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February 23, 2016
FDA Safety Communication: PENTAX validates reprocessing instructions for ED-3490TK Video Duodenoscopes
PENTAX has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the
original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using
PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible.
Summary of Problem and Scope:
As noted in the FDA’s February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing.
Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If not properly reprocessed, residual body fluids
and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection.
If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections. The FDA has been working with
duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and
show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the
duodenoscopes.
In February 2015, PENTAX began modifying its reprocessing protocol and, in May 2015, initiated testing to validate its updated reprocessing
instructions. Between July and September 2015, PENTAX conducted additional testing to ensure its high-level disinfection protocols demonstrated
an adequate safety margin. In October 2015, PENTAX submitted their cleaning, high-level disinfection and sterilization reports to the FDA. The
Agency reviewed this data and requested additional cleaning tests, which PENTAX conducted. PENTAX submitted additional test data in January
2016, which the Agency reviewed and found to be adequate.
The updated reprocessing instructions for the ED-3490TK Video Duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning,
high-level disinfection and liquid chemical sterilization procedures. In addition, updated instructions include additional text, figures, cautions and
warnings intended to clarify the validated reprocessing procedure. The Agency believes that when followed, these updated, validated reprocessing
instructions demonstrate consistent and reliable cleaning, high-level disinfection and sterilization of PENTAX’s ED-3490TK’s Video Duodenoscope.
Please note the key changes to the reprocessing procedure for PENTAX’s ED-3490TK Video Duodenoscope:
Pre-cleaning:
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Additional detail regarding flushing of the elevator mechanism with detergent
Manual Cleaning: Additional detail regarding detergent solution preparation and use
New steps detailing brushing with existing PENTAX Medical cleaning brushes (models CS-C9S and CS6021T) and flushing of the elevator
mechanism
Increased volumes of fluids for internal channels
Additional detail regarding brushing of the instrument channel inlet
Increased number of endoscope rinses after detergent immersion
Additional warning regarding the potential for instrument channel obstruction
Manual High Level Disinfection (HLD):
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Additional detail regarding high level disinfectant preparation and use
Additional detail regarding flushing of the elevator mechanism during HLD
Increased volumes of fluids for internal channels
Increased number of endoscope rinses after disinfectant immersion
Sterilization:
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Removal of ethylene oxide as a sterilization method
Addition of STERIS System 1E as a liquid chemical sterilization method
In addition, the FDA has the following recommendations for facilities and staff that use and reprocess PENTAX’s ED-3490TK Video Duodenoscope:
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Implement the updated manual cleaning and high level disinfection procedures for PENTAX’s ED-3490TK Video Duodenoscope in
accordance with the manufacturer’s reprocessing instructions. Facilities that opt to sterilize the ED-3490TK Video Duodenoscope should
also follow sterilization procedures in accordance with STERIS’ instructions.
Train appropriate staff on PENTAX’s updated reprocessing instructions and implement them as soon as possible.
Contact your PENTAX Medical sales representative to arrange for in-servicing and training regarding the updated duodenoscope
reprocessing procedures. PENTAX will also follow up with customers to assess their in-servicing or training needs.
Visit the FDA for the communication.
Zika is possibly the scariest virus since HIV
Normally, we ignore or downplay infectious disease scares. As is the case with so many other scares, the eventual
outcome rarely resembles the scare, let alone being worthy of the media hysteria surrounding it.
Even though it is invoked every year at the start of the flu season, we have not had anything close to the 1918-19 flu
pandemic. In 2014, Ebola did some awful damage in isolated regions of Africa but did not engulf the world. As scary as it
seemed a few years ago, anthrax barely moved the needle in the U.S.
But every once in awhile, you get something different and unexpected, like HIV decades ago and Zika today. There is
nothing virologically special about HIV, except that its target is a key component of the immune system. And Zika could
be just another flavivirus, like hepatitis C, yellow fever, and West Nile, except … who knows? There is something new
discovered about it almost daily. And it is all but proven to cause birth defects — perhaps the scariest scare of them all.
Other viruses are known to harm neonates. For example genital herpes can be fatal to a newborn, but this can be
overcome by choosing a C-section over a natural birth. Rubella (German measles) also causes birth defects, but there has
been a highly effective vaccine available since 1969. But, neither is spread by mosquitos, which is why this scare is quite
different, and why Zika is still a big unknown.
It is primarily being spread by the Aedes aegypti mosquito, which clearly prefers warm areas, but they are not the only
carrier.
For those of us living in cooler areas, a key, yet unanswered question is, will Culex, a family of mosquitos that is common
to the entire country, be able to transmit Zika? It is a carrier for West Nile, however fewer than 6,000 people were
sickened by the virus in 2012 in the U.S. If Culex (there are many subspecies) gets involved, everything changes.
