Senate Report Links Duodenoscope Infection Outbreaks to Inadequate Warnings and Oversight

January 15, 2016

A new Minority Staff Report from the Senate Health Committee focuses on the alleged connection between a device used for medical procedures in the small intestine and two dozen outbreaks of antibiotic resistant infections.

The device, a flexible lighted tube known as a closed-channel duodenoscope, is used to diagnose and treat problems in the bile and pancreatic ducts. The active end of the device includes a mechanism that is reportedly difficult to sterilize between uses.

The Report, released on January 13, 2016, discusses alleged failures by:

  • Manufacturers to report issues with their devices,

  • Hospitals to report outbreaks to federal regulators

  • The Food and Drug Administration to identify the problems and alert the public

The Report concludes with seven legislative and regulatory recommendations on pages 29-31 that the authors believe could lead to quicker identification by regulators of problems with the devices. Duodenoscope manufacturers cooperated with the Senate investigation by producing documents and answering questions and are reviewing the recommendations. Following the release of the report, an FDA spokesperson described mitigating the risk of infections associated with duodenoscopes as a “top priority.”

Click here to read the full report.