on medical scopes trigger infections
The deadly pattern of illnesses began to emerge in 2012 at hospitals in
Seattle, Pittsburgh, and Chicago. In each case, the culprit was a bacteria
known as CRE, perhaps the most feared of superbugs, because it resists even
"last defense" antibiotics â€” and kills up to 40% of the people it infects.
And in each case, investigators identified the same source of transmission:
a specialized endoscope, threaded down the throat of a half-million patients
a year to treat gallstones, cancers and other disorders of the digestive
system. They found that the devices, often called duodenoscopes, accumulate
bacteria that are not always removed by conventional cleaning, so infections
can pass from patient to patient.
Yet neither the scopes' manufacturers nor the Food and Drug Administration,
which regulates them, have publicized or offered guidance on the problem.
So, many doctors who use the scopes â€” and most of the patients they treat â€”
don't know the risks. Nor do they know that steps can be taken to cut those
"Most hospitals that do these procedures are not even looking for this
problem, or they may not be aware, and that's got to change," says Jeffrey
Duchin, a physician who heads communicable disease control at the Seattle
and King County Public Health Department.
Many of the resulting infections may go unnoticed, says Duchin, who directed
the investigation of the CRE outbreak in Seattle. In that case, seven
patients died with infections that were associated with contaminated
duodenoscopes; five of them with CRE.
When contaminated scopes transmit CRE, it's likely to get attention, because
the infections involve especially perilous, "red-flag" bacteria, Duchin
says. But more common bugs may elicit little more than a quick prescription
for antibiotics â€” and no investigation. "There's a likelihood that we're
just seeing a very small subset of the universe of infections from these
types of scopes," Duchin says.
The FDA says in a written statement to USA TODAY that it is "aware of and
closely monitoring" the infection risks associated with the scopes. "Some
parts of the scopes may be extremely difficult to access and clean
thoroughly," the agency adds, "and effective cleaning of all areas of the
duodenoscope may not be possible."
The agency is studying the problem and working with manufacturers to
determine whether new cleaning protocols should be mandated or the scopes
should be redesigned entirely. Meanwhile, the scopes' "lifesaving" ability
to detect and treat potentially fatal digestive disorders outweighs their
infection risks, the statement adds. "It (is) important for these devices to
Few dispute the scopes' importance. But public health officials and
endoscopy experts who have studied the problem believe the FDA and scope
manufacturers have been slow to bring attention to the infection risks and
publicize steps hospitals can take to reduce them dramatically.
Most of the patients involved had undergone a procedure known as ERCP, or
endoscopic retrograde cholangiopancreatography. In the procedure, the
duodenoscope is used to inject a contrast dye into the bile and pancreatic
ducts, of which X-rays are taken to reveal blockages, tumors, gallstones and
other problems. The scope also can be used to gather material for biopsies,
remove stones or other obstructions, or install stents to open the ducts.
Last year, after linking the CRE outbreak in Chicago to ERCP scopes, the
Centers for Disease Control and Prevention issued a warning about the risks
of spreading infections among patients who undergo the procedure. The
problem, investigators found, is that biological material can collect in the
"elevator" mechanisms that control tiny devices that extend from the tip of
Even when the devices are cleaned strictly in accordance with manufacturers'
FDA-approved guidelines, "they have a lot of intricate mechanisms and pieces
that are very difficult to disinfect," says Alex Kallen, an
infectious-disease physician at the CDC who helped direct the investigation.
"There definitely is a risk of (disease) transmission with these scopes."
Several hospitals that have linked CRE outbreaks to their duodenoscopes have
not waited for guidance from the FDA and scope manufacturers; they've
developed new safety procedures on their own that are showing great promise.
At Virginia Mason Medical Center in Seattle, officials adopted new
scope-cleaning protocols and now require that all scopes be quarantined
after cleaning, then tested for any residual bacteria before they can be
The hospital had to purchase additional scopes, and more staff were needed
for cleaning and testing, according to Duchin, the county health official.
He says the changes cost the hospital an estimated $1 million, but the
investment paid off: No infections have been linked to the scopes since the
new procedures were put in place.
