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发表于 2012-5-31 00:36:16
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What is role of the Class 6 indicator?
OR Manager Vol.25 No.4 April 2009
With a new type of sterilization monitor, the Class 6 emulating indicator, on the market, managers are asking how the new device fits into their sterilization quality assurance programs. Two companies recently had Class 6 indicators cleared by the Food and Drug Administration for sale in the US: Steris Corp of Mentor, Ohio (Verify SixCess brand), and Steritec Products of Castle Rock, Colorado (Emugraph brand).
面对市场上出现的一种新的灭菌监测产品，即第六类模拟指示物，管理者们想要知道如何去适应新的灭菌质量确认体系。最近有两家公司的第六类指示物被FDA批准在美国销售，分别是Sterisd的Verify SixCess brand和Stecritec的Emugraph brand。
Managers will need to be armed with knowledge to sort out the new information and differing opinions.
管理者需要用新的知识来武装一下自己，理清新的信息和不同的意见。
A different approach
Class 6 indicators use a different approach than biological indicators (BIs), which have been used for years in sterilization monitoring. BIs are defined as having a known number of microorganisms with known resistance to the sterilization process. BIs need to be incubated to verify that all of the microorganisms have been killed.
第六类指示物使用了和已经在灭菌监测中运用多年的生物指示物不同的方法。生物指示物被定义为对灭菌过程已知数量的微生物和已知的抗力。生物指示物需要进行培养来确认所有的微生物被灭杀。
In contrast, Class 6 indicators use a chemical ink formulated to change abruptly when the indicator reaches the “stated value(s)” for that sterilization cycle. The “stated values” correspond to critical variables the sterilizer manufacturer has defined for the sterilization process.
相对的，第六类指示物使用化学墨水的突变明确表示灭菌循环中指示物到达“状态值”。“状态值”应当符合灭菌厂商对于灭菌过程中定义的关键参数。
A Class 6 indicator, for example, can be set to have a stated value of 4 minutes at 270° F (132° C), the standard dynamic air removal steam sterilization cycle, notes Lon Bruso, vice president of Steritec Products. Thus, when this Class 6 indicator shows a pass result, it means the indicator was exposed to conditions that met those parameters.
Seeritec 的副主席Lon Bruso说，举个例子，第六类指示物，能够设定一个蒸汽灭菌循环空气移除的典型状态，即4分钟/132℃的状态值。因此当第六类指示物显示结果为通过的话，意味着指示物被暴露在达到了这些参数的条件下。
Whether that is equivalent to a sterility assurance level (SAL) of 10-6 is a question. By definition, an SAL is based on the chance that a given number of microorganisms will remain viable after being subjected to a sterilization process. Chemical indicators do not contain microorganisms.
不论哪种对无菌保障水平（SAL）10-6来说都是一个问题。从定义看，SAL是基于给定一个数量的微生物在灭菌过程后还剩余多少的可能性上。而化学指示物不含有微生物。
In another difference, Class 6 indicators are designed and validated for specific sterilization cycles. In general, a different Class 6 indicator is needed for each type of cycle to be monitored. This also means Class 6 indicators can be designed to monitor the longer times needed for extended cycles, which have become more common with large, complex instrument sets. Stocking a larger number of indicators might be a challenge for managers because staff would have to be educated about the need to match the right indicator with the right cycle.
另一个不同，第六类指示物是为特殊灭菌循环设计和验证的。一般而言，一个不同的第六类指示物需要对不同类型的循环监测。这也意味着第六类指示物能够被设计来监测针对越来越多越来越常见的复杂外科器械的更长时间的延长循环。因为员工们需要学习为正确的循环配备正确的指示物，或许采购指示物，对管理者来说是一个巨大的挑战。
Class 5 and Class 6 indicators
How do Class 6 indicators differ from Class 5 chemical indicators (CIs), which have been on the market for some time?
