The FDA hopes to harness the power of the public in better monitoring adverse events associated with medical devices, drugs and vaccines through its newly released MedWatcher mobile app.
Released on the iTunes market this month, MedWatcher invites patients, care-givers and healthcare professionals alike to report problems, monitor specific therapies and follow news pertaining to flagged items.
"Take control. Participate in your healthcare," it reads on the app’s Apple download page. "MedWatcher is the only app that allows you to report bad side effects or adverse events directly to the FDA to make medical products safer for everyone."
MedWatcher provides a number of functions, including a customizable "Watch List" that allows the user to highlight specific technologies and receive updates when there are new adverse event reports or other news. The app also comes with a "Library" of information on medical devices, vaccines and drugs, although there’s not yet much information for medical devices or vaccines (the drug section seems pretty well fleshed-out).
The app is pretty straight-forward and relatively easy to use. It does not appear that users can search for specific devices by brand, but rather by general product category.
The reporting section asks users to identify the product type, the diagnosis and any additional products involved. Users can also provide photos of the device alongside the report. The form asks for the event date and details about the experience, including any available lab data and patient co-morbidities. The app then asks some patient information, such as gender and age, but barring any identifiable information such as as social security numbers. Finally, the user must provide information for a profile, which the FDA insists will remain confidential, and the report goes to the FDA for filing.
The mobile reporting platform is part of the FDA’s larger efforts to revamp post-market surveillance for medical therapies using automated systems that could help better and earlier identify potential risks. The new surveillance program leverages electronic medical records, insurance databases and manufacturer registries, according to a Wall Street Journal report.
The app, free to download and available for iPhones, iPads or directly via the web, was foreshadowed earlier this month by FDA medical device chief Dr. Jeffrey Shuren, who announced the program at the Medical Device Manufacturers Assn. meeting in Washington, D.C.
"The app will push through adverse events into the database that will replace MAUDE," Shuren told MDDI Online in an interview after the speech. "It would make it easier for aggregating adverse event reporting."
The project was developed by Boston Children’s Hospital and Harvard Medical School, in collaboration with the FDA. Boston Children’s Hospital spin-out Epidemico is running the project.
