Number of scope-related infections higher than previously reported by FDA, Senate committee finds

More than 250 infections are linked to duodenoscopes worldwide in a three-year span, and U.S. hospitals were generally slow to report such infections, a newly released Senate committee report found.

Sen. Patty Murray (D-Wash.) pushed for the investigation after duodenoscopes were linked to infections caused by antibiotic-resistant bacteria like carbapenem-resistant Enterobacteriaceae at hospitals like Seattle-based Virginia Mason Medical Center and Las Angeles-based Ronald Reagan UCLA Medical Center.

According to the Seattle Times, the Food and Drug Administration identified 142 infections caused by duodenoscopes since 2010. The Senate committee estimates the number is closer to 250 between 2012 and spring 2015.

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Highlighted below are five additional findings from the Health, Education, Labor and Pensions Committee's investigation.

1. At least 16 hospitals in the U.S. traced infections to duodenoscopes, but "generally did not raise alarms about these infections with federal regulators." When they did report the adverse events, the hospitals tended to do so informally and did not include all necessary information.

2. Olympus, a major duodenoscope manufacturer, knew about two lab reports finding the closed-channel duodenoscope could harbor and spread bacteria in early 2013, the investigation found. But Olympus "never brought this information to the FDA, and did not alert hospitals, physicians or patients in the U.S. to the risk of infection until February 2015," according to the investigation.

3. The FDA started investigating duodenoscopes for infection risk in September 2013 but did not tell hospitals or other organizations of the possible risks for 17 months — a span of time when at least 68 patients contracted an infection from the scopes.

4. The FDA's adverse event database is "outmoded," according to the report.

5. The Senate committee report suggests several changes to "minimize future delays in identifying and addressing device safety issues," including:

  • Congress requiring unique device identifiers to be included on insurance claims and to fund a National Medical Device Evaluation System
  • The FDA possibly recalling closed-channel duodenoscopes after evaluating their design
  • Hospitals being required to report adverse events related to medical devices to participate in Medicare

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