A Reporting Role for Mobile Apps
FDA Outlines Steps to Strengthen Postmarket Surveillance
Of Medical Devices
As part of its broader plan to modernize adverse event reporting, the U.S. Food and Drug Administration is touting use of the MedWatcher mobile app for healthcare providers, caregivers, and patients to report problems with medical devices using a smartphone or tablet.
The app allows users to upload photos of medical devices to help identify such visible problems as corrosion. Users will receive MedWatch Safety alerts, FDA safety communications, recall information, relevant articles, and other information.
The agency stresses that MedWatcher is not meant to fulfill mandatory reporting requirements for manufacturers and facilities. To learn more about downloading the app, please click here.
Broader Plan
The mobile app element is one of the suggestions emphasized in Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps(pdf), which incorporates feedback from healthcare providers and patients collected online and through a series of public meetings put on by the FDA to discuss postmarket surveillance. It follows up on a report released last September by the Center for Devices and Radiological Health (CDRH) on its surveillance system plans.
Establishing a unique device identification (UDI) system and promoting its incorporation into electronic health information is one of the agency’s big goals mentioned in the report. By the end of the year, the agency hopes to complete reports on a pilot detailing the challenges of incorporating UDI in a multihospital information system.
Having a UDI system in place has been a top priority for a while. The FDA says the system will provide a way to document device use in EHRs and unearth previously unavailable information on the benefits and risks of devices.
“Data from the UDI might be able to pinpoint the source of a safety problem to a specific model, avoiding broader recalls of similar devices and even preventing unnecessary surgeries to remove a device that although similar, may not be the actual source of the problem,” William Maisel, MD, notes in the FDA Voice Blog. Maisel is the chief scientist and deputy director for science at CDRH.
Other ambitious targets for the year include the establishment of a planning board to identify practices, policies, and procedures necessary to create an integrated postmarket surveillance system. The board’s actions would complement existing initiatives, the report notes.
CDRH says it also plans to promote the development of national and international registries for selected products, with a task force identifying existing registries that might provide useful contributions.
Posted: May 1, 2013