Posted by: Jenny Laurello
EHR, EMR, FDA, SCM, Supply chain management, UDI, UDI rule, unique device identifiers
Guest post by: Karen Conway, Executive Lead for Industry Relations, Healthcare Supply Chain, GHX
On July 10, 2012, the Federal Register published the FDA’s long-awaited proposed Unique Device Identification (UDI) rule, kicking off a 120-day period during which interested parties can comment on the specifics of the proposal to require manufacturers to uniquely identify medical devices through distribution and use. Specifically, manufacturers will need to label their products with approved identifiers in both human and machine readable forms, and then provide additional information on those products to an FDA UDI database. While the rule itself only applies to manufacturers, providers, too, should pay attention. After all, if providers don’t use the unique identifiers, much of the intended value of UDI will be lost. But providers may also find the UDI part of their regulatory lexicon in the not too distant future.
The Office of the National Coordinator for Health IT and the FDA have been talking for some time about including the documentation of UDIs in electronic medical records (EMRs) as part of stage 3 of meaningful use. And the National Quality Forum is looking at the role of UDIs in quality measures, such as those for infusion therapy. Both efforts could eventually impact how providers are reimbursed and/or accredited.
Whether required or not, under healthcare reform, providers need to better understand the role products play in delivering greater value for our healthcare dollar. UDIs can make it easier to electronically (and in turn more accurately and easily) capture data on products used at the point of care, which can help providers determine total costs per procedure, increase billing accuracy and improve inventory management. UDIs can be captured in product registries and used for research to determine what (including products) contribute to the best care at the most optimum cost. UDIs in EMRs can also have an immediate impact on patient care; for example, consider the value of knowing which implant a patient has prior to revision surgery. By sharing consumption (or demand) data with suppliers, providers and their trading partners can help reduce costs associated with expired, excess and obsolete inventory. Now is the time for providers to start educating the various stakeholders as to the value of UDIs and building the business case for the IT investment necessary to capture and share the identifiers with clinical, financial and supply chain systems.
Meanwhile, suppliers, especially those with multiple production lines around the world, have a considerable amount of work to do to retrofit their labeling systems to include the identifiers and, in many cases, dynamic data such as lot and serial numbers and expiration dates. That alone is enough to keep them busy until the compliance deadline, which is likely less than 2 years away for Class III devices. But I encourage suppliers to do more than just what is required to check the regulatory box. Siemens Healthcare Diagnostics outlined in a case study how the company took a more holistic approach to improve patient safety, supply chain efficiencies and customer service. By treating UDI readiness as a strategy, not a project, suppliers can realize a much greater return on what for many will be a required investment. The same could be said for providers.
I recently wrote a series of blog posts in the Healthcare Hub on UDI: its history, the specifics of the proposed rule (including timelines for compliance) and what both suppliers and providers should be doing now to get ready. Let me know what you think of the proposed rule and what your organization is doing to prepare. I look forward to hearing from you.