A new congressional report says as many as 404 people experienced potentially deadly duodenoscope-related superbug infections.
|Olympus' TJF-Q180V duodenoscope, as shown on the company's website|
A new congressional report finds that infections related to a special endoscope, mostly manufactured by Olympus, were even more widespread than previously thought.
The House Committee on Oversight and Government Reform report also finds that Olympus waited more than two years to alert U.S. healthcare providers about a cleaning brush it had recommended in Europe the scopes, called duodenoscopes, the report says.
The House committee obtained an FDA document, which covers the time period from January 1, 2010, to October 31, 2015, and includes incidents in which duodenoscopes were contaminated, as well as patients who were infected or exposed to bacteria in 30 facilities in the U.S. and 11 abroad.
The document reveals that there have been:
- as many as 404 patient infections;
- 44 additional patient exposures to contaminated devices;
- 41 facilities that experienced incidents in the U.S. and abroad--30 in the United States and 11 overseas;
- 34 incidents in which patients were infected or exposed to contaminated devices; and
- 319 medical device reports on patient infections, exposure, and device contamination.
Following a yearlong committee investigation that he requested, U.S. Rep. Ted Lieu, D-CA, introduced legislation last week aimed at closing gaps in existing law that Lieu believes contributed to superbug outbreaks due to tainted duodenoscopes. The House investigation followed one by the U.S. Senate, whose results, released in January, indicated 250 duodenoscope-related illnesses.
In addition to introducing a companion bill to the Senate bill introduced by Sen. Patty Murray D-WA, Lieu submitted legislation that would require manufacturers to notify FDA when they change device designs or reprocessing instructions, regardless of whether they must resubmit the devices for regulatory approval, and inform FDA when they alert foreign customers of problems with the design and cleaning of their devices. The legislation would also require FDA to regulate rapid assessment tests as medical devices.
An additional 32 healthcare provider reports indicated that U.S. patients were exposed to contaminated scopes, and 17 more reports mentioned device contamination. FDA did not identify the facilities involved, nor the device manufacturers. Fujifilm and Pentax also make scopes sold in the U.S. The agency told the Los Angeles Times, which originally reported the committee's findings, that federal law prohibits it from naming the facilities.
FDA does not comment on pending congressional legislation, but "we appreciate the report from the House Committee of Government Oversight and Reform and will carefully consider its findings," the agency said in an email statement. "The FDA will continue to work with manufacturers and other stakeholders to improve the safety of reprocessed medical devices and to protect patients from bacterial infections associated with these devices."
Olympus, which sells the majority of duodenoscopes in the U.S., disagreed with some of the report's conclusions, but did not elaborate. "The ongoing discourse demonstrates the shared responsibilities of manufacturers, hospitals, and government authorities, each of which can contribute to increasing patient safety," the company said in an email statement.
Medical device trade group AdvaMed said it is reviewing the legislation. "FDA has extensive post-market authorities--including requirements for quality systems, adverse event reporting, mandatory recalls, corrections & removals--to help ensure the safety and effectiveness of medical technologies once they are on the market," the group added. "We look forward to a continued conversation with Rep. Lieu, other members of Congress, FDA and other stakeholders on these issues."
Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.
Nancy Crotti is a contributor to Qmed and MPMN.
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