Sen. Patty Murray (D-Wash.) introduced a bill last week that would give the FDA additional tools to review and ensure the safety of medical devices, such as duodenoscopes.
The legislation, called the Preventing Superbugs and Protecting Patients Act, follows an ongoing investigation into contaminated devices linked to antibiotic-resistant infections at Virginia Mason Medical Center in Seattle and nationwide.
Last month, an investigation led by Murray determined that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to the duodenoscopes ().
Murray said the investigation also found evidence that certain manufacturers failed to properly test whether the device could be cleaned reliably between uses. Further, there was evidence that certain manufacturers failed to seek necessary FDA clearance before marketing devices with modifications that affected the safety and effectiveness of those products.