At University of Pittsburgh Medical Center and Advocate Lutheran General
Hospital outside Chicago, officials have begun using EtO gas sterilization
to ensure that any bacteria lingering on scopes after manual cleaning are
destroyed. The process requires special facilities and equipment because the
gas is toxic, but the hospitals have reported seeing no infections since
they began using it.
The FDA says it is working with all three major manufacturers of
duodenoscopes â€” Olympus, FUJIFILM and Pentax â€” to assess potential design
changes and determine whether new disinfection processes can ensure the
scopes' safety in their current configuration.
Visit USA Today for the report.
Data on payments
from drugmakers to doctors is marred by error
Youâ€™d think drug and medical device makers would know how to spell the names
of their own products. But when companies submitted data to the federal
government last year on their payments to doctors, some got the product
names wrong. Forest Laboratories misspelled its depression drug, Fetzima, as
â€śFetziimaâ€ť 953 times, in more than one-third of all the reports on the drug.
Medical device company Amedica Corp. sometimes called its Preference screw
Amid much anticipation and after a lengthy delay, the government in
September unveiled its Open Payments database, saying it would bring
transparency to relationships between physicians and the drug and medical
device industries. But this openness has been clouded by numerous errors
that detract from its usefulness.
The database mistakes surfaced as an app was developed and rolled out this
month with The Upshot, to identify the drugs and medical devices that were
most heavily promoted to doctors in the last five months of 2013, the period
covered by the data. The New York Times found that many of the drugs
with the highest spending werenâ€™t cures or even medical breakthroughs, but
rather â€śme-too" drugs that were little different than other drugs on the
It was learned that the Centers for Medicare and Medicaid Services, which
administers the Open Payments database, doesnâ€™t double-check what companies
â€śWe are very committed to not altering data,â€ť said Shantanu Agrawal,
director of the agencyâ€™s Center for Program Integrity. â€śOur role is not to
spell-check for the industry. The act of transparency also will improve the
data itself.â€ť As companiesâ€™ errors are exposed, he explained, they will work
to fix them.
While misspelling product names was an obvious, infrequent error, a variety
of other problems were discovered. Companies, for instance, routinely
recorded payments associated with a single drug under multiple names.
Take H.P. Acthar Gel, an expensive injectable drug used to treat multiple
sclerosis, kidney disease, lupus and other conditions. The drugâ€™s maker,
Questcor Pharmaceuticals, logged payments related to the drug under eight
names, including Acthar, Acthar-Pulm, Acthar-IS, Acthar-Rheum and Acthar-MS.
The payments associated with each name didnâ€™t stand out much. But when they
were all added together, the drug ranked in the top 20 for spending on
doctors. For our analysis, we grouped them together.
Sanofi and Genzyme US Companies reported more than 31,800 payments totaling
$1.7 million associated with Lantus, its long-acting insulin, but listed the
drug under a variety of names: Lantus Timely Insulin, Lantus-Vial, Lantus
TML and Lantus Capture Insulin.
Another complication was that about 8.5 percent of the 4.3 million general
payments companies reported to the government were not connected to specific
products. More than 140 companies did not list products at all in their
Other companies didnâ€™t leave product fields blank but, in some cases, might
as well have. Gilead Sciences listed the product associated with eight
payments as â€śunrecognizedâ€ť and connected two dozen more to â€śGilead
Corporate.â€ť Novo Nordisk and its subsidiaries attributed 90 payments
totaling $133,000 to a product called â€śDisease State,â€ť a phrase that is
physician talk for a medical condition like diabetes, not a particular drug.
It was also learned that some companies listed products in the wrong
category, or listed them as both drugs and devices in the same payment
records. Luitpold Pharmaceuticals Inc., a drug maker, did this in more than
8,000 payment records.
Companies were able to associate each payment with up to five drugs and five
devices, so summing up spending by drug and device was tricky. When a
payment was connected to more than one product, companies did not break out
how much was attributable to each. Rather than guessing how to apportion
such payments, ProPublica applied the full payment amount to each product.
Since some companies routinely listed multiple drugs for individual
payments, excluding such spending would have substantially distorted their
Janssen Pharmaceuticals, a division of Johnson & Johnson, did this hundreds
of times with its arthritis drug Simponi, listing it as both drug No. 1 and
as drug No. 2 in records for the same payments. A company spokeswoman said
although Janssen submitted the same name twice, the second reference was to
Simponi Aria, a distinct product. As a result, code had to be written to
count these payments only once.
