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For many years, textiles such as muslin wraps were popular packaging materials. Some of these products provided relatively poor barriers to microbial contamination. Early studies conservatively suggested that a thirtyday shelf-life standard was at the limit of sterility assurance. The idea that shelf-life could be designated by a specific expiration date which set a limit on the number of days an item was safe for use, however, was being questioned by at least the mid-1980s. For example, the Central Service Technical Manual (published by the International Association of Healthcare Central Service Materiel Management) which was then in use discussed shelf-life procedures relative to the period of time that sterility was generally implied to be maintained. However, the Technical Manual went on to state that “shelf life considerations create more misconceptions, confusion, and misleading information than any other one facet of the preparation and use of sterilized products.”
多年以来，布类一直作为包装材料，但部分布类对于微生物的污染屏障作用有限，早期的研究将无菌包的有效期建议为30天，这种观点认为设定一个到期的时间天数，物品在这个天数之内可以安全被使用。然而，这种理论在80年代中期受到质疑， 比如，在当时出版的《中心供应室技术手册 Central Service Technical Manual》 (由国际医疗无菌物品供应管理协会印刷International Association of Healthcare Central Service Materiel Management) 中讨论了无菌物品维持无菌状态的时间，同时进一步指出“有效期相对于无菌物品的其他准备情况和使用因素，会导致概念错误、误解和误导性的信息”。
Modern technology has yielded packaging materials that create very effective barriers to microbial contamination. These help keep package contents sterile for very long time periods (almost indefinitely). This has eliminated the historic reason that timerelated shelf-life standards were required. The increased use of event-related shelflife standards has also occurred, in part, because Central Service staff have observed the use of this method by industry in its pre-packaged products.
(Note: Hospitals cannot duplicate industry workplace conditions; also, expiration dates in hospital settings are placed on individual items not on boxes of items.
The concept of event-related standards, however, has been strengthened by its use in industry.)
现代科技的应用使得包装材料形成了有效的生物屏障，这有助于包内物品保持相当长时间的无菌状态（几乎无限期），所以客观上消除了由于历史原因形成的与时间有关的有效期概念，与事件有关的有效期产生（部分原因也是因为供应室的工作人员观察到工业生产上对于预包装产品上这种方法的使用）。
(备注：医院没有工业生产中的条件，在医院中的有效期标注在单个的产品上，非整箱的产品。与事件有关的标准在工业上使用广泛。)
Along with packaging improvements, changes in policies and procedures– resulting from an increased emphasis on quality and on-going educational programs stressing proper storage environments, proper handling, and stock rotation–enable a conversion to eventrelated shelf-life. Studies by the Centers for Disease Control and others show that properly packaged, correctly stored, and effectively handled items will remain sterile for a significant length of time beyond what has historically been assumed. Without these controls, indefinite shelf-life is impossible.
随着包装技术的提高，在政策和程序上的改变，导致强调在质量、适合的储存环境、正确地处理以及储存循环上确保了事件相关有效期的发展。疾控中心研究表明正确地打包、适当地储存、有效地处理可以显著地提高无菌物品的保持时间。没有这些控制，长时间的保存是不可能的。
In summary, time is normally not a significant variable affecting shelf-life.
Rather, handling, sterilization processes, and storage environments are among the
most critical factors affecting the continued sterilization of package contents.
总之，时间通常情况下不是一个显著影响有效期的因素，相反，处理过程、灭菌过程、储存环境是无菌物品保持无菌状态的关键因素。
Packages that are stored in either the time or event-related system must be dated.
Stock rotation concerns must be addressed; packages in storage the longest should be used first. Regardless of the system in use, it is important that staff be trained to properly handle sterile packages.
