Medicine in Boston, MA, and author of the book
The Antibiotic Paradox. The
presence of MRSA in the community setting may also serve as a grim reminder
of how the overuse of antibiotics can facilitate the spread of this deadly
infection. (ABC News Medical Unit) To read the full article see
THIS
LINK

California
Governor vetoes
hospital disclosure proposal
Under pressure from the politically robust hospital industry, Gov. Arnold
Schwarzenegger has rebuffed a legislative proposal that could help
California catch up with other parts of the nation by allowing patients to
learn the safety and surgical success rates of specific hospitals and
doctors. Healthcare experts say that one of the most inexpensive and
effective ways to encourage hospitals to improve patient care is to make
their failures public. Schwarzenegger has endorsed this approach, saying as
recently as March that greater transparency would “drive healthcare
providers to perform at peak levels,” “boost the power of consumer choices,”
“save a lot of money” and “save a lot of lives.” But the governor on Friday
vetoed a bill passed by the Legislature that contained provisions that would
have made it easier for the public to review hospital performance.
The governor’s own healthcare bill, released last week, adopted
many sections of the legislative plan. But he omitted or weakened
patient-oriented provisions that are objectionable to the California
Hospital Assn., one of Sacramento’s biggest lobbyists and donors. The
proposal does not require the state to release any information to the
public, leaving those decisions to the discretion of the governor. “Without
addressing quality shortfalls, we’re just adding people onto a sinking
ship,” said Peter Lee, chief executive of the Pacific Business Group on
Health, a coalition of more than 50 large employers. “Instead of putting a
stake in the ground, we’re going to issue a report? That is all this
requires to be done.” Kimberly Belshe, Schwarzenegger’s secretary for health
and human services, defended his proposal Thursday, saying it struck the
right “balance” and would go “far beyond what the state has done so far.”
More than two decades after the state started collecting data from
hospitals, the state’s performance continues to be less than inspiring.
California has issued studies on how hospitals handle just two conditions,
heart attacks and pneumonia, and one operation, coronary artery bypass
grafts, even though a 1980s law requires the state to complete at least nine
reports each year. The few studies that are released become obsolete
quickly. When the bypass report was published in July, its data were already
3 years old. The state's latest pneumonia report relies on 2004 information,
and the most recent heart attack data are from 1998. “The record is dismal,”
said Dr. Robert Brook, a UCLA professor of medicine who sits on a panel that
advises the state on putting together its studies. “All the ice in the
Arctic will have melted before we have a real transparent system in
California unless we really change what we’re doing.”
Other states, including New Jersey, Kentucky, Missouri and
Maryland, are doing more. Last month, New York City began releasing annual
infection and death rates at the city's 11 public hospitals. Healthcare
experts say Pennsylvania does the best job, reporting each year how
effectively its hospitals treat 19 common ailments, including blood clots,
heart and kidney failure and strokes. Pennsylvania also publishes data
showing how well its hospitals repaired hip fractures, unblocked seized-up
hearts and performed 10 other procedures. California is particularly far
behind other states in compelling hospitals to reveal how likely patients
are to contract an infection while in a hospital. Prodded by Consumers
Union, a nonprofit advocacy group, lawmakers in 19 other states have
mandated that hospitals release that data. Infections acquired at California
hospitals, nursing homes and similar institutions cost $3.1 billion to
treat, according to a state estimate. (Los Angeles Times) To read the
original article see
THIS LINK

