The adoption of a universal unique identifier system for medical devices has long been considered the holy grail for hospital supply-chain managers.The miraculous powers of a standard unique device identification, or UDI, system are said to include cutting costs by producing greater efficiencies in ordering and tracking inventory, as well as improving patient safety by more rapidly identifying devices that are in need of a recall or locating those that a manufacturer announces are in need of a modification. While nearly everyone believes such a system could streamline the supply chain, not all providers are ready to start investing in one. Some hospitals, such as those in the 15-hospital Bon Secours Health System, Marriottsville, Md., are waiting for the next move by the Food and Drug Administration on the details before making the pricey leap of faith. "This is a very costly venture," says Michelle Allender, director of clinical resource management at Bon Secours. "If it's determined that a certain responsibility lies on the vendors or that the burden lies on the local facilities, then we will make budget adjustments." The FDA, after years of consideration, said this past November that it would pursue adopting a mandatory UDI system that would be universally applied across the healthcare industry. The announcement came as part of an FDA action plan on how to beef up its surveillance of devices. The next step is a proposed rule from the FDA, which could come out as early as this year, and that would likely include a timetable for rollout and adoption. The goal of the system is to uniquely label devices so they could be read by computer systems -- with perhaps a bar code or radio frequency identification, or RFID, tag -- or manually by staff who then would punch the ID numbers into a computer database. At this point, however, no one knows what the standard would look like or how it would work. Getting all those involved in the supply chain to follow a uniform system is complex because several third parties have already developed device identifiers -- that could serve as the basis for standards. The problem would be similar to the interoperability issue with information technology systems: how to coalesce around one approach. In 2004, the FDA established bar-coding rules for drugs but omitted similar rules for medical devices. At the time, the reasons for not requiring devices to be bar-coded included cost concerns, the number of devices on the market and challenges with labeling small devices. Then last year, the agency requested recommendations in an effort to answer questions such as: Which devices should be labeled? Who would do the labeling? Could any of the existing standards such as those developed by third parties be used? Would RFID tags, bar codes or something else be required? Hospitals, vendors or distributors that are now investing in supply-chain-management technology are using existing standards from third parties or developing their own in-house standard. But variation leads to inefficiencies, which is why many providers are backing an FDA mandate. For example, one device can be given three different labels -- one each from the manufacturer, distributor and healthcare provider -- that can't be identified by the others' computer systems. "The biggest issue is that none (of the standards) is identical," says James Keller Jr., who directs the medical-device evaluation program for ECRI, a not-for-profit healthcare research firm. The FDA contracted with consulting firm Eastern Research Group, Lexington, Mass., to develop some cost estimates, and ERG Executive Vice President John Eyraud unveiled preliminary numbers during an FDA hearing last October. Collectively, the nation's hospitals would have to invest nearly $2 billion for equipment, installing scanning systems and first-year training, he says. After that, recurring charges for maintenance and training would total more than $500 million annually, Eyraud says. Eyraud's analysis also showed that hospitals would save about $35 million annually through a more streamlined process to handle device recalls, with hospitals saving hundreds of hours in staff time per year. According to the calculations, hospitals with 100 to 399 beds could save an average of 104 to 124 hours per year in searching for devices that had been recalled, and hospitals with 400 beds or more could save an average of more than 300 hours. Allender says the UDI system would be a worthwhile investment because of its effect on patient safety. She noted how it can be difficult and time-consuming to locate devices throughout her system when there's a recall. However, one of her concerns is that organizations such as Bon Secours might start investing in a UDI system and then final federal regulations would require a different type of system to be put in place.
This story initially appeared in today's edition of Modern Healthcare magazine.
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