Bar-code rule for medical devices may be imminent.

As if hospitals didn’t already have enough concerns about the FDA’s changes to its existing bar-code rules for drugs, health systems also have to worry about a first-time FDA regulation mandating a unique device identifier (UDI) system for medical devices. Hospitals that want to take advantage of devices that are likely to be marked with GS1-compatible bar codes will have to upgrade their software systems, a task that could be complicated and costly. GS1 is the international standards group that also prescribes product identification (ID) numbers for drugs. Yet a number of major benefits of a national UDI program will probably balance out these shortcomings. Advantages include more timely and less costly recalls, better hospital safety records for implanted devices, and the ability to transmit more patient data into electronic medical records (EMRs), thereby allowing hospitals to meet the definition of “meaningful use.” The upcoming proposed rule for a UDI system, which is similar to a couple of recent FDA initiatives related to the tracking of drug packages, stems from the FDA Amendments Act (FDAAA), which Congress passed in 2007. Under the FDAAA, the FDA requires manufacturers to mark (or identify) their devices; however, the agency has moved very slowly in prescribing UDIs. In September 2011, the FDA held a 2-day workshop, at which Jeff Shuren, Director of Devices and Radiological Health, said, “I recognize that many of you have been waiting for this regulation for a long time; so have we.” Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, followed up by saying: “The UDI proposed regulation is close to coming out.” Since then: nothing. Before that September meeting, the FDA had sent a proposed rule to the White House Office of Management and Budget (OMB), which is responsible for approving all new proposed rules. The UDI rule is probably politically sensitive; in its regulatory agenda, the FDA rates it as “economically significant.” Some proponents of the UDI plan suggest that medical device manufacturers might have pressed the Obama administration to water down the proposed rule, but a spokesperson for AdvaMed (Advanced Medical Technology Association), the medical device manufacturer’s organization, denied this. Hospital executives see many benefits resulting from implementation of the UDI system. “UDI is essential to maximizing the value of electronic health records,” says Christopher M. Dadlez, FACHE, President and Chief Executive Officer of Saint Francis Hospital and Medical Center in Hartford, Conn. Referring to the 5 years of FDA workshops that centered around the UDI since the FDAAA was passed, Mr. Dadlez emphasized, “The time to act is now. UDI is too important to patient safety to delay any longer.” In February 2012, a coalition of health care trade associations wrote to Jef f Zients, Acting Director of the OMB. The letter stated: