Product News and Recalls

FDA lacks system for tracking devices

According to a report by ProPublica, medical devices have no unique code that would allow the government to track problems.

Although many manufacturers imprint a serial number on their devices, there’s no standardized system that would enable the government to easily monitor them. And critics say this gap in FDA oversight has contributed to numerous high-profile cases of medical devices malfunctioning in recent years – injuring and even killing patients.

For example, the report mentions a group of Pennsylvania doctors who noticed patients showing severe complications a few years after getting an IVC filter.

The IVC filter is a device designed to capture blood clots. The problem was that pieces of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. The doctors conducted their own study in 2010, and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006. According to the FDA, the device was meant to be removed after a few months, not left in permanently.

ProPublica reports that the FDA depends primarily on voluntary reports from medical professionals, manufacturers, patients and hospitals to learn of problems with devices already on the market. Although the agency has some power to require manufacturers to conduct further studies or track a particular device once it’s sold, many devices don’t get that level of surveillance.

Cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring, is quoted as saying: “It’s much like a patchwork of streams of information getting to the FDA. The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If you’ve received an IVC filter, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a IVC filter lawyer familiar with the case to discuss your legal rights.

See the story here:

http://www.propublica.org/article/how-does-the-fda-monitor-your-medical-implants