Bacterial strain that causes ear
infections emerges;
resistant to antibiotics, pneumococcal vaccine
A strain of the bacteria Streptococcus pneumoniae, which can cause ear
infections in children, has been detected that is resistant to all
FDA-approved antibiotics for treatment of ear infections and is not covered
by the pneumococcal 7-valent conjugate vaccine, according to a study in the
October 17 issue of JAMA. Antibiotic resistance to the bacteria
pneumococci has been a focus in community-based pediatric medicine because
it is the most frequent cause of bacterial respiratory infections,
especially acute otitis media (AOM; middle ear infection), which is the most
commonly treated bacterial infection in children.
“The introduction in 2000 of a pneumococcal 7-valent conjugate vaccine
(PCV7) in the
United States
offered considerable promise in curtailing pneumococcal infections in
children, with a particularly favorable impact on penicillin- and multidrug-resistant
strains,” the authors write. In the early years following widespread use of
PCV7, the incidence of AOM decreased by 20 percent and the frequency of
persistent and recurrent AOM has been reduced by 24 percent, according to
the article. Because of overuse of antibiotics for children, there has been
concern that a bacterial strain could emerge that would be untreatable by
U.S. Food and Drug Administration–approved antibiotics. Michael E.
Pichichero, M.D., and Janet R. Casey, MD, of the University of Rochester and
Legacy Pediatrics, Rochester, NY, examined the shifts in bacteria causing
ear infections following the introduction of PCV7 in the strains of
Streptococcus pneumoniae that cause AOM, with particular attention to
certain pneumococcal serotypes and antibiotic susceptibility. Among 1,816
children in whom AOM was diagnosed, tympanocentesis was performed in 212,
yielding 59 cases of S pneumoniae infection.
The researchers found that one strain of S pneumoniae belonging to serotype
19A was a new genotype and was resistant to all antibiotics approved by the
FDA for use in children with AOM. This strain was identified in nine cases
(2 in 2003-2004, 2 in 2004-2005, and 5 in 2005-2006). Four children infected
with this strain had been unsuccessfully treated with two or more
antibiotics, including high-dose amoxicillin or amoxicillin-clavulanate and
three injections of ceftriaxone; three had recurrent AOM; and for two
others, the infection was the first one in their life. The first four cases
required tympanostomy (the creation of a hole in the tympanic membrane) tube
insertion after additional unsuccessful antibiotic therapies. Levofloxacin
was used in the subsequent five cases, with resolution of infection without
surgery. “While the studied children represent a relatively small subset of
all children in our practice with AOM, these observations are clearly
worrisome, especially since there are no new antibiotics in phase 3 clinical
trials for AOM in children. The study suggests that an expanded pneumococcal
conjugate vaccine to include additional serotypes may be needed sooner than
previously thought, with an outer-membrane protein-based vaccine to follow,”
the authors write. “Changes in the pathogen distribution and antibiotic
resistance patterns of bacteria that cause AOM will require continuous
monitoring, especially as new vaccines become available.”

Financial relationships between industry
and medical schools,
teaching hospitals highly prevalent
In a national survey of department chairs at medical schools and teaching
hospitals, more than half report relationships with industry, including
receiving financial and in-kind support, according to a study in the October
17 issue of JAMA. The authors suggest that these findings underscore
the need for the disclosure and management of these relationships.
“Institutional academic–industry relationships (IAIRs) exist when academic
institutions, or any of their senior officials, have a financial
relationship with or financial interests in a public or private company,”
the researchers write. “Similar to relationships between individual faculty
members and industry, relationships between academic institutions and
industry, when they conflict, or have the appearance of conflicting, with
the core missions of academic medical centers create an institutional
conflict of interest, which exists when a department chair supervises
faculty who conduct research for companies with which the chair has a
personal financial relationship.”
There have been calls for the establishment of policies and practices for
disclosure, evaluation, and management of IAIRs. No national data exist that
describe the extent of IAIRs or that could be used for the development of
policy. Eric G. Campbell, Ph.D., of
Massachusetts General
Hospital,
Boston, and colleagues conducted a study to determine the nature, extent,
and consequences of IAIRs by surveying department chairs of 125 accredited
allopathic medical schools and the 15 largest independent teaching hospitals
in the United States. The researchers found almost two-thirds (60 percent)
of department chairs had some form of personal relationship with industry,
including having served: as a paid consultant for a company (27 percent); as
a member of a scientific advisory board (27 percent); as an officer or
executive of a company (7 percent); as a founder of a company (9 percent);
as a member of a board of directors (11 percent); and as a paid speaker (14
percent).
Clinical chairs were significantly more likely than nonclinical chairs to
have served on a speakers’ bureau. Two-thirds (67 percent) of departments as
administrative units had relationships with industry. Clinical departments
were significantly more likely than nonclinical departments to receive
research equipment (17 percent vs. 10 percent), unrestricted funds (19
percent vs. 3 percent), support for research seminars (36 percent vs. 13
percent), support for residency and fellowship training (37 percent vs. 2
percent), and support for department-administered continuing medical
education (65 percent vs. 3 percent). Clinical departments were also
significantly more likely than nonclinical departments to receive
discretionary funds to purchase food and beverages in the department,
support for professional meetings, and subscriptions to professional
journals. Nonclinical departments were significantly more likely to receive
money from licensing of intellectual property developed by researchers in
the department. More than two-thirds of department chairs perceived that
having a relationship with industry had no effect on their professional
activities, 72 percent viewed a chair’s engaging in more than one
industry-related activity (substantial role in a start-up company,
consulting, or serving a company’s board) as having a negative impact on a
department’s ability to conduct independent unbiased research.
“This study presents the first empirical data showing that IAIRs are
frequent in medical schools and teaching hospitals and thus deserving of
attention. Future research is needed to better understand the impact of
IAIRs on the independent unbiased performance of the education and research
missions of medical schools, the management and disclosure of these
relationships at the institutional level, and the impact of institutional
policies. Failure to address the existence and influence of industry
relationships with academic institutions could endanger the trust of the
public in U.S. medical schools and teaching hospitals,” the authors
conclude.