And here are other reasons why it might rightfully be the scariest virus since HIV:
It was just revealed that Zika was detected in amniotic fluid of two Brazilian women who gave birth to babies with
microcephaly. This suggests that the virus can cross the placenta. And a few days earlier, the first evidence was produced
of Zika in the brains of babies whose mothers were (probably) infected with the virus during their first trimesters.
The first cases were seen on Bonaire this week.
Puerto Rico is now using only imported blood for transfusions, and a travel alert has been issued for Aruba.
There have been 82 cases reported in the U.S., all from travelers.
The virus has been detected in semen, urine, and saliva.
Even given the evidence that surfaced this week, there is still far more that it is not known about Zika than is known.
Even vaccine and infectious disease expert Dr. Paul Offit, long-time trustee here at the American Council on Science and
Health, can only take an educated guess. Dr. Offit’s take on Zika is as follows:
There is very little that we know about this virus. It is not unreasonable that Zika could infect more common mosquito
species, such as Culex, which could then put much of the country at potential risk.
Although there are successful vaccines for other flavivirus infections (yellow fever), it will take years at a minimum to
develop a Zika vaccine.
Dr. Offit is very concerned about the “worldwide vaccine infrastructure.” At one time there were 28 drug companies doing
vaccine research; there are now four.
Visit The American Council on Science and Health for the report.
FDA to start testing foods for residue of Glyphosate herbicide
The U.S. Food and Drug Administration (FDA) announced that it would start testing food products sold in the United
States for residues of glyphosate.
Monsanto developed the herbicide glyphosate for U.S. crops and marketed it as Roundup in 1974. The chemical soon
dominated the pesticide market, eventually becoming the most-used agricultural chemical worldwide.
How much of the pesticide gets into the food supply, however, has been difficult to determine largely because the
regulatory community in the United States said this would be a waste of time and money given that the agrichemical
industry already claimed to have proven the chemical as safe.
Monsanto said that trace amounts of the chemical in foods are not harmful and that glyphosate does not pose
unreasonable risk to humans and the environment.
The World Health Organization (WHO), however, which conducted a review of more than 400 studies in 2015,
rated glyphosate, along with malathion and diazinon, as "probably carcinogenic to humans" in March 2015. The WHO
based its classification on studies in Sweden, Canada and the United States showing that those who work with
glyphosate-based herbicides have elevated risks for non-Hodgkin lymphoma, albeit another large U.S. study did not find
such link.
With the prevalent use of the chemical and suspected problems linked to use of the weed killer, experts have called for
regulators to reassess the chemical's toxicity and to make take the necessary steps to protect people from exposure to
the chemical.
Visit Tech Times for the article.
Urging openness about superbug infections, doctor omits cases in own hospital
As superbug outbreaks raised alarm across the country last year, a prominent doctor at a Philadelphia cancer center
wrote in a leading medical journal about how to reduce the risk of these often-deadly patient infections.
Dr. Jeffrey Tokar, director of gastrointestinal endoscopy at Fox Chase Cancer Center, pointed to recent outbreaks from
contaminated medical scopes and discussed steps doctors and hospitals should take to ensure patient safety in his Sept.
22 article in the Annals of Internal Medicine.
“Healthcare facilities and providers should strive to establish an environment of open information exchange with patients
about what is being done to maximize their safety,” Tokar and his two co-authors wrote.
What Tokar didn’t mention was that a tainted device at his own cancer center may have infected three patients with
drug-resistant bacteria. In accordance with federal rules, the hospital reported the possibility to the manufacturer,
Fujifilm, in May 2015, and the manufacturer filed the information with U.S. regulators.
The information only came to light last month when a U.S. Senate committee unveiled the results of a yearlong
investigation into scope-related infections that sickened nearly 200 patients across the country from 2012 to 2015,
including those potential cases at Fox Chase in Philadelphia.
The incident in Philadelphia illustrates a larger problem, experts say: a lack of public disclosure when medical devices are
suspected of posing a risk to patients.
Dr. Michael Kochman, one of Tokar’s co-authors and a gastroenterologist at the University of Pennsylvania Health System,
said he wasn’t aware of the Fox Chase incidents while working on the journal article. Had he known, he said, he would
have published some of the details.
Under current federal rules, hospitals must report serious injuries potentially caused by devices to the manufacturer
within 10 business days and notify both the manufacturer and the FDA about any suspected device-related deaths.
Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have
been caused by a device.
Senate investigators said the present system fails patients because it ignores “the reality that manufacturers and
healthcare providers have strong competing priorities that weigh against rapid and robust disclosure, such as moving new
products to market quickly and avoiding costly litigation.”