In a number of cases, multiple subsidiaries of a company reported payments
related to the same drugs. Five subsidiaries of Johnson & Johnson reported
payments associated with the diabetes drug Invokana: Janssen Research &
Development LLC; Johnson & Johnson Health Care Systems Inc.; Animas Corp.;
Janssen Pharmaceuticals Inc. and LifeScan Inc.
Thereâ€™s no indication that companies were being deliberately evasive â€”
indeed, payments could have come from different subsidiaries. But the
complexity shows how difficult it would be for the general public to get a
true sense of payments from the publicly released data sets.
The Pharmaceutical Research and Manufacturers of America, the industry trade
group, said mistakes were understandable since this had been the first year
companies reported this information publicly and the government repeatedly
changed its guidance for companies. Officials hope the coming year goes more
smoothly. Data covering the full year 2014 is expected to be released this
Visit the New York Times for the article.
HBI China 2015
promotes Sino-foreign business and academic exchange
The healthcare reform has brought about development opportunities for the
Chinese healthcare market, and new challenges for the domestic and
international hospital construction industry.
The Hospital Build & Infrastructure China (HBI China) Exhibition &
Congress that will be held from May 23 â€“ 25 at the Dalian World Expo Center
once again reinforces its commitment towards promoting sino-foreign business
and academic exchange, by presenting more comprehensive exhibition segments
as well as diversified learning and networking platforms.
Since its inception in 2011, HBI China has been committed to the healthy and
orderly development of the industry. Regarded as Asiaâ€™s flagship event for
the hospital build and infrastructure industry, the integrated trade show
provides industry players with the best platform for mutual exchange and
cooperation between the government, and decision makers from hospitals and
According to Chinaâ€™s State Council, the total scale of China's health
service industry will exceed RMB 8 trillion by 2020, and over RMB 4 trillion
will be invested in infrastructure. Chinaâ€™s healthcare industry is on its
way to becoming the world's largest emerging market.
To address the market demand of China's health service industry, HBI China
aims to promote the development and upgrade of China's medical and health
service system. Centered on the theme of â€śReform, Innovation, Development
and Guidanceâ€ť, HBI China 2015 will present a bigger and better show, with
improvements in terms of size, service, effect, and overall quality.
The 2015 edition is expected to attract close to 300 exhibitors and more
than 15,000 professional visitors over three days.
The 16th China Hospital Construction Forum will also be held concurrently
with HBI China 2015. As the most authoritative national academic conference
in China's hospital construction industry, the forum will attract over 500
hospital construction project owners, bringing with them procurement
requirements of over RMB 80 billion. At the forum, more than 2,600 core
decision makers will be present, 85 percent of whom are involved in making
procurement decision, including presidents and vice-presidents of hospitals,
as well as chiefs of infrastructure divisions.
With over 200 distinguished industrial experts and over 100 top global
hospital architects invited to speak at the forum, the 16th China Hospital
Construction Forum will provide delegates with a quality academic exchange
platform with the worldâ€™s top academic experts.
To learn more about the HBI China Exhibition and Congress 2015, visit www.hospitalbuildchina.cn/en/.
The best medications to use if you suffer migraine headaches are listed in a
new study. Researchers reviewed recent scientific literature and concluded
that a number of classes of drugs were effective for treating acute
These include triptans, dihydroergotamine (DHE) and many NSAIDS (nonsteroidal
anti-inflammatory drugs that include aspirin, ibuprofen and naproxen). Also
on the list: butorphanol nasal spray, and the combination medications
sumatriptan/naproxen and acetaminophen/aspirin/caffeine.
Several other medications are "probably effective" or "possibly effective,"
according to the study in the January issue of the journal Headache.
While powerful opioid pain drugs such as butorphanol, codeine/acetaminophen
and tramadol/acetaminophen are likely effective migraine treatments, they
are not recommended for regular use, the researchers said.
The study will form the basis of new American Headache Society guidelines
for the treatment of migraine.
