A longtime leader in healthcare improvement, we’re developing new ways to revolutionize the industry.
Medical devices cover a wide array of simple to complex products which are integral to patient care. The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel and/or import medical devices sold in the United States. With a lengthy list of registered medical devices, the importance of being able to precisely identify each device is critical to understanding how devices are intended to be used, which devices are recognized as authentic to keep out counterfeits and how to know which devices are to be removed in the case of an emergency or recall.
The unique device identification system was established by the FDA to identify medical devices from manufacturing through patient use. A phased rollout began in 2014 requiring the labeling of Class III medical devices with unique device identifiers (UDIs) and will conclude Sept. 24, 2022, (barring any extensions) with the requirement for Class I devices. Device classification depends on the intended use of the device. There are approximately 20,000 to 40,000 new UDIs registered every month.
In addition to satisfying the requirements of the UDI system, healthcare organizations must also meet requirements to comply with Meaningful Use and prepare to consume and maintain accurate UDI information for ultimate deposit in patient records.
OSF Healthcare, an integrated health system owned and operated by The Sisters of the Third Order of St. Francis and headquartered in Peoria, Illinois, had made more than one attempt at bringing UDIs into their system. At the time, there was a lot of promise from vendors saying they could help in this space, but not a whole lot of delivery. “We were ready to bring the whole thing in-house,” said Scott Everett, Regional Supply Chain Director, OSF.
In early 2020, Everett met Carl Gomberg, Premier’s Lead Solutions Analyst. Gomberg works with organizations looking to adopt UDIs and keep them current. “Monthly, we match UDIs with item masters for upload into enterprise resource planning (ERP) systems,” explained Gomberg. “The joined data flows downstream to the organizations’ electronic medical record (EMR) technology.”
Clinicians then scan items at point of use where it is recognized by the EMR and stored in the patient record. Because of the UDI connection to the item master, full supply data is available from that one barcode scan. This gives back valuable clinician time once used for keying in multiple product fields.
Everett and the team at OSF have been using Premier’s UDI Matching Service for nearly two years. “We thought, when we started that we would just be rolling out UDI scanning to procedural nursing,” said Everett. “But pretty soon, we hit general nursing. They already had scanners, so the transition was easy. We’ve seen efficiencies upon receiving shipments too. The mobile receiving from our ERP scans the UDI and because it is matched to our item master, we know without a doubt what’s coming in our doors,” explained Everett.
Today, the team at OSF Healthcare has confidence in knowing exactly which devices are in use within their system, and more importantly have patient level data to connect patient care with medical device use.
To satisfy system needs, avoid noncompliance with regulatory requirements and gain efficiencies, talk to your Premier representative about the UDI Matching Service. If you are interested in learning more, connect with us today.