February 20, 2024


The article discusses a critique by physicians on the current medical device recall system in the United States, highlighting its inefficiencies and failures in meeting public health needs. These observations are detailed in a recent publication in the journal Health Affairs and come amidst an ongoing review of device recalls by the Government Accountability Office (GAO).

  1. Physicians’ Assessment of the Current Recall System: Physicians argue that the existing system for monitoring and recalling medical devices is inadequate, failing to protect patients effectively.
  2. GAO’s Historical Involvement and FDA Oversight: The GAO last examined medical technology vigilance in 2011, leading to recommendations for the Food and Drug Administration (FDA) to enhance its recall oversight. These recommendations influenced the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012. However, subsequent changes in medical device safety, as per the New England Journal of Medicine, were limited.
  3. Increasing Concerns Over Recalls: The authors of the Health Affairs paper observed an increase in serious recalls, adverse event reports, and prolonged durations for Class I recalls, indicating a deteriorating situation in public health safety.
  4. Recommendations for Improvement: The physicians propose three main recommendations:
    • Strengthen FDA’s Pre-Authorization Safety Identification: Suggest reforms to the 510(k) pathway and new evidence thresholds for supplemental approvals to mitigate safety risks.
    • Enhance Collaboration on Device Recalls: Focus on expediting recall timelines and revisit the implementation of unique device identifiers (UDIs), which have seen limited adoption by payers and providers.
    • Clarify FDA’s Enforcement Authority: Provide clear guidelines on when and how the FDA should use its existing enforcement powers to reduce political pressure on the agency.

The article underscores the urgency to revamp the medical device recall system to better safeguard public health and calls for concerted efforts from the GAO, FDA, and other stakeholders to address these challenges.