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This project applies a new health care regulation on unique device identification (UDI) to the patient care setting and has high potential to inform U.S. health care.It will investigate the use of UDI technology in surgical services at Mayo Clinic Arizona, where an automated barcode system will serve as a model for an implemented UDI system.
This project applies a new health care regulation on unique device identification (UDI) to the patient care setting and has high potential to inform U.S. health care in the areas of patient safety, enhanced quality, efficiency and lowered costs. Release of the final FDA UDI Rule is pending. Manufacturers of medical devices will be mandated to label their marketed medical devices with UDI, a unique number reflecting manufacturer, make, model and lot number/serial number/expiration date similar to UPC in retail. There is no current mandate, however, to require use of UDI, and many hospitals are seeking information to determine if they should ready their systems for UDI use in advance of hospital-directed regulation or meaningful incentive.
Achieving full expected value of UDI, which is supportive of patient safety and enhanced quality and includes standard device documentation, more comprehensive device recall management, enhanced post-market surveillance, efficiency and cost savings in clinical, supply chain and billing processes, requires that hospital systems address process and information technology needs in order to capture UDI electronically. There is currently no standard across U.S. health care for documentation of medical devices. Despite increasing use of health information technology, hospitals may still be using manual processes, non-standard numbers, descriptive information, paper or electronic records and diverse IT systems with poor interfacing capabilities for documentation of device identifying information, with resultant impact on patient safety, quality, clinical and operational efficiency and cost.
This project investigates this issue in surgical services at Mayo Clinic Arizona, where an automated barcode system will serve as a model for an implemented UDI system. Nursing implant documentation time, clinical implant documentation error, implant billing error, operational costs associated with nursing time and billing errors and impact on physicians, nurses and OR supply chain staff in orthopedic surgery will be assessed before and after implementation of an automated barcode system for medical devices.