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.