Impact of Barcode Scanning using Unique Device Identification in Orthopedic Surge

Arizona State University-Tempe Campus, Tempe AZ

Investigators

Abstract

DESCRIPTION (provided by applicant): Impact of Barcode Scanning in Orthopedic Surgery 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 Food and Drug Administration (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, which requires UDI use in hospitals, and many hospitals are seeking information to determine if they should ready their systems for UDI use to support patient safety and efficiencies in advance of hospital-directed regulation or meaningful incentive. This project investigates this issue in surgical services at Mayo Clinic Arizona, where an automated barcode system will serve as a natural experiment and model to study the impact of an implemented UDI system. Nurse implant documentation time, clinical implant documentation error, implant billing error, operational costs associated with nurse time and billing errors and impact on orthopedic surgeons, nurses and OR supply chain staff will be assessed before and after implementation of an automated barcode system for medical devices. There is currently no standard across U.S. health care for documentation of medical devices. Despite increasing use of health information technology (HIT) systems, hospitals may still be using manual processes, non-standard numbers, descriptive information, paper or electronic records and diverse HIT systems with poor interfacing capabilities for documentation of device identifying information, with resultant impact on patient safety, quality, clinical and operational efficiency and cost. Expected value from UDI use and integration into HIT systems includes a standard for device documentation, more comprehensive device recall management, enhanced post-market surveillance, efficiency and cost savings in clinical, supply chain and billing processes. Achieving this value will require tha hospital systems address process and IT needs in order to capture UDI electronically. This project proposes to validate the use of UDI and integration into HIT systems, thus giving health care providers incentive to address these technology needs and implement a UDI system.