Sunday, April 26, 2015

Radically Rethinking Medical Education : Shots

Katherine Streeter for NPR

Katherine Streeter for NPR

Poor old Dr. Krebs. His painstaking Nobel-winning work on cellular metabolism, called the Krebs cycle, has made him the symbol for what's ailing medical education.

"Why do I need to know this stuff?" medical students ask me.

"How many times have you used the Krebs Cycle lately?" senior doctors jokingly reminisce.

For decades, first-year medical students have had to cram the details of the Krebs cycle into their heads. Now the biomedical model of educating doctors, based largely on a century-old document called The Flexner Report, is coming under fire.

From one end, our long-standing medical education model is attacked as out of tune with the information age. By some estimates, our entire body of medical knowledge doubles every three or four years.

Critics say med students can't possibly master so much
information, which quickly becomes outdated anyway. Instead, the new
theory goes, students should be taught and evaluated on their ability to
find, assess and synthesize knowledge. And they should be educated in teams to help prepare them for what goes on in the real world.

another angle, critics of the Flexner model correctly point out that
Flexner himself, an educational theorist with no medical training, was
silent on issues such as poverty, housing, nutrition and other factors
that we now call the social determinants of health.

We now know these factors collectively affect our overall health more than even the $3 trillion health care industry.

times I've seen patients and found the tools I was trained to use
aren't nearly enough to provide help. No physical exam or X-ray can find
a homeless person a bed. No lab test or medication can provide a
laid-off worker with job training or education.

It took more
than a decade for me to learn to ask patients about hunger. I found out
that many of the people I've cared for suffer from food insecurity – not
knowing where their next meal will come from.

"But what can I do about those problems?" my students ask. "Isn't that just social work?"

The answer may surprise you.

In my role as a medical educator, I attended the Beyond Flexner conference in Albuquerque, N.M., in early April. The main theme of the meeting, sponsored by the W.K. Kellogg Foundation and others, was this question: "What is the social mission of medical education?"

The conference came about as an outgrowth of a 2010 paper that ranked medical schools by their social commitment rather than their research dollars or U.S. News and World Report
scores. It began as something of a shot across the bow to organized
medicine, challenging orthodoxy, such as making students memorize the
Krebs cycle.

Over the years since then, more research has shed light on the economic and health impact of social determinants. The media has caught on to this as well.

400 medical educators, activists, policymakers and students turned up
to share ideas, hash out strategy and plan a road map for changing
medical education.

Our hosts from the University of New Mexico
demonstrated that medical schools that are serious about community
engagement build strong partnerships that take social determinants into
account. We heard how community health workers and a re-imagination of
the agricultural extension model for health education are improving the health of New Mexicans.

me, the most surprising aspect of the meeting was just how many medical
schools are now getting serious about the importance of social

Many of the sessions at the conference explored
obstacles that stand in the way of a culture change in medical
education. At the top of the list: How to deal with a payment system
that still prioritizes the quantity of medical care over quality? A decision
by Medicare earlier this year to base a large proportion of future
payments on quality and value has convinced many of us that the health
system is on the path of change.

I left the conference with new
ideas and fresh energy. I also was left wondering what will replace the
Krebs cycle in the medical education pantheon.

My bet? It will
be a team of students finding ways to break the vicious cycle of
poverty that contributes to so much suffering, illness and early loss of

John Henning Schumann is a writer and doctor in
Tulsa, Okla. He was recently named interim president of the University
of Oklahoma, Tulsa. He also hosts Public Radio Tulsa's
Medical Matters. He's on Twitter: @GlassHospital

 : NPR

Friday, April 3, 2015

Safety Communications > Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes

Medical Specialties: Gastroenterology, Infection Control

Device: Olympus Duodenoscope model TJF-Q180V

has issued new, validated manual reprocessing instructions for the
TJF-Q180V duodenoscope to replace those provided in the original
labeling. The FDA has reviewed these new reprocessing instructions and
the validation data as part of its ongoing review of the 510(k), and
recommends that any facilities that are using Olympus’ TJF-Q180V
duodenoscope train staff on the new instructions and implement them as
soon as possible.

