多酶清洗液清洁骨科植入器械后的内毒素测定

背景：大量研究表明多酶清洗液对骨科植入性医疗器械的清洗效果明显优于不加酶清洗，但是缺乏统一、简单、广泛被接受的清洗效果评价标准。多酶洗液中内毒素的定量检测有助于建立骨科植入性医疗器械清洁成功的微生物学评价标准，并在一定程度上反应多酶洗液清洗器械的效果，使多酶清洗液得到科学有效地应用。 目的：检测手工应用3M多酶清洗液清洁骨科植入器械后器械表面及多酶洗液中内毒素的含量，以评价骨科植入器械的清洗效果。 方法：随机抽取骨科植入性手术器械600件，用3M多酶清洗液进行分批次连续清洗，清洗前后分别采集器械表面及酶液中内毒素样本，采用鲎实验法，取8 EU/mL的内毒素标准品，稀释至不同的浓度的8个点，测其反应时间，建立标准曲线方程，根据方程计算样本的内毒素含量。 结果与结论：在多酶洗液最大有效清洗限度内，酶液中内毒素的含量不超过6.0 EU/mL。提示多酶洗液中内毒素的含量可以作为评价骨科植入器械清洗成功的可靠指标。

Endotoxin detection in multi-enzyme cleaner after cleaning implantation instruments of orthopedics

BACKGROUND: Plenty of studies have shown that 3M multi-enzyme cleaner to clean implantation instruments of orthopedics manually is better than that without multi-enzyme cleaner, but there is no widely accepted measures to judge success of cleaning implantation instruments of orthopedics. Endotoxin detection benefits establishing evaluation criteria of cleaning implantation instruments of orthopedics successfully, and reflecting the cleaning effect to a certain extent in order to effectively apply the multi-enzyme cleaner. OBJECTIVE: To detect endotoxin quantitatively in the surface of implantation instruments of orthopedics and the cleaner after using 3M multi-enzyme cleaner to clean implantation instruments of orthopedics manually, so as to evaluate the cleaning effect of implantation instruments of orthopedics. METHODS: A total of 600 implantation instruments of orthopedics were selected randomly and cleaned by 3M multi-enzyme cleaner. The samples of the surface of instruments (before and after clean medical instruments) and in multi-enzyme cleaner were collected. Using Ltoy Lalt method, 8 EU/mL endotoxin was obtained and diluted to eight different concentrations. The reaction time was measured, standard curve equation was established, and the endotoxin in the sample was quantified according to the equation. RESULTS AND CONCLUSION: In the maximum cleaning effectiveness of the multi-enzyme cleaner, the endotoxin content in the multi-enzyme cleaner was less than 6.0 EU/mL after cleaning. Results show that endotoxin quantification in the multi-enzyme cleaner can be used to judge success of cleaning implantation instruments of orthopedics.