不论使用时间相关还是事件相关的系统，无菌包必须标明日期，必须强调存货周转，储存时间长的物品应该首先使用。不管使用那种系统，人员必须培训如何正确地处理无菌物品。
Packages are sometimes required to contain expiration dates. Examples include those which contain products such as rubber which may degrade, and other packages containing date-specific medication. A significant problem with time-related standards has already been noted: packages can be contaminated even if the maximum time-related shelf life has not been reached. Also, unnecessary rework occurs when products are unnecessarily reprocessed. The need to handle sterile packages to check dates (which itself can contaminate packages if they are mishandled), along with additional “wear and tear” on medical devices from unnecessary reprocessing, are additional disadvantages to the use of a time-related shelf-life standard.
有时，无菌包需要包含失效期，比如那些包含橡胶制品（时间长发生老化）的物品以及包含有时间限制的器械。应用时间相关的标准，一个显著的问题的是尽管有效期没有达到，但包裹已经被污染；或者，在包裹没有受到污染即仍在无菌状态时却因为有效期的到达而重新被灭菌。其他的缺点是，需要检查包裹的日期（处理不当会污染物品），在重新灭菌时对器械造成的损伤。
With either shelf-life system, it is important that staff be properly trained to handle sterile products.
不管使用哪一种有效期系统，非常重要的一点是人员受到正确培训。
While the primary advantage to using event-related shelf-life is the elimination of re-work, labor and material costs are also reduced as products no longer require monthly sterilization. Disadvantages of an event-related shelf-life standard can include a higher probability of contaminated packages if the staff are not consistently aware of proper handling and storage procedures. Also, the staff may be less likely to rotate packages and to closely examine the packages prior to use.
使用事件相关的有效期标准，首要的优点是减少了重复工作、减少劳动力和材料的损耗，缺点是如果工作人员不注意正确地处理和储存程序，则非常容易受到污染，而且工作人员可能很少在使用之前检查库存。
Implementation of policies requiring rotation and effective training of staff can help address these possible disadvantages.
实行库存控制政策并有效地培训工作人员，可以克服以上缺点。
All personnel who handle sterile products at any point from the warehouse to patient
bedside must know and consistently use proper handling techniques.
在任何场所处理无菌物品的人员必须知道而且使用正确地处理技术。
Currently, there are no organizations recommending time-related shelf-life. By contrast, the Association for the Advancement of Medical Instrumentation (AAMI) has stated that “the shelf-life of a packaged sterile item is event-related and depends on the quality of the wrapper material, the storage conditions, the conditions during transport, and the amount of handling.” Further, the Association of Operating Room Nurses (AORN) also states: “The shelf-life of a packaged sterile item is event-related.” It goes on to indicate that an event must occur for the sterility of the packaged contents to be compromised. Examples of these events include multiple handlings leading to seal breakage or loss of package integrity, moisture penetration and airborne contaminants. Finally, the Joint Commission on Accreditation of
Healthcare Organization (JCAHO) notes that “written policies for addressing the
shelf-life of all stored sterile items” are required. This position does appear neutral
relative to the AAMI and AORN statements. However, JCAHO has moved away from an earlier standard which stated that shelf-life liability for hospital wrapped
and sterilized medical items should be designated with a specific expiration date setting a limit on the number of days an item would be considered safe for use.
当前，没有任何组织推荐使用时间相关的保存期，相反，医疗器械促进协会 Association for the Advancement of Medical Instrumentation (AAMI)指出：“无菌包的储存期限与事件相关，取决于包装材料的质量、储存条件、运输条件和处理环节”，手术室护士协会Association of Operating Room Nurses (AORN) 也指出：“无菌包的储存期限与事件相关”，它接着指出，无菌包内物品在失效之前必然经过某种事件，如中转过程中的密封受损、包装破损、湿气穿入和微粒污染等。医疗机构促进协会Joint Commission on Accreditation of Healthcare Organization (JCAHO) 指出“需要‘表明所有储存的无菌物品有效期限的书面政策’” ，这种说法相对于AAMI和AORN显得中性，但这个条款是JCAHO对于以前要求所有的无菌物品需要指名一个明确的有效期条款的修改。 |
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