|April 4-8, 2016
April 8, 2016
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Hospitals' digital drug ordering boosts safety
but can lead to fatal errors
Banned chemical in hospital IVs linked to ADHD
in critically ill children
Former UnitedHealth executive to launch new
Stimulant, banned from sports, found in
dietary supplements in U.S.
Patient secretly recorded doctors as they
operated on her
IBM wants Watson to be more like humans
The Joint Commission and NQF recognize
Premier, Inc. for improving healthcare safety and quality
Medtronic says new inversion rules won’t hurt
Hospitals' digital drug ordering boosts safety but can lead to fatal errors
Hospitals' use of
digital medication orders have dramatically reduced the number of dangerous
drug errors, but their computer systems still fail to flag 13% of
potentially fatal mistakes, a report released Thursday shows.
Medication errors are
by far the most common mistakes made in hospitals —and hospital errors are
the third leading cause of death in the United States. Digital drug
ordering is part of so-called "computerized physician order entry," or CPOE,
which was designed to address the problem.
"These findings show
the transition from pen and paper to electronic ordering and prescribing is
making patients safer — with the systems flagging nearly 9 in 10 possible
errors," said Andrew Gettinger, a physician and chief safety officer in the
Office of the National Coordinator for Health IT in an email. "But the
report also serves as an important reminder to clinicians and the health IT
community broadly that there is more work to do when it comes to our top
priority: the health and safety of our patients."
Research released in
1999 found CPOE reduced serious medication errors by 88%.
Ninety-seven percent of hospitals use CPOE, thanks in large part to the
stimulus bill of 2009. To receive the money, CPOE is required — and must
alert about errors — in the electronic health records that the Affordable
Care Act pushed doctors and hospitals to use. Many doctors have complained
the records are too costly, time consuming and hard to use.
Other critics have
long charged that the systems lack the safeguards needed, such as to keep
doctors from copying information from one chart to another either by mistake
or to commit fraud.
The new report by data
analytics company Castlight Health and the hospital rating organization
Leapfrog Group, suggests they're right. About 40% of the most common,
serious errors overall weren’t caught.
records aren't required to be accurate, notes Reed Gelzer, a physician
and records expert who co-leads two international standards development work
groups on records systems. Other studies have shown a substantial number of
potentially harmful errors are caused by inaccurate or otherwise defective
patient information in the records, notes Gelzer.
Visit USA Today for the report.
Banned chemical in hospital IVs linked to ADHD in critically ill children
A chemical that has
been banned from use in children’s toys but is still used in medical
devices, such as plastic IV tubes and catheters, has been linked to the
development of attention deficit hyperactivity disorder in critically ill
The devices contain a
high level of plastic-softening chemicals called phthalates which circulate
in the blood and can seep into the bloodstream, according to EU funded
researchers. Phthalates have long been banned in toys and other products, in
both the US and EU, due to their potential toxic effects but there is no
such prohibition for their use in medical devices.
Research carried out
under Soren Verstraete, from Leuven, Belgium found a “clear match between
previously hospitalized children’s long-term neurocognitive test results and
their individual exposure to the phthalate DEHP during their stay in
intensive care.” DEHP, is the most commonly used plastic softener in medical
forty-nine children, ranging from newborns to age 16, who were treated in
pediatric intensive care units and whose care involved between one and 12
medical tubes were tested. One hundred healthy children were also tested for
measured blood levels of DEHP metabolites, or byproducts, and found that
levels were not detectable in the blood samples of healthy children but were
“sky high” in children admitted with catheters. These remained 18 times
higher than levels in healthy children until they were discharged from the
Visit RT for the study.
Former UnitedHealth executive to launch new health plan
With a fresh infusion
of $80 million in venture capital funding, a Minneapolis start-up is
preparing to launch a health insurance plan it says will make life simpler
for consumers and be a more effective partner for hospitals and clinics.
“There’s a better way
to better health,” said Bob Sheehy, a retired UnitedHealthcare CEO and one
of three health care heavy hitters behind Bright Health.
The upstart health
plan aims to start selling policies directly to consumers who don’t get
coverage at work in 2017, mostly through state healthcare exchanges and
independent brokers. It plans to offer Medicare Advantage plans for those 65
and older starting in 2018.
Bright Health will
create exclusive partnerships with a leading healthcare system in each
market, providing billing and claims processing as well as mobile technology
to help patients with wellness plans and to more easily communicate with
their doctors and Bright Health.
Such narrow alignments
with providers can give consumers fewer choices but, in theory, helps
providers better monitor their patient’s health by being able to see if
they’ve filled prescriptions or wound up in the emergency room after a visit
to the family doctor.
Bright Health is
jumping into a health insurance marketplace that is becoming both more
cost-conscious and consumer-centric as a result of the Affordable Care Act.
It is more common for providers and insurers to team up to try to keep
patients healthier and costs down. Tuesday’s announcement that Fairview
Health System will bring the UCare health plan under its corporate umbrella
is the latest example locally.
Bright Health is among
a host of new players hoping to find ways to make the healthcare system more
effective, she said, including Oscar Health Insurance, a $1.5 billion New
York-based start-up that launched last year.
Bright Health will
offer consumers a range of options, from high-deductible plans with low
premiums to low deductibles and higher cost-sharing. It will work with
providers to offer such things as bundled payments, in which something like
knee surgery is assigned a single cost that covers surgery and all the other
doctors’ visits and physical therapy.
Based in the North
Loop area of downtown Minneapolis, the company is in the process of hiring
25 full-time employees. It expects to have close to 50 by the end of the
year, and plans to be selling insurance policies in three to five markets in
the next several years. It expects to announce its first market in the next
Visit the Star Tribune for the story.
Stimulant, banned from sports, found in dietary supplements in U.S.
A stimulant banned
from competitive sports has been found in more than a dozen dietary
supplements marketed for "burning" body fat.
Researchers found the
stimulant -- called oxilofrine -- in 14 supplement brands sold in the United
States. All of the products listed the substance on their labels, but under
the alternative name of methylsynephrine.
Experts said the
results raise more questions about the loose regulation of dietary
supplements in the United States. Unlike drugs, supplements do not have to
be proven effective, or even safe, before hitting the market.
stimulant, raises blood pressure and heart rate, and in some countries it's
used as a prescription drug for low blood pressure. The World Anti-Doping
Agency considers oxilofrine a doping agent, and has banned it from sports,
the researchers noted.
Since 2009, several
athletes have been suspended after testing positive for the drug. But
they've claimed they unknowingly ingested oxilofrine through supplements.
"So it's been known
since at least 2009 that dietary supplements may contain oxilofrine," said
Dr. Pieter Cohen, lead researcher on the new study and an assistant
professor at Harvard Medical School in Boston. Now there's "definitive
proof," said Cohen, who reported the findings in the journal Drug Testing
An FDA spokesperson
said the agency is taking action. Last week, it sent warning letters to
manufacturers of eight dietary supplements that list methylsynephrine on
The substance fails to
meet the definition of a "dietary ingredient," the FDA said, so any
supplement containing it is misbranded. The companies were given 15 days to
report the "specific steps" they will take to bring their products into
compliance with the law.
Cohen noted that no
one knows what risks a healthy person could face from taking oxilofrine
regularly. But, he said, it's essentially a synthetic version of ephedra --
which the FDA banned from dietary supplements more than a decade ago because
of serious risks including heart attack and stroke.
The current study
analyzed 27 supplement brands marketed for "fat burning" that listed
methylsynephrine on the label. It turned out that 14 actually contained the
ingredient in varying doses, but six brands served up prescription-level
doses or higher, the researchers found. (HealthDay)
Visit UPI for the article.
Patient secretly recorded doctors as they operated on her
Last summer, Ethel
Easter wanted nothing more than to see a doctor. A hiatal hernia had caused
her to suffer more than a hundred abdominal attacks within 24 hours, her
stomach was bruised, and she found urine in her blood. The pain was
excruciating, so Easter prayed that a surgery could be scheduled as soon as
The doctor who would
be operating on her at Lyndon B. Johnson Hospital in Houston did not share
her urgency. He told the 44-year-old Easter that she would have to wait two
months, and Easter burst into tears.
Shaken, Easter later
went to see her family doctor, who told her that the surgeon had taken notes
on their meeting and raised “red flags” about her attitude — “as if I was
the problem,” Easter said in a phone interview with The Washington Post
From the start,
Easter was troubled that she didn’t trust her own surgeon, but she was in
too much pain to cancel the operation. Then she had an idea: She would go
through with the surgery — it was ultimately scheduled about a month later,
for August — but she would sneak a recorder into the operating room so that
her family could know what happened to her in case things went wrong. She
had a “bad feeling,” after all.
It began with the
surgeon asking Easter about what happens to her when she takes penicillin.
“When I was a baby, they said I swelled up,” Easter can be heard responding
in the recording.
The surgeon also used
the name “Precious” several times in a manner that Easter interpreted as
racial. After the doctors concurred that there had been many “teaching
moments” that day, the anesthesiologist asked, “Do you want me to touch
While much of the
exact dialogue is difficult to discern from the recording, Easter was
distressed by what she believed to be its subject matter. She thought
“Precious” might be an allusion to the 2009 movie of the same name,
chronicling the life of an illiterate African American teenager who suffers
What bothered Easter
the most were moments in the recording when, in her view, the doctors acted
flippant about her health and well-being. She was disturbed that the surgeon
talked on his cellphone at one point during the surgery, and even more so
that he seemed unbothered by her penicillin allergy.
He said in the
recording that swelling and rashes were not severe enough reactions to
preclude Easter from receiving Ancef, an antibiotic injection that causes
side effects in a small percentage of penicillin-allergic patients. The
surgeon suggested first giving Easter a small dose as a trial.
This would prove an
unfortunate decision. At the end of the recording, a groggy Easter can be
heard telling a doctor that she was “itchy.” Shortly after the surgery,
Easter said, her arms swelled up and started getting rashes, though her
hernia was successfully repaired. Her husband brought her back to the
hospital — this time to the emergency room, where she was treated for an
Last fall, Easter sent
the hospital a letter with her complaints with the recording attached.
Stacey Mitchell, the administrative director of risk management and patient
safety for the Harris Health System, responded by thanking her for providing
them a copy of the recording “to better analyze your concerns.”
Visit the Washington Post for the story.
wants Watson to be more like humans
In the near future,
IBM will be interested in working on technologies that could help Watson
detect emotions in written human communications. The effort involves
exploring that aspect of artificial intelligence that will stress more on
ability of computer to address the needs of people. If such a breakthrough
is possible, there will be two way communication: men to computers and vice
communicate with us on our terms. They will adapt to our needs, rather than
us having to interpret and adapt to them”, said Rob High, chief technology
officer at IBM’s Watson Solutions at the GPU Technology Conference in San
AI has already made
many things possible such as services related to speech and image
recognition, language translation and autonomous cars. IBM and many other
companies are looking forward for something that would involve humans and
computers working together.
