A standard unique device identification system could reduce costs and improve patient safety, but many hospitals are waiting for FDA to provide more details before investing in the expensive technology, Modern Healthcare reports.
Hospitals, vendors and distributors currently are using existing standards from third-parties or developing their own standard. However, many providers are waiting for an FDA mandate because "variation leads to inefficiencies," according to Modern Healthcare.
FDA in 2004 created bar-coding rules for drugs but did not establish similar rules for medical devices because of cost concerns, the number of devices on the market and the difficulty of labeling small devices. FDA in November 2006 said it would pursue adoption of a mandatory unique device identification standard that would be universally adopted as part of the agency's action plan to improve device surveillance.
FDA as early as this year could release a proposed rule with a timetable for adoption of the technology. The system would streamline the supply chain by labeling devices with bar codes or radio frequency identification tags. The system would help hospitals more quickly identify devices that have been recalled or that need to be modified, Modern Healthcare reports.
FDA contracted with Eastern Research Group, a consulting firm in Massachusetts, to estimate the cost of universally adopting a standard unique device identification system. Hospitals collectively would have to spend nearly $2 billion for equipment, installation and training, according to Eastern Research Group Executive Vice President John Eyraud. In addition, recurring maintenance and training costs would total more than $500 million annually, Eyraud said.
However, Eastern Research Group's analysis found that hospitals would save about $35 million annually by streamlining the process of handling device recalls and hundreds of hours in staff time.
Michelle Allender, director of clinical resource management at Bon Secours Health System in Maryland, said the unique device identification system would be a worthwhile investment because of its impact on patient safety (Mantone, Modern Healthcare, 1/22).