那么，面世已经有段时间的第六类指示物和第五类指示物有什么区别呢？
Both are covered in the Association for the Advancement of Medical Instrumentation (AAMI) manufacturer standard for chemical indicators (ANSI/AAMI/ISO 11140-1:2005). The standard defines classes of indicators and performance requirements and/or test methods for CIs.
它们都被包括进了ANSI/AAMI/ISO 11140-1:2005化学指示物标准中。该标准定义了化学指示物分类的性能要求和测试方法。
Under the standard, the response of Class 5 CIs is required to correlate to a BI at 3 times and temperatures. The response of Class 6 indicators is not required to correlate to a BI. That is an advantage or a disadvantage, depending on your point of view.
在标准中，第五类化学指示物的应答需要对应生物指示物的3个时间点和温度。第六类指示物的应答不需要对应生物指示物。这个到底是优势还是劣势取决于你的观点。
Steris says Class 6 indicators have an advantage, giving the example of a 270° F sterilization cycle, which has several variations: 3 minutes for metal or nonporous items (no lumens) in a flash sterilization cycle, 4 minutes for wrapped items in a prevacuum cycle, 10 minutes for metal items with lumens in a flash gravity cycle, and 15 minutes for a wrapped item in a gravity cycle. A Class 5 indicator, which is timed to match a BI, can indicate that 2 minutes of steam have been delivered but can’t indicate that for 3, 4, 10, or 15 minutes. A Class 6 indicator could be matched to each cycle.
Steris 说，第六类指示物有优势。例如在132℃灭菌循环中有好几个不同：3分钟的金属或无孔物（非管腔）快速灭菌循环，4分钟的有包装物品预真空循环，10分钟的金属管腔快速重力循环，和15分钟的无孔物重力循环。一个时间对应生物指示物的第五类的指示物，能够指示2分钟的蒸汽覆盖循环，但不能指示3、4、10或者15分钟的循环。而第六类指示物却能够匹配所有的循环。
On the other hand, 3M, which sells BIs and Class 5 indicators, maintains that Class 5 indicators have an advantage because, in mimicking BIs, they can detect types of sterilization process failures, such as air-steam mixtures and inadequate air removal, not detected by physical monitors or other types of CIs, including the Class 6.
而另一方面，销售生物指示物和第五类指示物的3M，主张第五类指示物有优势。因为它们是在模拟生物指示物，他们可以监测灭菌过程失败的原因，如：空气蒸汽混合和不充分的空气排除，而这些不能通过物理监测或包括第六类在内的其他类型化学指示物监测到。
3M refers to AAMI’s steam sterilization standard for health care facilities (ANSI/AAMI ST79:2006 and A1:2008), which states, “Biological monitoring provides the only direct measure of the lethality of a sterilization cycle.” Martha Young, MS, CSPT, senior technical service specialist for 3M adds: “Neither Class 5 nor Class 6 CIs contain spores and thus do not directly measure the lethality of a sterilization process.”
3M参考了AAMI关于健康保健设备的蒸汽灭菌标准（ANSI/AAMI ST79:2006 and A1:2008)）中的陈述，“生物监测提供了灭菌循环的灭杀效果的直接评价”。高级技术服务专员Martha Young还说：“无论是第五类还是第六类指示物都不含有芽孢，因此都不能直接评价灭菌程序的灭杀效果。”
She adds: “Both sterilizer manufacturers and medical device manufacturers use BIs to validate their sterilizers and devices to ensure there is sufficient lethality to produce the desired sterility assurance level (SAL) for the device, typically 10-6. CIs cannot be used to determine the SAL.”
她补充到：“所有的灭菌提供商和医疗设备厂商都使用生物指示物来验证他们的灭菌器和设备，确保产品有足够的灭杀结果，从而达到这个设备的无菌保障水平10-6。而化学指示物不能用来判定灭菌保障水平。
Role in sterilization monitoring?
What role would Class 6 indicators play in current sterilization monitoring? Professional guidelines do not yet address this question, and opinions differ.
