UDI information will form a required part of the electronic health records’ common clinical data set under the ONC final rule on 2015’s health IT certification criteria, the FDA said in an emailed statement to stakeholders. That’s important because providers and hospitals prefer to use certified electronic health records and associated technology. The FDA explained that the common clinical data set is required to be included in a patient’s summary of care documents.
The move is a win for proponents of the initiative to carefully track individual implants and other devices. UDI codes (to be included in a human- and machine-readable format) not only identify individual devices, but they also contain a lot of associated information, such as a device’s expiration date and in some cases the lot number (which is used to identify devices that need to be recalled).
In addition, the ONC finalized its proposed implantable device list certification criteria “to enable the baseline functionality necessary to support the exchange and use of UDIs in certified health IT.” The final rule explains that “the need to exchange and have access to this information wherever patients seek care is broadly relevant to all clinical users of health IT, regardless of setting or specialty, so that they may know what devices their patients are using (or have used) and thereby prevent device-related adverse events and deliver safe and effective care. This need is most acute for implantable devices, which by their nature are difficult to detect and identify in the absence of reliable clinical documentation.”
ONC describes the (many) technicalities of the implantable device list, and its response to stakeholder’s comments on the previous draft proposal, in the final rule. Experts from the Pew Charitable Trust’s medical device initiative told FierceMedicalDevices in an email that crucial details include the requirement that electronic health records be able to link with the FDA AccessGUDID database for the extraction of UDI information. Pew also successfully requested during the comment period that ONC require the incorporation of additional data elements in electronic health records, including a device’s brand name, company name, MRI safety status, and whether it contains latex.
Crucially, CMS endorsed ONC’s move in its concurrent final rule on the requirements that providers and hospitals need to meet to collect incentive payments for the proper use of electronic health records. “These regulations are expected to go into effect during the spring of 2016 and will create a new source of information to improve patient and clinician decision-making because it will give providers access to information about their patients’ implantable devices,” the FDA said in its emailed statement.
While UDIs are gradually being integrated into electronic health records, efforts to include them in insurance claim forms have been less successful. Former CMS administrator Marilyn Tavenner responded negatively to Sens. Elizabeth Warren (D-MA) and Charles Grassley’s (R-IA) letter urging the agency to include the information in the forms, saying doing so would be costly and technically challenging. However, a debate in Congress indicated that the institution may soon mandate that UDIs appear on Medicare claim forms.
The second means of disseminating UDI information is important because electronic health records only track events that happened to a patient in the same hospital. If someone has a device implanted while on vacation due to an unexpected heart attack, that information will not be recorded on the electronic health record at the patient’s usual hospital.
UDIs are a crucial plank of the FDA strategy to shift more of its resources toward postmarket surveillance while accelerating premarket approvals. The Medical Device Registries Task Force recently laid out its vision for a medical device evaluation system that would incorporate UDIs as part of a system of integrated data registries. The recommendations echo those of the Brookings Institution, which in February called for a comprehensive public-private post-market medical device surveillance system in a report of its own.
REFERENCE: Fierce Medical Devices; 14 OCT 2015; Varun Saxena