The challenges of identifying faulty implantable medical devices can be alleviated with the help of a computerized tracking system that scans electronic medical data for reports of the faulty devices, according to a study published on Tuesday in the Journal of the American Medical Association, Reuters reports.
For the study, researchers — led by Frederic Resnic of Brigham and Women’s Hospital in Massachusetts — used a tracking system to evaluate data on seven heart devices used in more than 74,000 heart procedures between 2003 and 2007.
Although FDA requires manufacturers to inform the agency when a physician or patient reports a problem with a device, only about 5% of such events are believed to be reported, according to Reuters.
The tracking system looked for reports of at least three common safety problems with the devices, and it identified two products with potential safety issues.
Resnic said the new study illustrates how electronic health records and data registries can be used to track the safety of implantable medical devices. He added that the tracking system’s signaling of a device does not mean there is a problem with the device but that it is an indicator to companies and regulators for additional scrutiny (Steenhuysen, Reuters, 11/9).
Source: iHealthBeat
