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FDA seeks your input on medical devices
New updates to the Food and Drug Administration program of post-market surveillance of medical devices are designed to incorporate more feedback from you and your patients to help ensure patient safety.
New updates to the Food and Drug Administration (FDA) program of post-market surveillance of medical devices are designed to incorporate more feedback from you and your patients to help ensure patient safety.
The revised reporting system “would expand the engagement of both health professionals and patients in identifying programs, and is intended to more quickly and accurately identify problems as devices are used by a larger number of patients,” William H. Maisel, MD, MPH, wrote yesterday in his FDA Voice blog. He is deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
Among the changes announced in the report titled Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps:
- A unique identifiable code would be assigned to most device models and would appear on labels and packaging as well as in a public database. The agency also would aim to have the tracking codes incorporated into electronic health record systems, multi-hospital information systems, claims data sources, and registries. A goal of the resulting reporting of adverse events would be to negate the need for some large recalls and device removal surgeries when safety issues were identified as being confined to a specific model of a device.
- A new app, MedWatcher, will allow physicians and others to voluntarily report suspected or known device problems from smartphones and tablets.
- A new multi-stakeholder planning board will help create a “sustainable, integrated medical device post-market surveillance system that leverages and complements existing and ongoing efforts.”
- National and international registries will be created for some medical devices.
The FDA says it developed the updates with input from healthcare professionals, patients, device makers, and academic experts after the agency issued an initial report of its intentions in September 2012.
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