21st Century Cures Bill Indicates Congressional Desire for Medical Device “Unique Device Identifiers” to be Documented in Electronic Health Records

On July 10, 2015, the U.S. House of Representatives passed H.R. 6, commonly known as the 21st Century Cures Bill. While the broad scope of the bill deals with accelerating the discovery, development and delivery of 21st century medical cures, an amendment to the bill signals Congressional intent that Unique Device Identifiers, currently required on most medical devices used in patient care, be documented in the patients electronic medical records.

House Amendment 661 to H.R. 6 states that the purpose of the amendment is to “express a sense of Congress that Unique Device Identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for post market surveillance purposes.”

In 2013, the United States Food and Drug Administration released a final rule establishing a unique device identification system designed to adequately identify medical devices through distribution and use, to be phased in over a seven year period.  This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler, usually the manufacturer or distributor, must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID).  However, this identifying information is not currently required to be included in a patient’s electronic medical records.

While the stated intent of Amendment 661 is to enhance the availability of medical device data for post-market surveillance purposes, the potential impact on product liability litigation is noteworthy. Any future requirement that UID’s be documented in a patient’s medical records could have significant evidentiary implications, in that an electronic record of the manufacturer/distributor  and model of the device used in a specific procedure, along with the lot, batch number or serial number of a specific device would be memorialized in a patient’s medical records.

Currently, there is no similar legislation pending in the United States Senate, and no indication from the U.S. Congress that additional legislation on this front will be forthcoming in the short term. However, recent high-profile news events involving the use of certain medical devices, and the FDA’s approval process, have heightened the discussion surrounding patient safety and the approval and clinical use of medical devices.  It is likely that these issues will continue to be an area of focus for future legislation and administrative rule making, which device manufacturers and distributors should continue to monitor.

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