In 2013, the U.S. Food and Drug Administration (FDA) established a unique device identification system to adequately identify medical devices through their distribution and use. The system, when fully implemented in 2020, will require the labels of most devices to include a unique device identifier (UDI) in a form that uses automatic identification and data capture technology and is searchable in the publicly available Global Unique Device Identification Database (GUDID). Life-supporting or life-sustaining class III medical devices, such as implanted pacemakers and heart valves, were required to be appropriately labeled and added to the GUDID by September 2015. By this September, class II devices will have to be compliant, followed by class I devices in 2018.
FDA’s reason for establishing the UDI system was twofold: to reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use, and to improve the quality of information in medical device adverse event reports. From a supply chain perspective, adopting standards can also help improve and streamline inventory management.
Any way you look at it, adopting standards is a good idea—better adverse event reporting leads to increased patient safety, while supply chain efficiency results in cost reduction. But it’s also an expensive one. Standards adoption requires investments in new or upgraded systems that can read the data, as well as be interoperable with other clinical, supply chain and finance systems in the organization, according to Carrie Wilkie, vice president of standards management for GS1 US, a nonprofit charged with setting standards to improve supply chain management and one of the FDA’s three accredited issuing agencies for UDIs.
“It can be a huge undertaking because all of the systems, hardware and software have to speak the same language,” she says. “But that’s also the beauty of standards. Having one single standard means you always know your systems are talking and you can plan for what’s coming, in terms of new standards initiatives.”
The massive scope of standards adoption means hospitals, in general, have been slow to adopt them, says Greg Bylo, vice president of healthcare for GS1 US. That, and the standards just aren’t that commonplace—yet.
To read the blog post in full, click here.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
