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Proposed Legislation Addresses Reusable Medical Device Safety

Federal lawmakers are currently considering legislation that aims to improve the safety of reusable medical devices. The bill would require makers of devices, such as duodenoscopes, to obtain special preclearance from the U.S. Food and Drug Administration (FDA) before marketing their products.

As previously discussed on this San Diego Injury Blog, closed-channel duodenoscopes have now been linked to 25 incidents of drug-resistant infections. In California, three patients lost their lives. A Congressional investigation into the deadly superbugs concluded that the three leading manufacturers of duodenoscopes in the United States were aware that the reprocessing procedures used to clean the devices could be ineffective to prevent infections. It further found that hospitals that experienced outbreaks and FDA also failed to follow proper procedures that could have prevented further infections.

Sen. Patty Murray (D-Wash.), who commissioned the investigation, proposed the new medical device legislation. The “Preventing Superbugs and Protecting Patients Act” (S. 2503) would establish requirements for reusable medical devices relating to cleaning instructions and validation data.

“I asked my staff how the outbreaks could have occurred in the first place, and what Congress could do to protect patients and families going forward,” Murray stated during an executive session. “So, I’m pleased to introduce a bill today that would take some initial steps to improve patient safety by giving the FDA additional tools to review and ensure the safety of medical devices. That yearlong investigation showed that we need to significantly [improve] our medical device surveillance system to ensure risks to patients are identified earlier.”

The bill would specifically require device makers to submit proposed labeling, including instructions for use, as part of a pre-market 510(k) submission to the FDA. In addition, manufacturers would be required to submit validated data regarding cleaning, disinfection, and sterilization. We will be closely tracking the status of the legislation and will post updates as they become available.

If you or someone you care about has suffered serious harm due to a defective medical device, don’t hesitate to contact a San Diego medical product liability lawyer at the Law Offices of Robert Vaage for a free consultation.