Department of Supply Chain Management, WP Carey School of Business, Arizona State University, Tempe, Arizona.
School of Human Evolution and Social Change, Arizona State University, Tempe, Arizona.
J Arthroplasty. 2014 Feb;29(2):251-5. doi: 10.1016/j.arth.2013.06.027. Epub 2013 Jul 25.
FDA's Unique Device Identification (UDI) Rule will mandate manufacturers to assign unique identifiers to their marketed devices. UDI use is expected to improve implant documentation and identification. A 2012 American Association of Hip and Knee Surgeons membership survey explored revision total hip and knee arthroplasty implant identification processes. 87% of surgeons reported regularly using at least 3 methods to identify failed implants pre-operatively. Median surgeon identification time was 20 min; median staff time was 30 min. 10% of implants could not be identified pre-operatively. 2% could not be identified intra-operatively. UDI in TJA registry and UDI in EMR were indicated practices to best support implant identification and save time. FDA's UDI rule sets the foundation for UDI use in patient care settings as standard practice for implant documentation.
美国食品和药物管理局(FDA)的独特器械标识(UDI)规则将要求制造商为其上市的器械分配独特的标识符。UDI 的使用有望改善植入物的文档记录和识别。2012 年,美国髋关节和膝关节外科医师协会(American Association of Hip and Knee Surgeons)的一项会员调查探讨了翻修全髋关节和膝关节置换术植入物的识别流程。87%的外科医生报告说,他们经常使用至少 3 种方法在术前识别失败的植入物。外科医生的中位识别时间为 20 分钟;员工的中位识别时间为 30 分钟。10%的植入物无法在术前识别。2%的植入物无法在术中识别。TJA 注册中的 UDI 和 EMR 中的 UDI 是支持植入物识别和节省时间的最佳实践。FDA 的 UDI 规则为在患者护理环境中使用 UDI 作为植入物文档记录的标准实践奠定了基础。