Vital Signs Blog

Groups push for final rule on medical device identifiers

Healthcare industry groups are pressing regulators to issue the delayed final rule requiring manufacturers to mark medical devices with unique identifiers to improve patient safety and help healthcare providers during product recalls.

The Food and Drug Administration previously said the final rule would be released by June 30. An agency spokeswoman said in a July 15 e-mail that the rule is currently under administrative review.

In a July 12 letter (PDF) to Sylvia Mathews Burwell, director of the Office of Management and Budget, the Advancing Patient Safety Coalition called for the release of the final rule, calling the unique device identification system rule “critical to achieving patient safety improvement initiatives and medical error reduction.”

The coalition is made up of group purchasing organizations, hospitals, healthcare professionals and others.

The Premier healthcare alliance, which is part of the Advancing Patient Safety Coalition, also partnered with Pew Charitable Trusts to write a separate letter July 8 (PDF) to OMB urging issuance of the final rule.

Congress passed a 2007 law first mandating the development of the unique-device identification system. A law passed last year required the final rule to be released within six months of the closing of the comment period for the proposed rule.

The FDA has proposed a risk-based approach to the roll-out of the UDI system, starting with the packaging of high-risk medical devices and eventually including low-risk devices over a seven-year period.

Device manufacturers have said they need more time for the roll-out and have expressed concern about whether and how the proposed identifier system will benefit the public.

Follow Jaimy Lee on Twitter: @MHjlee


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