Librarians have known for a long time that the key to good information is to be able to identify it, store it, and retrieve it.  Medieval librarians shelved their materials by size, color, or some other identifying mark.  It really didn’t matter because they knew their entire collection by heart and could find anything in it. Of course, most of the books in a monastery library were chained to the shelves anyway.  In the more modern world, librarians add subject classification systems to books in libraries; and booksellers use an “International Standard Book Number” to identify books– a big boost to huge supply chain industries such as Amazon.

On July 3, the Food and Drug Administration (FDA) proposed that medical devices also carry a unique identification system called a “universal device identifier” or UDI.  It’s a logical step so it’s hard to imagine that it’s been more than 5 years in coming.  Congress first approved the plan for UDIs in 2007, but the rule has been stalled in government red tape ever since.  Bipartisan support put back the initiative when it was attached to a Senate bill about the FDA this summer.  The legislation required the FDA to issue a final rule this year.

The goal of the proposal is to improve patient safety by making it easier to log adverse events and target recalls.   The UDI will contain information which is unique to that particular model of the device, including characteristics which may prove useful to clinicians.  The UDI can be stored in the clinical information system, such as an electronic health record, and searched at a later time as needed. Quality data helps solve problems and these data will help identify defective devices faster.  It’s all about identifying, storing, and retrieving information.

The UDI can also assist in tracking devices in the supply chain. According to the FDA, this may help secure the devices against counterfeiting and diversion, as well as helping to prepare for medical emergencies. The proposal also indicates that the information will be kept in a publically available database.  Imagine that a patient could check to make sure a proposed device isn’t a lemon before the surgery!

As with all new programs, it is not without cost.  Vendors, healthcare facilities, and providers will have to adjust their information systems to input and store the UDI. Change costs money.  This brings us back to the concept of meaningful use.  It’s not enough just to input and store the information, it has to be used by the industry, the FDA, providers, and consumers in order to achieve the goal and make the use of medical devices safer for patients.

Written by Debi Warner, Clinical Librarian, Anthelio Healthcare Solutions