The 27-member Advancing Patient Safety Coalition is calling on the Office of Management and Budget to speed its review of a proposed rule to establish a unique device identifier for medical devices.
OMB review is one of the final steps before publication of a rule and the coalition has been clamoring for such a rule, which was mandated in 2007. The Food and Drug Administration sent the proposed rule to ONC on July 11, 2011.
Under the rule, the unique identifier will identify a device through distribution and use, and may include the lot or serial number. In a letter dated Sept. 19 to OMB Director Jacob Lew, the Advancing Patient Safety Coalition said the rule is imperative and asked for an update on OMB's review process. What follows is the letter:
"The Advancing Patient Safety Coalition is committed to improving patient safety through the establish of a national unique device identification system. As prominent hospital, physician, nursing, research, quality and patient advocacy organizations, we are writing to express our strong interest in seeing the Office of Management and Budget release the proposed rule on the unique device identification system for medical devices. The Food and Drug Administration Amendments Act of 2007 requires the FDA to release a regulation implementing a UDI system.
"It is imperative that OMB work expeditiously to release the proposed UDI rule, as the rule is critical to patient safety improvement initiatives and medical error reduction. Unlike other products on the market in America, there is no uniform identification system for medical devices. The resulting ad hoc approach results in increased clinical risks to patients and an estimated $16 billion in costs annually due to inefficiencies in the medical products supply chain.
"The rapidly rising number of medical device recalls, accelerated by the increasing complexity of the variety of medical devices, strongly points to the need for an effective UDI system which will promote a better managed system of recalls and corrections, and effectively match each patient to the device prescribed. Due to the absence of a UDI system, providers must often use manual and imprecise systems to identify products that are recalled, as well as provided to the patient, adding unnecessary costs and delays to the healthcare system.
"Finally, an effective UDI system is essential to maximizing the value of electronic health records. EHRs will require that data standards, including those for medical devices, are in place and used by providers to transmit information. The 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.
"We look forward to hearing about OMB's plan for releasing the proposed rule on a UDI system for medical devices, and we ask that you provide us with an update on where OMB is in the process."
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