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Legislation Seeks to Improve Medical Scope Safety

A California lawmaker recently introduced legislation aimed to curb infections due to tainted duodenoscopes. Congressman Ted W. Lieu introduced the two bills after the House Committee on Oversight and Government Reform concluded that regulatory gaps contributed to the recent outbreaks.

Rep. Lieu proposed two bills. The DEVICE Act (Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency) aims to increase patient safety by requiring device manufacturers to notify the U.S. Food and Drug Administration (FDA) whenever they change the design or cleaning instructions of their devices. The bill also requires manufacturers to notify the FDA whenever safety warnings are issued in foreign countries related to the design and cleaning of devices. In addition, the proposed measure requires the FDA to further regulate tests of medical devices to determine whether bacteria are present.

A second companion bill, Preventing Superbugs and Protecting Patients Act, established cleaning instructions and validation data requirements.

The bill would require:

  • Device makers to submit proposed labeling
  • Device makers to submit instruction sof ruse
  • Manufacturers to submit valid data about cleaning & sterilization

These would be submitted as part of a pre-market 510(k) submission to the FDA.

In announcing the legislation, Rep. Lieu stated:

Antibiotic-resistant bacteria are a major threat to public health. I am proud to introduce these pieces of legislation today in response to the numerous superbug outbreaks happening in hospitals across the nation. Patients and hospitals deserve to know that the medical devices being used on patients can be properly cleaned and are designed effectively. Patients should not be worried that undergoing a routine medical procedure could lead to them becoming infected with a deadly superbug. What happened to the patients and families at UCLA Medical Center and hospitals across the country should not happen again.

We are closely tracking the proposed bills and will provide updates as they become available.

If you or someone you care about has suffered serious harm due to a dangerous or defective medical scope, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation. Our legal team has successfully represented clients against manufacturers and distributors of medical devices for more than 30 years.