Summary of Problem and Scope:

As noted in FDA’s February 2015 Safety Communication,
the complex design of ERCP endoscopes (also called duodenoscopes) may
impede effective reprocessing. Reprocessing is a detailed, multistep
process to clean and disinfect or sterilize reusable devices. Recent
medical publications and adverse event reports associate
multidrug-resistant bacterial infections in patients who have undergone
ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing
instructions are followed correctly. 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 September 2014, Olympus initiated testing to
validate new reprocessing instructions. The cleaning validation reports
were provided to FDA in October 2014. While FDA found Olympus’ cleaning
validation data acceptable, initial high level disinfection reports did
not demonstrate an adequate safety margin, and so Olympus conducted
additional testing. At the end of February 2015, Olympus submitted new
high level disinfection validation data to FDA. The agency has reviewed
this data and believes that, when followed, the new, validated
reprocessing instructions for the Olympus TJF-Q180V duodenoscope are
robust, and demonstrate consistent and reliable cleaning and high-level
disinfection. At FDA’s request, Olympus has issued the new, validated
instructions for reprocessing the TJF-Q180V duodenoscope.

validate reprocessing instructions for duodenoscopes, manufacturers
should soil their device with bacteria to simulate use in a procedure
and then demonstrate that the device can be adequately disinfected
through a sufficient reduction in microbes when the reprocessing
instructions are correctly followed. To support high level disinfection
of duodenoscopes, the disinfectant should result in a six-log reduction
in the number of microbes at each of several locations on the scope –
that is a one million-fold reduction; or a reduction of 99.9999%.

FDA is closely monitoring the possible association between reprocessed
duodenoscopes and the transmission of infectious agents, including
multidrug-resistant bacterial infections caused by Carbapenem-Resistant
Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia
coli. 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’s investigation into the possible
association between inadequately reprocessed duodenoscopes and patient
infections, including the agency’s recommendations for health care
facilities, is more fully discussed in its February 2015 Safety Communication.

Olympus sent letters dated March 26, 2015
 to health care facilities and other users of the TJF-Q180V outlining
the new, validated reprocessing instructions, and will soon be
distributing revised user manuals.

Please note the key changes to the reprocessing procedure for Olympus’ TJF-Q180V duodenoscope:


  • During immersion, raise and lower the elevator three times
Manual Cleaning:

  • Additional brushing of the forceps elevator recess area
    • The
      revised cleaning procedure requires brushing of the forceps elevator
      recess with two different-sized brushes. In addition to the brush that
      is currently used to clean the elevator recess area, the MAJ-1888 brush
      (or MAJ-1888 equivalent) will be provided for further cleaning of this
      area. Olympus anticipates shipping the MAJ-1888 brushes to facilities no
      later than May 8, 2015.
  • Additional flushing of forceps elevator recess area
  • Additional raising/lowering the forceps elevator
Manual High Level Disinfection:

  • Additional manual flushing steps and increased flushing volume of each endoscope channel, as well as the elevator recess area
  • Additional raising/lowering the forceps elevator
In addition, FDA has the following recommendations for facilities and staff that use and reprocess the Olympus TJF-Q180V:

  • Implement
    the new manual cleaning and high level disinfection procedures for the
    Olympus TJF-Q180V duodenoscope in accordance with the manufacturer’s
    reprocessing instructions
    • Implement the new TJF-Q180V high level
      disinfection procedure immediately. The high level disinfection
      procedure does not require additional equipment for implementation.
    • Implement
      the new TJF-Q180V manual cleaning procedure as soon as possible. It
      involves the use of a new, smaller bristle cleaning brush (model
      MAJ-1888) which Olympus anticipates shipping to facilities no later than
      May 8, 2015. Continue using the existing cleaning procedure for manual
      cleaning of the TJF-Q180V until the new brush is available.
  • Train appropriate staff on Olympus’ new reprocessing instructions and implement them as soon as possible.
  • Contact
    Olympus directly with specific questions and concerns or to schedule a
    site visit with their Endoscopy Support Specialists:
    • Technical Assistance Center (TAC), 1-800-848-9024, option 1 Monday - Friday between 7AM EST - 8 PM EST.
recommendations are based on currently available information. If new,
important information becomes available, FDA will update its

