Last month, members of a Senate committee investigating multiple outbreaks of deadly superbug infections released a report detailing serious flaws in the U.S. Food and Drug Administration’s policies for monitoring medical device safety. The devices at issue, known as closed-channel duodenoscopes, are regularly used in gastrointestinal procedures in hospitals throughout the world. Unfortunately, the design of the scopes makes it extremely difficult for them to be properly cleaned between uses. The report claims that in September 2013, doctors at a Seattle hospital “traced a cluster of antibiotic-resistant infections to a medical device” but inexplicably the FDA failed to issue any public notices regarding the issue until 2015.
This revelation from members of the Senate Committee on Health, Education, Labor and Pensions confirms allegations that Olympus Corp., the leading manufacturer of duodenoscopes, knew of the issues with the device but failed to notify U.S. hospitals and government agencies about the dangers. The report found that unlike open-channel duodenoscopes, closed-channel duodenoscopes can trap and transmit bacteria in tiny crevices and poor-quality sealing found at the end of the scope. The committee estimates that between 2012 and 2015, at least 141 patients in nine U.S. cities were infected due to the contaminated devices. The report also determined that Olympus repeatedly presented misleading information about the dangers of the faulty design and minimized the number of patient infections.
While the Government did begin to investigate the scopes in 2013, the report states that the FDA, “wasted valuable time” in obtaining information on whether the procedure for disinfecting the scopes was adequate. As early as 2013, the Dutch Health Ministry reported that Olympus did not have the data to show that their cleaning instructions worked consistently and effectively. Unlike the FDA’s monitoring of drugs, where they are able to quickly and accurately query information about serious problems, the FDA has no way to seek out independent information about problems linked to medical devices.
The report goes on to conclude that the agency “appears to have been left with such incomplete information that it was unable to develop an accurate sense of the frequency and severity of these outbreaks.” The committee has recommended that the FDA needs to quit depending on device manufacturers and hospitals to report problems caused by medical devices. Instead, the committee recommended that the reporting system should be changed so the devices have unique identifying numbers that can be tracked in pharmacy insurance claims and electronic health records.
If you need more information on any part of the above, contact Jake Jeter, a lawyer in our Consumer Fraud and Commercial Litigation Section, at 800-898-2034 or by email at Jake.Jeter@beasleyallen.com.
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