Like IBM, Google and
other companies are trying to humanize AI to transform computing. The idea
will change the way people work and communicate on computer. The idea of a
computer with cognitive system will be seen coming true within ten years.
This is what IBM aimed with Watson to bring a day when computer will guide
people on various fronts.
Watson already has a
tone analyzer API that can measure similar emotions in samples of text from
a sentence to a single word. Such an analyzer could judge whether a text is
written out of which emotional experience such as anger, joy or confusion.
Thus, it would guide that certain texts need to be changed for better
The Watson Developer
Cloud has personality insights service as well. This could extract insights
from a lengthy piece of text by a particular person and can measure
characteristics such as introversion or extroversion and conscientiousness.
Such a system could help recruiters hire the right candidate.
Visit PerfScience for the report.
Joint Commission and NQF recognize Premier, Inc. for improving healthcare
safety and quality
Premier, Inc. has been
nationally recognized by The Joint Commission and National Quality Forum (NQF)
for improving patient safety and healthcare quality through its national
quality improvement initiative, QUEST.
Premier has received
the national 2015 John M. Eisenberg Patient Safety and Quality Award. The
Joint Commission, the nation’s largest standards-setting and accrediting
body in healthcare, and NQF, a leader in improving healthcare quality
through measurement, established the annual award to honor John M.
Eisenberg, MD, former administrator of the Agency for Healthcare Research
and Quality, and member of the founding board of directors for NQF. The
award recognizes major national achievements to improve overall healthcare
quality by making care patient-centered, reliable, accessible and safe.
QUEST was launched in
2008 to help health systems reliably deliver the most efficient, effective
and caring experience for every patient, every single time. Approximately
350 health systems volunteered to transparently share data and define a
common framework with consistent measures that would continually set a top
performance goal for both participants and the nation. To date, QUEST
participants have prevented more than 176,000 deaths, reduced healthcare
spending by more than $15 billion and improved readmission rates by 32
Residing in almost
every U.S. state, QUEST participants are large and small, teaching and
non-teaching, urban and rural, and high and low disproportionate share
Two years ahead of the
Affordable Care Act, QUEST was designed to support health systems as they
transitioned to a reforming care delivery and payment environment. What
began as a test bed for performance improvement, the multidimensional
initiative has set national standards of excellence based on increasingly
automated measures for readmissions, harm, mortality, patient/family
experience, cost and evidence-based care. To achieve these goals, QUEST
leverages a proven methodology for performance improvement that enables
providers to learn from top performers, share data and outcomes, and
accelerate and sustain quality, efficiency and safety innovations across
Visit Premier for the announcement.
Medtronic says new inversion rules won’t hurt finances
Medtronic Inc. on
Wednesday said the Treasury Department’s new proposed tax regulations on
inversion deals won't have a material financial impact on the medical supply
company, which moved its corporate address abroad in a deal last year.
In January 2015,
Medtronic closed a $43 billion acquisition of Ireland’s Covidien PLC,
combining two of the world’s largest medical-supply companies. Medtronic,
formerly based in Minneapolis, redomiciled in Ireland upon completion of the
merger, part of a wave of controversial deals aimed at taking advantage of
lower corporate-tax rates overseas.
Wednesday that the acquisition “was undertaken for strategic reasons and has
created a company that is positively impacting the lives of more patients,
in more ways and in more places around the world.”
On Monday, the
Treasury Department imposed tough new curbs on corporate inversions, making
it harder for companies to move their tax addresses out of the U.S. and then
shift profits to low-tax countries using a maneuver known as earnings
The new rules—the
government’s third wave of administrative action against inversions—shocked
Wall Street and forced Pfizer Inc. and Allergan PLC to terminate their
planned $150 billion merger, which was on track to be the biggest deal of
regulations would limit what is known as earnings stripping, a practice that
follows many inversions and other cross-border acquisitions that helps lower
companies’ effective tax rates.
fact, all non-U.S.-based companies—can lend money to their U.S.
Those moves create
deductible interest in the U.S., reducing the income subject to the 35% U.S.
corporate tax rate and shifting income to a lower-taxed jurisdiction. If a
U.S.-based company tried the same technique by borrowing from its offshore
subsidiaries, the government would tax that income at the U.S. rate.
Visit the Wall Street Journal for the story.
April 7, 2016
Download print version
Roche seeks to avoid cancer-drug drama with
cost-effective U.K. price talks
More evidence that obesity is a global
catastrophe in slow motion
Fentanyl, a prescription opioid deadlier than
heroin, is now showing up on the streets
Antiarrhythmic drugs found beneficial when
used by EMS treating cardiac arrest
Value-based insurance program raises
White House to transfer Ebola funds to combat
FDA approves first leadless pacemaker to treat
heart rhythm disorders
US departments finalize new version of the
summary of benefits and coverage helping consumers better understand their
Roche seeks to avoid cancer-drug drama with cost-effective U.K. price talks
Roche Holding AG said
it’s open to discussing ways to set prices for tumor-fighting treatments in
the U.K., signaling that the world’s biggest maker of cancer drugs will seek
to avoid a repeat of last year’s heated dispute with authorities over the
cost of two key medicines.
The U.K., where cancer
survival rates lag those of other developed countries, is in a unique
position because its state-run National Health Service covers 54 million
people in England. Under the Cancer Drugs Fund, which pays for therapies
that aren’t deemed cost-effective enough for routine NHS use, the government
put technology in place that may have the ability to track how patients are
doing on treatment and help guide payment policy.
Roche is open to
giving some money back to the NHS if patients don’t respond well to a
treatment, or to limit payments for those needing to take the drug long-term
to keep the cancer at bay. The U.K. could follow the example of Italy, where
Roche is testing money-back-guarantees and other cancer-drug pricing models
with the Italian Medicines Agency.
Switzerland-based drugmaker quarreled with the NHS last year over its
decision to stop paying for some cancer medicines including Roche’s Kadcyla
and Avastin. Roche Chief Executive Officer Severin Schwan called the choice
“stupid” and “completely arbitrary” because it focuses on the price of
medicines rather than potential savings to the overall health system.
Kadcyla was later covered by the drug fund for a type of breast cancer,
though it’s still not backed for routine NHS use.
The Cancer Drugs Fund
in its existing form ended in March, and the new version begins in July with
a 340 million-pound ($485 million) annual budget. That’s in addition to the
1.2 billion pounds the NHS spends on cancer drugs each year. NICE is set to
review 37 medicines available through the fund and decide whether they offer
the NHS value for money. Because of their high prices, new cancer therapies
often fail to win NICE’s backing unless manufacturers offer discounts.
Avastin is still not
available for NHS patients with bowel cancer, he said, though it’s routinely
used for that disease in the rest of the developed world. The medicine
brought in about $7 billion in global sales last year, making it Roche’s
second-best selling therapy.
Visit Bloomberg for the article.
evidence that obesity is a global catastrophe in slow motion
Sometimes it is harder
to see things that move in slow motion. Perhaps if the global obesity
epidemic moved any faster, it would garner an emergency response similar to
Ebola, Zika, and other infectious disease epidemics that have gripped the
world in recent years. As two recent studies published in The Lancet
and authored by the Non-Communicable Disease (NCD) Risk Factor Collaboration
have re-emphasized, the sheer magnitude of the global obesity epidemic
dwarfs those of most other epidemics.
The impact may be much
greater as well, accounting for many more deaths (over 3.4 million a year)
and more costs (over $2 trillion a year).
Larry Cheskin, MD,
Associate Director of our Global Obesity Prevention Center (GOPC) at Johns
Hopkins University and Associate Professor at the Johns Hopkins Bloomberg
School of Public Health, describes the global obesity epidemic as “a
catastrophe happening in slow motion.”
One of the Lancet
studies confirmed that obesity and overweight is a growing problem
worldwide, even in countries that in the past have had problems with lack of
food. The study analyzed the change in body mass index (BMI) from 1698
studies among 19.2 million adults in 200 countries from 1975 to 2014. The
researchers found that during this time period the average BMI increased
from 21.7 to 24.2 kg/m2 among men and from 22.1 to 24.4 kg/m2 among women.
By comparison, the
prevalence of people who are underweight, presumably from lack of enough
food, decreased from 13.8% to 8.8% among men and 14.6% to 9.7% among women.
The other Lancet
study showed a substantial worldwide increase in diabetes since 1980 by
analyzing 751 studies that included nearly 4.4 million people.
As the study’s senior
author Professor Majid Ezzati form Imperial College explained, “obesity is
the most important risk factor for type 2 diabetes and our attempts to
control rising rates of obesity have so far not proved successful.
Identifying people who are at high risk of diabetes should be a particular
priority since the onset can be prevented or delayed through lifestyle
changes, diet or medication.”
The study found that
between 1980 and 2014, diabetes prevalence more than doubled from 4.3% to
9.0% among men and climbed by over 50% from 5.0% to 7.9% among women. This
corresponded to the number of adults with diabetes worldwide nearly
quadrupling from 108 million to 422 million.
While attention to the
obesity epidemic has grown in recent years, has there been enough concern,
energy, action, and urgency to match the true magnitude and severity of this
epidemic? Over the past several decades many of the obesity-measures have
focused on the individual person such as diets and exercise programs.
True, some larger
efforts here and there around the world have emerged to prevent and control
obesity. For example, the World Cancer Research Fund International (WCRF)
NOURISHING framework catalogs efforts aimed at improving diets to reduce
obesity such as sugar sweetened beverage taxes in Mexico and Berkeley, CA.
Other initiatives have tried to increase physical activity such as the
United States First Lady Michelle Obama’s Let’s Move Campaign and the Aspen
Institute’s Project Play. However, the two recent Lancet studies suggest
that no country so far has truly successfully curbed the obesity epidemic.
But the two Lancet
studies also provide further evidence that obesity is resulting from forces
beyond the individual. It is highly unlikely that laziness and poor choices
can explain such large increases in obesity and diabetes in so many
different countries, including low and middle income countries that do not
have the luxuries and access to food that high countries do. Such broader
trends imply that other wider societal forces are at play such as
fundamental changes in food, environmental, cultural, economic, and social
systems. Therefore, more global and systems approaches to the obesity
epidemic may be necessary.
Visit Forbes for the article.
Fentanyl, a prescription opioid deadlier than heroin, is now showing up on
police officers don't have much trouble finding dealers who claim to be
selling heroin. Recently, though, lab tests are showing that what officers
are buying on the street isn't heroin, but something even deadlier — a
painkiller known as fentanyl, typically prescribed after surgery or for
patients with a terminal illness. It is as much as 50 times stronger than
"Sometimes it's 100
percent fentanyl," said Lt. Rich Lane, who oversees OPD's Drug Enforcement
Division. "But it's always sold to us as heroin and that's the scary part
... it's like heroin on steroids."
This is how so many
addicts looking for their next hit end up as another number in the morgue.
They think they are shooting up with the dope they know. They have no idea
they were just sold a fatal dose.
