How to Stay Up-to-Date on Medical Device Safety and Recalls

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Published on
April 27, 2012

Medical devices undeniably save and improve lives, but they can also malfunction or prove to be defective and pose serious risks for patients. So, as someone in the medical field, how do you stay up-to-date on medical device safety and recalls? The FDA does its best to keep doctors informed about medical device recalls, but communication from the FDA doesn't always reach doctors soon enough. Sometimes a device has been recalled, and you won't even know about it for a few weeks, which means that you may keep on using recalled devices to the possible detriment of patients.

In the first half of 2010, the FDA took 23 different kinds of implantable cardiac devices off the market. In fact, according to the National Institute of Standards and Technology, around 20% of all recalled devices are cardiac devices. Since cardiac devices can do the most good and do the most harm, this is cause for concern. According to the Medical Device Innovation, Safety, & Security Consortium, makers of medical devices need to adopt security technology and procedures that will prevent medical device malfunction and defectiveness. Experts at the Medical Device, Innovation, Safety, & Security Consortium believe that devices need to go through a more rigorous testing process before they reach patients and doctors. Unfortunately, as of now, most devices do not go through a rigorous testing process. According to the Archives of Internal Medicine, some medical devices don't even have to go through clinical trials before they reach patients. This means doctors have to do their best to stay informed about recalls and safety concerns.

One of the best ways to find out about medical device recalls and safety concerns is by frequently visiting the FDA website's Medical Device Safety page (http://www.fda.gov/MedicalDevices/Safety/default.htm). You can find the most recent medical device recalls on this page. You can also search for medical devices that have been recalled at the http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/textsearch.cfm website.

Although it's crucial that doctors and hospitals stay informed about safety issues and recalls regarding medical devices, I think that it's also crucial that medical device manufacturers re-examine the way they test their devices before those products reach the public. Additionally, I believe it's essential that the FDA raises the bar and requires that all medical device manufacturers test their new medical devices using clinical trials and other rigorous testing methods.

Author's Bio: Carolyn is a guest post writer on the subjects of medical education, medical device technology, and RN schools.