Fox Chase did follow federal rules and notify the scope manufacturer. In response, Fujifilm sent employees to the medical
center to learn more and ultimately the company quarantined the scope.
But the cancer center — and its GI endoscopy chief — made no public disclosure of the incident, nor were they legally
required to. It’s not known whether the three unidentified Fox Chase patients mentioned in the federal injury report were
told that a bacteria-laden scope may have caused their antibiotic-resistant infection. The infections can kill up to half of
affected patients, though the fate of the three at Fox Chase could not be determined.
In 2014, Tokar received $6,366 from Fujifilm for travel and lodging in Tokyo, where the company is based, according to a
federal database on industry payments to doctors and teaching hospitals. Temple University Hospital, which is affiliated
with Fox Chase, also received $134,697 from Fujifilm that same year for consulting work.
In 2010, Fujifilm announced a five-year research and development deal with Fox Chase for endoscopy products. The
company hailed its partnership with “one of the most prominent cancer prevention and treatment facilities in the United
States.”
Academic medical centers say patients benefit from these industry ties because they can lead to medical breakthroughs.
But critics say it can create conflicts of interest and make hospitals hesitant to share information that reflects poorly on an
industry partner.
Visit Kaiser for the full story.
This new research could help us fight off superbugs. Here’s how
The fight against antibiotic-resistant superbugs has only just begun, but research published Monday in the journal Nature
suggests there may be hope. The new findings give us insight into how we might win bacterial wars by busting up some
walls, so to speak -- hijacking a system that many bacterial cells use to maintain a defensive barrier against external
threats, be they pharmacological or immunological.
Researchers from the University of East Anglia are the first to describe a novel method by which proteins are stuck into
the outer membrane of the Gram-negative bacteria E. coli. This is important because it’s critical that we find new ways to
bring down harmful Gram-negative bacteria, which can cause cholera, plague, pneumonia and infections of the
bloodstream, surgical sites and wounds, as well as meningitis -- and which happen to be gosh darned hard to kill. Gramnegative bacteria are notorious for their drug resistance and ability to wreak havoc in healthcare settings.
The secret behind their relative hardiness lies in the bacterial outer membrane investigated in the new paper. A hallmark
of the Gram-negatives, the presence of this membrane makes the bacteria less likely to succumb to treatment.
All bacteria have what I’ll refer to here as an “inner membrane,” a kind of cellular envelope that keeps all the bacterium’s
junk in a neat little blob. But Gram-negative bacteria have a second layer -- an outer membrane. The lack of this outer
membrane makes Gram-positive bacteria more susceptible to antibiotics; the presence of it makes Gram-negative
bacteria tough as nails.
Researchers at UEA have discovered the mechanism by which E. coli puts the OMPs into its precious outer membrane.
And if you know how a cell is doing something, well, it becomes quite a bit easier to dream up ways to stop that process.
Here’s how it works, according to the new study: The outer membrane proteins are made in the soupy inside of the cell
and are then transported across the inner membrane to that thin goo layer between the inner and outer membrane, the
periplasm. From here, it falls to the beta-barrel assembly machinery, known as BAM, to correctly assemble and insert the
OMPs into the cell wall. The BAM complex is tasked with making the gates to inside the cell -- gates that, when
functioning properly, keep the cell safe from outside attack. The individual structures of the BAM complex have been
described, but until now we didn’t know the mechanism of their action or what the complete structure of the complex
looks like.
This finding is particularly exciting because it opens up a new way to fight hard-to-kill Gram-negative bacteria. But what
would these new drugs do?
According to the group leader, Changjiang Dong from UEA, “Our work and others suggested that the [drugs] would kill E.
coli if the small compounds could disrupt the interaction between the subunits BamA and BamD,” two of the subunits that
have been identified as critical to the BAM complex and thus critical for cell survival.
With knowledge of this mechanism, researchers can now begin to figure out how to use medicine to disrupt it.
“We will start to design small molecules and test whether the design molecules can kill bacteria, in particular drugresistant Gram-negative bacteria," he said.
And the best part? This research was conducted in part with Diamond Light Source, a piece of ultra-advanced scientific
equipment that is capable of producing light 10 billion times brighter than that of our sun, allowing scientists to examine
almost any material in atomic detail.
The race against drug resistance might be in its infancy but, as promising research like this so keenly demonstrates, there
is a bright glimmer of hope on that horizon.
Visit the Washington Post for the research.
CMS publishes Medicare Fee-for-Service provider & supplier lists
As part of the CMS efforts to improve care delivery, data sharing, and transparency, the Centers for Medicare & Medicaid
Services is releasing two public data sets regarding the availability and use of services provided to Medicare beneficiaries
by ground ambulance suppliers and home health agencies, as well as a list of Medicare fee-for-service (FFS) providers
and suppliers currently approved to bill Medicare.
