|Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA|
The central issue facing unique device identification (UDI) is no longer implementation--it's utilization.
After all, "if nobody in a hospital uses the UDI, we've accomplished very little," said Dr. Joshua Rising, director of the Pew Charitable Trust's Medical Device Initiatives, in an interview. Incorporating UDIs into insurance claims is crucial to ensuring that the benefits of device identification are reaped, he and other experts said June 10 in a testimony to a Department of Health and Human Services advisory committee.
The benefits include improved postmarket surveillance and device recalls. "Currently, more than half of the highest-risk device recalls conclude with not all products identified or removed from the market," Rising testified, according to his prepared remarks.
The FDA's postmarket Sentinel initiative would also benefit from the claims data. Expanded to include the monitoring of devices in 2012, the program needs more granular data, Rising told FierceMedicalDevices, pointing to deaths and injuries resulting from metal-on-metal hips and faulty defibrillator leads. Currently, Sentinel cannot distinguish between different brands of the same device type, such as an artificial hip, but that could change if such information is captured in insurance claims data, he said.
Complementary efforts are underway to incorporate UDI into electronic health records that enable healthcare provider surveillance, Rising said. But unlike insurance claims, EHRs are unstandardized and suffer from interoperability challenges, he added, noting that they are not always updated when a patient switches hospitals or healthcare providers.
In his testimony, Rising stressed the importance of UDI adoption and information exchange, saying, "The Department of Health and Human Services should--working with providers, device manufacturers, distributors, insurance companies and other healthcare stakeholders--develop a plan to promote the adoption and nationwide exchange of UDI data to improve patient care. In particular, CMS, which has access to large amounts of data, should participate in the development of this plan, especially regarding UDI integration into claims."
In an interview, healthcare consultant Jay Crowley, who spearheaded the creation of UDI while at FDA, concurred that public and private payers must drive adoption. In fact, managed healthcare company Aetna testified in support of the inclusion of UDI data into claims data, but it is too early for insurance companies to make reimbursement conditional on the data's inclusion. High-risk devices will have UDIs starting in the upcoming fall, and all devices should have them by 2018.
The task of integrating UDI into insurance claims will require a series of "convoluted" steps, including the advisory committee's consent, Crowley said during the interview. (He did not testify at the hearing.)
It took years for the FDA to implement UDI via a final rule issued last year. And ensuring that the system is adopted and utilized will prove just as challenging. "When I was at FDA we were completely overwhelmed by all of the steps that need to be taken to ensure adoption," Crowley admitted.
- read testimony from the hearing "Use of UDI in Administrative Transactions"