The FDA recently unveiled plans to modernize its early warning system for high-risk medical devices through the use of a smartphone application and other information technology-related initiatives.
“Before most medical devices are allowed on the market, the U.S. Food and Drug Administration works intensively with manufacturers to analyze and review their scientific and technical data on the device,” William H. Maisel, M.D., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, wrote on an agency blog. “But not everything can be known about a device before it is marketed. That’s why it’s important to have a robust post-market system to collect data on how well medical devices work for patients once they have been marketed. While our current monitoring system is working well, we have proposed updates that rely in part on new technologies to collect better quality and more timely data.”
The move is the second part of a medical device monitoring program outlined in an initial report released in 2012 titled “Strengthening Our National System for Medical Device Postmarket Surveillance.” The first version contained four key proposals: Establish a unique device identification (UDI) system and promote its incorporation into electronic health information; promote the development of national and international device registries for selected products; modernize adverse event reporting and analysis; and develop new methods for evidence generation, synthesis and appraisal.
In April, the agency issued the second part of the report. The update for 2013 moves the ball a little further down the field, adding greater detail to the goals laid out last year.
Among the items the agency hopes to finalize is the UDI system. The program, once enacted, according to FDA officials, will allow “rapid and precise” responses to a reported problem while avoiding unnecessary responses. For example, data from the UDI might be able to pinpoint the source of a safety problem to a specific device model, which would help to avoid broader recalls of similar devices and even prevent unnecessary surgeries to remove a device that may not be the actual cause of the problem.
But among the other action items on the agency’s to-do list, a mobile application called “MedWatcher” is a standout feature. The app is intended to allow medical device users to easily report suspected or known problems with a device from a smartphone or tablet. Manufacturers and healthcare facilities, however, will continue to report problems through the established Medical Devices Reporting
System and the Medical Product Safety Network.
Ask most medical device company professionals who have gone through the review process at the FDA to describe the agency’s handle on technology, and one of the first phrases used won’t be “cutting edge.” Even FDA leadership acknowledges that the group has had to work double time to improve its across-the-board use of IT. The new mobile app is a clear step in the right direction. If I can do my banking securely from my iPhone, why not share critical information about a knee implant or infusion pump?
And clarity is exactly what the FDA is trying to provide. Patients, healthcare providers and industry have called for greater transparency. To that end, the FDA went live (also in April) with a new website called “FDA Patient Network,” which is designed to educate consumers about the process of getting medical devices and drugs from the idea stage to approval. But as demonstrated by the device app, the FDA also wants more patient feedback, actively soliciting patients to share ideas about drugs and medical devices. The site will be a gateway for caregivers, patients and patient advocates to email their views and hear live chats, webinars and open meetings, including scientific advisory panels. Consumers also can sign up to participate in some FDA meetings.
It’s a brave new world of stakeholders that has gone largely untapped by the FDA in such a direct manner. It will be interesting to track how it develops and evolves over time. I hope that mining the data that patients provide will lead to better outcomes and improved device design and performance.
Now that would be something worth tweeting.