At 100 times more
potent than morphine, it only takes a little fentanyl to kill. Joshua
Stephany, interim medical examiner for Orange and Osceola counties, says
more people are dying this way. Back in 2013, his office tallied just 18
deaths tied to fentanyl. In 2014, 34 people died after taking the synthetic
opiate. The number of fentanyl deaths more than doubled in 2015 to 70. So
far, in the first three months of this year, there have been five cases of
fentanyl-related fatal overdoses. And that number is likely to go up because
Stephany is still waiting on lab results to come back on some cases.
This is what police
and addicts — and, yes, those two can be on the same team — are now up
against: dealers who have no idea what they are really selling or just don't
When addicts hear
about a rash of overdoses — such as the deaths that occurred last summer at
the condemned condominium complex — dealers consider that good marketing.
That isn't even the scariest part. This problem is spreading beyond heroin
In the Tampa Bay area,
police have found overdose victims with counterfeit oxycodone and xanax
pills laced with fentanyl.
"What we are now
seeing are deaths of persons associated with fentanyl that are not known to
use IV drugs, but rather pills obtained on the street or black market," said
William Pellan, director of investigations at the medical examiner's office
in Pinellas and Pasco counties. "These are pills that are being pressed out
to appear to be authentic pharmaceutical xanax and/or oxycodone. ... This is
particularly alarming and very dangerous, considering the potency of
A drug that doctors
have long prescribed in patch form to control pain at the end of patients'
lives is now being manufactured by drug cartels and used to increase the
potency of other street drugs. Police want to get the word out.
Visit the Orlando Sentinel for the story.
Antiarrhythmic drugs found beneficial when used by EMS treating cardiac
confirmed that certain heart rhythm medications, when given by paramedics to
patients with out-of-hospital cardiac arrest who had failed electrical shock
treatment, improved likelihood of patients surviving transport to the
hospital. The study was published online in the New England Journal of
Medicine and helps answer a longstanding scientific question about the
effectiveness of two widely-used antiarrhythmic drugs, amiodarone and
lidocaine, for treating sudden cardiac arrest.
The study followed the
patients from hospital admission to hospital discharge. Although neither
drug significantly improved the overall rate of survival to hospital
discharge, amiodarone showed a favorable trend in that direction. Survival
to discharge is the point at which a patient is discharged from the
“This trial shows that
amiodarone and lidocaine offer hope for bringing patients back to life and
into the hospital after cardiac arrest,” said principal study author Peter
Kudenchuk, M.D., a cardiac electrophysiologist at the University of
Washington Medical Center in Seattle. “While the overall increase in
survival to hospital discharge of about 3 percent with amiodarone was not
statistically significant, it came very close. Importantly, there was a
significant improvement in survival to hospital discharge with either drug
when the cardiac arrest was bystander-witnessed.” A bystander-witnessed
cardiac arrest is one that is witnessed by another person.
Sudden cardiac arrest
is a condition in which the heart suddenly or unexpectedly stops beating,
cutting off blood flow to the brain and other vital organs. More than
300,000 people are treated for out-of-hospital cardiac arrest each year,
with the vast majority occurring at home, according to the American Heart
Association. Studies show that nationally only about 10 percent of people
who suffer cardiac arrest outside the hospital survive. Effective
treatments, such as CPR and defibrillation, can greatly increase a victim’s
chance of survival. This study adds the possibility of additional benefit
from the use of the heart rhythm medications.
EMS (emergency medical
services) providers commonly use antiarrhythmic drugs for out-of-hospital
cardiac arrest that is not responsive to defibrillation shocks to the heart
for restoring its normal rhythm. However, doctors remain unclear whether
these drugs have proven survival benefit or if any benefit might be undone
by possible drug side effects. As a result, use of these treatments by
Adverse effects from
the drugs were infrequent, and scientists are continuing to analyze findings
from the trial to gain additional insight into its results.
Visit NIH for the study.
Value-based insurance program raises compliance
economic incentives to participate in health screenings and take their
prescribed medications resulted in decreased hospitalizations and increased
medication adherence, a small study has found.
"The positive results
in this case should encourage other payers to incorporate reduced cost
sharing for high-value services across entire episodes of care in their
benefit plans," wrote Richard Hirth, PhD, of the University of Michigan, in
Ann Arbor, and colleagues in the April issue of Health Affairs.
The study involved
64,000 employees of the state of Connecticut who were enrolled in the
state's health insurance plan; of those, about 98% enrolled in the state
government's Health Enhancement Program. The program uses principles of
value-based insurance design (VBID) -- incentivizing patients to receive
care that's more clinically valuable by having them spend less for it.
Under the program,
co-pays for office visits dealing with chronic conditions were eliminated (a
savings of $15 per visit) and co-pays for medications associated with
asthma, chronic obstructive pulmonary disease (COPD), diabetes heart
disease, hypertension, and hyperlipidemia were reduced or eliminated.
enrollees also had to do their part -- they were required to participate in
health risk assessments, screenings, and physical exams -- such as
mammograms or colorectal cancer screenings. Those with certain chronic
conditions also had to obtain guideline-based clinical services and
participate in disease management -- for example, eye exams for diabetes
patients or blood pressure checks for hypertensive patients. In addition,
patients had to pay a $35 co-pay for an emergency department (ED) visit that
didn't result in a hospitalization.
participated in the program were exempt from a $100 monthly premium
surcharge that nonparticipants paid, and those with chronic conditions who
met all of the program's requirements received a $100 annual bonus, the
authors explained. They compared outcomes from the Connecticut group over a
2-year period with those of a control group of 215,000 employees and their
dependents enrolled in employer-sponsored plans in six states.
visits and nearly all of the targeted preventive screenings showed
significant gains from baseline in both the first and second program years,
relative to the comparison group, the investigators found.
There were significant
increases in physician office visits among patients with chronic conditions
compared with the comparison group, the researchers found. The likelihood of
having an office visit increased by 1.6 percentage points in year 1 and by
1.2 percentage points in year 2.
And for asthma or COPD,
hyperlipidemia, diabetes, and hypertension, medication possession ratios for
some drug classes -- a measure of medication adherence -- for enrollees in
the Health Enhancement Program increased significantly relative to the
comparison group between baseline and subsequent years, the authors noted.
In terms of ED visits,
although there was no change in year 1, there was "a significant
1.0-percentage point decrease in the probability of an ED visit between
baseline and the second year" compared with the control group, the
researchers wrote. "In contrast, the total number of ED visits without a
resulting hospital admission decreased significantly in both years."
found that spending in year 1 of the Health Enhancement Program increased by
about $730 per enrollee from baseline and in year 2 by about $961 per
enrollee from baseline compared with the comparison group.
Michael Chernew, MD,
of Harvard University in Cambridge, MA, said the study results "generally
show that consumers respond to prices and so ... They are consistent with a
whole range of other literature; when you lower prices for high-value
services you can increase the use of those things and there seems to be some
[cost] offset" such as in this case a reduction in ED use.
Visit MedPage Today for the report.
White House to transfer Ebola funds to combat Zika virus
officials say the Obama administration has decided to transfer leftover
money from the largely successful fight against Ebola to combat the growing
threat of the Zika virus. Most of the $600 million or so would be devoted to
the Centers for Disease Control, which is focused on research and
development of anti-Zika vaccines, treating those infected with the virus
and combating the mosquitoes that spread it.
The officials spoke
Tuesday on condition of anonymity because they were not authorized to
publicly discuss the matter before an official announcement expected from
the White House on Wednesday.
Researchers fear Zika
causes microcephaly, a serious birth defect in which a baby's head is too
small, as well as other threats to the children of pregnant women infected
President Barack Obama
has asked for about $1.9 billion in emergency money to fight Zika but the
request has stalled in the GOP-controlled Congress. While the administration
has acknowledged that substantial Ebola funding is left over, it has already
committed much of it to helping at least 30 other countries prevent, detect
and respond to future outbreaks and epidemics.
The upcoming move
comes as there's greater urgency to battling the virus as summer weather
leads to mosquito season and a broader spread of the virus.
Republicans on Capitol
Hill had suggested the administration consider reshuffling existing funds
and have said they are open to paying the money back in future legislation
if it's needed for Ebola or some other purposes.
announcement would come as it's become plain that action on a stand-alone
emergency spending bill is virtually impossible in the bitterly partisan
atmosphere in Washington, though such funding could be attached to larger
legislation later in the year. Congress approved about $5 billion in 2014 to
Visit the Associated Press for the story.
approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug
Administration approved the first pacemaker that does not require the use of
wired leads to provide an electrical connection between the pulse-generating
device and the heart. While the Micra Transcatheter Pacing System works like
other pacemakers to regulate heart rate, the self-contained, inch-long
device is implanted directly in the right ventricle chamber of the heart.
Nearly 1 million
people worldwide are implanted with pacemakers each year. The leads in a
traditional single chamber pacemaker run from the pacemaker, implanted under
the skin near the collarbone, through a vein directly into the heart’s right
ventricle; the leads deliver electric pulses from the generator to the right
ventricle and help coordinate timing of the chamber’s contractions. Micra
eliminates these leads, which can sometimes malfunction or cause problems
when infections develop in the surrounding tissue, requiring a surgical
procedure to replace the device.
“As the first leadless
pacemaker, Micra offers a new option for patients considering a single
chamber pacemaker device, which may help prevent problems associated with
the wired leads,” said William Maisel, M.D., M.P.H., acting director of the
Office of Device Evaluation at the FDA’s Center for Devices and Radiological
Health. Micra is intended for patients with a heart arrhythmia called atrial
fibrillation or those who have other dangerous arrhythmias, such as
contraindicated for patients who have implanted devices that would interfere
with the pacemaker, who are severely obese, or who have an intolerance to
materials in the device or the blood thinner heparin. It is also
contraindicated for patients with veins that are unable to accommodate the
7.8 millimeter introducer sheath or pacemaker implant. The Micra device is
manufactured by Medtronic.
Visit the FDA for the announcement.
departments finalize new version of the summary of benefits and coverage
helping consumers better understand their health coverage
The Department of
Health and Human Services (HHS), the Department of Labor (DOL) and the
Department of the Treasury announced key enhancements to the Summary of
Benefits and Coverage (SBC) template and Uniform Glossary. The improvements
include an additional coverage example and language and terms to improve
consumers’ understanding of their health coverage.
Under the Affordable
Care Act, issuers and health plans are required to provide a brief summary
of what the plan covers and the cost sharing responsibility of the consumer,
in order to help individuals make more informed choices among health plan
options and better understand their coverage. Plans and issuers are also
required to provide a comprehensive uniform glossary of commonly used health
coverage and medical terms.
“Only when a consumer
has a clear understanding of what their plan can do for them as well as what
they are responsible for can they feel completely confident in their health
plan choice,” says Marketplace CEO Kevin Counihan. “That is why we continue
to improve upon the SBC requirements in order to provide that peace of mind
to our consumers.”
