By: William Maisel, M.D., M.P.H.
Whether they are inserted into the human body to repair organs and joints or used outside the body to test and treat injuries and disease, medical devices in our high-tech world can seem miraculous.
But while they can help the lame to walk, make damaged hearts beat and even, in a recent innovation, help the blind with a rare disease to actually perceive some images and movement, they are not always perfect.
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. 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.
These updates will combine new technologies with a reporting system that expands the engagement of both health professionals and patients in identifying problems, and is intended to more quickly and accurately identify problems as devices are used by a larger number of patients. At the same time, information from our updated system can help new devices get to patients who need them as quickly as possible.
- A Unique Device Identification system: As proposed, a unique device identifier (UDI) is an alphanumeric and automatically identifiable code that would have to be assigned to every device model, unless exempt, and appear on their label and package. Once available, the UDI will allow rapid and precise responses to a reported problem while avoiding unnecessary responses. Data from the UDI might be able to pinpoint the source of a safety problem to a specific model, avoiding broader recalls of similar devices and even preventing unnecessary surgeries to remove a device that although similar, may not be the actual source of the problem.
- The MedWatcher mobile application (app). This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet. Manufacturers and health care facilities will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network.
- A new planning board, which includes stakeholders outside the FDA, to facilitate the creation of a sustainable, integrated medical device post-market surveillance system; and
- Medical device registries for selected medical devices.
All of these updates are tailored to protect the privacy of patients, and they can be accomplished under existing FDA authorities. They were developed in consultation with patient groups, academic experts, health care professionals and device makers.
Rapid technological advances are creating increasingly complex devices. We are determined to keep up, and believe this enhanced system will help us protect patients while making sure they can take advantage of life-saving and life-enhancing devices.
William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health