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How to Adopt Unique Device Identifiers for Medical Devices

By Jennifer Bresnick

Unique device identifiers can improve tracking of medical devices for research and patient safety.

- In response to new FDA requirements for all medical devices to have a unique device identifier (UDI) within the next few years, the Brookings Institute has helped to develop a roadmap for adopting and integrating UDI technology in order to improve patient safety and provide better data for research and analytics.  The roadmap includes a number of critical steps to help bring UDIs into provider systems, administrative transactions, and patient-directed tools.

Medical Device Identifiers

“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,” the document says.  “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.”

“Other benefits include: efficient identification and communication of device safety concerns, active learning about the long-term quality and performance of devices, facilitation of premarket device approval/clearance and expanded indications for existing devices, data collection to support better value, increased reimbursement transparency, and more accurate and efficient supply chain processes.”

The recommendations include 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.

• UDIs should be integrated across the entire healthcare ecosystem, including through the supply chain, clinical processes, and revenue cycle management to achieve the highest return on investment.

• UDIs should be incorporated into the criteria for Stage 3 meaningful use as well as the EHR certification criteria.

• 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.

• Provider systems, payers, and other stakeholders should commission studies and pilots to highlight use cases for UDIs and demonstrate the benefits of integrating medical device data into the workflow.

The roadmap focuses primarily on the highest risk devices, which are typically implantable, but adds that all medical devices that impact a patient’s care, even transient equipment such as MRI machines, can significantly benefit from UDI labeling and tracking.  “The UDI system, which will be phased in over several years, represents a landmark step towards improving patient safety, modernizing device post-market surveillance, and facilitating device innovation,” the roadmap says. “These promised benefits will only be fully realized with the adoption and integration of UDIs into the health care delivery system.”

 

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