Regulatory Focus™ > News Articles > Reporting Adverse Events? There's an App for That, But Not for Industry--Yet

Reporting Adverse Events? There's an App for That, But Not for Industry--Yet

Posted 24 April 2013 | By Alexander Gaffney, RAC

Need to report an adverse event related to a medical device? Now patients are about to find there's an app for that, US regulators revealed yesterday.


The US Food and Drug Administration (FDA) takes in an enormous number of adverse event reports each year through various systems, including MedWatch.

One issue, however, is that manufacturers, healthcare providers and patients are held to different standards. Medical device manufacturers, for example, are held to medical device reporting regulations that require them to report to MedWatch any adverse events they are made aware of, including for off-label uses.

Patients and healthcare providers, meanwhile, are able to report adverse events, but are not required to do so.

That difference has led to significant under-reporting of adverse events according to some estimates, posing a challenge for regulators in their attempts to transition more of the regulatory assessment process to postmarket settings. If, for example, a particularly dangerous adverse event is only seen in one out of every 10,000 patients, it might not be picked up by clinical testing. Once on the market, lax adverse event reporting practices by healthcare providers could delay the time at which the company and regulators become aware of that safety issue, potentially putting more consumers at risk for a dangerous event.

A New App

That's where FDA's new MedWatcher adverse event reporting application (iOS version) (Android version) comes in, said Bill Maisel, deputy director for science and the chief scientist at FDA's Center for Devices and Radiological Health (CDRH), in a statement.

"This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet," he said. Users in this context include patients, caregivers, and healthcare professionals, FDA explained.

Maisel later said in an interview with the Wall Street Journal that the crux of the issue for FDA was: "How can we all find out earlier than we have been finding out?"

"We'll get access to better data more quickly now," he hypothesized.

The audience the application is not to be used by is worth noting in this context: Medical device manufacturers and healthcare providers. Maisel said that these two groups, "will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network."

Indicative of Future Changes?

But as Jeffery Shuren, director of CDRH, said at the Medical Device Manufacturers Association's (MDMA) annual meeting in April 2012, the system could be a harbinger of changes to come for industry.

According to MD+DI's Arundhati Parmar, Shuren said that the MedWatcher app "will push through adverse events into the database that will replace the Manufacturer and User Facility Device Experience (MAUDE) database. "It would make it easier for aggregating adverse event reporting."

That functionality could eventually lead to device manufacturers being given the same reporting capabilities as consumers-an outcome that seems all the more likely given that the MedWatcher app is basically just a more user-friendly version of FDA's Form 3500, according to FDA.

"We're transforming this network into a modern system that uses electronic health information," William Maisel confirmed in an interview with the Wall Street Journal.

But the idea of an app hasn't received unanimous support. Paul Ivsin, a consulting director for clinical trials, argued last week that FDA would be better served by avoiding the use of apps entirely, and instead focus on "developing a robust set of Application Programming Interfaces (APIs) that can be used by the teams who are developing medical data apps." That would result in a wider array of more customizable options to meet the needs of hospitals, manufacturers and patients, he argued. In addition, they could link up with other databases, such as the Sentinel Initiative, giving users access to more information. That would also be in line with a 2012 White House directive ordering agencies to make more data open to the public via APIs.

For now, though, FDA can only wait and see whether consumers actually use the applications. As of the time of this article's publication, the app has been downloaded more than 10,000 times.

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