CMS recently published a Federal Register notice on February 2, 2016 (effective January 29, 2016) extending the
temporary enrollment moratoria on new ground ambulance suppliers and home health agencies sub-units, and branch
locations in the Medicare, Medicaid, and the Children’s Health Insurance Programs (CHIP) for an additional six months in
seven geographic areas. Such moratoria provisions were authorized by the Affordable Care Act and serve to reduce fraud,
waste, and abuse while ensuring that patient access to care is not interrupted.
Future data releases may include comparable information on additional health services outside the seven moratoria areas.
The Moratoria Provider Services and Utilization Data Tool includes interactive maps and a dataset that shows national-,
state-, and county-level provider and supplier services and utilization data that can be used by CMS to determine which
geographic and health service areas might be considered for a moratorium on new provider and supplier enrollments.
The data provides the number of Medicare providers and suppliers servicing a geographic region, identifies moratoria
regions at the state and county levels, and identifies the number of people with Medicare benefits who use a specific
health service in that region. The data can also be used to reveal service levels related to the number of providers and
suppliers in a geographic region. Utilization data and geographic regions for these services can be easily compared using
interactive maps.
To view the Public Provider Enrollment data set and a related fact sheet, visit CMS.
HHS awards $500,000 in funding to Flint health centers
U.S. Department of Health and Human Services Secretary Sylvia M. Burwell announced $500,000 in funding to help two
area health centers increase and expand activities in response to the lead contamination of Flint’s water.
Following a tour of the Hamilton Community Health Network, Inc. (HCHN), Burwell and HHS Assistant Secretary for
Preparedness and Response Dr. Nicole Lurie, who is leading the federal response and recovery effort in Flint, announced
that HCHN and Genesee Health System (GHS) will each receive $250,000 in emergency supplemental funding to hire
additional personnel and provide more lead testing, treatment, outreach, and education to meet the increased need for
health services in the Flint community.
In addition to touring HCHN, Burwell met with community members and elected officials, including Governor Rick Snyder,
about the federal government’s response and recovery effort. The focus of the federal response is to work at every level
of government to support state and local officials in ensuring Flint has access to safe water, and there is a clear
understanding of the impact of lead exposure on residents’ health in order to mitigate the damage.
Last week, during a meeting with members of House Democratic leadership and the Michigan delegation, Burwell and
Lurie confirmed that HHS anticipates being able to quickly approve a number of requests, including a major Medicaid
coverage expansion for children and pregnant women in Flint that would include blood-lead level monitoring, behavioral
health services nutritional support, and comprehensive targeted case management, among other services.
Learn more on HHS’s response to the Flint Crisis.
Visit here for the release.
The "big data" app that predicts employees' health
Some employers are turning to data -- lots of it -- to help them reduce their costs of providing employees with health
insurance. But some experts worry that such technology could prove intrusive, allowing companies to pry into workers'
medical history.
One corporate giant using "big data" for health purposes is Walmart, the world's largest retailer. It is an early customer of
Castlight Health, whose app collects medical data on workers and then nudges them with information that could help
them make the best care decisions.
In one example, the app tracks female employees who have stopped filling their birth control prescriptions, and then
matches that information with a woman's age. The app then sends them messages about how to find an OB/GYN to help
them with prenatal care.
If that seems invasive, you're not alone -- the app has raised ethical concerns about how employers might use that
information. Castlight says that personal data about individual workers isn't relayed to employers, which guards against
managers learning who might be at risk for diabetes or who is thinking about having a child, among other scenarios.
Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), employers aren't allowed to access a
worker's personal medical information. But there's more leeway when it comes to data mining, aggregating information
and tapping data that doesn't personally identify a worker.
Meanwhile, the risk of workers being discriminated against on the job due to medical issues or pregnancy remains all too
real, statistics show. In 2013, alleged pregnancy discrimination prompted more than 5,000 complaints with the Equal
Employment Opportunity Commission. And pregnancy discrimination charges are increasing, with the number of
allegations rising by about one-third during the past decade, according to the National Partnership for Women & Families.
Such concerns aren't stopping a growing number of employers from tracking their workers' health, offering Fitbits or
standing desks. One group is urging companies to report statistics about their employees' health as another financial
metric that shareholders can judge them by, on the theory that a fitter workforce is a stronger one.
Castlight's Alka Tandon, the lead product manager, said that workers can opt out of the program, although she didn't
have data on the share of employees who have done so. The early results of the program, which is only three months
old, have shown that workers are using their health plans more effectively, she added.
Visit CBS News for the article.