DeJohn Paula
Mater Manag Health Care. 2009 Nov;18(11):14-7.
After much work and research, the Food and Drug Administration is preparing to publish a proposed rule for unique device identifier (UDI) standards for medical devices. The UDI would be used to identify a vast array of medical products and would streamline the hospital supply chain while improving patient safety. For instance, having a UDI in place would assist product recall efforts. But getting hospital supply chain leaders, manufacturers, group purchasing organizations and others to embrace UDI standards won't be easy. Here's a look at what's ahead.
经过大量工作和研究,美国食品药品监督管理局正准备发布一项关于医疗器械唯一设备标识符(UDI)标准的拟议规则。UDI将用于识别大量医疗产品,并在提高患者安全性的同时简化医院供应链。例如,实施UDI将有助于产品召回工作。但要让医院供应链负责人、制造商、集团采购组织及其他各方接受UDI标准并非易事。以下是未来的情况。