25 orgs urge FDA to create 'unique device identification' system for medical devices
The Advancing Patient Safety Coalition (APSC) has urged FDA Commissioner Margaret Hamburg, MD, to issue a proposed rule to establish a “unique device identification” (UDI) system for medical devices in a letter last week.
The coalition, comprised of 25 organizations including the American Hospital Association (AHA) and the American Nurses Association (ANA), stated that it “believes the proposed rule must be published now as UDI is critical to patient safety improvement initiatives as well as implementing EHRs and the delivery system reforms included in the recently enacted health reform bill.”
“[T]he efficiencies gained through UDI will save the healthcare system billions of dollars, which providers could reinvest in initiatives to improve the quality and safety of care,” the letter added.
The letter stated that although the coalition recognizes and appreciates the FDA’s work on UDI, as more time passes without a UDI system in place, patients' lives are put at a “needless risk.”
Asserting that UDIs are the “missing link” to protect the safety of patients by improving processes for device recalls and corrections, the letter pointed out that more than 700 medical device recalls were issued in 2008, including more than 100 Class 1 recalls (defined as dangerous or defective products that predictably could cause serious health problems or death).
“Manufacturers also issue many ‘device corrections’ that can have serious consequences for patients if not handled correctly. Because of the absence of UDI, providers often must use manual and imprecise systems to identify if they have any recalled products,” the authors wrote.
With the passage of the American Recovery and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act, the letter stated that UDI will be essential to EHRs since they require data standards. “Having a UDI system for medical devices is a basic requirement that must be in place before automated identification systems are fully effective,” the coalition contended.
According to the ASPC, UDI will also greatly benefit the U.S. healthcare supply chain through increased efficiencies and improved order accuracy, resulting in substantial savings. The group cited a 2009 survey from the University of Arkansas which found that the average healthcare provider spends more than $72 million a year on supply-chain functions; nearly one-third of its annual operating budget.
“Patients will be the ultimate beneficiaries of a more efficient supply chain system because providers will be able to track recalled products more accurately and improve the quality, safety and affordability of care they provide their patients,” the letter stated. “[W]e again thank you for the work of the FDA on this important issue and reiterate we cannot wait any longer."
The coalition, comprised of 25 organizations including the American Hospital Association (AHA) and the American Nurses Association (ANA), stated that it “believes the proposed rule must be published now as UDI is critical to patient safety improvement initiatives as well as implementing EHRs and the delivery system reforms included in the recently enacted health reform bill.”
“[T]he efficiencies gained through UDI will save the healthcare system billions of dollars, which providers could reinvest in initiatives to improve the quality and safety of care,” the letter added.
The letter stated that although the coalition recognizes and appreciates the FDA’s work on UDI, as more time passes without a UDI system in place, patients' lives are put at a “needless risk.”
Asserting that UDIs are the “missing link” to protect the safety of patients by improving processes for device recalls and corrections, the letter pointed out that more than 700 medical device recalls were issued in 2008, including more than 100 Class 1 recalls (defined as dangerous or defective products that predictably could cause serious health problems or death).
“Manufacturers also issue many ‘device corrections’ that can have serious consequences for patients if not handled correctly. Because of the absence of UDI, providers often must use manual and imprecise systems to identify if they have any recalled products,” the authors wrote.
With the passage of the American Recovery and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act, the letter stated that UDI will be essential to EHRs since they require data standards. “Having a UDI system for medical devices is a basic requirement that must be in place before automated identification systems are fully effective,” the coalition contended.
According to the ASPC, UDI will also greatly benefit the U.S. healthcare supply chain through increased efficiencies and improved order accuracy, resulting in substantial savings. The group cited a 2009 survey from the University of Arkansas which found that the average healthcare provider spends more than $72 million a year on supply-chain functions; nearly one-third of its annual operating budget.
“Patients will be the ultimate beneficiaries of a more efficient supply chain system because providers will be able to track recalled products more accurately and improve the quality, safety and affordability of care they provide their patients,” the letter stated. “[W]e again thank you for the work of the FDA on this important issue and reiterate we cannot wait any longer."