Medical Device Tracking System Seen as EHR Roadblock

Federal regulatory efforts to create a unique identifier system for medical devices has raised concerns that incorporating such data on insurance claims will add yet another stumbling block to healthcare’s implementation of electronic health-record systems.

As a result, “I think the whole process is going to go better if we’re very thoughtful about starting with UDI cases where the clinical benefits and the administrative burden reduction benefits are the greatest,” said Mark McClellan, M.D., Ph.D., a senior fellow and director of the Health Care Innovation and Value Initiative at the Brookings Institution.

The unique device identification (UDI) system was established in 2013 after the U.S. Food and Drug Administration issued a final rule requiring device makers to include a unique device identifier on device labels and packages. The system was intended to “adequately identify devices through distribution and use,” according to the FDA’s website.

Product makers of class three devices, such as implanted pacemakers and heart valves, have been required to include a UDI since September 2014, with all medical devices required to have UDI by 2020.

But efforts by the FDA to include a UDI onto health claims to better track devices and more quickly identify when a product recall is necessary has been opposed by some who contend such a move would be costly for providers who have invested millions to implement electronic health-record systems.

The agency estimates about 50,000 serious adverse events related to medical devices are reported each year, resulting in some 3,000 deaths.

Among those opposed is the Centers for Medicare and Medicaid Services, which, according to The Wall Street Journal, believes adding the UDI to claims poses too many technical problems. In that article, McClellan was quoted as saying the CMS was “channeling the concerns of hospitals” in its opposition to the plan.

McClellan, who ran CMS during President George W. Bush’s administration, said in a recent interview that any such implementation of UDI must include incentives for providers and initially should be conducted on a voluntary basis to allow hospitals time to adopt.

“Healthcare providers are concerned about these administrative burdens, they’re concerned about an added burden related to UDI reporting, but they’re also very concerned about all of the administrative burdens they are facing now,” McClellan said.

The American Hospital Association, in an e-mail statement, expressed its support of the use of UDI, saying the system held “great promise” toward improving medical-device safety and creating greater efficiency along the supply chain. It stressed, however, that the priority in terms of UDI implementation must first be on how it is best applied within the practice of clinical care.

“With scarce resources, hospitals need to focus first on where it would make the most positive impact for patients,” the statement read.