Not too familiar with the unique device identification (UDI) system? It may be time to get up close and personal.
The Food and Drug Administration (FDA) established the UDI system to identify and monitor the distribution and use of medical devices. Manufacturers are currently required to print UDI data in both human and machine readable formats (i.e. scanned barcodes) on all Class II and Class III device packaging. UDIs make it easier to determine faulty products and streamline recalls, improve patient safety, modernize device post-market surveillance and facilitate medical device innovation.
The question is: how does UDI implementation impact hospitals, health systems and clinicians?
Because most electronic health records (EHRs) are required to include UDI information as part of the Common Clinical Data Set (CCDS), healthcare providers should be preparing to support UDI data collection, tracking and reporting.
Preparing for UDIs
Though full implementation of the UDI system will take several years, healthcare providers need to assure that their information systems are able to meet, document and support UDI requirements. With this, hospitals will be able to use UDIs to more efficiently and accurately identify patients’ implantable devices, as well as help prevent and/or respond to adverse events.
Now is the time to start developing and implementing processes, workflow and infrastructure to incorporate standard, structured device information into provider information systems (such as administrative; clinical, quality/safety, financial, supply chain, inventory and/or materials managements).
For most, preparation for UDI won’t be easy. Providers and clinicians may face challenges assuring access to and interoperability of UDI data. For instance, some EHR and enterprise resource planning and tracking systems are not yet prepared to incorporate UDI data.
Additionally, the FDA’s Global Unique Device Identification Database (GUDID, pronounced “Good ID”), which contains information on specific devices submitted by manufacturers for tracking and safety purposes, allows providers to upload UDI data. This effort requires extensive resources since currently there are more than 1.6 million unique devices to match.
Maintenance of GUDID data within the supply chain/materials management master database is also crucial. Master databases of provider items are always changing and new items will need to be aligned with the GUDID. With thousands of new devices being added to GUDID monthly, frequent resynchronization translates to hours of labor.
How to Quickly and Easily Sync UDI Data
Aligning all these device records manually is a time-consuming task that requires periodic download and matching of several million product records against item masters and EHR systems. Healthcare providers need a comprehensive update of their databases to easily capture, record and use UDI information, as well as avoid significant limitations in the ability to recall, charge or establish efficient procurement.
Premier’s UDI Sync solution answers these challenges – removing the hassle and expense from healthcare facility data management efforts. The UDI Sync solution uses algorithms that clinically vet all of a healthcare provider’s item master records and match the products within Premier’s library of more than six million medical devices – and this process only takes two weeks. Additionally, our monthly synchronization ensures data is updated automatically.
I am a supply chain analytics expert living in Asheville, NC who educates, implements and delivers value to healthcare systems’ procurement life cycle. When I’m not working, you’ll find me spending time with my wife and 4 teenage children. I also like traveling and cheering on my kids during their many sporting events. Connect with me on LinkedIn.