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U.S. Senate Report Finds Fault with Hospitals Reporting Processes during Outbreak of Infections Linked to Medical Scopes

U.S. Senate Report Finds Fault with Hospitals Reporting Processes during Outbreak of Infections Linked to Medical Scopes

The United States Senate has released a report on the outbreak of deadly bacterial infections linked to contaminated medical scopes.  According to the report, Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, the duodenoscope-related infections, which StayAlert! covered extensively in 2015, were significant and wide-spread.  The report is the result of an investigation initiated by Senator Patty Murray, Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions.

Key findings of the investigation include:

  • Duodenoscopes spread life-threatening superbug and other antibiotic-resistant infections among patients in a number of hospitals throughout the United States and Europe in 2013 and 2014.
  • As early as 2012, however, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the United States was aware that its closed-channel duodenoscope could harbor dangerous bacteria even after repeated and careful cleaning according to instructions.
  • Multiple hospitals were also aware that duodenoscopes were linked to superbug and other antibiotic-resistant infections in ERCP patients.
  • None of the three manufacturers of duodenoscopes sold in the United States – Olympus, Fujifilm, and Pentax – and only one hospital ever alerted CDC to the infections.
  • The device manufacturers and most hospitals largely failed to meet their legal obligations to provide complete and timely information about serious patient infections and deaths to manufacturers and/or FDA.

The investigation’s conclusions about failures on the part of the FDA and device manufactures are important and fully discussed in the Senate report.  Yet it is the conclusions about hospital failures that should be of interest to compliance officers.

The senate investigation found that hospitals did not proactively communicate information to federal agencies.  Under 21 C.F.R. § 803.30(a)(1), hospitals are required to report medical device related deaths (but not serious injury) to the FDA no more than ten days after becoming aware of the incident and hospitals may always submit adverse event reports to the FDA relaying other suspected problems.  According to the report,

“While several hospitals did eventually submit MedWatch reports to FDA, less than one percent of all the adverse
event reports (related to the duodenoscope-related infection outbreak) were submitted by hospitals, suggesting
that hospitals are not meeting their obligations to report deaths that devices may have caused or contributed to.”

The report continues, “…hospital staff interviewed by Committee staff almost universally were unfamiliar with any obligation to report to FDA.”

The findings of this Senate investigation send a clear message to hospitals.   Compliance with 21 C.F.R. § 803.30(a)(1) is an integral part of an overall patient safety program.

See next week’s blog for a review of 21 C.F.R. § 803.30(a)(1) in detail.


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