第六类指示物在当前灭菌检测里面又扮演了什么样的角色呢？专业准则也尚未解决这个问题，观点仍有分歧。
Bruso of Steritec Products says Class 6 indicators can monitor that the sterilization process met conditions beyond the 2 minutes where BIs are typically killed, as in the full 4-minute 270° F steam cycle.
Steritec的Bruso说在4分钟132℃的灭菌循环中，第六类指示物能够监测超过生物指示物被完全杀灭的2分钟这个时间点以后的条件。
But Chuck Hughes of SPS Medical, an independent lab that conducts validation testing for sterilizer and medical device manufacturers, questions whether that higher degree of resistance means a Class 6 indicator is better than a BI. SPS Medical also makes BIs and Class 5 indicators.
但是一个给灭菌器和医疗设备生产商做验证测试的独立实验室，SPS Medical的Chuck Hughes提出，如果第六类指示物有着更高的抗力程度，是否意味着比生物指示物更好？SPS Medical也生产生物指示物和第五类指示物。
“I would throw out the question: ‘Do we need something more resistant than the BI or Class 5 indicators, which are cleared by the FDA as equal to a BI?’” Hughes says.
“我必须指出：我们真的需要被FDA批准一个等同生物指示物，某些抗力比生物指示物和第五类更强的（第六类指示物）?”Hughes说道。
He notes that 1 to 2 minutes of saturated steam is what is needed to kill the most resistant microorganisms, as presented by a BI. He says the 4 minute cycle actually is 100% overkill beyond what is needed to kill a BI, which is a requirement of the FDA.
他指出，1-2分钟是饱和蒸汽灭杀生物指示物所提供的最顽固的微生物需要的时间。他说，那么4分钟的循环实际上就能够100%过度灭杀生物指示物，这也FDA的必要条件。
“There is no question that you can make a chemical indicator more difficult to pass than a biological indicator,” Hughes says. “But is more resistant better?” He adds, “The only value I see in that is in monitoring a prion cycle,” which is an extended cycle of 18 minutes at 270° F in a prevacuum sterilizer. Currently, indicators are not available in the US for prion cycles.
“毫无疑问，你可以制造一个化学指示物的通过难度大于生物指示物，但多难才是好呢？”Hughes说。“我认为仅在监测朊病毒循环中才有这个意义”。朊病毒循环是一个132℃/18分钟的延长循环。当前美国也没有对朊病毒循环的监测。
He maintains that users looking for the convenience of a CI that is as accurate as a BI but that does not require incubation can use Class 5 indicators, as recommended by AORN and AAMI ST79.
他支持用户找到一种同生物指示物一样准确反应的但是又不需要进行培养的，AORN和AAMIST79推荐的第五类化学指示物。
Monitoring extended cycles
An area where Class 6 indicators might be helpful is for monitoring sterilization cycles, such as extended cycles of 8 minutes or 20 minutes at 270°F.
或许第六类指示物对于监测这样一类的灭菌循环是有益的，如：132℃的8分钟或者20分钟的延长循环。
“It would be nice to have a Class 6 indicator that is cycle specific for some of these extended cycles,” says Cynthia Spry, RN, MSN, CNOR, an independent consultant.
Cynthia Spry，一位独立顾问。她说“第六类指示物似乎对一些特殊延长循环很好。”
A drawback is that extended cycles have not been standardized. Under FDA rules, indicators can be released only for currently validated cycle parameters. These are not necessarily the same as some of the manufacturers’ extended cycles.
延长循环的一个缺点就是不能标准化。FDA的规定中，化学指示物当前经过验证的周期。同制造商的延长循环一样，这些不是必需的。
Manufacturers have been working with the FDA to resolve this issue. AAMI has a new technical information report that addresses extended cycles titled Process Challenge Devices/Test Packs for Use in HealthCare Facilities (TIR31). The report requests that manufacturers standardize their cycles, which would allow indicators to be developed for those cycles.
