Devices & Diagnostics, Health IT, Pharma

One way everyone can help with post-market surveillance of medical devices and drugs

As part of the FDA’s push to strengthen surveillance of medical devices after they’re cleared […]

As part of the FDA’s push to strengthen surveillance of medical devices after they’re cleared for use, the agency worked with a data analytics startup to develop an app that consumers can use to report adverse events to FDA.

MedWatcher is a free app that medical device users or caregivers can use to report their experiences with a product that doesn’t perform as it should, and stay up to date on government safety alerts and experiences of others using the same device.

Users can ‘watch’ products they use to see the latest news and updates on those products. If they experience an adverse event or side effect, they can fill out the form shown below and upload photographs to share their problems. The form is de-identified before being delivered to the FDA shared with the MedWatcher community.

The app’s searchable product database also includes drugs and vaccines.

The downside is that it can’t be used to fulfill mandatory reporting requirements for devicemakers — at least for now. Companies can use it, however, to track what’s being posted about their own products or competitors’ products.

MedWatcher is run by Epidemico, a health data company that spun out of Boston Children’s Hospital, Harvard and MIT, and was developed in collaboration with the FDA’s Center for Devices and Radiologic Health.

[Image credit: MedWatcher]

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