Cefotetan available in ready-to-use IV container;
B. Braun adds new antibiotics to DUPLEX System
Helping to reduce medication errors, patients prescribed Cefotetan for
bacterial infections can now have the antibiotic delivered to them in a
safe, ready-to-use I.V. drug delivery system. B. Braun Medical Inc.
announced that Cefotetan 1g and 2g is available to healthcare facilities
nationwide in its DUPLEX Drug Delivery System. With a unique closed system
design, the DUPLEX System helps ensure accurate dosage delivery and allows
for room-temperature storage to decrease waste often associated with I.V.
antibiotics. “Cefotetan is the fifth antibiotic drug made available in the
DUPLEX System since the product was introduced,” said Rick Williamson,
Director of Marketing, Drug Delivery, B. Braun Medical Inc.
DUPLEX, a dual chamber pre-filled, PVC-free, DEHP-free, and Latex-free IV
container, stores the drug and diluent in separate compartments until the
seal is broken just prior to administration, helping clinicians comply with
The Joint Commission and USP <797> Guidelines that specify medicines should
be dispensed in their “most ready-to-use form.” Prior to activation, it can
be stored at room temperature for up to 12 months and does not require
thawing. The system is also equipped with a unique barcode system that
references the final admixture which can be used to reduce medication
errors, automate patient charting, track inventory and facilitate
reimbursement tracking. B. Braun is currently assisting customers with
orders for DUPLEX for use with Cefotetan. B. Braun can be reached at
1-800-BBRAUN-2 (800-227-2862). For more information see
THIS LINK.

October
16, 2007
Download print version
Superbug outbreak hits baby unit
Hospital trust boss resigns after superbug
outbreak
Approximately $71,000 of dietary supplements
seized at FDA request
$1.9 billion debt deal sours
2 studies highlight the risks and significant
healthcare costs
of NSAIDs injury
Dräger celebrates double centennial of medical
and safety
technology excellence
Amerinet announces two agreements with Skytron
Superbug outbreak hits baby unit
Infection experts are battling an MRSA outbreak
at a neo-natal unit in
England after six babies tested positive for the bug. The
neo-natal unit of the Royal Blackburn Hospital in Lancashire
closed to new admissions last month when the PVL strain of the
MRSA outbreak was found. The East Lancashire Hospitals NHS
Trust has said MRSA was found to have “colonized” the babies,
but had not entered their bloodstream, which can lead to
serious complications and death. A spokeswoman said none of
the babies had fallen ill. Since the outbreak infection
control has been called in and no new cases have been found.
The hospital said it hoped the unit would reopen to new
admissions soon.
Rineke Schram, medical director for East
Lancashire Hospitals NHS Trust, said: “I can confirm our
Neonatal Intensive Care Unit has been closed to admissions
since mid-September when the MRSA organism was identified in
the unit. We have very recently found out that the strain is
Panton Valentine Leukocidin (PVL) positive MRSA, a strain
which can cause more serious illnesses in immuno-suppressed
people, that is the elderly, severely ill or people with blood
poisoning and wound infections. We are closely monitoring the
situation and the babies who have been identified as carrying
the organism are being treated in accordance with infection
control guidelines. The babies are not seriously ill due to
the PVL positive MRSA and are receiving treatment but continue
to be nursed in separate areas within the unit, which is also
in line with the guidance. Other babies within the unit are
being screened on a regular basis to ensure we keep in control
of the situation.”
There have been seven deaths in
England and
Wales associated with the PVL strain of MRSA over the last two years,
including the two recently reported at a hospital in the
West Midlands.
Most of these were unrelated to hospital care. PVL-MRSA is resistant to
some, but not all, antibiotics, and is therefore treatable. (The
Independent) For more information see
THIS LINK

