Integrate UDIs Into EHRs For Better Safety

By Katie Wike, contributing writer

By integrating unique device identifiers into the existing EHR, providers can track medical devices and make recall situations easier.

In 2012 the FDA proposed that unique device identifiers (UDIs) be used to track medical devices. This database of UDIs would enable the FDA to respond to recalls faster and more efficiently. “This very important proposal is a first step towards a standardized way to identify devices across all information sources and systems,” said the agency at the time. “We are proposing a phased-in, risk-based approach to its implementation, focusing on the highest-risk medical devices and exempting low-risk devices from some or all of the requirements.”

According to the FDA, UDIs are codes which have two parts - a unique numeric or alphanumeric code, called a Device Identifier, which is specific to a device model, and a Production Identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

Now, a report from the Brookings Institution provides a roadmap for providers to integrate these UDIs right into the EHR system. “The benefits of UDI implementation across the health care system are significant and, while the path to full implementation is complex, there are relatively straightforward steps that can be done now to begin realizing many of them,” says the report.“Recording UDIs at the point-of-care (POC) in electronic health records (EHRs) and in claims data could significantly enhance the nation’s ability to conduct medical device safety surveillance and manage recalls.”

According to iHealth Beat, the report’s authors write that using UDIs could help to:

• determine devices' long-term quality and performance
• efficiently identify and communicate device safety concerns
• improve reimbursement transparency
• make supply chain processes more efficient and accurate
• streamline premarket device approval

The Brookings Institute recommends the following:

• Providers should incorporate UDIs into their EHR systems, and may consider adopting automatic identification and data capture (AIDC) technology to make the process more efficient. Patient safety reporting should be automated.
• The device identifier portion of the UDI should be included as a situational element at the claim detail level for high risk, implantable devices.
• Patient advocacy groups, the FDA, and providers should work together to promote patient education on the subject of UDIs, and encourage patients to be aware of their devices and any potential recalls or issues related to their equipment.
• UDIs should be integrated into personal health records to easily provide patients with appropriate device data. Developers should collaborate with patient organizations to provide proper resources related to UDIs.