Drugs

Congressman Introduces 2 Bills on Device Safety

Congressman Ted W. Lieu (D-CA) has introduced two bills that would place additional requirements on medical device makers when they make certain changes to their devices. The bills are in response to a yearlong investigation he requested by the House Committee on Oversight and Government Reform that found significant gaps in existing law that likely contributed to a nationwide problem of superbug outbreaks due to tainted duodenoscopes. “Patients and hospitals deserve to know that the medical devices being used on patients can be properly cleaned and are designed effectively,” the congressman said.

Here are details on the bills:

The DEVICE Act (Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency) — The bill seeks to increase patient safety by requiring device makers to notify FDA whenever they change the design or cleaning instructions of their devices. The bill also requires them to notify the agency whenever safety warnings are issued in foreign countries related to the design and cleaning of devices. Finally, it requires FDA to further regulate tests of medical devices to determine whether bacteria are present.

The Preventing Superbugs and Protecting Patients Act — The measure seeks to improve safety for patients undergoing medical procedures by requiring that the reprocessing instructions for medical devices be scientifically validated. It would ensure that the cleaning instructions for medical devices actually work. This is the House companion bill to a Senate bill introduced last month by Sen. Patty Murray (D-WA).

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome