The FDA has been consulting with industry stakeholders on such a rule since 2005 and in recent months has come under pressure to finish the task. Legislation enacted last fall to revamp the FDA mandates a unique identifier on the label of medical devices. The law, however, does not specify what types of medical devices would fall under the regulations.
In February, Jay Crowley, senior advisor for patient safety at the agency, said the FDA was “busily writing” a proposed rule, but he did not give a timeline.
A national identifier can improve patient safety by reducing the risk of counterfeit products being used on patients, the 24-member Advancing Patient Safety Coalition told Eschenbach.
Coalition members include the American Association of Medical Colleges, Alliance for Advancing Nonprofit Health Care, Alpha-1 Association, Alpha-1 Foundation, American Association of Orthopaedic Surgeons, American Heart Association, American Hospital Association, Association for Healthcare Resource & Materials Management, Association for Professionals in Infection Control and Epidemiology, Bon Secours Health System, Catholic Health Association and COPD Foundation.
Also: Federation of American Hospitals, National Association for Continence, National Rural Health Association, Novation, PeaceHealth, Premier Inc., Texas Health Resources, The Society for Healthcare Epidemiology of America, University HealthSystem Consortium, VHA Inc., West Penn Allegheny Health System, and White River Health System.
The coalition is developing a public Web site.
Following is the complete text of the coalition’s letter:
“We are writing to reiterate our strong interest in seeing the U.S. Food and Drug Administration (FDA) develop a mandatory unique device identification (UDI) system for medical devices and request a timeline from the FDA on its plans to publish a proposed rule.
“As you may know, the Advancing Patient Safety Coalition is a broad-based organization comprised of prominent hospital, physician, nursing, research, quality and patient advocacy organizations. The coalition is interested in this issue because UDI is a crucial factor to improving patient safety, reducing medical errors, facilitating device recalls, improving device adverse event reporting and improving post-market surveillance efforts.
“Last fall, the coalition supported the successful efforts of Representatives Doyle (D-PA), Sessions (R-TX) and Hooley (D-OR) in enacting legislative language that requires your agency to create a UDI system for medical devices. The “Food and Drug Administration Amendments Act of 2007” (H.R. 3580), which contained this important language, was approved in the House by a wide margin of 405-7. The Senate then approved it unanimously and it was signed by the President.
“A national UDI standard has great potential for our entire healthcare system. It will improve patient safety while increasing efficiency for manufacturers by reducing the potential for counterfeit products being used on a patient. A UDI standard would also help contribute to the success of EHRs and improve patient care by providing appropriate healthcare providers with accurate information.
“We appreciate the great effort that the FDA has put into the national UDI standard issue under your leadership and all of its work to date. However, it is important that the agency move as quickly as possible in promulgating regulations.
“We look forward to hearing about the FDA’s timeline for publishing a proposed rule on a UDI system for medical devices as we all continue to work to enhance patient safety and improve health care efficiency.”
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