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FDA Statement

Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

For Immediate Release:
Statement From:

One of the touchstones of medical device safety lies in the authority of the U.S. Food and Drug Administration to order manufacturers to conduct postmarket surveillance studies to address a new and significant health concern. Such studies yield important information that often lead to a broader understanding about a device’s risks and prompt the agency to issue new recommendations or policies to mitigate those risks.

To that end, today, the FDA is reporting new information from postmarket surveillance studies on rates of contamination after the cleaning and reprocessing of certain duodenoscopes; these flexible lighted scopes are vital for minimally invasive procedures to diagnose and treat conditions of the pancreas and bile duct. For the past several years, the agency has undertaken an extensive and ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, including multi-drug resistant bacteria infections. These steps have included evaluating the effectiveness of current duodenoscope reprocessing instructions in health care settings and releasing voluntary standardized protocols for duodenoscope surveillance sampling and culturing. As a result, we’ve made strides in mitigating infections associated with reprocessed duodenoscopes and have seen a dramatic decline in reports of patient infections.

But we’re continuing to evaluate the benefit-risk profile of these devices, and we’d like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections. Currently, that evidence is lacking, and we’re considering what additional regulatory actions may be necessary.

In 2015, the FDA ordered the three U.S. duodenoscope manufacturers—Olympus, Fujifilm and Pentax—to conduct two postmarket surveillance studies to better understand the transmission of infections and assess the factors that contribute to their occurrence. Specifically, as part of their approved study plans, all three manufacturers are required to conduct a study to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, as well as a human factors study to assess whether trained hospital staff are following the reprocessing instructions.

In December, the FDA issued a Safety Communication detailing the preliminary findings from these studies announcing a 3% contamination rate for “high concern” organisms. Today, we are providing a new update on these interim results from the sampling studies that show up to 5.4% of all properly collected samples tested positive for “high concern” organisms, which is significantly higher than the earlier results reported. “High concern” bacteria are more often associated with disease, such as E. coli or Staphylococcus aureus.

Additionally, up to 3.6% of properly collected samples tested positive for low to moderate concern organisms; while these organisms don’t usually lead to dangerous infections, they are indicative of a reprocessing failure. When the sampling studies were designed, the FDA expected to see a total contamination rate for any type of organism of less than 1% or as close to zero as possible for duodenoscopes.

Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further. The FDA previously instructed the manufacturers to conduct root cause analyses following the preliminary results announced last December to better understand these culturing results. These analyses are currently underway with an analysis of the newly collected samples, and final results are expected later in 2019.

In the meantime, the FDA is exploring additional steps to take to reduce contamination rates. We have been consulting with the Centers for Disease Control and Prevention and other federal health partners to obtain their input and guidance on the issue of infection control and reprocessing of these difficult to clean scopes. Next month, the FDA plans to discuss this issue at the Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting to seek input on improving the safety of reprocessed devices. We are considering whether additional recommendations will be necessary to help health care facilities with proper cleaning and high-level disinfection of duodenoscopes to lower contamination rates to less than 1%. For example, we are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might offer a more effective option. This will take careful consideration because we know some sterilization methods could damage the duodenoscope over time and lead to a shorter lifespan for the expensive device.

We will also be relying on the fulfillment of the duodenoscope manufacturers’ postmarket surveillance studies to provide additional crucial information that will help inform us as we determine whether additional steps need to be taken. This is especially critical in light of the concerns we’ve outlined to date with compliance in these studies. Last March, the FDA issued warning letters to all three duodenoscope manufacturers for failure to comply with their surveillance study commitments. While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies. If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action.

Finally, we are working with manufacturers on new duodenoscope designs that could reduce the risk of contamination as well as disposable duodenoscopes that would avoid the need for reprocessing altogether.

While the current contamination rates we’re seeing in the postmarket studies show the need for improvement, 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. It’s important to note that we’ve seen a 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 submitted to the FDA indicates that the number of reports associated with patient infections peaked in 2015 at 250 reports and has declined by 62% to fewer than 100 reports per year in 2017 and 2018. Our recent actions have yielded improvements, but we also received reports of three deaths of U.S. patients in 2018 that were related to infections associated with duodenoscopes. That’s three deaths too many.

Our efforts to reduce patient exposure to infections in health care settings remains an important public health goal, and the FDA understands the importance of keeping patients and health care providers updated and informed of the latest findings. We remain committed to our goal of reducing rates of contamination of these devices down to nearly zero and we will consider taking additional actions as needed to ensure that manufacturers meet their obligations to us on the postmarket surveillance studies. These actions are part of our larger efforts to enhance the safety of medical devices outlined in the Medical Device Safety Action Plan. This plan aims 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.



Deborah Kotz

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