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 with their Unique Device Identification (UDI) labeling requirements.
The company supplies linens and reusable medical equipment such as gowns and drapes to hospitals across the country. Since their inventory is classified as medical devices, the UDI requires the company to provide a unique product label in a barcode format on every device. This label includes pertinent information such as the manufactured date and lot number.
Since this health services company supplies reusable medical equipment, this equipment must ensure an aggressive sterilization process. This posed a challenge for the company because the existing label stock and printing equipment were not producing a compliant barcode after sterilization.
AB&R® engineers began the process with a site survey. During the site survey, AB&R® analyzed the current sterilization process to help paint a picture of the entire supply chain. Onsite, we learned that the label being used needed to withstand a hot steam sterilization process with temperatures near 300°F for a significant amount of time. Throughout the site survey, AB&R® documented challenges faced with the current process, as well as making note of the customer’s organizational goals.
A successful site survey and SRDS document led AB&R® to recommended a custom label solution that included new equipment capable of producing printed barcode label that met the compliance standards. In addition, AB&R® recommended new labels that would withstand extreme moisture and temperature.
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 that would withstand the exact harsh environments the company was facing. AB&R® also produced a validation report which documented all business requirements were being met and all potential issues were resolved for success. A major part of the validation included the use of barcode grading equipment that analyzed the barcode label before and after sterilization to ensure UDI compliance.
The health services company chose AB&R® to ensure their operations were UDI compliant. The implementation of new printers, labels, and equipment has allowed the company to provide critical medical supplies to hospitals around with country in a safe and efficient manner. In addition, AB&R® committed to introducing this new process at other locations to ensure the company exceeds UDI requirements for Class I and II medical equipment.