The SBC includes
coverage examples that demonstrate the cost sharing amounts an individual
might be responsible for in three common medical situations. In addition to
the current coverage examples that address diabetes care and childbirth, the
updated template has a new coverage example that addresses coverage for a
foot fracture so that a consumer understands what a plan covers in an
Changes have also been
made to the SBC to improve readability for consumers. The new templates
include more information about cost sharing, such as enhanced language to
explain deductibles and a requirement that plans address individual and
overall out-of-pocket limits in the SBC.
reflect input from consumer groups, the National Association of Insurance
Commissioners, and other stakeholders. Health plans and issuers will use
this final SBC template beginning on the first day of the first open
enrollment period that begins on or after April 1, 2017.
The SBC is available
for every Marketplace plan and most non-Marketplace plans.
regarding the SBC and supporting materials can be found at
April 6, 2016
Download print version
What Yelp can tell you about a hospital that
official ratings can’t
Medicare is often overbilled by hospices, and
pays twice for some drugs
Never mind Zika and Ebola: It’s Yellow Fever
we should be worried about
Zika mystery deepens with evidence of nerve
Concern over the rising cost of insulin
MEDICA Education Conference returns in 2016
symplr and Cactus Software merge in healthcare
provider credentialing software
FDA drug safety communication: Diabetes
medications containing Saxagliptin and Alogliptin have risk of heart failure
Yelp can tell you about a hospital that official ratings can’t
If you've ever taken
the time to give Yelp your two cents about a hospital, you'll be happy to
know that someone's listening and that they've deemed the crowd sourced
information not only useful — but unique.
In what is believed to
be the first large-scale analysis of such data, researchers from the
University of Pennsylvania looked at 17,000 Yelp reviews of 1,352 hospitals
from consumers. They found that the online information provides a broader
sense of a facility than the current gold standard — a
U.S. government survey that costs millions of dollars to develop and
implement each year.
The Hospital Consumer
Assessment of Healthcare Providers and Systems Survey or HCAHPS has been
used since 2006 and involves asking discharged patients questions about
their stays. It covers 11 main categories including communication with
nurses and doctors, responsiveness of staff, the cleanliness and quietness
of the hospital environment, and pain management.
Yelp offers consumers
the ability to rate hospitals on a scale of one to five stars and write a
review to accompany that rating. The U-Penn researchers used natural
language processing to take apart the narratives and put them into buckets
that were similar to the categories used by the HCAHPS. They gave as an
example a post that had words such as "pain," "nurse," "medication," "gave"
and how that might be assigned to the pain category.
Their paper, published
in the April issue of Health Affairs, found that Yelp
reviews encompassed only about seven of the 11 categories covered by the
HCAHPS. That was disappointing. But there was also a big surprise in the
data. The Yelp reviews had information about 12 additional categories that
weren't addressed in the government survey. Those include the cost of the
hospital visit, insurance and billing, ancillary testing, facilities,
amenities, scheduling, compassion of staff, family member care, quality of
nursing, quality of staff, quality of technical aspects of care, and
specific type of medical care.
For positive reviews
they included caring doctors, nurses and staff; comforting;
surgery/procedure and peri-op; and labor and delivery. And for negative
reviews, they included insurance and billing and cost of hospital visits.
Read the article at the Washington Post.
Medicare is often overbilled by hospices, and pays twice for some drugs
Hospices often bill
Medicare for a higher level of care than patients need, and Medicare often
pays twice for the prescription drugs provided to people who are terminally
ill, federal investigators say in a new report. The extra cost to Medicare
was put at more than $260 million a year.
found that Medicare was paying hospices almost four times as much as it
should have for some patients. The patients were receiving “inpatient care”
when all they needed was less-expensive routine care in their homes, the
Medicare now pays
hospices an all-inclusive rate of $720 a day for inpatient care and no more
than $187 a day for routine home care. Most hospice care is provided to
Medicare beneficiaries in their homes. But if their pain or symptoms become
too difficult to manage at home, they can be admitted to a hospital, nursing
home or hospice inpatient unit.
inspector general, Daniel R. Levinson, found that hospices were billing
Medicare for a higher, more expensive level of care than patients needed in
about a third of such cases.
In response to the
report, Andrew M. Slavitt, the top Medicare official, said he was stepping
up supervision of hospices because he was concerned about “care being billed
for but not provided, long lengths of stay and beneficiaries receiving
benefit covers a combination of medical, social and counseling services, as
well as prescription drugs, for people with a life expectancy of six months
or less. It emphasizes the alleviation of pain and suffering rather than the
cure of illness. Hospice patients generally forgo Medicare coverage for
curative treatment of the terminal illness and related conditions.
In about 20 percent of
hospice claims for inpatient care, Levinson said, the Medicare beneficiary
did not need such care at all. In another 10 percent, he said, the patient
needed the higher level care for only part of the inpatient stay.
And “in 1 percent of
stays,” he said, “there was no evidence that the beneficiary elected hospice
care or was even certified as having a terminal illness.”
Visit the New York Times for the full article.
Never mind Zika and Ebola: It’s Yellow Fever we should be worried about
Yellow Fever is a
nasty way to die. Your muscles ache, your head hurts, and your skin starts
turning yellow. You run a fever, and start vomiting. Eventually, if left
untreated, you start having seizures and bleeding from your eyes and your
mouth, until your organs pack up.
In Angola, at least
178 people have died this way since the beginning of a new Yellow Fever
outbreak in December 2015. In total, an estimated 450 people have been
infected with the disease, and that’s just the official statistics: experts
estimate that the true figures could be as much as 10 times higher. That’s a
lot of sick people, and a lot of dead bodies.
In contrast, the Zika
virus, which has dominated health news in 2016, has claimed only a handful
of lives, although it has caused nearly 1,000 cases of infants born with
microcephaly in South America. If Zika is a public health emergency — and
there’s no doubt that it is – then Angola’s Yellow Fever outbreak should be
To make matters even
worse, Yellow Fever – unlike Ebola or Zika – is entirely preventable. A
highly effective vaccine exists. Had the vaccine been administered in
Angola, like it is as a matter of routine in many countries across the
world, the current outbreak would not exist. Given Angola’s vast oil wealth,
there is no doubt that the country could have afforded to implement a
vaccination program that would have prevented these deaths.
Now, both Angolan and
global authorities are scrambling to react. The World Health Organization
has shipped its entire stock of six-million vaccinations to Luanda, where
they are being rolled out as quickly as possible. But Luanda alone has a
population of 7.2-million, so there are simply not enough vaccines to go
While efforts are
under way to increase production, the Angolan outbreak underlines just how
important it is to maintain sufficient vaccine stockpiles for emergency use.
Without enough vaccines, virologists are concerned that Angolan Yellow Fever
epidemic will spread quickly, both within Angola and the region. Already,
people infected in Angola have been identified in Kenya, Mauritania, the
Democratic Republic of Congo and China.
another approach. In the wake of the Zika outbreak, several scientists
advocated for a radical solution: the complete elimination of the Aedes
aegypti mosquito, through which the Zika virus is spread. It just so
happens that this same mosquito is also the primary vector for Yellow Fever.
One biologist described this proposed specicide as “the ultimate swatting” –
and said it could save up to a million human lives.
Visit the Daily Maverick for the story.
mystery deepens with evidence of nerve cell infections
Top Zika investigators
now believe that the birth defect microcephaly and the paralyzing
Guillain-Barre syndrome may be just the most obvious maladies caused by the
mosquito-borne virus. Fueling that suspicion are recent discoveries of
serious brain and spinal cord infections - including encephalitis,
meningitis and myelitis - in people exposed to Zika.
Evidence that Zika's
damage may be more varied and widespread than initially believed adds
pressure on affected countries to control mosquitoes and prepare to provide
intensive - and, in some cases, lifelong - care to more patients. The newly
suspected disorders can cause paralysis and permanent disability - a
clinical outlook that adds urgency to vaccine development efforts.
Scientists are of two
minds about why these new maladies have come into view. The first is that,
as the virus is spreading through such large populations, it is revealing
aspects of Zika that went unnoticed in earlier outbreaks in remote and
sparsely populated areas. The second is that the newly detected disorders
are more evidence that the virus has evolved.
"What we're seeing are
the consequences of this virus turning from the African strain to a pandemic
strain," said Dr. Peter Hotez, dean of the National School of Tropical
Medicine at Baylor College of Medicine.
The suspicion that
Zika acts directly on nerve cells began with autopsies on aborted and
stillborn fetuses showing the virus replicating in brain tissues. In
addition to microcephaly, researchers reported finding other abnormalities
linked with Zika including fetal deaths, placental insufficiency, fetal
growth retardation and injury to the central nervous system.
Doctors also are
worried that Zika exposure in utero may have hidden effects, such as
behavioral problems or learning disabilities, that are not apparent at
"If you have a virus
that is toxic enough to produce microcephaly in someone, you could be sure
that it will produce a whole series of conditions that we haven't even begun
to understand," said Dr. Alberto de la Vega, an obstetrician at San Juan's
University Hospital in Puerto Rico.
First discovered in
the Zika forest of Uganda in 1947, the virus circulated quietly in Africa
and Asia, causing rare infections and producing mild symptoms. A 2013
outbreak in French Polynesia, the largest at that time, led researchers to
make the Guillain-Barre link. Other neurological effects were noted but
scientists made little of them at the time.
viruses - including dengue, Japanese encephalitis and West Nile - are known
to directly infect nerve cells in the brain and spinal cord. But such
viruses are seldom associated with Guillain-Barre, and never with
microcephaly, said Baylor's Hotez.
In a recent paper, WHO
researcher Mary Kay Kindhauser wrote that Zika "appears to have changed in
character," noting its transition from a mild infection to one causing
"large outbreaks linked with neurological disorders."
Zika in Brazil now are reporting the same neurological disorders seen in
French Polynesia. From April through July 2015, doctors in Brazil identified
a spike in Guillain-Barre cases.
Zika exposed patients
have had other neurological problems as well, including acute disseminated
encephalomyelitis, which causes inflammation of the myelin, the protective
sheath covering nerve fibers in the brain and spinal cord. Other patients
experienced tingling, prickling or burning sensations, which are often
markers of peripheral nerve damage.
In addition to Brazil
and French Polynesia, at least 11 more countries and territories have
reported hundreds of cases of Guillain-Barre syndrome linked to Zika. In
Brazil, Guillain-Barre cases jumped 19 percent to 1,708 last year.
El Salvador, a country
that has an annual average of 196 cases of Guillain-Barre, reported 118
cases in six weeks in December and January.
Pardo-Villamizar, a neurologist at Johns Hopkins University School of
Medicine, is studying Zika complications with colleagues in five Colombian
research centers. They have seen cases of encephalitis, myelitis and facial
paralysis associated with Zika and want to understand what is triggering
They also want to
study whether prior infection with dengue or chikungunya - two related
viruses - are contributing to neurological disorders seen in patients with
Visit Reuters for the report.
Concern over the rising cost of insulin
The average price of
insulin tripled between 2002 and 2013, according to a research letter
published in JAMA, and that has led to higher costs for diabetics.
