As Ed Hisscock of Trinity Health pointed out so poignantly at the recent AHRMM UDI Forum, his supermarket sends him texts when a product he bought has been recalled, but hospitals and manufacturers don’t text patients when a recalled medical product has been implanted in their bodies. At this forum, many healthcare providers lamented how long it takes and how difficult it is to trace a recalled item to a patient and the frustration and exhaustion that it causes staff. This is clearly a problem when you consider that in 2023, there were 975 medical device recalls, impacting over 283 million units — the highest in seven years.
Accurate UDI data is the foundation of effective and swift recall management. It’s vital for ensuring the consistent identification and tracking of all medical devices and supplies throughout their lifecycle, from manufacturing to patient care. Not only is it essential for device traceability and recall management, however, but also for regulatory compliance, supply chain integrity, and healthcare interoperability. As the FDA explains, the UDI system also reduces medical errors by enabling healthcare providers to more rapidly and precisely identify a device using its pedigree information, which helps prevent confusion and ensure that the correct device is used for the patient. It also helps combat counterfeiting, which poses risks to patient safety.
Nevertheless, the achievement of accurate UDI data is still elusive. UDI compliance problems, such as misprinted barcodes, missing information from GUDID, non-adherence to GS1 standards, and multiple Device Identifiers for the same product, are widespread and greatly affect hospital operations and patient safety.
As Indira Konduri, the FDA’s UDI Implementation Lead, stated at the UDI Forum, the FDA’s focus is now on getting widespread UDI adoption and implementation throughout the healthcare system, and on seeing it used to manage clinical inventory and ensure a healthy functioning supply chain.
VueMed’s data capture technologies – VueTrack (barcode scanning) and VueTrack-RF (RAIN RFID) – have been successfully enabling hospitals to be UDI compliant for years. With our systems in place, recalls are tracked to specific patients within seconds, not weeks.
Accurate UDI data is essential for the effective and swift recall management of medical devices and supplies. It enhances traceability, ensures compliance, improves communication, and most importantly, protects patients by enabling the rapid removal of unsafe products. By adopting robust UDI management practices, the healthcare industry can drive operational excellence and maintain the public’s trust in medical devices.