Hospital trust boss resigns after superbug outbreak
The chairman of the hospital trust that was hit by an outbreak of a killer
bug, claiming the lives of at least 21 patients has resigned. James Lee
stood down after Alan Johnson, the Health Secretary, announced a Department
of Health review of his role leading the
Maidstone
and Tunbridge Wells Hospitals NHS Trust in Kent. The trust faced withering
criticism from the Healthcare Commission in a report into outbreaks of the
C. difficile infection between 2004 and 2006. Describing its findings as a
“truly shocking document”, Johnson told MPs he wanted to apologize on behalf
of the Government and the NHS. Lee faced criticism when it emerged that the
trust’s former chief executive Rose Gibb, who resigned days before the
report’s publication, was offered a severance package worth a reported
£250,000. Johnson ordered the trust to withhold the payment, pending legal
advice.
The Commission found that 1,176 patients were infected with C. difficile
during two outbreaks of the bug at the
Maidstone
and Tunbridge Wells Hospitals NHS Trust between April 2004 and September
2006, of whom at least 345 later died. Its report concluded that C.
difficile was probably or definitely the main cause of death in 90 cases and
that there was no doubt it was to blame in at least 21 of the deaths.
Johnson said: “We must all shoulder our share of the blame. But I hope the
House will recognize the awful failures in Maidstone and Tunbridge are
entirely unrepresentative of the standards of care that patients and the
public rightly expect and is delivered across the country, day after day.”
Andrew Lansley, the shadow Health Secretary, said the outbreak was not an
isolated occurrence. He said: “We have had other cases and the common link
is that managers in the NHS have been more focused on the Government's
targets ... than they have on patient safety.” (The Independent) For more
information see
THIS LINK

Approximately $71,000 of dietary supplements seized at
FDA request
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals
seized on Tuesday approximately $71,000 of goods from FulLife Natural
Options Inc., of Boca Raton, FL, which marketed and distributed Charantea
Ampalaya Capsules and Charantea Ampalaya Tea. Although these products are
labeled as dietary supplements, they are being promoted by FulLife for use
in treating serious conditions, such as diabetes, anemia, and hypertension.
These claims are evident in the products’ labeling, including promotional
literature and FulLife’s Internet Web site. FDA considers these products to
be unapproved new drugs because they make claims related to the prevention
or treatment of diseases in the products’ labeling. Tuesday’s action
protects consumers who may rely on unapproved products and unsubstantiated
claims associated with these products when making important decisions about
their health.
The Complaint, filed by the U.S. Attorney’s Office for the
Southern District of Florida, charges the products are in violation of the
drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
Following an investigation of the firm’s marketing practices, FDA officials
advised FulLife that the claims related to prevention or treatment of
diseases made these products subject to regulation as drugs. Despite FDA’s
warnings, the firm failed to bring its marketing into compliance with the
law. During subsequent inspections, FDA inspectors found that the offending
claims were still being made. The seizure Tuesday at FulLife is the second
such enforcement action in two months taken by FDA against dietary
supplements being promoted with drug claims to cure or treat diabetes and
other diseases or conditions. On August 23, 2007, at the request of FDA,
U.S. Marshals in the Northern District of Florida seized an estimated
$41,000 worth of inventory of Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi,
Super-Flex, MSM-1000, and Atri-E-400 capsules being promoted and distributed
by Charron Nutrition of Tallahassee, FL, for use in treating diabetes,
arthritis, and other serious health conditions.

