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products. It is important that these instruc- tions are followed. However, despite best intentions, in a busy sterile processing department it is possible to inadvertently process a device or load in a sterilization cycle which is not recommended by the manufacturer. It is also possible to use inappropriate accessory items and sterile barrier systems, which can, individually or in combination compromise process effi- cacy.9
SELF-STUDY SERIES
color change, which are easily interpre- table under less than ideal conditions, are therefore more valuable than others which do not. It is essential that manufacturers provide comprehensive educational and training material not only for SPD staff but also for the practitioners (e.g. Operating Room staff) who will interpret the color change at the point of use.
at locations within a pac identified during PQ will ensure that the end user can see that sterilizing conditions were met at the point(s) of placement and therefore aid in answering the question “is the sterility of the pac confirmed, as discussed in the WHO surgical safety checklist.6
The value of reference colors – a warning
The interpretation of color change of CIs is subjective and depends on human fac- tors such as the experience, health, visual acuity, or stress levels of the operator, and environmental factors such as the bright- ness of incident light.10
The presence of a
color reference, either printed on the CI or in instructions, might aid or confuse interpretation, if not a good match for the pass color. CIs placed inside sterile packs will be interpreted by practitioners who are under pressure to use the instruments and might be in subdued light, so many indicators exhibiting marginal fails might be interpreted as passes. CIs with a clear
The placement of type 4 VH2O2 CIs Summary
CIs form part of an overall quality assur- ance system, which when taken as a whole, provides assurance that each and every pack is sterile. The use of chemical indicators of good quality in terms of performance and ease of interpretation is vital in order to make meaningful judge- ments. HPN
References:
1. Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labelled as Sterile. Guidance for Industry and Food and Drug Administration Staff, January 21 2016, Food and Drug Administration, Washington, USA
2. Wallace, C, Breaking the Chain of Infection, Self-Study Series, Healthcare Purchasing News, October, 44-47, 2020.
3. EN ISO 11138 Sterilization of health care products - Biological indicators - Part 1: General requirements, 2017,
4. EN ISO 11140-1, Sterilization of health care products - Chemi- cal indicators - Part 1: General requirements, 2014
5. ANSI/AAMI ST 58.:2013 Chemical sterilization and high-level disinfection in health care facilities , 2013, Association for the Advancement of Medical Instrumentation.
6. World Health Organization, WHO surgical safety checklist, 2009.
7. Kirk, B. Evaluation of a number of chemical indicators for monitoring vaporized hydrogen peroxide (VH2O2) sterilization
processes. Zentr Steril, 2020; 28(4), 208-217
8. Kirk, B. Detecting vaporized hydrogen peroxide sterilization (VH2O2) process failures in clinical settings using chemical indica- tors. Zentr Steril, 2020; 28(6): 334-343.
9. Talapa, L, Vaporised Hydrogen Peroxide VH2O2 Sterilization; riding atop a new wave, presentation at IAHCSMM 2019 annual conference April 27th to May 1st, Anaheim, CA2019.
10. Hurlbert A, Pearce B, Aston S. All illuminations are not created equal: The limits of color constancy. In: 38th European Conference on Visual Perception (ECVP). 2015, Liverpool, UK: Sage Publications Ltd.
Dr. Brian Kirk is Director of Brian Kirk Ster- ilization Consultancy Group Ltd, specializing in Standards Development, Education and terilization Consultancy. irk is ualified as a pharmacist. He holds a Master’s degree in Phar- maceutical Analysis and a PhD in Pharmaceutical Sterilization Technology. He received the 1985 annual award for best submitted
paper to the Parenteral Drug Associations Journal. Kirk joined 3M Health Care in 1989 as a development scientist for steril- ization monitoring products, where he was responsible for developing and supporting a number of new products. He has had special responsibilities for monitoring the develop- ment of national, European and international standards relating to sterilization. He has participated in a number of BSI, CEN and ISO committees responsible for developing standards for chemical and biological steriliza- tion indicators and steam, ethylene oxide and vaporized hydrogen peroxide sterilizers and sterilization processes.
Page 50
Table 3: The exposure conditions for a pass and fail response for a type 1 and 4 VH2
O2
CI according to EN ISO 11140-1.
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