運用醫療失效模式與效應分析於器械清潔、包裝與滅菌之確效探討：以供應中心與手術室工作室為例

Using Healthcare Failure Mode and Effect Analysis to the Investigation of Instrument Clean Packaging Sterilization

病人安全是醫療品質的根本，對於健康照護過程中的所可能產生的風險，應採取預防措施。而供應中心肩負醫院無菌用品提供核心單位之責，當器械要再次使用，需要進行清潔、包裝與滅菌等等近上百道複雜步驟程序，醫療持續精進而器械更多元與精密化的演進更加重了器械再處理的困難若再處理過程中發生瑕疵，使病人於手術中使用受到生物汙染的器械，則會增加病人發生感染的風險；病人一旦發生感染不僅會增加疾病嚴重度、住院天數更會增加死亡率的風險，些微的疏忽不僅影響病人及工作人員的安全，更可能引發醫療糾紛，除了造成醫院財物的損失之外，更會重創醫院的形象。因此，運用醫療失效模式與效應分析 (HFMEA) 為預防性工具，透過風險優先指數 (RPN) 大於 8分及決策樹分析的關鍵弱點，評估出流程潛在失效原因，發現潛在失效原因與教育訓練不足、未依標準作業流程執行業務及未執行監督查核有關。在對策實行後風險優先指數由 96 降為 44 分，確實優化器械清潔、包裝與滅菌流程，並提升工作同仁作業成效與品質，進而確保醫療服務品質，達成守護病人安全權益之目標。

Patient safety is the foundation of medical quality, and preventive measures should be taken for possible risks in healthcare. Supply centers are responsible for providing sterile supplies to hospitals. Reusable equipment must undergo nearly a hundred complex steps, including cleaning, packaging, and sterilization. Improving medical treatment and diversifying sophisticated equipment are crucial. Errors during reprocessing that result in the use of biologically contaminated equipment increase patients’ risk of infection, which can not only increase the severity of a disease but also the number of days of hospitalization. Even slight negligence can increase the risk of mortality, affect the safety of patients and staff, and result in medical disputes. In addition, it can cause the loss of hospital property and severely damage a hospital’s reputation. The Healthcare Failure Mode and Effect Analysis is a preventive tool based on the risk priority index that can be used to identify key weaknesses through decision tree analysis and to evaluate potential causes of failure, insufficiencies related to education and training, noncompliance with standard operating procedures, and instances of failure to perform supervision and inspection. After countermeasures were implemented, the risk priority index decreased from 96 to 44 points, indicating improvements in the equipment cleaning, packaging, and sterilization processes and an increase in employees’ efficiency, thereby ensuring the quality of medical services and protecting the safety and rights of the patients.