"We hope that this assessment of the efficacy of currently available
migraine therapies helps patients and their physicians utilize treatments
that are the most appropriate for them," said study co-author Dr. Stephen
Silberstein in a society news release. He is a professor of neurology and
director of the Jefferson Headache Center of Thomas Jefferson University in
When selecting a medication for migraine patients, doctors must consider the
medicine's effectiveness and possible side effects, the researchers said.
Migraines affect about 36 million Americans, according to the American
Migraine Foundation. (HealthDay)
Visit NIH for the study.
sitting not offset by exercise: meta-analysis
Greater sedentary time was associated with increased risk of adverse health
outcomes including early death, even in those who otherwise exercised
regularly, a meta-analysis indicated.
With data pooled from 41 primary research studies, researchers found that
long periods of sitting time were positively correlated with all-cause
mortality and other outcomes, after adjustment for levels of physical
activity, compared with study participants reporting relatively little
The risk was generally greater at lower levels of physical activity,
according to David A. Alter, MD, PhD, at University Health Network in
Toronto, and colleagues, writing in the Jan. 20 issue of Annals of
In an accompanying editorial, Brigid M. Lynch, PhD, and Neville Owen, PhD,
both of the Baker IDI Heart and Diabetes Institute in Melbourne, Australia,
wrote, "The implications of these findings are far-reaching. Sedentary
behavior is ubiquitous. Society is engineered, physically and socially, to
Governments and professional organizations around the world are now warning
that too much sitting can be hazardous to health, noted Lynch and Owen. But
they also wrote that our understanding of how sitting affects cardiovascular
disease is rudimentary.
"Understanding the mechanisms by which sedentary behavior increases risk for
disease and the precise amounts of sitting that generate risk may enable us
to more effectively characterize the most at-risk groups within the
population," they said.
To help fill the research gap, they proposed three areas of research.
Isotemporal substitution modeling, which looks at the difference in
associations when time spent doing one behavior is altered by another
activity while time is constant, could be used to look at the relative
advantages of doing activities other than sitting.
In addition, future research should have objective activity monitoring,
Lynch and Owen wrote. Most of the research done has been self-reported and
looks at only one measure, like overall hours of sitting or total television
viewing time. Researchers could use devices like inclinometers or
accelerometers to track activity to reduce measurement error.
The meta-analysis included studies in which the sedentary time of adult
participants was correlated to at least one health outcome independent of
physical exercise. Sedentary behavior was defined as sitting, watching
television, or lying down. Alter and colleagues excluded studies that
reported indirect surrogate outcomes with unclear end points, like quality
of life, metabolic biomarkers, and weight gain.
Visit MedPage Today for the study.
Tide turning in
Ebola fight after hard lessons
A top U.N. official in the fight against Ebola greeted just three patients
at one treatment center he visited this week in Sierra Leone. Families in
Liberia are no longer required to cremate the remains of loved ones to halt
the spread of the virulent disease. And in the streets of Guinea's capital,
it is rare to see the formerly ubiquitous plastic buckets of bleach and
water for hand washing.
Ten months after it dawned on health officials that they were facing an
unprecedented Ebola outbreak in West Africa, experts and officials agree the
tide is turning, although previous lulls have proved short-lived.
There is still no vaccine or licensed treatment, nor is it clear whether the
international community has actually learned any lessons from an epidemic
that killed at least 8,675 people.
Previous disease outbreaks, including SARS and bird flu, prompted calls to
build strong health surveillance systems and to reinforce agencies like
the World Health Organization. But little has changed.
After the 2009 swine flu pandemic, WHO commissioned an independent review,
which recommended creating a $100 million emergency fund for health crises
and beefing up rapid-response health experts. Neither has been done.
The human toll of Ebola can be starkly seen in one plot of land in Liberia's
capital where only Ebola victims are buried now. Cards placed on sticks and
stuck into the ground carry the names of those who died. One day, families
hope they will be replaced with concrete gravestones marking the years of
birth and death as sunrise and sunset.
