Medical device manufacturers have worked to meet the Food and Drug Administration’s (FDA’s) stricter regulations for Unique Device Identification (UDIs) every year since September 2014. Now humans and computers can access vital product information like never before, all from the special barcodes on the latest medical devices. The lot number, serial number, manufacture date and, when necessary, the device’s expiration date can be quickly referenced and searched for—but only if providers capture the barcodes.
UDIs are a true technological breakthrough for managing not only patient care, but also medical device recalls. But many health systems are struggling to make the best use of them. The first roadblock is with electronic health records (EHRs). In theory, it should be easy to trace UDIs back to patient records, but the technology for managing EHRs hasn’t caught up with the new UDI system. Providers will need to update their inventory management systems in order to utilize UDIs effectively.
The other concern with recall management relates to patient tracking. Being able to electronically search inventory with the right UDI data is only half the battle. The next step is to locate the individuals with the affected devices. Patients need to be notified of any care plan changes in a timely manner, but taking immediate action is particularly challenging when the patient systems aren’t up-to-date. Using multiple communication channels is key. When address and other contact information has changed since the patient’s last visit, a strong recall notification plan can help ensure compliance.
As the Q2 2017 Recall Index shows, recalled medical device units increased 628 percent over the previous quarter, and the number of units considered Class I – the most serious situation – increased significantly in the first half of 2017. In the face of these challenges, making recall execution more efficient is top of mind for medical device manufacturers and other stakeholders.
Because most medical providers don’t have the necessary equipment for recording UDIs in their system, early adopters of effective UDI management will be in a highly strategic position when recalls occur. The potential exists for UDIs to dramatically improve patient care, so long as stakeholders have the proper technology and procedures in place.
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