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.
This project applies a new health policy initiative, the Food and Drug Administration (FDA) Proposed Unique Device Identification (UDI) System Rule, to the patient care setting. An automated barcode system in surgical services at Mayo Clinic Arizona will serve as a model of an implemented UDI system, allowing study of the impact of scanning implantable device barcodes in the operating room on quantitative and qualitative measures of patient safety, quality, efficiency and costs, thus providing an objective evaluation of implementation to inform other U.S. hospital systems. __SpecificAimsTextDelimiter__ SPECIFIC AIMS The goal of the proposed study is to provide an objective evaluation of the impact of implementation of an automated barcode system for medical devices on patient safety, quality, efficiency and cost. An automated barcode system in surgical services at Mayo Clinic Arizona (MCA) will serve as a natural experiment and model of an implemented unique device identification (UDI) system, allowing study of the impact of scanning implantable device barcodes on 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. Whereas the FDA UDI Rule will mandate manufacturers to label their marketed devices with UDI, there is not currently a mandate that requires UDI use in hospitals. 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. The expected broad value of UDI use which 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 has been discussed for quite some time in FDA workshops and professional conferences, yet empirical data is lacking. This project proposes to validate UDI use and integration into health information technology (HIT) thus giving health care providers incentive to implement a UDI system. This project is supportive of AHRQ portfolio goals, including HIT to support health or clinical documentation;identification of organizational practices that enhance efficiency;assessment of practices that are potentially scalable to other delivery systems;and analysis of health care management strategies to improve value. Specific Aim 1: Measure and document the impact of an automated barcode system for implant documentation in surgical services on quantitative measures of patient safety, efficiency and cost. We will conduct a retrospective before-and-after quasi-experimental study to compare nurse implant documentation time, error rates in clinical implant documentation and implant billing and operational costs associated with nurse time and billing errors, in a surgical specialty that transitioned to barcode scanning in the OR and a surgical specialty that did not transition to barcode scanning. Hypothesis 1: Implementation of the automated barcode system will reduce nurse implant documentation time, clinical implant documentation error rates, implant billing error rates, and operational costs associated with nurse time and billing errors. Specific Aim 2: Measure and document the qualitative impact of an automated barcode system for implant documentation in surgical services on orthopedic surgeons, nurses, and OR supply chain staff, including end users'job tasks and perceptions of patient safety, quality of care, error reduction, efficiency and cost. We will perform key informan interviews after the implementation to evaluate the transformation process and attempt to better understand how and why the intervention impacts the quantitative outcome measures measured in Specific Aim 1. Hypothesis 2: Implementation of the automated barcode system will lead to key informant perception of enhanced patient safety and quality of care, error reduction, staff efficiency, cost savings and better implant documentation.