制造商们试图同FDA一起解决这个问题。AAMI有一个题目是“延长循环的医疗保健设备的过程挑战装置/测试包” 新的技术信息报告，
“Class 6 emulating indicators lend themselves perfectly to extended cycles,” says Richard Schule, MBA, FCS, FAST, director of clinical education for Steris. “The goal of extended cycles is to lengthen the exposure of complex sets or devices, allowing every surface to contact steam.” He said a Class 6 indicator can demonstrate that the sterilizer achieved these conditions, adding that Class 6 indicators are the “only indicators capable of targeting the specific exposure time requirements for extended cycles.”
“第六类模拟指示物自身对延长循环是完美的，”Steris的临床教育总监Richard Schule说“延长循环的目的是延长复杂器械或设备的暴露时间，使所有的表面接触蒸汽。”他还说到，第六类指示物能够证明灭菌器能够达到这些条件，第六类指示物是“”
Hughes says he does not think Class 6 indicators are necessary for monitoring extended cycles. The issue, he says, is making sure the BIs and Class 5 indicators are in the right locations in the tray; that is, where the steam is least likely to penetrate. The purpose is to verify that all of the tray’s nooks and crannies are exposed to 2 minutes of saturated steam.
Hughes不认为第六类指示物是监测延长循环所必需的。他提出，确保生物指示物和第五类指示物放置在灭菌容器中正确的位置，即蒸汽最难渗透的地方。其目的是为了验证灭菌容器所有的角落和缝隙都能暴露在饱和蒸汽中2分钟。
The reason for extended cycles, Hughes says, is that when a company is validating a tray for sterilization, the process may take 5 minutes or more to ensure steam has reached all parts of the tray. Under the FDA’s overkill requirements, the cycle must then be doubled to 10 minutes for the FDA to clear the tray for marketing.
Hughes说，延长循环的原因是，当一个公司验证一个灭菌容器的时候，程序至少要5分钟或者更多来确保蒸汽到达容器所有部分。按照FDA对平准上市销售的灭菌容器的过度灭杀要求，循环必须变成双倍即10分钟。
Hughes says, in his view, steam penetration can be monitored by locating BIs and Class 5 indicators in the hardest-to-reach areas of the tray.
Hughes认为，放置灭菌容器中在最难达到位置的生物指示物和第五类指示物监测到蒸汽渗透。
Load release
The burning question is whether Class 6 can be used for the release of sterilizer loads containing implants. Current professional guidelines recommend use of a BI for every load containing an implant, with items quarantined until the BI result is negative. It is also recommended that a Class 5 indicator be used within the BI process challenge device. The guidelines include those from AORN, AAMI (AAMI ST79), and the Centers for Disease Control and Prevention (CDC).
目前亟待解决的一个问题是：第六类指示物能否作为植入物的放行标准？当前的专业指南推荐使用生物指示物的检验结果阴性作为植入物的放行标准。并且也推荐使用一个第五类指示物配合生物挑战装置。这份指南来自包括AORN、AAMI（AAMI ST79）和CDC。
Information from Steris says its Class 6 indicators “may be used to release all loads.” That creates a quandary for OR and central services (CS) managers.
来自Steris的信息则说，第六类指示物“也可以作为所有的负荷的放行标准”。这给手术室和供应中心的管理者带来新的困惑。
Standards and guidelines
Managers rely on professional guidelines in setting policies for sterilization monitoring. The Joint Commission’s infection control standards (IC.02.02.01) require hospitals to use reprocessing methods “consistent with regulatory and professional standards.”
AORN, AAMI ST79, and the CDC’s newly revised Guideline for Disinfection and Sterilization in Healthcare Facilities do not yet address the Class 6 indicator.
管理者们通过专业指南制定灭菌监测的制度。联合委员会的感染控制标准（IC.02.02.01）需要医院使用的再处理方法“符合感控标准”即AORN,AAMI ST79和CDC最新修订的医疗保健设备消毒和灭菌指南，而这些还不包含第六类指示物。
AAMI’s steam sterilization hospital practices working group is waiting for published scientific evidence before providing guidance on the Class 6 in AAMI ST79, says Spry, the working group’s cochair.
