New U.S. Medical Device Identification System May Help Save Lives

Scartelli Olszewski P.C.

A medical device meant to stop deadly blood clots from reaching the heart or lungs fails, causing a piece of the filter to break loose into the man’s bloodstream. The tiny foreign object is carried to his heart, where it pierces the muscle and forces him to undergo emergency open-heart surgery. What happened? Was the device damaged during surgery when it was installed? Was it damaged before that? Or was the failure the result of a design or manufacturing flaw, which could mean that thousands of similar units are poised to seriously injure or even kill the unsuspecting patients who have the filters implanted in their circulatory systems? Until just recently, these questions have been incredibly difficult for physicians, medical investigators, and device manufacturers to answer. Pinpointing the nature and extent of problems with defective medical devices – and then taking steps to fix the problem and prevent harm to affected patients – can be so costly and time-consuming that some device manufacturers instead attempt to pretend the problem doesn’t exist. As we all know from the headlines, those cases can result in enormous lawsuits and monetary damages, usually after many people have been injured or killed. How can we keep this from happening to others? One obvious way would be to make it easier for investigators to examine the history of a medical device. The federal government recently took steps to do just that. In 2013, the U.S. Food and Drug Administration (FDA) proposed new rules to ensure that medical devices distributed in the United States could be tracked all the way from the manufacturing plant to a healthcare facility and then on to – or into – patients. The goal was to improve what the industry calls “track and trace” – the ability to identify so-called “aftermarket” issues with medical devices and help make sure faulty devices are recalled quickly and completely. That system, Unique Device Identification, or UDI, now is in the middle of a multi-year implementation phase. Every company that manufactures or distributes medical devices of any kind in the United States, from arterial stents and contacts to IV bags and latex gloves, is working to update its systems and procedures to comply with the new regulations. That’s good news for patients across the country. The better news, though, is that this initiative also includes the creation of a public database of information about the medical devices that we depend on every day. The Global UDI Database (GUDID) is freely accessible to any member of the public, and AccessGUDID, the FDA’s web-based search portal for the database, already is up and running. It will be a few years before every single device that is covered by UDI regulations is entered into the database, but information about those that pose the highest risk to patients, such as cardiac pacemakers and other life-sustaining devices, already can be found there. We applaud the arrival of the UDI system and are particularly pleased to see the effort that the FDA has made to ensure that medical device information is transparently available to the people whose tax dollars have helped to pay for the project. Of course, just because the GUDID information is freely available to the public doesn’t mean that it’s easy to understand or interpret. If you believe that a medical device has damaged your health or that of a loved one, call the offices of Scartelli Olszewski to discuss the situation. Together, we’ll find the answers you need.