As noted inFDA’s Updated Information for Healthcare Providers Regarding Duodenoscopes
issued March 4, 2015, Olympus has a pending 510(k) application for its
TJF-Q180V duodenoscope and the company continues to market its device
while its application is under review. The removal of its device from
the market could lead to an insufficient number of available
duodenoscopes to meet the clinical demand in the United State of
approximately 500,000 procedures per year.

FDA Activities:

FDA is actively engaged with other government agencies, including
Centers for Disease Control and Prevention (CDC), and the manufacturers
of duodenoscopes used in the United States to identify the causes and
risk factors for transmission of infectious agents and develop solutions
to further increase the safety margin of reprocessed devices and
minimize patient exposure to infectious agents.

The agency will convene a public Advisory Committee Meeting
on May 14th and 15th, 2015 to seek expert scientific and clinical
opinion related to reprocessing of duodenoscopes and other endoscopes,
as well as use of automated endoscope reprocessors for duodenoscope
reprocessing, based on available scientific information. The committee
will make recommendations on: (1) The effectiveness of cleaning, high
level disinfection, and sterilization methods; (2) the amount and type
of premarket validation data and information needed to support labeling
claims and technical instructions; (3) the appropriate use of other risk
mitigations, such as surveillance cultures; (4) best practices and
guidelines for reprocessing duodenoscopes and endoscopes at user
facilities to minimize the transmission of infections; and (5)
recommended approaches for ensuring patient safety during ERCP
procedures, including a discussion of appropriate patient selection.
Recommendations on these issues will assist FDA in minimizing patient
exposure to infectious agents that may result from reprocessed
duodenoscopes and endoscopes.

The FDA is also working closely with
the manufacturers of reusable medical devices such as duodenoscopes to
ensure that their reprocessing instructions are adequate to clean and
disinfect the devices. The FDA continues to actively monitor this
situation and will provide updates as appropriate.

Reporting Problems to the FDA:

Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

reporting of adverse events can help the FDA identify and better
understand the risks associated with medical devices. Health care
providers should submit voluntary reports of the transmission of an
infection due to an inadequately cleaned duodenoscope to the agency via
the Medical Device Reporting (MDR) process.

a health care provider suspects bacterial contamination—either because
of an increase in infections after ERCP, or because of the results of
bacterial surveillance culturing of duodenoscopes—we encourage the
health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Model TJF-Q180V Duodenoscopes

GastroBreak: White House War on 'Superbugs,' CMS Hep C $$

The latest news and research in gastroenterology.

The White House published an extensive plan to slow the emergence and spread of antibiotic-resistant bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Clostridium difficile.

Olympus has issued new disinfecting instructions for its duodenoscopes, which are unapproved by the FDA and have been linked to carbapenem-resistant Enterobacteriaceae (CRE) infections at UCLA Medical Center.

Medicare spent $4.5 billion in 2014 on hepatitis C drugs, a 15-fold
increase compared with 2013's spending on earlier generation
medications, reported ProPublica.

Nearly two-thirds of patients with colorectal cancer have survival
rates of greater than 5 years, due to improvements in early detection
and treatment, according to a CDC report.

But one-third of adults are still not getting the recommended screening for colon cancer. One gastroenterologist explains how to decrease that number.

Patients with inflammatory bowel disease who are on immunosuppressive
therapy have a less robust response to routine vaccinations, reported
researchers in Digestive Diseases and Sciences.

Three alcoholic drinks per day can cause liver cancer, while coffee may have a protective effect, according to a report published by the Continuous Update Project.

 | Medpage Today