Bertrand E, Schlatter J
University Hospital of Ambroise Paré, Boulogne-Billancourt, France.
Pharmazie. 2010 Jan;65(1):64-8.
Ancillaries are surgical instruments, such as orthopedical instruments set for reconstruction of knee (a mounting arm...) used to implant or extract prosthesis. Their management involves the departments of sterilization and surgery as well as the suppliers. Such a long circuit exposes the instruments to potential risk hazards like a lack of traceability as the suspicion of Creutzfeldt-Jakob. In order to reduce the risk of errors we will propose the implementation of radio-frequency identification (RFID) to trace the ancillaries during each step of the supply chain. The objective of our study is to analyze and to map the risks associated with RFID implementation. A preliminary analysis of risks (APR) is conducted to map out the hazards for the implementation of RFID. The APR identifies 162 scenarios with a maximum risk connected to environment and technology. To reduce the risks identified, 22 courses of action are proposed, such as audits, training, and internal controls. For each action, a procedure has been designed and evaluated. This preliminary analysis of risks allows targeting the potential dangers for the RFID implementation applied to ancillaries and reduces them significantly.
辅助器械是外科手术器械，例如用于膝关节重建的骨科器械套装（安装臂……），用于植入或取出假体。其管理涉及消毒和外科部门以及供应商。如此长的流程使器械面临潜在风险危害，如缺乏可追溯性，就像克雅氏病的疑似情况。为了降低错误风险，我们将提议实施射频识别（RFID）技术，以便在供应链的每个环节追踪辅助器械。我们研究的目的是分析并描绘与实施RFID相关的风险。进行了风险初步分析（APR）以确定实施RFID的危害。APR识别出162种场景，其中最大风险与环境和技术相关。为降低已识别出的风险，提出了22项行动方案，如审计、培训和内部控制。针对每项行动，都设计并评估了相应程序。这种风险初步分析能够确定应用于辅助器械的RFID实施过程中的潜在危险，并显著降低这些危险。
