IOM: FDA must improve monitoring of medical device safety

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According to a panel report issued this week by the Institute of Medicine (IOM), the FDA does not possess a satisfactory system for tracking safety standards for medical devices for both adults and children.

Key panel recommendations to the FDA include:

  • The organization should boost efforts to track studies performed by device manufacturers after products are on the market;

  • Collaborate with the private sector to enhance device tracking methods;
  • Create a more transparent environment regarding information that pertains to the benefits and risks of devices;
  • Collaborate with NIH to prioritize research on devices used on children;
  • Work with parents, patient advocates, health organizations and the medical device industry to improve the information available regarding safety concerns;
  • Use insurers' electronic claims databases to understand patterns for possible device problems to prevent further problems;
  • Finally, Congress should require the FDA to create a public database which would allow the public to track the status and findings of studies regarding devices as well as grant the FDA authority to do additional follow-up studies on medical devices.