$1.9 billion debt deal sours
Jackson Memorial
Hospital’s deal to sell eight years worth of
outstanding patient bills has drawn a lawsuit from the buyer, a collection
company claiming the accounts were undervalued and the hospital told debtors
not to pay. The suit provides a glimpse into the inner workings of
South
Florida’s largest hospital, strapped for cash, facing more budget cuts and
getting little return on nearly $2 billion in unpaid bills.
International
Portfolio Inc. (IPI), of West Conshohocken, PA, filed
the complaint against Jackson and the Public Health Trust of Miami-Dade
County in Miami federal court on Oct. 2. It accuses the hospital of breach
of contract, breach of implied duty of good faith and fair dealing, and not
fulfilling accounting obligations. In a prepared statement,
Jackson
said it strongly disagrees with the allegations and will defend its position
vigorously. Jackson has 1,757 licensed beds and has the worry of major
budget cuts amid the push to cut taxes in Florida. Last December, IPI signed
a deal to pay
Jackson
$5.7 million for patient accounts receivable with a balance of $1.87
billion. These past-due self-pay, insurance and managed care accounts were
from 1998 through 2005. IPI planned to liquidate those accounts over 16
months and recover 5.8 percent of the balance, which would be $108.6
million.
Most public
hospitals pay collection agencies a contingency fee and rarely sell their
accounts receivable, said Bob Campbell, a vice chairman of
Deloitte & Touche
based in Austin, TX, and head of the accounting firm’s public sector
practice. Selling the accounts outright is more common in industries such as
student lending. Under Jackson’s agreement with IPI, these accounts couldn’t
be for patients who had their liability to pay released. But by February,
Jackson
found that $984 million of the accounts it sold IPI weren’t qualified to be
part of the agreement, the plaintiffs allege. The problems included patients
who were dead, bankrupt, on Medicare or Medicaid, plus those who didn’t owe
anything or had duplicate accounts. The agreement called for the hospital to
give IPI new collection accounts rather than a refund of its purchase price.
So in March, Jackson replaced the $984 million in unqualified accounts with
another batch of receivables. But IPI says the replacement accounts were
worth $682 million, or $302 million less than what it paid. The hospital
also purged these replacement accounts from its records, IPI says, which
prevented IPI from getting enough information on the debtors to pursue
collection. When debtors paid the hospital for an account purchased by IPI,
Jackson was supposed to forward that money to the company, according to the
agreement. The lawsuit said that didn’t happen for the $682 million in
replacement accounts because Jackson didn’t recode them as belonging to IPI.
In August, Jackson offered to refund the entire purchase amount and take the
accounts back, but IPI wants the hospital to stick to the agreement and give
it enough accounts to boost the value back to $1.87 billion. (South Florida Business Journal) To read the original
article see
THIS LINK

