Background: U.S. health care is responding to significant regulation and meaningful incentives for higher quality care, patient safety, electronic documentation and data exchange. FDA's Unique Device Identification (UDI) Rule, a relatively new regulation aligned with these goals, requires standard labeling of medical devices by manufacturers. This lays the foundation for UDI scanning and documentation in the electronic health record, expected to change the landscape of medical device identification and postmarket surveillance. Methods: We developed national projections for time, cost and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA) using American Association of Hip and Knee Surgeons 2012 membership survey data, Nationwide Inpatient Sample 2011 data and THA/TKA demand projection data. Results: Our projections suggest that cumulative surgeon time spent identifying failed implants could reach 133,000 h in 2030, representing opportunity to perform over 500,000 15 min established patient office visits. Staff time could reach 220,000 h with a cost of $3.3 m. Failed implants that cannot be identified may be greater than 50,000 preoperatively and 25,000 intraoperatively in 2030. Conclusion: Study projections indicate significant time, cost and inability to identify failed implants, supporting need for improvement of implant documentation. FDA's UDI Rule sets the foundation for UDI scanning and documentation in the electronic health record, a process poised to serve as the standard system for device documentation.
All Science Journal Classification (ASJC) codes
- Health Policy