AAMI的蒸汽灭菌医院实践工作组的联合主席Spry说，工作组正在等待发表的科学证据以便为第六类指示物在AAMI ST79中提供指导。
To date, independent published research on the Class 6 indicator is lacking.
时至今日，关于第六类指示物的独立公开研究还很缺乏。
“A Class 6 emulating indicator is not a BI. They both have application,” Spry says. “The question is, what is the most appropriate use in the US market?” Class 6 indicators have been used in some European countries, most notably in France, where all steam cycles are 18 minutes. Class 6 indicators are available in Europe to match the 18-minute prion cycle.
Spry说，“第六类模拟指示物并非生物指示物，它们都有各自用途。问题在于哪一种最适合在美国市场使用？”。第六类指示物在欧洲某些国家使用，最典型就是法国，它们的灭菌循环是18分钟。第六类指示物在欧洲运用在18分钟的朊病毒循环中。
Like AORN and AAMI ST79, the CDC guideline continues to recommend monitoring with a BI for every load with implants, quarantining the items whenever possible until the BI is negative. The guideline was finished before the Class 6 indicators entered the market.
像AORN、AAMI ST79和CDC指南中继续推荐每个植入物中使用生物指示物监测，尽可能的知道生物指示物的检测结果为阴性。这些指南都是在第六类指示物进入市场前完成的。
In a comment to OR Manager, the CDC guideline’s senior author, William Rutala, PhD, MPH, said Class 6 indicators “are not a substitute for a biological indicator.” He added: “No professional organization has recommended the use of Class 6 emulating indicators as a substitute for biological indicators, and there are no data (to include our own data) that demonstrate that a Class 6 indicator mimics a biological indicator at suboptimal sterilization times.” He has completed a study that has not yet been published.
CDC指南的资深作者William Rutala对手术室管理者的一个建议，第六类指示物“不能取代生物指示物”。他补充道：“还没有专业组织推荐使用第六类指示物取代生物指示物，并且也没有数据（包括我们所有的数据）证明在最优化的灭菌时间下第六类指示物能够模拟生物指示物。”他刚刚完成一项还没有发表的研究。
How to proceed?
Until more evidence is available, Spry suggests that managers can use the AORN Recommended Practices for Product Selection in Perioperative Practice Settings as a framework for decision making. The recommended practices outline a general process for product selection.
在得到更多的证据之前，Spry建议管理者使用AORN的关于围手术期产品选择的推荐做法作为判断框架。这个推荐做法简略的描述了关于产品选择的通用方法。
OR and central service managers interviewed by OR Manager say they are interested in the new Class 6 indicator technology but find the competing claims confusing. They say they would like to see published scientific evidence on the Class 6. They also are waiting for guidance from the professional standards, though these can take years to be updated.
手术室和供应中心的管理者介绍说，他们对新的第六类指示物很感兴趣，但是相互矛盾的要求使他们困惑。他们期待看到有关第六类指示物的科学证据发表。他们也正在等待来自专业标准的指导，虽然这些需要一些年头来更新。
—Pat Patterson
References
Association for the Advancement of Medical Instrumentation.
Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health
Care Facilities. ANSI/AAMI ST79:2006 and A1:2008. Arlington, Va:AAMI, 2006, 2008.
Association for the Advancement of Medical Instrumentation.
Sterilization of Health Care Products: Chemical Indicators—Part 1: General Requirements. ANSI/AAMI/ISO 11140-1:2005. Arlington, Va: AAMI, 2005.
Association of periOperative Registered Nurses. Recommended Practices for Product Selection in Perioperative Practice Settings. Perioperative Standards and Recommended Practices. Denver: AORN, 2009.
Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Atlanta: CDC, 2008.
www.cdc.gov/ncidod/dhqp/index.htm
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