Meanwhile, the cost of noninsulin therapies has trended downward, the
A major driver of the
increasing cost is analog insulin, a man-made insulin developed in the
1990s, according to the study. Analog insulin is considered superior to the
other man-made insulin, known as human insulin, which was first engineered
in the 1980s to be genetically identical to the body's naturally-produced
Analog insulin is
faster-acting than human insulin, is considered more convenient to use and
may lead to fewer low blood sugar reactions, says Dr. Bill Herman, a
University of Michigan professor of medicine and epidemiology and co-author
of the research letter.
But analog insulin is
also more expensive, he says. A vial can cost $300 and diabetics generally
need two to three vials a month, adds Herman, which he says can be hard to
afford for those who have to pay out-of-pocket for their drugs.
Analog insulin now
accounts for about 90 percent of the insulin market, says Herman, who adds
that for many people with Type 2 diabetes, human insulin is safe and
effective, in addition to being more affordable.
The cost of insulin is
increasing at a time of growing national anger over the skyrocketing costs
of various prescription drugs.
products required significant research and development and are expensive to
manufacture, says Herman. Still, "you have to balance that with the fact ...
that the cost of the medications, even since the time that they were
launched, has continued to go up each year," he says.
"There's just not a
lot of transparency in terms of what is actually research and development
and manufacturing costs, versus what is profit," he says.
which are less expensive than analog or human insulin, are also an option
for some patients.
Herman and his
co-authors say the increases in the cost of insulin "suggest a need to
reassess the effectiveness and cost-effectiveness" of the noninsulin
Visit SCPR for the report.
MEDICA Education Conference returns in 2016
The German Association
for Internal Medicine and Messe Düsseldorf will organize the MEDICA
Education Conference again this year during the MEDICA trade fair. This
conference offers participants a unique opportunity to exchange information
about new medical technologies. MEDICA will take place from November 14 –
17, 2016 at the fairgrounds in Düsseldorf, Germany.
“Science meets Medical
Technology”, is this year’s educational theme. Sessions will be geared
towards professionals from all medical segments – from clinics and practices
to anyone interested in medicine and medical technology in science,
research, development and manufacturing. Scientific lectures will offer
overviews or in-depth information while practical sessions will educate
physicians about daily patient care.
In addition to the
interdisciplinary offerings, the conference also provides an international
information and networking platform with the majority of the events held in
Each of the four MEDICA education conference days will have a specific
On Monday November 14,
the topics will be “New Operative Techniques in Surgery”. In addition to
innovative techniques and future visions, current standards of surgical
methods will be presented in a diverse and compact form.
The sessions on
November 15 will address “Imaging and Interventional Procedures” such as
magnetic resonance tomography and sonography. These procedures find
application throughout medicine in diagnosis and therapy and are important
elements of daily outpatient and inpatient clinical patient care.
The third conference
day (November 16) will focus on “Internal Medicine: Future Technologies and
Remote Patient Management”. Experts will discuss questions such as “What
does telemedicine mean for chronic diseases such as diabetes” and “To what
extent can digital solutions such as remote monitoring in case of heart
failure help to avoid a hospital stay?”
The program on the
final day (November 17) will look at “Diagnostics in Internal Medicine,
Laboratory Medicine, Toxicology and Hygiene”. Determination of laboratory
parameters, correct interpretation and connection to individual clinical
symptoms will be the discussion topics.
Conference day passes
can be purchased online in advance and include the MEDICA trade fair on the
same day. The conference is structured to end at 3:30 pm daily to give
participants the opportunity to walk to the neighboring exhibition halls and
see new the technologies at MEDICA 2016 (the show closes at 6:30 pm).
More information about the conference is available online at www.medica-tradefair.com/mec2.
For further information on visiting or exhibiting at MEDICA 2016, visit www.mdna.com.
symplr and Cactus Software merge in healthcare provider
symplr, a provider of
Software as a Service (SaaS) based healthcare compliance and credentialing
solutions, announced a merger with Cactus Software. Cactus Software provides
management software for hospitals, managed care organizations, CVOs, and
For more information
or to contact symplr, visit www.symplr.com.
drug safety communication: Diabetes medications containing Saxagliptin and
Alogliptin have risk of heart failure
An FDA safety review
has found that type 2 diabetes medicines containing saxagliptin and
alogliptin may increase the risk of heart failure, particularly in patients
who already have heart or kidney disease. As a result, FDA is adding new
warnings to the drug labels about this safety issue.
alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor
drugs, which are used with diet and exercise to lower blood sugar in adults
with type 2 diabetes.
FDA evaluated two
large clinical trials conducted in patients with heart disease. Each trial
showed that more patients who received saxagliptin- or alogliptin-containing
medicines were hospitalized for heart failure compared to patients who
received an inactive treatment called a placebo.
In the saxagliptin
trial, 3.5% of patients who received the drug were hospitalized for heart
failure versus 2.8% of patients who received a placebo. This is the same as
35 out of every 1,000 patients compared to 28 out of every 1,000 patients.
Risk factors included a history of heart failure or kidney impairment. In
the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized
for heart failure versus 3.3% in the placebo group. This is the same as 39
out of every 1,000 patients compared to 33 out of every 1,000 patients.
professionals should consider discontinuing medications containing
saxagliptin and alogliptin in patients who develop heart failure and monitor
their diabetes control. If a patient’s blood sugar level is not
well-controlled with their current treatment, other diabetes medicines may
Patients taking these
medicines should contact their healthcare professionals right away if they
develop signs and symptoms of heart failure such as: Unusual shortness of
breath during daily activities; Trouble breathing when lying down;
Tiredness, weakness, or fatigue; Weight gain with swelling in the ankles,
feet, legs, or stomach; Patients should not stop taking their medicine
without first talking to their healthcare professionals.
Read the FDA MedWatch safety alert FDA Drug Safety Communication.
April 5, 2016
Download print version
Interference between CT and electronic medical
House Committee on Ways and Means pushes back
on PAMA Laboratory payment reform timeline
Bypass boosts survival in heart failure,
10-year study says
Statin intolerance is real, researchers find.
Another (more costly) drug may get around the problem
Why didn't Flint treat its water? An answer,
Medicare spends billions on chronic kidney
disease, study finds
AORN 2016 Coverage:
Olympus introduces light & boom portfolio to
support big screen surgery
Buffalo Filter celebrates 25th anniversary
UMF Corporation's PerfectCLEAN OR System
receives AORN Seal of Recognition for 4th year
Encompass Group offers continuing educations
courses at AORN
Mölnlycke Health Care doubles up on Biogel PI
Micro Surgical Double-Gloving System
Interference between CT and electronic medical devices
CT is a valuable type
of diagnostic imaging. Most patients undergo CT scans without any adverse
consequences. However, the FDA has received a small number of reports of
adverse events that they believe to be associated with CT imaging of some
implantable and wearable electronic devices (eg. insulin pumps, cardiac
implantable electronic devices and neurostimulators).
understanding is that when a CT scanner directly irradiates the circuitry of
certain implantable or wearable electronic medical devices (i.e. when the
device is visible in the resulting CT image), it can cause sufficient
electronic interference to affect the function and operation of the medical
device. The probability that this interference can cause clinically
significant adverse events is extremely low. Furthermore, the probability of
x-ray electronic interference is lower when the radiation dose and the
radiation dose rate are reduced.
completely avoided when the medical device is outside of the primary x-ray
beam of the CT scanner.
The electronic medical
devices for which they have received reports of adverse effects and have
updated our recommendations are: Insulin pumps, Cardiac implantable
electronic devices (pacemakers and implantable cardioverter defibrillators),
The presence of the
devices mentioned above should NOT preclude the performance of an
appropriate, medically indicated CT scan. The probability of an adverse
event being caused by exposing these devices to CT irradiation is extremely
low, and it is greatly outweighed by the clinical benefit of a medically
indicated CT examination.
CT continues to be the
preferred tomographic imaging technology for patients with implantable or
wearable medical devices. CT is safer for patients with devices of
unknown magnetic resonance imaging (MRI) safety status. You should be aware
that an MR Conditional device is only safe within the MR environment that
matches its conditions of safe use. Any device with an unknown MRI safety
status should be assumed to be MR Unsafe.
manufacturers, distributors, importers, and device user facilities (which
include many healthcare facilities) must comply with the Medical
Device Reporting (MDR) Regulations of 21 CFR Part 803.
included: seizures, dizziness, fainting, injuries related to falls, heart
failure, hypertension, and one death.
Although the adverse
effects listed above were reported to occur during CT scanning, there is no
evidence of direct causation from the CT irradiation. The number of adverse
event reports received is very small compared to the number of patients with
insulin pumps who were scanned without adverse effects. Although there
is literature to document the rare effects on implantable cardioverter
defibrillators (ICDs) and pacemakers, there is no equivalent evaluation of
Visit the FDA For the warning.
House Committee on Ways and Means pushes back on PAMA Laboratory payment
Independent Laboratory Association (NILA), representing community and
regional independent clinical laboratories across the country, applauds the
Chairman and members of the House Ways and Means Committee Subcommittee on
Health for raising concern about the implementation of new regulations by
the Centers for Medicare and Medicaid Services (CMS) to reform Medicare
laboratory test reimbursement.
A bipartisan majority
of the Ways and Means Subcommittee on Health, under the leadership of
Subcommittee Chairman Pat Tiberi (R-OH) and committee members Congressman
Patrick Meehan (R-PA) and Bill Pascrell (D-NJ) sent a letter to CMS Acting
Administrator Andy Slavitt, that strongly advises CMS not to rush the
reconfiguration of the Part B Clinical Laboratory Fee Schedule (CLFS) under
the Protecting Access to Medicare Act (PAMA) of 2014.
The Ways and Means
committee members join the chorus of many other House Representatives, the
Senate Finance Committee Chairman and Ranking Member, and other Senators who
have asked for a delay in the regulations and expressed significant concern
with rushing the implementation of a complex payment reform system.
The release of the CMS
PAMA regulations on October 1, 2015, came over 17 months after Congress
passed the law that requires laboratories on January 1, 2016, to begin
reporting all non-capitated privately-contracted insurance rates for every
laboratory test they provide and the associated test volumes for each rate.
NILA is extremely concerned about the impact this law and corresponding
regulations will have on regional and community laboratories and the
Medicare beneficiaries they serve.
With the release of a
late proposed rule and no feedback since comments on the rule closed in
November, NILA fears that CMS might rush the finalization of these complex
regulations such that NILA members will not have the time or ability to
prepare for reporting and to make business adjustments to handle the
requirements. At this point, CMS has never pilot tested the new first-time
reporting system or provided any understanding of how it will operate.
