03 Jan Case Study: Major Medical Company Meets UDI Compliance
Background and Challenge
A leading health services company, responsible for providing Class I and II medical devices, needed assistance from AB&R® to help them meet Unique Device Identification (UDI) compliance labeling requirements.
The medical company supplies linens and reusable medical equipment, such as gowns and drapes, to hospitals nationwide. Since their inventory falls under the “medical devices” classification, they are required to provide a unique product label in a barcode format on every “device.” This UDI label includes pertinent information such as the manufactured date and lot number.
Since this health services company supplies reusable medical equipment, this equipment and its labels must endure an aggressive sterilization process. This sterilization process posed a significant challenge for the company. The existing label stock and printing equipment were not producing a UDI compliant barcode after sterilization.
AB&R® engineers began the solution process with a site survey. Our team analyzed the current sterilization process during the site survey and helped paint a picture of the entire supply chain. Onsite, we learned that the labels needed to withstand a hot steam sterilization process with temperatures near 300°F for a significant period. Throughout the site survey, AB&R® documented the challenges faced in the current process and noted the customer’s organizational goals. Knowing where our customers want to go helps us build a plan to get them there with our AIDC technology solutions.
After a successful site survey and Solution Design Specification (SDS), our AB&R® team recommended a custom label solution. The solution included new equipment capable of producing printed barcode labels that would continually meet the compliance standards. Additionally, we suggested new labels that could withstand extreme moisture and temperature, maintaining the labels’ integrity even through their extensive sterilization process.
With the scope of work defined, AB&R® implemented a pilot program to test the solution. This pilot program introduced new printers and card stock, a solution crafted to withstand the company’s exact harsh environments. We also produced a validation report documenting that all business requirements were being met with the new solution, and all potential issues were resolved for success. A significant part of the validation included using barcode grading equipment. This equipment analyzed the barcode label before and after sterilization to ensure UDI compliance.
The medical company chose AB&R®’s customized solution to ensure its operations were UDI compliant. The implementation of new printers, labels, and equipment has empowered the company to provide critical medical supplies to hospitals nationwide safely and efficiently. Also, AB&R® committed to introducing this new process at other locations to ensure the entire company exceeds UDI compliance requirements for Class I and II medical equipment.
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