The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that in order 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 & Medicaid Services (CMS) have issued final rules requiring unique device identifiers (UDIs) be included in patients’ electronic health records (EHRs).
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. The FDA established this system in 2013, but full implementation is not expected until 2020. Under the ONC’s 2015 Edition Health IT Certification Criteria, implantable device UDIs 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 “health IT to exchange, record, and allow a user to access a list of UDIs associated with a patient’s implantable devices.” "Recording and exchanging UDIs in patients' electronic health records would enable this information to travel with patients as they move among providers and throughout the healthcare system. With access to this information at the point of care, clinicians can accurately identify a patient's implantable devices and prevent adverse events resulting from misidentification or non-identification of the device and its associated safety characteristics (such as MRI compatibility and latex content)," the ONC stated in a Federal Register notice.
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. Some of these incentives pertain to UDI integration and were designed to encourage providers to incorporate UDIs within their EHR systems. "Incorporation of UDIs into electronic health information is a critical cornerstone of the FDA’s plan to strengthen our 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," the FDA UDI team said in a statement. The final CMS rule will become effective Dec. 15, 2015.