Under the CMS proposed
regulation, reporting requirements would have commenced between January
2016-March 2016. CMS would have then quickly evaluated the anticipated
billions of reported data sets to issue new proposed rates by November 2016,
issuing new Clinical Laboratory Fee Schedule rates by January 1, 2017 –
providing just two months for laboratories to comprehend the impact these
adjustments will have on their business and their ability to provide
“While NILA has never
supported the approach of this law, we want to ensure that a new process for
determining Medicare reimbursement rates does not ultimately force smaller
laboratories out of Medicare or perhaps out of business
altogether-negatively affecting market competition and access to Medicare
laboratory services,” says Mark Birenbaum, Ph.D., NILA Administrator. “The
law itself is fundamentally flawed, as it requires CMS to determine a
weighted median of all the test rates/volumes reported in order to set new
payment rates. Clearly, the largest players in the laboratory market - the
two national publicly traded laboratories - will drive the test volumes, and
their rates will dominate CMS’s evaluation. The law does nothing to consider
variances in the market and the impact that adjustments will ultimately have
on community and regional laboratories, particularly those that offer
significantly smaller test menus in comparison to their national
The laboratory market
is derived of independent clinical laboratories – national, regional, and
community laboratories, and hospital and physician-owned laboratories. In
addition to fast-tracking implementation in the absence of final
regulations, the proposed rule seeks to exclude a majority of clinical
laboratories, including all hospital and nearly all physician-owned
laboratories, from the reporting requirements, which many in the laboratory
community believe will inappropriately reduce the new Medicare reimbursement
Visit NILA for the request.
Bypass boosts survival in heart failure, 10-year study says
Heart failure patients
with clogged arteries have a better chance of surviving 10 years if they get
bypass surgery plus medicine rather than just drugs alone, according to an
Earlier results from
the same research raised questions about the benefits of bypass versus
medicine alone, but researchers say the long-term evidence clearly favors
The lead author of the
study, Duke University cardiologist Dr. Eric Velazquez, said the results
"are so definitive and so robust" that they would likely to lead to stronger
recommendations favoring bypass surgery for these patients.
Nearly 6 million
Americans and 23 million people worldwide have heart failure, and many of
them also have artery disease similar to those studied. In recent years,
bypass surgery has increasingly been recommended for such patients, along
with medicines to ease heart failure symptoms.
Concerns were raised
when results after nearly five years of research showed about equal number
of deaths in bypass patients and in those who got only medicine, despite
fewer heart-related deaths in the bypass group. Those findings were
published in 2011.
The 10-year results
were published in the New England Journal of Medicine and presented
at an American College of Cardiology meeting in Chicago. The study involved
1,200 heart failure patients in 22 countries, including the United States.
Most were men around age 60 when the study began. All were taking heart
medicines, and about half were assigned to also get bypass surgery.
More than half the
patients in each group lived beyond the study's first phase. The 10-year
results are a look back at all patients studied.
A total of 359 bypass
patients died from any cause, or about 59 percent, compared with 398
medicine-only patients who died, or 66 percent. Deaths from heart
disease-related causes totaled 247 in the bypass group, or 41 percent,
versus 297 medicine-only patients, or 49 percent.
Visit Tampa Bay Times for the story.
Statin intolerance is real, researchers find. Another (more costly) drug may
get around the problem
Statins such as
Lipitor and its generics have revolutionized cardiovascular care for nearly
two decades as an effective, inexpensive way to reduce LDL cholesterol, the
so-called bad cholesterol in the bloodstream.
Not everyone can take
them, though; a significant number of people complain of muscle pain,
weakness and cramping so severe that they discontinue the therapy even at
the risk of a heart attack or stroke. Their resistance to the medication has
been controversial, because in most cases there are no biomarkers for the
muscle problems individuals describe. Some researchers have speculated that
the problem is psychological, the “nocebo” effect of blaming the medication
for the pain.
But a study released
Sunday shows for the first time that statin intolerance is very real and
that a newer, different kind of drug can have a strong impact on these
patients’ high cholesterol.
Researchers found that
42.6 percent of people who had complained of muscle pain while taking at
least two different statins experienced the same symptoms when given a
statin during the study but had no ill effects when administered a placebo.
They were then able to reduce their LDL cholesterol levels by more than half
when given a PCSK9 inhibitor, evolocumab, for 24 weeks, compared with just a
16.7 percent reduction on ezetimibe, another medication.
The Food and Drug
Administration approved PCSK9 inhibitors last year, but only for small
groups of people, including those with an inherited disease that
dramatically elevates their LDL cholesterol levels.
“This problem of
statin intolerance is one of the most vexing problems for both patients and
physicians in cardiovascular medicine,” Steven E. Nissen, chairman of the
Department of Cardiovascular Medicine at the Cleveland Clinic, said in an
interview. He said the new study, which he led, offers hope for people who
have not been able to take statins because of side effects.
Mary Norine Walsh,
vice president of the American College of Cardiology and medical director of
Heart Failure and Cardiac Transplantation at St. Vincent Heart Center in
Indianapolis, called the study “encouraging.” PCSK9 inhibitors, she added,
are “going to be, possibly, an option for patients who are statin-intolerant.”
But that may not
happen for a while. In addition to requiring FDA approval, the drugs are
much more expensive — from $10,000 to $15,000 a year. And because evidence
of statin intolerance is largely subjective, insurance companies may balk
until there are ways to more conclusively prove that patients are unable to
take the cheaper drugs.
In another study
released Sunday morning, researchers showed that a drug that raises HDL
cholesterol, often called good cholesterol, and lowers LDL cholesterol does
not help high-risk heart patients. In fact, the study of more than 12,000
people was cut short after the results revealed that the drug, evacetrapib,
did not prolong the time until death, heart attack, stroke, coronary artery
bypass surgery or hospitalization for chest pain due to restricted cardiac
It was the third
failure for drugs in a class known as cholesteryl ester transferprotein (CETP)
inhibitors, which disrupt the process by which HDL cholesterol is converted
to LDL cholesterol, the ACC said in a release.
Visit the Washington Post for the report.
didn't Flint treat its water? An answer, at last
Back in 2014, Flint
water treatment workers expected they'd add corrosion control to the
city's drinking water -- chemicals that would that would have prevented a
public health crisis -- after the city switched its water supply. But the
Michigan Department of Environmental Quality said they didn't have to.
Up to this point, it's
been hard to understand why the state didn't require Flint to use corrosion
control, chemicals that stop lead from leaching into the city's water
supply. And the state's rationale, that it misunderstood federal guidelines,
has mystified water treatment experts interviewed by the Free Press. It
also drew scorn from the Flint Water Advisory Task Force, appointed by Gov.
Rick Snyder himself to investigate the crisis -- the task force called
MDEQ's interpretation of the rule "egregious" and "lax," saying it bypassed
important and obvious questions about water safety.
But testimony at a
legislative hearing from the city's utilities chief may help explain why:
When Flint began to pump drinking water from the Flint River, the
city's water treatment plant wasn't capable of adding corrosion control
treatment, not without equipment upgrades the broke city couldn't afford.
In fact, Flint didn't
start to install the required equipment until November 2015, when MDEQ
signed off on an October permit application for a temporary phosphate feed
system while a permanent feed was under construction, according to state
That's the same month
Snyder finally acknowledged that there was a problem in Flint, that the
abundant evidence amassed by independent researchers was accurate, and that
the city's drinking water was not safe.
It's critical context
for understanding the state's disastrous decision-making in Flint.
Michael Glasgow, then
a lab supervisor and now the city's utilities administrator, testified at a
legislative hearing about the Flint water crisis.
The state has said,
for months, that MDEQ misinterpreted the federal Lead and Copper Rule, a
guideline for treating water to prevent the kind of public health crisis
that happened in Flint -- because water pumped from the Flint River hadn't
been dosed with corrosion control chemicals, the city's residents were
exposed to lead-contaminated water, for almost two years, including nearly
9,000 children younger than 6.
And even after the
U.S. Environmental Protection Agency told the state last spring that
Flint must begin corrosion control immediately, the state didn't act -- in
official emails, claiming it was appropriate to continue monitoring the
city's water before changing its treatment, even as two rounds of state
testing showed lead levels in the city's drinking water climbing.
The decision to skip
corrosion control certainly didn't save money. Corrosion-control chemicals,
which keep lead contained by coating the inside of plumbing pipes, are
cheap; some reports estimate the cost of treating Flint River water at less
than $150 a day.
however, are expensive. A 2014 engineering report, performed in conjunction
with a bond offering for a new regional water authority the state OK'd Flint
to join in 2013, said the local treatment plant would require $8 million in
upgrades to process the Lake Huron water the new system would pump.
Flint was broke by the
time it joined the new regional water authority, and under the oversight of
a state-appointed emergency manager hired to cut costs. And it was still
broke the next year, when a different emergency manager opted to pull
drinking water from the Flint River while the new system was under
construction, instead of purchasing water from the Detroit system Flint had
patronized for years.
Both choices were
billed as cost-saving measures, justified because of Flint's financial
That 2009 report
didn't specify how much of that $8 million total installation of corrosion
control equipment would account for, but the idea that Flint's plant needed
a corrosion control upgrade wasn't new. A 2009 engineering analysis
associated with the same water system detailed equipment necessary to add
corrosion control at Flint's plant: a 6,000-gallon bulk storage tank, a
transfer pump and a 120-gallon day tank and chemical metering pumps.
According to MDEQ, no
upgrades to corrosion-control equipment were made at the plant before it
began to pump and treat Flint River water, more corrosive than the Lake
Huron water it expected to use when the new system was complete.
Visit the Detroit Free Press for the story.
Medicare spends billions on chronic kidney disease, study finds
Chronic kidney disease
affects nearly 14 percent of Americans and costs Medicare billions of
dollars a year, a new study reveals. In 2013, Medicare spent $50 billion on
chronic kidney disease among people 65 and older, and $31 billion on those
with kidney failure, the researchers found.
"This report is a
one-stop shop to try to understand the prevalence of kidney disease, how
it's being treated and how the burden affects various populations,"
researcher Rajesh Balkrishnan, a professor of public health sciences at the
University of Virginia School of Medicine, said in a university news
"If we can identify
which treatment modalities are working and how they're used and link these
treatments to outcomes, we can inform the government of the most
cost-effective ways to manage and treat the growing burden of kidney disease
in the U.S.," he added.
The study was
published online in March as a special report by the American Journal of
Balkrishnan led the
analysis of prescription drug use and found that in 2013, spending on
prescriptions for Medicare Part D patients with chronic kidney disease was
46 percent higher than for general Medicare patients -- $3,675 per patient
prescriptions for Part D patients with kidney failure was $6,673 a year per
patient, 2.6 times higher than for general Medicare patients. Dialysis
patients had the highest cost at $7,142 per person per year, the findings
Spending for Part
D-covered medications was more than two times higher for chronic kidney
disease patients who received Medicare's low-income subsidy than for those
who did not -- $6,088 versus $2,873. Out-of-pocket costs were 1 percent to 2
percent for patients who got the subsidy, and between 28 percent and 32
percent for those who did not, according to the report. (HealthDay)
Visit NIH for the report.
Perioperative Registered Nurses' Surgical Conference and Expo 2016 in
Anaheim, California April 3-5, 2016
Olympus introduces light & boom portfolio to support big screen surgery
announced it now sells surgical lighting, equipment booms and
infrastructure products through a distribution agreement with AMICO. The
agreement brings with it several innovative and differentiated
technologies, two of which will be featured this week at AORN 2016.
