UDIs, or unique device identifiers, have a simple purpose: these identifiers make it possible for care providers to easily look up a medical device’s specific model, or even a serial or batch number, manufacture data and expiration date via a production identifier provided by a code. Just about one month ago, the USDA released its draft guidance for regulations governing the marking of medical devices with UDIs. So, why is this so important for manufacturers of medical devices?
According to a recent article at the FDA website, this system will be phased in over a period of several years, providing many benefits as the unique device identifier is adopted and integrated into the health care delivery system. Not only will UDIs improve the safety of patients and reduce risks, it is also expected to facilitate medical device innovation and modernize device post market surveillance. The most recent guidance provided by the FDA states that the agency will require all devices considered life-supporting or life-sustaining to carry these codes by September 24 of this year, less than two months away. Even after medical devices have been taken out of the original packaging, it will be possible to track them. This is critical considering recent “super bug” outbreaks that have affected hospitals, such as an incident in which nearly 180 patients at the UCLA Medical Center in Los Angeles were potentially exposed to Enterobacteriaceae because of a manufacturer who may not have sterilized medical scopes sufficiently.
In the above situation, a large-scale recall was not required by the FDA because only a minute percentage of the manufacturer’s devices were affected; in addition, care providers were warned of the risk by the manufacturer. However, it’s important to realize that had the devices been equipped with a UDI, it would have been much simpler for all parties involved to track the medical scopes.
At REA JET, we provide a wide array of coding solutions for manufacturers in the pharmaceutical industry and many others including packaging, plastics, steel and metal, consumer packaged goods, and more. We understand the importance of industrial marking of date and production codes, ingredients, and other critical data for tracking and other purposes; solutions you can depend on. Give us a call today for all of your industrial coding and marking needs.