U.S. passes the UDI baton

For years, the eyes of the world were on the United States as it became the first country to publish and implement a regulation requiring manufacturers to identify their products with unique device identifiers (UDIs). Today, the focus is shifting to other regions of the world, as regulators in Europe, the Middle East and Asia have or are expected to soon release their own UDI rules. While not always self-evident, some anticipate what happens in the rest of the world will have an impact on not only manufacturers, but also hospitals and healthcare systems, in the U.S.

At the most recent GS1 Global Healthcare Conference in Noordwijk, Netherlands, attendees heard presentations on the status of the European UDI requirements, which were included as part of two much larger regulations published in 2017 impacting both medical and in vitro diagnostic devices. Sessions also covered regulations under development in Saudi Arabia and China, while hallway conversations among manufacturers quickly expanded to include similar regulations in the works in Taiwan, South Korea and Singapore, among others.

Jay Crowley, who played an instrumental role in development of the U.S. UDI rule and now consults globally on UDI with the firm USDM, says the pending regulations will address some of the issues that have only come to light as the industry has sought to put UDIs to work in practice. For example, one of the biggest challenges for nurses in the operating room is knowing which barcode to scan. The Saudi FDA (SFDA) seeks to solve that issue by requiring only one barcode that includes both the device identifier (DI) and associated production identifiers (PI), such as lot, serial number, expiration date, etc., on a package.

The most significant difference between the pending SFDA regulation and those issued to date in Europe and the U.S. are expanded requirements designed to increase the traceability of medical devices. The Saudi Arabian regulation will require capture of UDIs as products are imported into the country to detect counterfeit and recalled products and mandate that manufacturers, importers, distributors and health providers all store and maintain UDIs for devices they have both received and distributed in an easily searchable electronic format.

As the types of organizations covered by the UDI regulations expand, so, too, are the nature of the conversations around UDI. In the early years after the U.S. UDI regulation was published, most of the discussions at industry conferences focused on what manufacturers must do to comply. At the recent GS1 Conference, there was a notable difference, especially as hospitals from Ireland to Taiwan spoke about what they were doing to utilize the UDIs, even in the absence of government regulation. Greg Magrane, eCommerce Project manager for St. James’ Hospital in Dublin, spoke about the benefits his organization has achieved through its Scan4Surgery programme. By tracking products used at the point of care, St. James is better able to understand costs per procedure and improve clinical and supply chain processes to increase patient safety and efficiency. (See the January 2018 issue of Standard Practices “Take it from the Irish: Just Do It”).

In Taiwan, where UDI regulations are still voluntary (although expected to become mandatory), Kaohsiung Armed Forces General Hospital (KAFGH) has made significant strides in use of UDIs to identify products in a standardized and consistent manner across the enterprise. Dr. Shih-Chung Huang, a cardiologist and director of the hospital’s Medical Education and Research Center, shared how his institution has leveraged artificial intelligence to decode the UDI barcode and utilize the data in multiple clinical and business systems and processes. The hospital also shares the information with suppliers, enabling them to utilize cloud technology to obtain real time data on hospital stock levels and replenish products according to past usage patterns. The only significant challenge in UDI adoption faced by the hospital has been reluctance on behalf of some suppliers to label their products with UDIs, citing concerns about the costs and noting there are currently no regulatory requirements.

Progressive hospitals like those that spoke at the GS1 conference continue to advance their usage of UDIs and document the benefits, not just for themselves but also their trading partners, it will be interesting to see if the view of UDI changes globally, from another regulatory requirement to a foundational element in the move to make healthcare more efficient and more effective. hpn

Karen Conway works to advance the role of the supply chain as a critical enabler in the pursuit of a value-based healthcare system. As Vice President, Healthcare Value for Global Healthcare Exchange (GHX), Conway explores how the supply chain and improved data quality and visibility can support understanding of what increases value for patients and to those organizations that develop and deliver healthcare products and services.