單次使用醫療器材再處理之感染管制

Infection control in reusing single-use devices

醫療器材（medical device）產品在診斷與治療上帶來莫大助益，但因單次使用醫療器材（single-use devices, SUD）價格大多昂貴加上保險費用給付問題，在有限的資源下，對單次使用醫療器材經再處理後的使用也許是未來的趨勢。不過當單次使用醫療器材若無法進行徹底消毒，加上醫療器材進行重新處理後可能會改變其特性，損害醫材本身的性能，使其不再符合原始製造商的規格，這種做法有可能會給病人帶來風險傷害。所以本篇參考國內外文獻針對單次使用醫療器材的再處理，如醫材風險評估、醫材標籤、監控、管理、教育、倫理和法律影響等感染管制措施進行介紹。

Medical devices provide significant benefits to medical diagnosis and treatment. However, owing to the surmounting expenses from the use of single-use devices (SUDs) and the limitations of insurance claims, these devices may undergo instrumentation reprocessing and sterilization for repeated use. Such practice may cause a high risk to patients. Henceforth, this leads to the risk of incomplete disinfection or changes to certain specifications and properties of medical devices during the reprocessing, which might not meet manufacturers' quality standards. Owing to the increasing cost, limited resources, and urge for economic efficiency, repeated consumption of single-use devices becomes an unavoidable trend in the future medical environment. The corresponding consequences of repeated disinfection and infection control would become predictable. This article presents measures of infection control for repeated consumption of single-use medical devices, which include risk assessment, labeling management, quality control, operational management, education, moral ethics, and law enforcement. Despite the mutual agreement toward the cost-benefits brought by repeated consumption of medical devices, the overall impact over its effectiveness, safety, and quality issues has to be considered to ensure the overall safety of patients. In view of this, our goal is to ensure the security of repeated use of medical devices, monitor their status, track the number of repeated use, conduct internal staff training, and gather acknowledgements of patients and targeted users.