The FDA, endoscope manufacturers and hospitals share responsibility for the recent outbreaks of antibiotic-resistant infections associated with endoscopic retrograde cholangiopancreatography, or ERCP, duodenoscopes, according to the Senate Committee on Health, Education, Labor and Pensions’ report.
Senator Patty Murray (D-Washington), initiated an investigation in January 2015 to determine the extent of infections linked to duodenoscopes, why the response to the problem was so slow, and whether legislative changes are warranted.
Sen. Patty Murray
The investigation concluded that 25 incidents of antibiotic-resistant infections related to closed-channel duodenoscopes affected 250 patients worldwide between 2012 and spring 2015, and that the FDA’s surveillance system for ensuring medical device safety “failed to quickly identify and resolve the spread of [these] infections,” as it took the agency nearly a year and a half to alert hospitals that scope designs may hinder effective cleaning.
“While responsibility for the slow response is shared among Olympus and the other device manufacturers, hospitals, and FDA, the investigation overall demonstrates that FDA’s device surveillance system is overly reliant on device manufacturers and user facilities to make quick and complete reporting of safety issues over their own competing priorities,” the Committee wrote in the report.
Device manufacturers failed to comply with regulations
Duodenoscope manufacturers contributed to the problem by failing to comply with regulatory requirements, according to the report, which concluded that Olympus was aware that the design of its closed-channel duodenoscope could hinder effective reprocessing in 2012, “well before” the FDA’s investigation throughout 2014 and 2015.
“By the end of 2012, Olympus had two clear examples of contaminated scopes spreading antibiotic-resistant infections even after correct reprocessing but neglected to alert hospitals or regulators in the United States,” and did not acknowledge the problem in the U.S. until February 2015. Moreover, the company failed to file a 510(k) application for its duodenoscope design modification from an open- to a closed-channel device, failed to sufficiently test its reprocessing instructions, and submitted misleading medical device reports to the FDA that “understate[d] the number of patients affected [and pointed] to environmental contamination as a source of the infections rather than problems with the device itself,” according to the report.
“We appreciate that the … report noted Olympus’ cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the [FDA], each of which can contribute to increasing patient safety,” Mark A. Miller, vice president of corporate and medical communications for Olympus Corporation of the Americas, said in a statement to the media. “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.”
While the Olympus duodenoscope was linked to the majority of the 2012 to 2015 infections, Pentax and Fujifilm scopes were also implicated in infections during this time, and the report concluded that the companies also failed to meet regulatory expectations. Like Olympus, Fujifilm did not file a 510(k) application for modifications to its closed-channel duodenoscope; both Fujifilm and Pentax also failed to properly validate their reprocessing instructions; and both companies failed to submit medical device reports promptly and completely, according to the report.
“The protection of the health and safety of all patients remains the number one priority of Fujifilm and we are committed to working together with all stakeholders, including patients, hospitals, regulators and lawmakers, to ensure the long-term sustainable use of duodenoscopes,” Diane Rainey, a spokeswoman for Fujifilm, said in a statement to the media.
The FDA recently determined Fujifilm’s revised and validated manual reprocessing instructions for its ED-530XT duodenoscope met the agency’s expectations and should be implemented as soon as possible, according to an FDA press release.
Pentax Medical is also continuing to work with Congress, FDA and the industry “to reduce the risk of infection in flexible endoscopy,” Shannon Coughlin, a spokesperson for Pentax, said in a statement to the media. “Pentax Medical has established a Patient First initiative with the goal of promoting safe and effective ERCP procedures through commitment to training and education around device reprocessing,” she added.
Custom Ultrasonics also failed to validate the compatibility of its automated endoscope reprocessors with closed-channel duodenoscopes, and failed to sufficiently report problems with these devices to the FDA, according to the report.
Hospitals failed to report infections
Of at least 16 hospitals that identified duodenoscope-related antibiotic-resistant infections, all failed to effectively communicate with federal regulators and device manufacturers, the report concluded.
“It appears that not a single hospital that experienced infection outbreaks linked to the duodenoscopes sent the required adverse event form to the device manufacturers,” the Committee wrote. “When hospitals did report adverse events, it was generally late, notification was made informally by phone or email, and reports did not include all of the information necessary for the manufacturers to submit accurate and complete information to FDA.”
Hospital staff also failed to communicate with the FDA and CDC in general, according to the report.
Conversations between the Committee and hospital staff, health departments and device manufacturers “have revealed a disconcerting lack of awareness that these reporting obligations even exist,” according to the report.
FDA failed to recognize and respond quickly to the problem
By the time the FDA became aware of the potential for contamination related to ineffective reprocessing of closed-channel duodenoscopes in September 2013, at least 11 hospitals had already experienced outbreaks.
“Because of FDA’s reliance on a passive postmarket surveillance system, the agency had no way to identify this trend until the issue was directly brought to their attention,” the Committee wrote. Though the agency has since taken steps to address the problem, its response was “unacceptably slow,” and “without a more robust surveillance system independent from the reporting of manufacturers and hospitals, it is likely that the same gaps and delays will occur in other device related investigations.”
The report concluded by calling for a surveillance system similar to the FDA’s 2009 “Sentinel” initiative, which uses electronic health care data to monitor drugs using unique product identifiers called NDCs. “A system like Sentinel for surveillance of devices could have prevented life-threatening infections worldwide,” the Committee wrote.
The Committee’s final recommendations included that unique device identifiers should be required in insurance claims, electronic health records and device registries; that the FDA should determine whether closed-channel duodenoscopes require design modifications and mandate a rapid recall and repair protocol; that the FDA should update guidelines on 510(k) clearance requirements for device modifications; that the FDA should inform health care providers of patient safety issues with medical devices more quickly; that the FDA should deny 510(k) submissions when reprocessing validation data are insufficient; that compliance with medical device reporting should be a Condition of Participation in Medicare; and that Congress should fund a National Medical Device Evaluation System. – by Adam Leitenberger
United States Senate: Health, Education, Labor, and Pensions Committee. Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients. January 13, 2016.