FDA to Ramp Up Surveillance of Potentially Faulty Medical Devices

More than 1.7 million patient injuries and 83,000 deaths have been linked to defective medical equipment over a 10-year span.

The Food and Drug Administration is building a surveillance platform as part of its ongoing and decade-long effort to monitor potential safety issues arising from faulty medical devices.

The project — the status of which was updated this week in a report from the Government Accountability Office — is a response to the more than 1.7 million injuries and 83,000 deaths that have been potentially linked to faulty medical devices over a 10-year span in the U.S., FDA data show.

The surveillance will include everything from implantable pacemakers to surgical masks for medical devices used by tens of millions of Americans.

Tapping data from electronic health records, billing claims, pharmacy and other sources, the FDA surveillance will begin by Decemober 2024 with a few devices and expand over time.

In 2012, Congress ordered the FDA to establish an active post-market surveillance system for medical devices. However, major sticking points have included a lack of funding, and problems tracking patients' unique device identifiers.

To encourage the use of unique device identifiers, the agency may use advertising to explain the benefits to health systems. In addition, the agency has estimated current and future active surveillance costs and is searching for alternative funding sources.

The FDA’s efforts to monitor potentially defective medical devices dates to 2012, and so far have included:

• Establishing a coordinating center in 2016 to partner with FDA to organize a network of data sources (health systems and other collaborators);
   
• Completing in 2021 the cloud-based data infrastructure necessary to collect evidence of medical device performance while protecting patient privacy; and
   
• Planning active post-market surveillance of two medical devices by December 2024, with plans to expand over 5 years.