There will be a
presentation on ergonomic positioning of large monitors in the operative
field and a live demonstration of the Patient Lift Pendant (PLP) system.
The PLP is a patented, safe, and ergonomic method of transferring patients
into the surgical field directly from a ceiling mounted boom. Other
applications include elevating and holding appendages during long surgical
The partnership with
AMICO solidifies a key addition to the Olympus Systems Integration
business which will now include an OR design element. Combining a
best-in-class imaging system, robust integration offering, and
differentiated infrastructure product, Olympus has a highly competitive
and complete solution for all surgical environments.
Three weeks ago, at
the 2016 Society of American Gastrointestinal and Endoscopic Surgeons
(SAGES) in Boston, Olympus launched its Big Screen Surgery concept,
featuring the new Olympus 4K Imaging platform, which highlights the visual
elements – light, color and higher resolution – essential for laparoscopic
and arthroscopic surgery. Given the recommended use of a larger screen
with 4K imaging, appropriate infrastructure and ergonomics are recommended
for managing screen placement to best accommodate the surgical team.
For more information
about big screen surgery
Buffalo Filter celebrates 25th anniversary
Buffalo Filter is
pleased to announce that 2016 marks its 25th anniversary. In 1991,
Buffalo Filter was founded on the belief that there was a need to rid the
world’s surgical environments of the hazards associated with surgical
smoke plume exposure. Over the course of the last 25 years, Buffalo Filter
has set the standard with state-of-the-art surgical smoke plume evacuation
products and technologies; their world renowned education program has
changed the way the global healthcare community sees surgical smoke.
25th Anniversary will be commemorated with a variety of events and
promotions to be kicked-off at AORN in Booth #509.
UMF Corporation's PerfectCLEAN OR System receives AORN Seal of Recognition
for 4th year
For the fourth
consecutive year, the Association of periOperative Registered Nurses (AORN)
has awarded its AORN Seal of Recognition to the PerfectCLEAN Operating
Room Processing & Checklist System developed by UMF Corporation, a
Chicago-based innovator of infection prevention products, systems and
training for all healthcare markets.
For the PerfectCLEAN
OR Processing & Checklist System, the AORN Seal of Recognition confirms
that the content of the program has undergone thorough review by AORN and
meets the guidelines of the "AORN Guidelines for Perioperative Practice."
While not an endorsement, the Seal of Recognition is confirmation that the
PerfectCLEAN Operating Room education materials meet AORN's guidelines for
excellence in providing a safe patient environment.
UMF Corporation and
its PerfectCLEAN OR System were recently brought in as part of a
multimodal initiative at three Kentucky hospitals -- Bourbon Community
Hospital of Paris, Georgetown Community Hospital of Georgetown and James
B. Haggin Memorial Hospital of Harrodsburg -- to prevent transmission of
infections in the operating room. The initiative aligns the efforts of the
three hospitals' Environmental Services (ES) staffs responsible for OR
processing, Logan's Healthcare Linen and Uniform Rental of Shelbyville
(the hospitals' healthcare laundry); and UMF Corporation.
for safe patient care figure prominently in the hospital initiatives.
Logan's is accredited by the Healthcare Laundry Accreditation Council (HLAC),
which also is a recipient of the AORN Seal of Recognition. Last year,
Logan's joined UMF Corporation's expanding PerfectCLEAN Infection
Prevention Network (PC/Network) of specialized healthcare laundries
serving acute care hospitals and extended care and ambulatory surgical
Encompass Group offers continuing educations courses at AORN
Encompass is pleased
to offer two Continuing Education courses at this year’s AORN conference
in AORN Booth #1611: Mind the Gap: Utilizing Evidence-Based Outcome
Evaluation to Simplify Patient Warming; and Back to the Future: New
Innovations in Reusable OR Textiles.
Mölnlycke Health Care doubles up on Biogel PI Micro Surgical
Care is enhancing its Biogel PI Micro range to offer the Biogel PI Micro
Indicator Underglove for use with the Biogel PI Micro surgical glove –
creating the next-generation puncture indication system. The system offers
a thinner, more comfortable, synthetic double-gloving solution, giving the
best possible protection without sacrificing tactile sensitivity.
With Biogel PI Micro
Indicator Underglove, Mölnlycke Health Care is building on the success of
the 20-percent-thinner profile of Biogel PI Micro to provide continuous
improvement for customers. A recent user evaluation showed that 85 percent
of Operating Room staff preferred the new Biogel PI Micro Indicator
Underglove to the existing Biogel PI Indicator Underglove.
With Biogel PI
Micro, the company now offers a synthetic double-gloving solution that
both protects against latex sensitivity and allergic reactions, and
addresses the demand for tactile sensitivity and dexterity. Tactile
sensitivity is cited as one of the main barriers to adopting
double-gloving in the Operating Room.
evidence increasingly supports global recommendations for double-gloving
in all cases, a survey with 107 surgical staff members found that fewer
than one-third of surgeons report using double-gloving in > 75% of cases.
April 4, 2016
Download print version
Researchers find 1400 software vulnerabilities
in medical supply system
Ultrasounds missed her Zika infection—until
one showed serious harm to her fetus
FDA Alert: Sterile drug products by Medaus
CMS invites Quality Innovation Network-Quality
Improvement Organizations to submit special innovation projects to expand
their reach in improving care delivery
AORN 2016 Coverage:
Clorox Healthcare introduces povidone-iodine
alternative to antibiotics for nasal decolonization
Tru-D SmartUVC to showcase the gold standard
in disinfection technology at AORN
Nurse appreciation and patient care focal
points for Cardinal Health Showcase at AORN
TIDI Products to showcase Sterile-Z
infection-prevention products at AORN 2016 in-booth presentations
Researchers find 1400 software vulnerabilities in medical supply system
found vulnerabilities in end-of-life versions of CareFusion’s Pyxis
CareFusion, researchers Billy Rios and Mike Ahmadi identified the
vulnerabilities in end-of-life versions of CareFusion’s Pyxis SupplyStation
system, said the notice from the Industrial Control Systems Cyber Emergency
Response Team (ICS-CERT).
could be exploited remotely,” the advisory says. “Exploits that target these
vulnerabilities are known to be publicly available.”
systems are automated cabinets that dispense medical supplies and can
document usage in real time. They typically include a network of
workstations, located in patient care areas throughout a facility and
managed by the Pyxis SupplyCenter server, which links to the facility’s
existing information systems, according to ICS-CERT. The SupplyStation
system is designed to provide access to supplies in “fail-safe mode” if the
cabinet is rendered inoperable.
CareFusion will not
provide a patch for these outdated systems, but has begun providing
customers of end-of-life versions with an upgrade path. Those who choose not
to upgrade can apply a series of compensating methods detailed in the
always be discovered in connected devices,” John Smith, principal solution
architect at Veracode, said. “The security of all IoT devices must be looked
at holistically so that all devices, as well as their web and mobile
applications, and back-end cloud services, are secure by default.”
specializes in critical systems security – in which system failures can
cause disastrous events that can lead to death.
“A heart is a vital
organ and if it needs a pacemaker in order to survive, the pacemaker itself
becomes as vital as the heart,” Ahmadi said. “If you can find a
vulnerability that can cause a failure, then it is actually a digital
pathogen, the body doesn’t differentiate anymore between a carbon-based
virus and a digital one.”
Visit QMED for the story.
Ultrasounds missed her Zika infection—until one showed serious harm to her
Zika successfully hid
through nearly half of a District woman’s pregnancy, its damage to her fetus
not showing despite a series of early ultrasounds. But suddenly at 19 weeks,
another scan revealed significant abnormalities, and a more sophisticated
test one week later identified even greater damage in her baby’s brain. In
early February, the woman terminated the pregnancy.
The report, in the
New England Journal of Medicine, provides troubling new information
about the capacity of the virus to infect a fetus and cause serious harm.
The case also indicates that Zika may remain in the blood for a long time:
The 33-year-old woman still tested positive for Zika 10 weeks after she
likely was infected during a trip to Guatemala – far beyond what scientists
have thought is the case.
"This helps put more
pieces together in the puzzle because we know so little about how this virus
acts and when and how long it stays in your blood after you have symptoms,"
said Laura Riley, vice chair of obstetrics and gynecology at Massachusetts
General Hospital in Boston, who was not part of the study. Even though the
study only involves one patient, "it's very important because she was
followed so closely and there is so much detailed information.”
While the case offers
important details to researchers and obstetricians-gynecologists counseling
pregnant women who may have been exposed to the virus, "we're going to need
to study this with a large number of patients to provide guidance for
women," said Catherine Spong, acting director for the National Institute of
Child Health and Human Development.
The woman and her
husband traveled on vacation to Mexico, Guatemala and Belize in late
November when she was 11 weeks pregnant. The couple told researchers they
had been bitten by mosquitoes during their trip, particularly in Guatemala.
After returning home, the woman developed eye and muscle pain, fever and a
A series of
ultrasounds that began one week after her symptoms subsided -- at 13, 16 and
17 weeks of pregnancy -- showed none of the characteristic problems linked
to Zika. The most prominent in utero are an abnormally small head and brain
calcifications, bright, white spots that indicate something is amiss. Both
are key to a diagnosis of a rare condition called microcephaly.
Yet on the ultrasound
at 19 weeks, significant brain abnormalities appeared: The baby's brain was
small and contained an unusual amount of fluid. The cerebral cortex, its
outer layer, was very thin. By the 20th week, a fetal MRI showed severe
atrophy, especially in the front and top brain areas that are involved in
decision-making, learning, vision, hearing, touch and taste. The fetus did
not meet the threshold to be diagnosed with microcephaly.
In the initial
ultrasounds, "they only looked at the size of the head and looked for brain
calcifications to make sure she didn't have microcephaly and reassured her
that everything looks okay," said Rita Driggers, one of the study's lead
authors and medical director of Sibley Memorial Hospital’s maternal-fetal
medicine division. Driggers, an assistant professor of gynecology and
obstetrics at Johns Hopkins University School of Medicine, was involved in
the patient's care.
The takeaway for
clinicians, she and others said, is to make sure during ultrasounds to look
for other brain changes beyond microcephaly and intracranial calcifications.
Adre du Plessis, director of Children's National Health System's Fetal
Medicine Institute and another study author, said Wednesday that the lack of
those markers in the earlier ultrasounds may have led to "false
reassurances" for the mother. What's more, he said, such delayed diagnosis
of brain infection in the fetus may put women who'd opt to terminate a
pregnancy "outside the legal limits" of an abortion.
The study also
provides new information about how long the virus persists in the blood of
an infected person. The common thinking has been that the virus is only
present for seven days to about two weeks at the outer limits. But this
patient had virus in her blood from the time she became infected, when she
was about 11 weeks pregnant, up until the time of her abortion, at 21 weeks.
Visit the Washington Post for the article.
