More than one year after FDA issued its final rule requiring medical device manufacturers to assign and label products with unique device identifiers (UDIs) and publish additional data about those products to FDA’s Global UDI Database (GUDID), many questions still remain, especially for orthopaedic and spine manufacturers.
September 24 was the deadline for all Class III devices sold in the U.S. to be in compliance with the UDI rule, and there are reportedly records on more than 30,000 Class III devices in the GUDID. But many more devices still need to come into compliance. First, some Class III manufacturers requested and received extensions from FDA. Also, Class III devices represent only about ten percent of the products on the market. The bulk are Class II products (about 43 percent), which must comply by September 2016. Meanwhile, all implantable devices, regardless of class, plus products considered to be life-sustaining and life-supporting must be in compliance by September 24, 2015—less than 10 months from today.
One uncertainty that remains is how to apply UDIs to orthopaedic and spine products that often end up out of their packaging and in procedure trays long before they are used in surgeries. While UDIs can be used for many processes from procurement to payment, the original intended purpose of the regulation is to capture data on products used in patient care to improve adverse event reporting and recall management. To achieve this, the Office of the National Coordinator for Health IT is expected to propose that UDIs for implantable devices be captured and displayed in electronic health records (EHRs) as part of Meaningful Use Stage III. User facilities are already required to include the UDI, when available, in adverse event reports involving death or serious injury. But how do hospitals and surgery centers capture that data if the UDI is no longer physically associated with the product?
FDA is working with industry to address the challenges posed by procedural trays and other processes related to implantable devices. This will require involvement by many parties, including surgeons, nurses and others responsible for preparing supplies for procedures and for capturing and recording data on which products were used for a wide variety of purposes, from implant logs and EHRs to billing and replenishment.
UDI is an industry-wide initiative, and some of these more complex questions can only be addressed through industry-wide collaboration.
|Further reading on UDI implementation:
FDA Publishes Q&A on UDIs
UDI Implementation: What are Your Next Steps?