2024 NEW CSA UPDATE: Internal Chemical Indicator Type V in EVERY Package…Say’s Who?

The New 2023 Standards from the Canadian Standards Association.

The second edition of CAN/CSA-Z314, Canadian Medical Device Reprocessing in All Healthcare Settings was updated over a course of several years and released in 2023. It supersedes the previous edition (CAN/CSA-Z314:18) published in 2018 under the title Canadian medical device reprocessing. All editions of the standard address the safe and effective reprocessing of medical devices and supplies in healthcare facilities.

The editing of the title itself is part of the task of revising the Scope (Clause 1) to extend coverage of heath care settings to include professional offices, independent doctors’ offices, community health care centres, private practices, and additional health care settings including dental practices (CSA, 2023).The 2023 Standard was prepared by the Technical Committee on Medical Device Reprocessing, under the jurisdiction of the Strategic Steering Committee on Health and Well-Being, and has been formally approved by the Technical Committee (CSA, 2023).  This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group (CSA, 2023).

The CSA Standards are the evidence informed resources used by decision leaders such has public health and dental regulatory bodies to in turn write the standards dental offices.  This trickles down to the dental offices using the material distributed by regulatory bodies to build their IPAC libraries and shape their own policies and procedures and very important, educate and train the reprocessing staff.

The 2023 edition focuses even more on the selection of specific wording in paying close attention to the use of may, should, must and/or shall. Specific to the use of internal chemical indicators Clause 16 of the new standard states the type of indicator shall be chosen based on the sterilization cycle parameters being measured and in steam processes a Type 5 or Type 6 CI shall be placed inside each package being prepared for sterilization (CSA, 2023).

That takes care of the ‘who’ is telling us to place a Type V in every package.  What about the why? The why is simple when viewed through the lens of risk management. A type V indicator outperforms the current use of a type IV as an internal indicator. Type V measures the parameters of time, temperature, and pressure.  Whereas a type IV picks up on only two of the three parameters.  Does this matter?  It sure does in quality assurance.  Why choose a test that is well known to underperform? In risk management the choice is simple to select the top performer for accuracy in quality assurance and paramount safety to the public. Why take a chance with a type IV!!!!

In framing the two roles of the type V it makes sense why there needs to be one placed in every package.  The type V placed in the PCD in the sterilizer, is the ‘load leader’.  It tests, challenges, and validates the steam activity inside the sterilizer. The type V placed in every package, is the ‘package leader’.  It tests, challenges, and validates the steam entering the interior of the package. The load leader is recorded on the log sheet in the reprocessing room and the package leader is recorded in the client chart. 

Conclusion, who is telling us to place a type V in every package? The new CSA 2023 Standards. Why do we need to place a type V in every package? The type V offers a much-elevated risk management approach to quality assurance testing versus a type IV. Safeguarding both the public and the dental practice by mitigating risks! 

Michelle Aubé (Simmonds) RDH, maxill Dental Hygiene Educator

Michelle is a Dental Hygiene Speaker, Consultant and Educator with over 21 years of experience as a RDH and 4 years as a CDA. She has written dental hygiene articles for CDHA’s OH Canada professional publication and continues to practice clinically and teaches both clinical dental hygiene and practice management at Fanshawe College and the University of Western Ontario. She has served on the Discipline Committee at Algonquin College and held the position of a CDHO Quality Assurance Assessor for 7 years.

Canadian Standards Association (CSA). (2023). CAN/CSA-Z314:23, Canadian Medical Device Reprocessing in All Healthcare Settings. National Standard of Canada by CSA Group. Access via purchase: https://www.csagroup.org/store/product/CSA%20Z314%3A23/?gad_source=1&gclid=CjwKCAiAqY6tBhAtEiwAHeRopTg3YwxdAo0LCsCKf-3iMwQMppeCJlGeaM0y-bNZ3tsJlx92_yLU8BoCGsEQAvD_BwE