SILVER SPRING, Md.,
Dec. 10, 2018 /PRNewswire/
-- Advancing medical device safety remains a top priority of
the U.S. Food and Drug Administration. This means we are committed
to communicating when new, relevant information becomes available
about device safety risks, to ensure doctors and patients are
better informed about device benefits and risks.
For the past several years, the U.S. Food and Drug
Administration has worked extensively with device manufacturers,
public health authorities, hospitals and health care providers to
help protect patients from bacterial infections associated with the
use of duodenoscopes. These flexible, lighted tubes are vital for
minimally invasive, life-saving procedures to diagnose and treat
problems in the pancreas and bile duct. However, because they
contain many small working parts that come in contact with a
patient's bodily fluids, they must be thoroughly cleaned and
disinfected between each use to prevent transmission of
infections.
The FDA has been involved in an extensive and ongoing effort to
prevent patient infections associated with the transmission of
bacteria from contaminated duodenoscopes. As part of these efforts,
the FDA ordered all U.S. duodenoscope manufacturers—Olympus,
Fujifilm, and Pentax—to conduct two postmarket surveillance studies
to determine whether health care facilities were able to properly
clean and disinfect the devices. Specifically, all three
manufacturers are required to conduct two studies; one to sample
and culture reprocessed duodenoscopes that are in clinical use to
characterize contamination rates and to learn more about issues
that contribute to contamination (the sampling studies), and one to
assess how effectively the trained hospital staff follow the
manufacturer reprocessing instructions (the human factors
studies).
These studies are critical to our efforts to evaluate whether
the devices' instructions for reprocessing (e.g., cleaning and
disinfecting) are being adequately adhered to by health care
facilities, are properly preventing transmission of infections, or
should be re-evaluated. Earlier this year, the FDA issued Warning
Letters to all three device manufacturers for failure to meet these
postmarketing surveillance requirements. The manufacturers have
begun collecting the required data and provided the FDA with
preliminary study results.
Today, we are issuing a safety communication reporting on these
preliminary findings and providing important information for
hospitals and health care providers who use and reprocess these
devices. Interim results from the sampling studies indicate
higher-than-expected contamination rates after reprocessing, with
up to 3 percent of properly collected samples testing positive for
more than 100 colony forming units of low concern organisms that
are unlikely to cause serious infections (but an indication of a
reprocessing failure) and an additional 3 percent of properly
collected samples testing positive for "high concern" organisms.
These are bacteria more often associated with disease, such as E.
coli or Staphylococcus aureus (staph).
The manufacturers are currently conducting root cause analyses
to better understand these preliminary culturing results. Some
factors that may contribute to device contamination include device
damage and errors in reprocessing. Because of the
higher-than-expected contamination rates and to help protect
patients from bacterial infections associated with the use of
duodenoscopes, we have included in today's safety communication
updated recommendations regarding steps that health care providers
can take to enhance duodenoscope reprocessing.
Hospital and health care facilities that use duodenoscopes
should meticulously follow manufacturer reprocessing instructions.
In addition, health care facilities should consider implementing
supplemental reprocessing measures to reduce the risk of infection
transmission, such as microbiological culturing, sterilization, use
of a liquid chemical sterilant processing system and repeat
high-level disinfection. The FDA previously issued a safety
communication recommending these additional reprocessing steps to
further reduce the risk of infection and increase the safety of
these medical devices.
In today's safety communication, in addition to supplemental
reprocessing measures, we are also recommending that hospital staff
carefully inspect a component of the duodenoscope that is difficult
to clean, called the elevator recess, and to repeat cleaning if any
soil or debris is visible. We are also emphasizing that users
follow the manufacturer's recommendations for inspection, leak
testing and maintenance of the duodenoscope and return the
duodenoscope to the manufacturer, at least once a year, for
inspection, servicing and maintenance. We also strongly encourage
health care providers to participate in the manufacturers' sampling
and culturing studies, and consider initiating their own
duodenoscope surveillance sampling and culturing to reduce the
risks of infection.
However, it has become clear that following the manufacturer's
reprocessing and maintenance instructions, while critical, is not
sufficient to avoid all infections associated with the use of
duodenoscopes. That is why the FDA has also been working with
developers on new product designs, including disposable
components. Technological advances in product design hold
promise to reduce the risk of contamination and enhance patient
safety.
Finally, we rely on manufacturers to report infections
associated with duodenoscopes, as well as other adverse events
caused by medical devices, to the FDA in a timely manner –
generally within 30 days of learning about the event. When this
does not occur, patients' safety and sometimes their lives may be
put at risk. When this happens, the agency can and does take
action. The FDA's Office of Criminal Investigations recently
worked with the U.S. Department of Justice to bring criminal action
against Olympus for failing to adequately file adverse event
reports involving infections that occurred in Europe in 2012 and 2013 that were associated
with their TJF-Q180V duodenoscope. After pleading guilty to three
counts of distributing misbranding devices in interstate commerce,
the company was fined $80,000,000 and
ordered to forfeit $5,000,000.
As part of its plea agreement with the Justice Department, Olympus
is also required to undertake enhanced compliance measures.
I want to emphasize that an individual patient's risk of
acquiring infection from an inadequately reprocessed medical device
remains relatively low given the large number of such devices in
use. We have also seen a steady decline in medical device reports
associated with patient infections after the FDA implemented safety
measures to improve reprocessing techniques including issuing
recommendations to health care providers to enhance their cleaning
and high-level disinfection of these devices, working with
duodenoscope manufacturers as they reviewed and modified their
instructions for manual reprocessing and reviewing validated
instructions for manufacturers of automated endoscope reprocessors
that are used to reprocess duodenoscopes. A recent analysis of
medical device reports indicates that the number of reports
associated with patient infections peaked in 2015 at 250 reports
and has declined 62 percent to fewer than 100 reports per year in
2017 and 2018. We are hopeful that this decline is the result of a
successful effort on the part of health care facilities to
implement our enhanced safety measures.
Reducing patient exposure to infections in health care settings
remains a national priority involving multiple stakeholders with
overlapping responsibilities. The FDA's foremost concern is patient
safety and we are committed to enhancing the safety margin of
procedures with reprocessed medical devices, which include
duodenoscopes and other endoscopes. As part of our larger efforts
outlined in our Medical Device Safety Action Plan, our goal is to
protect patients and spur innovation of new products that are
safer, more effective, and address unmet medical needs.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Alison
Hunt, 240-402-0764, alison.hunt@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration