Senate HELP Committee Minority Staff Report Places Blame on Manufacturers, Hospitals, and FDA Regarding Duodenoscope-Linked Antibiotic-Resistant Infections

King & Spalding

On January 13, 2016, Senator Patty Murray (D-WA), Ranking Member of the United States Senate Health, Education, Labor, and Pensions (“HELP”) Committee, released a Minority Staff Report detailing the results of a year-long investigation into deaths related to antibioticresistant infections from contaminated duodenoscopes. The report, Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, attributes the infections to non-compliance with regulatory obligations by the duodenoscope manufacturers and hospitals using the scopes, as well as system failures by the Food and Drug Administration (“FDA” or the “Agency”).

Ranking Member Murray initiated the investigation in January 2015, after several outbreaks of antibiotic-resistant infections became public. According to the report, duodenoscopes can harbor bacteria and spread it to patients, even after they have been cleaned pursuant to manufacturer instructions. Multiple hospitals established the link between antibiotic-resistant infections and patients undergoing procedures with closed-channel duodenoscopes. The report alleges that the duodenoscope manufacturers and FDA were aware of the risk posed by the devices for 17 months before alerting hospitals, doctors, and the public.

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