Medical device recall system ‘failing to meet the needs of public health,’ physicians find

MedTech Dive February 20, 2024
Nick Paul Taylor

Amid a GAO review of recalls, the physicians advised the watchdog to revisit unique device identifiers and clarify the FDA’s enforcement authority.

Dive Brief:

The current system for monitoring and recalling medical devices is failing patients, physicians wrote in the journal Health Affairs on Thursday.
With the Government Accountability Office (GAO) reviewing device recalls, the physicians looked at the current process to generate suggestions for improving medical device safety in the U.S.
The physicians advised the GAO to propose ways to clear barriers to the implementation of unique device identifiers (UDIs) and assess how the FDA can better use the National Evaluation System for Health Technology.

Dive Insight:

The GAO last investigated medtech vigilance in 2011, leading to...

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2024-02-20T17:05:18-05:00