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UDIs for medical devices 'should be added to health claim forms'

IntubationTwo US senators have called for the unique device identifier (UDI) system for medical devices to be linked more closely to the health insurance system.

In a letter addressed to the head of the Department for Health and Human Services - Sylvia Burwell - the senators ask for an update on plans to add UDIs to health insurance claim forms "in order to improve post market surveillance and curb waste in the Medicare programme."

According to the FDA, the UDI system - which will be phased in over several years - offers a number of benefits that will only be fully realised with its adoption and integration into the health care delivery system.

Used effectively, UDIs can help "improve patient safety, modernise device post-market surveillance, and facilitate medical device innovation," according to the agency, which wants to use the UDI to incorporate medical device data into its post-market Sentinel initiative - a large electronic database comprised of primarily insurance claims data designed to evaluate the safety of medical products.

In the letter, Senators Charles Grassley and Elizabeth Warren take issue with what they say is opposition by the Centers for Medicare & Medicaid Services (CMS) to adding UDIs to claim forms which stems "solely from the technological challenges associated with the change."

The move has also been opposed by AdvaMed, a trade association representing medical technology companies, which has said that the move will impose "significant operational challenges" to device manufacturers.

In addition to the patient safety benefits afforded by the use of UDIs such as the better detection of adverse events and more efficient product recalls, inclusion in health claims will "help to protect the integrity of the Medicare programme," write the senators.

They cite an Office of the Inspector General (OIG) report which found that recalls of defective devices due to recalled or poorly performing medical devices have resulted in millions of claims for monitoring, replacement and follow-up care at significant cost.

Earlier this year, the Senate Health, Labor, Education and Pensions (HELP) Committee called for changes to the health insurance claims system for medical devices after a report found evidence that serious infections caused by contaminated duodenoscopes exceeded previous estimates

One of the main recommendations of the Committee was to add UDIs to health claims to improve tracking and monitoring of device safety and efficacy.

In 2013, FDA issued its final rule for requiring medical devices to bear the UDI - a two-part identifier containing a device identifier and a production identifier. Under the rule, FDA established a seven-year phase-in period for UDI compliance, depending on the medical device class and type.

Implementation has been ponderous and subject to considerable delays, however, with the agency lengthening the deadline for replacing legacy labels with UDI labels on some device types - including some orthopaedic implants and intraocular lenses - amid concerns that patient access to products might be impacted.


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