AAMI News March 2017

Experts Shed Light on UDI’s Next Steps

With the final implementation of the unique device identification (UDI) system expected to be completed by medical device manufacturers by 2020, attention is starting to turn to hospitals and other healthcare facilities. In the March/April issue of AAMI’s peer-reviewed journal, BI&T, a group of industry, healthcare technology management (HTM), and regulatory experts discussed the challenges healthcare delivery organizations must address in order to reap the proposed benefits of the UDI system.

“The UDI rollout has been so focused on the manufacturing side in terms of the technology. For healthcare facilities, a lot of the same questions apply: What do you do with that data? How do you track it?” said Jennifer Jackson, director of clinical engineering and device integration at Cedars-Sinai Medical Center in Los Angeles, CA. “Many hospitals across the board are still adopting some of the metrics that are required to fully realize the benefits of UDI.”

These benefits, according to the Food and Drug Administration (FDA), include improvements in patient safety, modernization of postmarket surveillance, and greater medical device innovation. As device manufacturers have found throughout the seven-year UDI implementation process, data management will be a huge challenge, noted Jay Crowley, vice president and UDI practice leader at USDM Life Sciences in Santa Barbara, CA. Crowley formerly worked at the FDA and is widely seen as the architect of the UDI initiative at the agency.

“The same problem that manufacturers had around master data, we also have in healthcare facilities,” he said. “Understanding how to manage data and incorporate master data into all of the systems and processes is really the next big challenge for healthcare facilities.” The solution is technology, according to Lena Cordie, owner of UDI consulting company Qualitas Professional Services in Minneapolis, MN.

This is an expensive proposition, Crowley pointed out, especially since healthcare delivery organizations are not federally mandated to implement UDI like medical device manufacturers were.

“Largely speaking, what we have in the hospital or healthcare facility space is a lack of a regulatory mandate,” Crowley said. “It, therefore, becomes a more difficult argument to make in that now you have to try to convince people to invest significantly in many changes—process changes, system changes—neither of which are inexpensive, to incorporate UDI, to provide the kind of visibility that can lead to a whole host of potential benefits.”

The lack of a regulation has also led to a lack of guidance, according to Cordie. “Manufacturers were fortunate to have had the UDI regulation for many years in its draft form and were aware of it and able to think about it and have input into the final regulation. In this way, UDI was less of a new concept for manufacturers and helped make the application and implementation . . . a bit easier when it was required,” she explained. “For healthcare facilities, guidance and best practices really aren’t available yet, which may be slowing down the overall adoption and implementation.”

Nevertheless, healthcare facilities are being challenged to find a way to incorporate UDI into IT systems and workflows, especially as UDI becomes part of the Centers for Medicare & Medicaid Services “meaningful use” criteria for 2018. Such a change will necessitate the involvement of all departments and all levels of personnel. HTM professionals, in particular, can play a big role in planning for and implementing this system.

“HTM professionals have great opportunities to be on the forefront of activities related to UDI and, moreover, to drive visibility into the performance and safety of products. I would encourage them to seek out those opportunities,” Crowley said.