FDA plans updates to device-tracking system

Tools

The Food and Drug Administration has announced updates to its post-market surveillance of medical devices in order to add more input from physicians and patients.  

The added updates are designed to create a system capable of "providing near-real-time assessments of the benefits and risks of medical devices throughout their marketed life," according to a paper on the plans.

"These updates will combine new technologies with a reporting system that expands the engagement of both health professionals and patients in identifying problems, and is intended to more quickly and accurately identify problems as devices are used by a larger number of patients," writes Dr. William Maisel, deputy director for science at the FDA Center of Devices and Radiological Health, in an announcement.

Among the updates:

  • Developing a unique device identifier (UDI) system made up of a tracking code on each device to allow quick response to problem devices while avoiding broad recalls.
  • The MedWatcher mobile app that allows patients to easily report known or suspected problems from a smartphone or tablet.
  • Registries for selected devices.

While it's impractical to have a registry for every device, registries are to be set up for devices in "selected areas of high importance as reflected by a large public health need, patient exposure, uncertain long-term or real-world device performance, or societal cost."

It plans to modernize adverse event reporting and analysis including issuing a final report from pilots on automatic reporting of device-related adverse events from EHRs and incident reporting systems, and implementing data-mining tools in at least three areas of medical devices.

The planned updates appear to go beyond monitoring health IT adverse reports through its manufacturers' medical device database, announced as part of its response to the 2011 Institute of Medicine call for improved patient safety. FierceEMR's Marla Durben Hirsch in January took issue with that approach.

Meanwhile, amid the proliferation of health-related apps, Christy Foreman, FDA's Director of the Office of Device Evaluation, told a House subcommittee in March that only a small subset of apps would require active FDA oversight. It's expected to release final guidance on medical apps by the end of 2013.

And recently, UnitedHealth and three provider organizations announced plans to independently measure the effectiveness of medical devices including stents, defibrillators, pacemakers, knee and hip implants, and heart valves.

To learn more:
- find the paper (.pdf)
- here's the announcement

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