Purpose

The common practice of short-cycle sterilization for ophthalmic surgical instrumentation has come under increased regulatory scrutiny. This study was undertaken to evaluate the efficacy of short-cycle sterilization processing for consecutive same-day cataract procedures.

Design

Testing of specific sterilization processing methods by an independent medical device validation testing laboratory.

Participants

Phaco handpieces from 3 separate manufacturers were tested along with appropriate biologic indicators and controls using 2 common steam sterilizers.

Methods

A STATIM 2000 sterilizer (SciCan, Canonsburg, PA) with the STATIM metal cassette, and an AMSCO Century V116 pre-vacuum sterilizer (STERIS, Mentor, OH) using a Case Medical SteriTite container (Case Medical, South Hackensack, NJ) rigid container were tested using phaco tips and handpieces from 3 different manufacturers. Biological indicators were inoculated with highly resistant Geobacillus stearothermophilus, and each sterility verification test was performed in triplicate. Both wrapped and contained loads were tested with full dry cycles and a 7-day storage time to simulate prolonged storage. In adherence with the manufacturers’ instructions for use (IFU), short cycles (3.0–3.5-minute exposure times) for unwrapped and contained loads were also tested after only 1 minute of dry time to simulate use on a consecutive case. Additional studies were performed to demonstrate whether any moisture present in the load containing phaco handpieces postprocessing was sterile and would affect the sterility of the contents after a 3-minute transit/storage time. This approximated the upper limit of time needed to transfer a containment device to the operating room.

Main Outcome Measures

Presence or absence of microbial growth from cultured test samples.

Results

All inoculated test samples from both sterilizers were negative for growth of the target organism whether the full dry phase was interrupted or not. Pipetted postprocessing moisture samples and swabs of the handpieces were also negative for growth after a 3-minute transit/storage time.

Conclusions

These studies support the use of unwrapped, short-cycle sterilization that adheres to the IFU of these 2 popular Food and Drug Administration–cleared sterilizers for sequential same-day cataract surgeries. A full drying phase is not necessary when the instruments are kept within the covered sterilizer containment device for prompt use on a sequential case.

中文翻译：

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序贯当日使用短周期灭菌法评估眼科手术器械的无菌性

目的

眼科手术器械的短周期灭菌的常规做法已受到越来越严格的法规审查。进行这项研究以评估短周期灭菌处理对于连续的同一天白内障手术的功效。

设计

由独立的医疗设备验证测试实验室测试特定的灭菌处理方法。

参加者

使用2个常见的蒸汽消毒器对来自3个不同制造商的Phaco手机进行了测试，并提供了适当的生物指示剂和控件。

方法

装有STATIM金属盒的STATIM 2000灭菌器（SciCan，Canonsburg，PA），以及使用Case Medical SteriTite容器（Case Medical，South Hackensack，NJ）的刚性容器的AMSCO Century V116预真空灭菌器（STERIS，Mentor，OH）使用来自3个不同制造商的phaco笔尖和手机进行了测试。用高抗性嗜热脂肪芽孢杆菌接种生物指示剂，每个无菌验证测试均进行三次。包裹的货物和包含的货物均经过完整的干燥循环和7天的存储时间测试，以模拟长时间存储。为了遵守制造商的使用说明（IFU），仅在干燥时间1分钟后就测试了未包装和容纳的负载的短周期（3.0-3.5分钟的暴露时间），以模拟连续使用的情况。进行了进一步的研究，以证明含有phaco机头的荷重在后处理过程中是否存在任何水分是否无菌，并且会在3分钟的运输/存储时间后影响内容物的无菌性。这近似于将密闭装置转移到手术室所需的时间上限。

主要观察指标

培养的测试样品中是否存在微生物生长。

结果

无论完全干燥阶段是否中断，从两个灭菌器中接种的所有测试样品均对目标生物的生长呈阴性。经过3分钟的运输/存储时间后，用移液器吸取的后处理水分样品和机头棉签也不利于生长。

结论

这些研究支持使用开卷的，短周期的灭菌方法，该方法应遵循连续两天的白内障手术中由美国食品和药物管理局批准的这两种流行的经过消毒的灭菌器的IFU。当器械被放置在有盖的灭菌器容纳设备中以便在连续使用的情况下迅速使用时，就不需要完全干燥阶段。