Project Summary/Abstract: Impact of Barcode Scanning using Unique Device Identification 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 enhanced quality, efficiency and lowered costs. The FDA released its proposed UDI Rule in July of 2012. Manufacturers of medical devices will be mandated to label medical devices with UDI, a unique number reflecting manufacturer, model and lot/serial number similar to UPC in retail. Achieving full potential value of UDI, which includes standard documentation and efficiency in clinical, supply chain and billing processes, enhanced recall management and post-market surveillance, requires that health care systems address process and information technology (IT) needs in order to capture UDI. There is currently no standard across U.S. health care for documentation of medical devices. Hospitals may use manual processes, proprietary numbers and diverse IT systems with poor connectivity, resulting in inefficiency, error and time taken away from clinical care. This project investigates this issue in surgical services at Mayo Clinic Arizona, with a focus on orthopedic surgery. Time taken by the nurse for documentation of implants in the operating room (OR), OR turn around time, error in clinical documentation, rate of billing error, and operational costs will be assessed before and after implementation of a barcode system and scanning technology for medical devices. More detailed measures of staff satisfaction, impact on workflow and patient care will also be assessed after the intervention. Project outcomes and assessment should provide data supporting the clinical and business reasons for hospital adoption and implementation of UDI and serve as a model for U.S. hospital systems to develop an automated process for capture of UDI in surgical services.
|Effective start/end date||4/1/14 → 3/31/16|
- HHS: Agency for Healthcare Research and Quality (AHRQ): $97,983.00