---
title: What's your definition of Sterilization?
description: What's your definition of Sterilization?
---

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## What's your definition of Sterilization?

<http://static1.squarespace.com/static/595689fc9de4bbc892200518/t/59568acb5fd63b5f2928783f/1498845454238//img.jpg.com/static/595689fc9de4bbc892200518/t/59568acb5fd63b5f2928783f/1498843851805/1000w/>

At times, nothing can be more polarizing  
 than the discussion of how to reprocess semi-critical and critical  
 devices.  I've experienced this first  
 hand as a member of the Reprocessing Subcommittee for the [CSA  
 Z314.8-14](http://shop.csa.ca/en/canada/sterilization/z3148-14/invt/27010632014) standard.  A room full of  
 experts with differing opinions on the concept of [A0](http://www.wfhss.com/html/educ/articles/educarticle_0009_en.pdf)  
 is something to behold (not quite as good as a fight between siblings mind you),  
 but passion abounds around A0! 

This brings me to this week's  blog and can devices be chemically  
 sterilized?   In keeping with the Talk  
 Clean To Me blog, my focus will be on liquid chemical disinfectants that are  
 registered by [Health  
 Canada](http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/disinfect-desinfect/disin_desin-eng.php) or by the [US  
 FDA](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6885) for use in reprocessing of semi-critical or critical devices. First, I  
 apologize, definitions by their nature are boring...generally I just hyperlink  
 to avoid making everyone read them but for the purpose of this discussion I  
 need to set the stage:

*"A **Sterilant**  
 is a substance, or mixture of substances, capable of destroying or irreversibly  
 inactivating all forms of microbial life present on inanimate objects,  
 including all forms of vegetative bacteria, bacterial spores, fungi, fungal  
 spores, and viruses, present on inanimate objects.  These are also referred to as **chemical sterilants** or **chemosterilants**, and include substances  
 which at the time of use are liquids, gases or vapours."*

As one would expect, there are approved  
 test methods that a company must use in order to obtain a claim for high level  
 disinfection and chemical sterilization. In Canada, a company can use either a [Quantitative Carrier Test](http://www.astm.org/Standards/E2111.htm) (ASTM  
 E2111-12) which provides proof of a 10-6 or greater log reduction  
 against [*Bacillus subtilis*](http://microbewiki.kenyon.edu/index.php/Bacillus_subtilis) and [*Clostridium sporogenes*](http://www.tgw1916.net/Clostridium/sporogenes.html)* *the  
 US FDA approved [AOAC 966.04](http://www.epa.gov/opp00001/methods/atmpmethods/MB-15-01.pdf)  
 Suture Loop / Penicylinder method in which the spore concentration must be 10-6  
 or greater and 0 of the 60 carriers can be positive for spore growth*.  * In general, by definition used in Canada and  
 the US, chemical sterilization equals a sporicidal reduction of 6 Logs (10-6).

 What  
 does this mean from an application perspective?   
 Well, liquid chemical disinfectants are generally used for reprocessing  
 of heat sensitive devices.  Certainly,  
 for non-heat sensitive devices, the gold standard is the use of steam or  
 thermal sterilization where the process can be monitored to verify that the  
 correct time and temperature has been reached in conjunction with the use of  
 biological indicators to verify sterility should be used.  However, there are times when access to such  
 devices is impossible and alternative methods for reprocessing needs to be  
 considered and do have a role to play in reprocessing of semi-critical and  
 critical devices. 

Why? First, they are effective (they  
 achieve the required 6 Log reduction against bacterial spores).  Second, they are approved for sale and use as  
 a sterilant in both Canada and the US and third, they are approved for use by  
 North American [Infection  
 Prevention and Control Guidelines](http://www.ipac-canada.org/links_evidence_guidelines.php).   

When should they be considered?  As noted above, the primary use is for  
 reprocessing of heat-sensitive devices.  However, another consideration is use by  
 healthcare workers (HCWs), healthcare or other facilities who do not have  
 access to mechanical sterilizers and perhaps most importantly, consideration  
 for use should be given by those who do not have the appropriate training and  
 ability to develop a preventative maintenance program to ensure sterility is  
 achieved.  I realize this seems  
 counterintuitive, however, simply having and using a steam sterilizer does not  
 ensure sterility is achieved.  Many  
 smaller clinics or homecare nurses do not the support of an acute care facility  
 and access to a Medical Device Reprocessing Department.  Case in point, a few years ago, I met a group  
 of nurses who had pooled together funds to jointly buy a steam sterilizer.  They were so excited!  When I spoke to them, they had had their  
 sterilizer in place for about 6 months.   
 They did not have a process in place to trace their reprocessing  
 batches, and had just learned that while they were doing biological tests, they  
 were not conducted correctly and that the machine they purchased was not  
 intended to sterilize wrapped instrument sets!   
 The long and the short was that all clients they saw over that time  
 period were put at risk.  

There are some cases where I think we need  
 to look not only at the risk of transmitting disease and what level of  
 disinfection or sterilization is needed, but also to look at the user and their  
 capabilities.  There are times when  
 perhaps the use of a chemically sterilized instrument is safer than a false  
 sense of security of a device that has "gone through a sterilization  
 cycle".

What do you think?

*Bugging Off!*

Nicole

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