Increasing the likelihood of faulty medical device reporting with new app

MedWatcher is making it easier for health care professionals to report faulty medical device equipment. (Screenshot of

WASHINGTON – Got a problem with a medical device, drug, or vaccine? Now, there’s an app for that.

It is called MedWatcher, and it’s part of an effort by the Food and Drug Administration to speed up reporting on faulty medical products.

According to the FDA, negative side effects from medical products injure an estimated 1.5 million people each year. And while there are mandatory reporting requirements for manufacturers and medical facilities, reporting for health care staff has always been voluntary.

MedWatcher is designed to change this by making the process more convenient for health care professionals and more accessible to the general public.

Doug Wood, a senior public health advisor for the FDA’s Center for Devices and Radiological Health, helped develop MedWatcher. He says the initial goal is to increase the number of reports and the quality of the reports the FDA gets from health care staff — the people who are on the front lines of medical care.

Home health care aides, for example, can report problems with everything from chair lifts to IV equipment. Wood explains it’s as easy as logging into the app and answering a series of questions, such as: when the incident happened, how it happened, the age of the patient, the sex of the patient and what was happening when the medical device failed.

The app does not ask for identifying information on the patient in order to protect his or her medical privacy. However, it does enable users to send a photo of a faulty piece of equipment. And Wood predicts that at some point in the future, the app’s users will also be able to send video.

The aim is to get first-hand reports to the FDA quickly — much faster than the old system, which relied on mail, phone and online reporting.

The app also serves as a search engine of sorts, enabling users to track the latest information about specific medical products. Wood says the FDA sees it as an important two-way flow of information.

“We want to get something from you but we want to give you something in return,” he says, emphasizing that voluntary reporting is essential to help the FDA’s investigators identify and respond to safety concerns.

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