"Recriminations are counterproductive, but it will be necessary to
understand whether this outbreak could have been responded to quicker with
less cost and less suffering," U.N. Ebola chief, Dr. David Nabarro, told the
U.N. General Assembly earlier this week
"The epidemic has turned," Ismael Ould Cheikh Ahmed, the new head of the
U.N. Mission for Ebola Emergency Response known as UNMEER, recently
declared. The number of cases in Guinea and Sierra Leone is at its lowest
since August, and in Liberia it's the lowest since June. Still, he and other
officials caution that they lack critical information about the cases that
do remain. Only about half of new cases in Guinea and Liberia are from known
contacts, meaning that the remainder is getting infected from unknown
No such statistics even exist for Sierra Leone, where deaths are still being
underreported because families want to carry out burials in accordance with
tradition, which involves touching bodies â€” one of the quickest ways to
The outbreak has not killed as many people as some predictions. At its
height, one estimate warned that as many as 1.4 million people could become
infected by mid-January if there were no additional interventions. Instead,
the probable, suspected and confirmed case toll is 21,797 with 8,675 deaths.
Nearly every agency and government stumbled in its response to Ebola, now
expected to cost the three most-affected countries at least $1.6 billion in
lost economic growth in 2015.
In an internal draft document obtained by The Associated Press last year,
WHO acknowledged there was "a failure to see that conditions for explosive
spread were present right at the start." WHO blamed incompetent staff and
said it let bureaucratic bungles delay people and money to fight the virus.
The document said the agency was hampered by budget cuts and the need to
battle other diseases flaring around the world.
Officials must also think about changing risky cultural practices in future
epidemics, said Dr. Peter Piot, director of the London School of Hygiene and
Tropical Medicine and co-discoverer of the Ebola virus. (Associated Press)
Visit ABC News for the story.
FDA clears new
medical app to track real-time glucose levels in diabetics
Doctors and other caregivers will soon be able to track the blood-sugar
levels of diabetic patients by simply logging into a smartphone app, in the
latest example of how mobile technologies are changing the health care
The Food and Drug Administration on Friday approved the first set of
glucose-monitoring medical apps aimed at automatically and securely sharing
data in real time. The system, produced by California-based Dexcom
Inc., includes a small, wire-like sensor inserted just under the skin that
continuously transmits data to a monitor that is worn externally.
Using the company's smartphone app, the patient can then designate
"followers" with whom to share their information. The app then receives
real-time data and transmits it to an Internet-based storage location, where
the follower can also download and view the information via the app. While
other similar app systems exist, Friday's approval marks the first of its
kind since the FDA started regulating certain medical apps as devices in the
fall of 2013.
The FDA's marketing approval for Dexcom's system could pave the way for
similar technologies. Because the app was approved as a "low- to
moderate-risk" medical device, other manufacturers that want to market a
similar app in the future won't need to receive prior clearance from the
agency. They will, however, have to register their product with the FDA.
The agency has made clear that it does not intend to crack down on the
majority of health-related mobile apps -- of which there are thousands,
because most pose little risk to consumers. But in its 2013 guidance, the
FDA said it would regulate a subset of mobile apps "that present a greater
risk to patients if they do not work as intended."
Visit the Washington Post for the announcement.
HPN wants your
Infection Prevention Success Stories
Healthcare Purchasing News
wants to share your Infection Prevention Success Stories. We will be
selecting and including the most effective and innovative stories in our
April 2015 feature. Below are some ideas that would tell our readers about
your facility's success story:
What specific infection was your facility aiming to reduce or eliminate, and
why was it chosen for the focus of the campaign?
When did your facility start this campaign to reduce or eliminate this
What was the rate of this infection before your facility began their
campaign to reduce or eliminate it?
What is the rate of infection currently, or at the end of the study?
Have they been able to sustain the reduced rate of infection?
Describe specific steps your facility took to reduce or eliminate this
If a product(s) was part of the solution, identify it and explain how it
contributed to reduction/elimination of this specific infection.
What department(s) was involved in formation and implementation of this
campaign? Was teamwork involved?
Did those charged with the task meet with any resistance by administration
or staff in implementing the changes? If so, how did they overcome it?
Please include how you quantified your successes with numbers and
percentages, monetary savings, time savings, and patient safety enhancement
figures. The deadline is February 5, 2015. Please send stories to
Visit here for the success stories from 2014.