Monday, December 8, 2014
Integrating unique device identifiers into electronic health record systems could improve medical device safety and make recall efforts easier, according to a Brookings Institution report released Friday, Politico’s “Morning eHealth” reports (Gold, “Morning eHealth,” Politico, 12/8).
In July 2012, FDA released a proposed rule to create a UDI system to track medical devices. Such a system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety.
FDA in September 2012 issued a report that outlined the agency’s approach to improving its post-market surveillance system for medical devices, including the creation of a UDI system (iHealthBeat, 9/3).
Details of Report
The report aims to advise providers on how to adopt and integrate UDIs to improve patient safety, research and analytics, according to EHR Intelligence.
Specifically, the report outlines key steps to integrating UDIs into:
•Administrative transactions; and
The report focuses on high-risk devices, but the authors note that all medical devices affecting patient care can benefit from tracking UDIs.
The report states, “Recording UDIs at the point of care in EHRs and in claims data could significantly enhance the nation’s ability to conduct medical device safety surveillance and manage recalls.”
In addition, the 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; and
•Streamline premarket device approval.
In the report, the authors recommend:
•Conducting studies to showcase the benefits of UDI use;
•Including UDIs in claims details for high-risk, implantable devices;
•Incorporating UDIs into EHR systems and personal health records;
•Increasing outreach about UDIs through collaborations between advocacy groups, FDA and providers; and
•Using UDIs across supply chain, clinical and revenue cycle processes to obtain the highest return on investment.
The authors also recommend including UDIs in Stage 3 requirements of the meaningful use program. Under the 2009 economic stimulus package, health care providers who demonstrate meaningful use of certified EHRs can qualify for Medicaid and Medicare incentive payments (Bresnick, EHR Intelligence, 12/5).