December 18, 2018 PR-M12-18-NI-062
SILVER SPRING, Md./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 communicationrecommending 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.
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