The House health reform bill unveiled on Thursday includes a provision for implementing a unique device identification system that healthcare providers say could save $16 billion a year.
Called UDI, the system will make it possible to electronically track medical devices that will help prevent adverse events and enhance patient safety, as well as save hospitals money, officials say.
Blair Childs, senior vice president for public affairs at the Premier healthcare alliance, based in Charlotte, N.C., said Premier is urging passage of the provision that would require the U.S. Food and Drug Administration to issue regulations for UDI implementation no later than six months after enactment of the bill.
"The distressing reality is that we can identify and remove tainted peanut butter and dog food from the market before reaching consumers, but in healthcare patients risk having a recalled medical device used in their treatment because there is no way to quickly and reliably locate a recalled device," Childs said. "Moreover, we know UDI will improve electronic ordering, inventory management and information sharing to generate estimated savings of $16 billion annually."
Childs said the FDA has been working on UDI regulations for more than five years.
"Patients cannot afford to wait any longer," he said, "and we urge FDA to act before the proposed six-month deadline in the interest of public safety."
Premier is made up of 2,200 U.S. hospitals and more than 63,000 other healthcare sites.
Premier conducted a survey of clinical professionals nationwide in 2006 to decipher methods used in healthcare settings to record and track information on medical devices. Findings from the survey include:
1. More than 80 percent of respondents stated that a national UDI system would enhance patient safety.
2. The most common method used to record information on a patient record regarding an implanted medical device is transfer of a product label into the patient's record (60 percent).
3. When recalls occur, nearly all hospitals conduct manual searches of records or logs to identify patients who received a recalled device or product.