AAMI has announced that, to improve the way healthcare providers are able to track the safety and performance of medical devices, the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services (CMS) have issued final rules requiring that unique device identifiers (UDIs) be included in patients’ electronic health records (EHRs). The final CMS rule will become effective December 15, 2015.
According to AAMI, UDI codes, which must have both a human- and machine-readable format, contain two parts. The device identifier corresponds to the type of device and its manufacturer. The production identifier includes additional information, such as the lot, batch, and/or serial number; expiration date; and date of manufacture. Established by the FDA in 2013, full implementation of the system is not expected until 2020.
Under the ONC’s 2015 Edition Health IT Certification Criteria, implantable device UDI codes will have to be included as part of an EHR’s Common Clinical Data Set (CCDS), which is included in a patient’s summary of care documents. This would allow for health IT to exchange, record, and allow a user to access a list of UDIs associated with a patient’s implantable devices. The ONC issued a Federal Register notice with details. The same day, CMS issued a final rule detailing the requirements healthcare professionals and hospitals must meet in order to qualify for Medicare and Medicaid EHR incentive payments for meaningful use.
The FDA UDI team stated that “incorporation of UDIs into electronic health information is a critical cornerstone of the FDA’s plan to strengthen our US National Medical Device Postmarket Surveillance system. Although full implementation of the unique device identification system will take several years, the inclusion of UDIs for implantable devices as part of EHR certification criteria and the CCDS are pivotal to developing the infrastructure needed to incorporate standard, structured device information into health IT.”
For more details, read the news announcement on the AAMI website.