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
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.