Alert: Sterile drug products by Medaus Pharmacy
FDA is alerting
healthcare professionals and patients not to use unexpired drug products
that are intended to be sterile that were produced by Medaus Pharmacy in
Birmingham, AL, due to lack of sterility assurance. Medaus’ products were
distributed nationwide and internationally.
During FDA’s recent
inspection of Medaus’ facility, investigators observed insanitary
conditions, including poor sterile production practices, which raise
concerns about Medaus’ ability to assure the sterility of drug products that
Administration of a
non-sterile product, intended to be sterile, may result in serious and
potentially life-threatening infections or death. The Alabama Board of
Pharmacy ordered Medaus to cease sterile compounding operations on March 22,
2016. On March 29, 2016, FDA recommended Medaus recall all unexpired drug
products that are intended to be sterile. To date, Medaus has not
voluntarily recalled any drug products intended to be sterile. Therefore,
FDA alerts health care professionals and patients not to use drug products
marketed as sterile from Medaus.
professionals and patients should immediately check their medical supplies,
quarantine any drug products marketed as sterile from Medaus, and not
Read the MedWatch Safety at FDA alert.
invites Quality Innovation Network-Quality Improvement Organizations to
submit special innovation projects to expand their reach in improving care
The Centers for
Medicare & Medicaid Services’ (CMS) Quality Improvement Organization (QIO)
Program is constantly evolving to help ensure that Medicare beneficiaries
receive better care, better health, and greater value. CMS is announcing the
program’s next evolution: two projects focused on supporting and scaling
quality improvement innovations.
announcement, Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs)
can collaborate with healthcare providers and/or partners to compete for 28
Special Innovation Project (SIP) awards that fall within two topic
categories totaling $8 million. Statements of Objectives will be released in
early April to the QIO community. Information regarding award dates will be
included in the Statement of Objectives.
SIPs are two-year
quality improvement projects that align with the goals of the
CMS Quality Strategy and emphasize the power of partnerships. There are
two categories of SIPs for QIN-QIOs to consider:
Innovations that Advance Local Efforts for Better Care and Smarter
Spending,” which will address healthcare quality issues that occur within
specific QIN-QIO regions.
Interventions that are Ripe for Spread and Scalability,” which will focus on
expanding the scope and national impact of a quality improvement project
that has experienced proven but limited success. The expectation is that
similar benefits would be experienced on a large scale if spread throughout
the greater health care community.
category aligns with the
CMS Strategic Innovation Engine (SIE), a new endeavor launched in August
of 2015. The SIE is working to rapidly move innovative, evidence-based
quality practices from research to implementation through the QIO Program.
In consultation with the SIE Executive Leadership Council, CMS is seeking
projects that: Streamline patient flow in various healthcare settings,
including hospital units, outpatient clinics, primary care offices,
ambulatory surgical centers, and cancer centers resulting in efficiencies,
improved satisfaction, decreased mortality, better care, healthier people,
and smarter spending.
Work with health plans
and/or care coordination providers to deploy an integrated approach to
post-acute care that results in enhanced care management, safe transitions
from one care setting to another, improved health outcomes, and reductions
patient affordability, and appropriate use of specialty drugs by applying
evidenced based criteria to prescribing practices and by monitoring
effectiveness when providers have a choice(s) among equally effective drugs
with differing costs.
Address acute pain
management. For example, more is needed to assist sickle cell patients: from
accurate identification of their illness to education of emergency
department staff on sickle cell disease while addressing the cultural
stigmas often associated with the disease.
Utilize big data
analytics to reduce preventable harm in healthcare.
For more information
about the CMS QIO Program and for a complete list of QIN-QIOs, please visit
the QIO Program website at
Perioperative Registered Nurses' Surgical Conference and Expo 2016 in
Anaheim, CA, April 3-5, 2016
Clorox Healthcare introduces povidone-iodine alternative to antibiotics
for nasal decolonization
To help healthcare
professionals in their ongoing efforts to protect patients from SSIs,
Clorox Healthcare is introducing Clorox Healthcare Nasal Antiseptic Swabs,
a povidone-iodine alternative to antibiotics, at AORN. Using an
antiseptic, like Clorox Healthcare Nasal Antiseptic Swabs, instead of an
antibiotic, like mupirocin, for preoperative nasal decolonization is a
simple and effective way for any healthcare facility to reduce unnecessary
The swabs offer
several key benefits as part of preoperative and inpatient decolonization
They are clinically
shown to be non-irritating and well tolerated in the nares after 10
applications. They are further shown to reduce 99.4% of S. aureus
at 1 hour and maintain persistence through 12 hours in an in vitro study.
ready-to-use swabs that are applied to a patient’s nostrils by a
healthcare provider one hour before surgery. This method shifts the
responsibility for nasal decolonization from patients to trained
healthcare professionals, increasing the likelihood of compliance.
Nasal Antiseptic Swabs contain povidone-iodine, an antiseptic that has
broad activity against gram-positive and gram-negative bacteria. This
antiseptic has been in use for over 50 years and to date, studies have not
shown that bacteria develop resistance to povidone-iodine.
will bring attention to nasal decolonization as an important part of plans
for SSI prevention and antibiotic stewardship through an immersive virtual
reality experience. Clorox Healthcare booth #313 attendees will be able to
view a 360° video that puts them in the shoes of a healthcare provider
performing nasal decolonization in a real-world setting. For those unable
to attend the conference, for an optimal 360° experience, watch the video
from your virtual reality headset or smartphone by visiting Clorox
Healthcare’s YouTube channel.
To further help AORN
conference attendees understand the issue of nasal decolonization, Dr.
Rosie D. Lyles will lead a continuing education (CE) presentation at the
Clorox Healthcare booth #313 titled, “Nasal Decolonization: Alternatives
to Antibiotics.” The free CE credit presentation will discuss the causes
and clinical and economic impact of HAIs and SSIs, problems associated
with antibiotic therapy, antiseptic alternatives to antibiotics for nasal
decolonization, and best practices.
information, including complimentary educational resources such as kits,
training materials and sample products, visit
Tru-D SmartUVC to showcase the gold standard in disinfection technology at
The pioneer in UV
disinfection robots, Tru-D SmartUVC will exhibit its state-of-the-art
technology at AORN in booth #1719. The leader in advocating for excellence
in perioperative practice and healthcare, AORN provides perioperative
nurses with resources for safe clinical practice and professional
Tru-D is a
germ-eliminating robot that is deployed in hospital rooms and operating
rooms after an environmental services member has completed traditional
cleaning methods. Operating from a single position and single placement,
it is seamlessly implemented into a hospital's work flow and allows for
operators to do other tasks while the disinfection cycle is completed.
Using patented Sensor360 technology, Tru-D analyzes the space including
size, shape and contents, to deliver a lethal dose of UV light, killing up
to 99.9% of pathogens in the room. Administering a single, measured cycle
of UV light, Tru-D removes the guesswork along with any chance of human
error in the cleaning process.
Nurse appreciation and patient care focal points for Cardinal Health
Showcase at AORN
humbly serve as the patient advocate throughout every procedure. So,
Cardinal Health will focus on being the nurses’ advocate by educating,
encouraging and energizing the nearly 5,000 who will attend the AORN.
Cardinal Health will
host four live continuing education (CE) activities, each approved for two
CE credits, and provided by Pfiedler Enterprises with grant funds provided
by Cardinal Health. These courses will be offered live in the Cardinal
Health CE theater, booth #1139.
While supplies last,
attendees can also visit their booth for two CE handouts from Pfiedler
Enterprises, which are approved for two CE credits, “Surgical Fires: Keys
to Awareness and Prevention,” and “Understanding Facial Protection: What
to Know and What to Wear.”
RNspire nurse appreciation program, which is dedicated to honoring and
inspiring nurses, will encourage nurses to “#ShowYourLove” in the Cardinal
Health photo booth. Nurses can get a photo strip of images sharing who –
or what – inspires them. Cardinal Health will donate $5 to Heart to Heart
International on behalf of every nurse that comes through the photo booth,
up to $5,000. A deserving nurse will also be surprised with a special
recognition in the Cardinal Health booth during the opening night session.
Cardinal Health will
further support clinician education at its booth by highlighting
cost-effective solutions that allow practitioners to focus on what matters
most – their patients. Attendees can learn more about healthcare
of tissue management module, the latest offering from Cardinal Health
Inventory Management Solutions, which provides automated tissue and
biological implant tracking that supports tissue management for ambient
and non-ambient environments. The module utilizes real-time inventory data
from RFID-enabled tools to help clinicians adhere to FDA and Joint
Commission compliance requirements, including documentation for chain of
custody, digital capture of tissue preparation, and identification if
tissue has been compromised due to infection, recall or expiration.
of Cardinal Health LiquiBand OCTYL Topical Skin Adhesive, which avoids
premature drying or clogging and allows adhesive to be expressed for up to
90 minutes after activation. The adhesive sets within approximately one
minute1,4 and the intuitive, dome tip applicator allows for ease of
Demonstration of new mobile app for the PackManager program, which
provides on-the-go, real-time access to information such as procedure pack
inventory, pricing and images. The app, currently available for Apple and
Windows tablet devices, reduces time capturing changes and allows
electronic signatures. A pack standardization feature helps standardize
supplies and reduce cost across the hospital or IDN.
Introduction of enhanced Cardinal Health SMS Surgical Drape features,
including a new royal blue color to help reduce glare from operating room
lights and provide color contrast for visual definition of critical zone.
Nurses can also learn about new drape designs, including Cardiovascular
Universal Drape Sets, Heavy Duty Orthopedic drapes and Robotics drapes.
of a new antiseptics line from Cardinal Health, including povidone-iodine
products, chlorhexidine gluconate solutions, hydrogen peroxide and
isopropyl alcohol, to offer hospitals the opportunity to standardize
products and reduce costs.
Visit Cardinal Health for more information.
TIDI Products to showcase Sterile-Z infection-prevention products at AORN
2016 in-booth presentations
TIDI Products, LLC,
announced they will showcase an array of solutions from their
infection-prevention portfolio at AORN 2016. TIDI will feature the
patented Sterile-Z product line, clinically designed to help protect the
sterile field and reduce infection risk. To aid perioperative
practitioners in meeting new AORN surgical-site infection (SSI) prevention
recommendations, TIDI will conduct presentations demonstrating Sterile-Z
back-table cover advantages at Booth #701.
covers can be applied and removed in seconds, and fit all standard-size
back tables. Sterile-Z technology has earned the AORN Seal of Recognition
and overwhelmingly positive clinical feedback since its introduction in
2014. In addition to Sterile-Z back-table covers, TIDI Products will also
feature Sterile-Z patient drapes, C-Armor equipment drapes, and the
TIDIShield Grab ‘n Go Eye Shields in a convenient, point-of-use dispenser.
TIDI will be located
in Exhibit Hall Booth #701 through Tuesday, April 5th. Sterile-Z
presentations will occur Monday, April 4th, on the hour, beginning at
10:00am, and Tuesday, April 5th, at 11:00am, 12:00pm, and 1:00pm.
about Sterile-Z, C-Armor, and TIDIShield eyewear dispensers is available
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