2 studies highlight the
risks and significant healthcare costs
of NSAIDs injury
Patients underreported their use of common but potentially dangerous
over-the-counter pain medications known as NSAIDs, according to research
presented at the Annual Scientific Meeting of the
American
College of Gastroenterology. “This is a serious issue given what we know
about the significant risk of injury and bleeding in the GI tract in
patients using NSAIDs,” said David Johnson, M.D., FACG, one of the
researchers and President of the America College of Gastroenterology.
Serious gastrointestinal complications such as bleeding, ulceration and
perforation can occur with or without warning symptoms in people who take
NSAIDS (non-steroidal anti-inflammatory drugs.) Ulcers and gastrointestinal
bleeding are serious health problems in the United States. With millions
taking NSAID pain medications every day, it is estimated that more than
100,000 Americans are hospitalized each year and between 15,000 and 20,000
Americans die each year from ulcers and gastrointestinal bleeding linked to
NSAID use. Of particular concern are patients with arthritic conditions.
More than 14 million such patients consume NSAIDs regularly. Up to 60
percent will have gastrointestinal side effects related to these drugs and
more than 10 percent will cease recommended medications because of
troublesome gastrointestinal symptoms.
Dr. Johnson and his colleagues at
Eastern
Virginia Medical School administered a survey to patients in a private GI
practice after a written and verbally confirmed report of current
medications to nursing staff. Almost one in five respondents to the survey
noted use of an NSAID that had not been reported verbally to nursing staff,
including 8 percent who reported daily use. For 22 percent of respondents,
they did not think the medications were important enough to list, while 30
percent cited the fact that the drugs were not prescribed by a physician.
“This reflects a common misperception that these medications are
insignificant or benign when actually their chronic use, particularly among
the elderly and those with conditions such as arthritis, is linked to
serious and potentially fatal GI injury and bleeding,” noted Dr. Johnson.
Physician experts from the American College of Gastroenterology warn that
patients who take over-the-counter pain medications on a regular basis
should talk with their physician about the potential for ulcers and other GI
side effects. Recent research suggests a role for acid suppression therapy
with a proton pump inhibitor (PPI) for patients at risk of developing
stomach ulcers due to long-term use of NSAIDs.
In another study presented at the American College of Gastroenterology, a VA
researcher, Neena S. Abraham, M.D. looked at the burden of cost from
hospitalization for GI bleeding related to NSAID use, and conducted a cost
benefit analysis of using PPIs to help protect against serious potential
injury to the GI tract. “Our analysis of a large patient population suggests
that it is cost beneficial to administer a proton pump inhibitor with NSAIDs
and points to significant savings in hospital costs relating to GI injury
and bleeding in the Veterans’ Administration medical setting,” explained Dr.
Abraham. Dr. Abraham and her colleagues reviewed prescription records linked
to inpatient, outpatient and death files for the VA medical system and
Medicare. In an overall population of almost half a million veterans, Dr.
Abraham identified 3,200 events of GI bleeding, of which 36 percent were
treated by the VA. A review of their prescription and hospitalization
records revealed that half of those with GI bleeding events were
hospitalized.
Importantly, the one third of patients with GI
bleeding events prescribed a PPI were 60 percent less likely to be
hospitalized. Their overall median total medical costs were significantly
lower than patients who were not prescribed a PPI. “This reduction in the
risk of hospitalization is where significant savings occur due to lower
utilization of health resources, endoscopy and surgery, not to mention the
impact on patients’ quality of life,” explained Dr. Abraham. While there are
costs to treat patients on NSAIDs prophylactically with PPIs, these findings
suggest that reduced hospitalization costs offset higher pharmacy costs.
“These are powerful data, especially because of the high risk for GI
bleeding in elderly patients who are in the highest risk category for GI
bleeding,” according to Dr. Abraham.

Dräger celebrates double centennial of medical and safety
technology excellence
Draeger
Medical Inc. celebrates 100 years of ventilation technology in October of
this year. In 1907, the company delivered the Pulmotor, the first-ever
mobile short-term respirator. 2007 also marks 100 years in the United States
for Drägerwerk AG, Draeger Medical’s
parent corporation. As part of its ongoing celebration of these
milestones, Draeger Medical will showcase an original Pulmotor alongside of
its latest respiratory care devices at the annual ASA Annual Meeting in San
Francisco, CA, October 13-17 and at the AARC Respiratory Congress in
Orlando, FL, December 1-4, 2007. Shortly after its release, the Pulmotor
became widely used by mine rescue teams across America, Germany, England and
Mexico and by mountaineering rescue squads in England. Due to its use in the
harsh environments of underground mines and in high altitudes, the
reputation of the breathing device quickly grew. The first users of the
ventilation products were soon dubbed “Draegermen;” and ever since, the term
has been synonymous with mine rescue teams worldwide. The use of Dräger
breathing apparatus quickly spread to other emergency services fields. For
more information, visit
www.draeger.com to download or read “The History of Dräger” brochure.

Amerinet announces two agreements with Skytron
Amerinet announces new
agreements with Skytron for OR lights, booms and OR tables. Effective
through August 31, 2010, these new agreements
provide Amerinet members with tremendous savings on Skytron’s lights, booms
and OR tables, as well as other value-added services and programs.
Headquartered in Grand Rapids, MI, Skytron is a division of the KMW Group
Inc. For more information, see THIS LINK

October
15, 2007
Download print version
Medtronic suspends distribution of Sprint
Fidelis defibrillation leads
Even occasional use of spray
cleaners may cause asthma in adults
Statins reduce loss of function, keeping old
lungs young, even in smokers
Blood test takes step toward predicting
Alzheimer’s risk,
Stanford researchers find
Annual report to the nation finds cancer death
rate decline doubling
Mortality rates 71 percent lower at
top-rated hospitals: HealthGrades 2008 hospital-quality study
B. Braun Contiplex Stim System redefines
standards for stimulating catheters; optimized for nerve
stimulation, easily visible under ultrasound
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