SThe Food and Drug Administration (FDA), manufacturers of duodenoscopes, and hospitals all failed to adequately communicate the risk of infection linked to these devices, putting patients’ lives at risk, according to a harsh U.S. Senate report released earlier this month. In particular, the report blasted what it described as the “failure” of the FDA’s medical device safety reporting system, calling for beefed-up monitoring of devices on the market.
“Without a comprehensive postmarket device surveillance system that supplements self-reporting from hospitals and manufacturers, future device issues are likely to go undetected for far too long and with life-threatening consequences,” concluded the report, Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.
Many experts believe that because of their complex design, duodenoscopes may remain contaminated even after proper cleaning, spreading bacteria between patients. Other experts believe that inadequate training on sterilization procedures also factors into contamination problems, although this report concluded that was not an issue with these devices. Based on the results of Senate staff’s year-long investigation, a specific type of duodenoscope was linked to life-threatening infections, including infections with the superbug carbapenem-resistant enterobacteriaceae, that sickened at least 250 patients worldwide between 2012 and the spring of 2015.
“Following the tragic impacts outbreaks have had on patients and families in my home state and across the nation, I made it my priority to ensure we fully understood how this could have happened in the first place, and what could be done to protect patients going forward,” said Sen. Patty Murray (D-WA), the ranking member of the Senate Health, Education, Labor, and Pensions Committee, which released the report. “Patients should be able to trust that the devices they need for treatment are safe and effective. Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”
The report is critical of Olympus, which manufacturers about 85% of the duodenoscopes used in the United States, saying it knew of potential contamination issues as early as 2012 but did not disclose this information to the FDA.
In response to the report’s release, Mark A. Miller, vice president of corporate and medical communications for Olympus Corporation of the Americas, issued a statement saying, in part: “We appreciate that the staff report noted Olympus’ cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration, each of which can contribute to increasing patient safety. Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations in the report as part of Olympus’ ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.”
The report also faulted U.S. hospitals, saying that at least 16 of them traced antibiotic-resistant infections directly to duodenoscopes, but they too did not raise the issue with the FDA.
“Failure by device manufacturers and hospitals to quickly and completely disclose important information to FDA, and FDA’s outmoded adverse event system, hampered the agency’s ability to accurately assess and respond to the infections,” the report stated.
According to the committee, this lack of prompt and complete information was one reason why it took the agency “overly long” to determine that duodenoscope-linked infections were not the result of hospital cleaning errors. Between the time the agency learned about the problem and issuing its first safety alert, 68 patients in the United States were infected with antibiotic-resistant bacteria.
“In the case of duodenoscopes, FDA was overly cautious and waited to alert the public and hospitals to the risks posed by duodenoscopes until the agency had finished its investigation and developed recommendations for supplemental reprocessing procedures,” the committee explained in the report. “FDA’s release of draft guidance on Dec. 31, 2015, which explains that the agency will now notify the public about emerging serious device issues more quickly, is a positive step that will allow the agency, the public, and hospitals to take action sooner when new device issues arise.”
To minimize future delays in identifying and addressing device safety issues, the report recommended several legislative and regulatory changes, including:
- Requiring unique device identifiers to be included in insurance claims
- Funding a national medical device evaluation system to ensure that the FDA is able to effectively monitor postmarket safety of medical devices rather than relying on adverse event reporting
- Evaluating the design of closed-channel duodenoscopes and implementing a phased recall to fix or modify the devices if necessary.
- Updating FDA guidance to clarify when manufacturers are required to seek 510(k) clearance when medical devices are modified
- Implementing the FDA’s draft guidance regarding “emerging signals” to more quickly disseminate information about potential device safety issues to healthcare providers
- Making compliance with adverse event reporting for medical devices a condition of participation in Medicare for hospitals
A new version of Olympus’s duodenoscope has just been cleared by the FDA. The updated device includes “modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections,” according to an FDA press release. Olympus will voluntarily recall its original model currently being used in healthcare facilities and make the needed repairs as quickly as possible.