Ensuring the Highest Standard of Care in Your Facility

Infection Prevention Expert Discusses Sterilization Guidelines and Best Practices

On April 27, Infection Control Today hosted the webinar “Sterilization and Liquid Chemical Sterilant Processing: An Expert Discussion Regarding the Latest Information” featuring clinical expert Nancy Chobin, RN, AAS, ACSP, CSPDM and Corporate Consultant and Educator for the Saint Barnabas Health Care System. The webinar, sponsored by Advanced Sterilization Products (ASP), educated healthcare professionals about the differences between terminal sterilization and liquid chemical sterilant processing. Nancy discussed achieving sterility assurance, conducted an easy-to-follow review of industry guidelines and shared monitoring and documentation best practices.

If you were unable to attend the live broadcast of the webinar, it is now available for on-demand. VIEW HERE.

Featuring:

• Nancy Chobin, RN, AAS, ACSP, CSPDM
  Corporate Consultant and Educator for the Saint Barnabas Health Care System

Sterilization and Liquid Chemical Sterilant Processing: An Expert Discussion Regarding the Latest Information Key Take-Aways:

• Nancy Chobin, RN, AAS, ACSP, CSPDM discussed the differences between sterilization and liquid chemical sterilant processing systems and explained that although the terms are similar, a liquid chemical sterilant processing system is not a sterilizer.¹
• Nancy explained that sterilization is the highest standard of care as it eliminates all forms of microbial life, providing a sterility assurance level of 10^-6.² She went on to note the benefits of terminal sterilization, including that terminally sterilized devices are wrapped providing a sterile barrier and that terminally sterilized devices are not immersed in liquid, resulting in a dry end product.
• The webinar presentation also highlighted the importance of following established guidelines for disinfection and sterilization and noted that multiple studies in many countries have documented that lack of compliance with the guidelines has led to numerous outbreaks. Importantly, AAMI, AORN and the CDC have separate guidelines for sterilization and high-level disinfection (HLD) given that they are two different standards of care.^3,4,5,6 Liquid chemical sterilant processing systems, which fall under the same guidelines as HLD are cleared for high-level disinfection of semi-critical medical devices, but are not intended for critical devices – all three organizations recommend sterilization for critical devices.^7,8,99 Further, semi-critical devices used in a sterile field must be sterilized.
• Nancy also described the role of monitoring in achieving sterility assurance, stating, “Monitoring is one of the most important aspects of the sterilization process.” She added that biological indicators are considered “the gold standard in sterility assurance, as they provide direct evidence that the sterilization process conditions are sufficient to kill spores and provide the only direct measure of sterilization lethality.”

Q&A Session:

Following are the most popular and pressing questions answered during the webinar:

Q: Now that the FDA has extended the transition deadline by six months, is there still urgency to transition?
A: While the deadline to transition is an important aspect of the process, healthcare facilities should remember why the FDA is requiring the transition – the device facilities have been using is no longer legally marketed and healthcare professionals must move to a alternative product. It is also important to remember that medical device manufacturers have started removing the SS1 from their IFUs, so it is better to transition as soon as possible. Regardless of when the deadline is, the urgency to transition should be driven by doing what is best for patients. The FDA extension does not mean healthcare facilities should slow their transition process down, rather it provides more time to become educated on the best process for your facility. I encourage you to take this as an opportunity to raise the standard of care in your healthcare facility.

Q: What is the difference between a liquid chemical sterilant processing system and a high-level disinfection device?
A: High-level disinfection (HLD) is the process that kills all microbial organisms, but not necessarily large numbers of spores, meaning it does not provide a 10-6 sterility assurance level, which can also be said of liquid chemical sterilants processing systems. As a result, HLD and liquid chemical sterilant processing systems fall under the same guidelines for AAMI and AORN.^11,12 HLD and liquid chemical sterilant processing are cleared for high-level disinfection of semi-critical medical devices, but these methods are not intended for critical devices.¹³ Further, semi-critical devices used in a sterile field must be sterilized. However, liquid chemical sterilant processing is cleared for sterilization of critical or semi-critical devices that are heat-sensitive or incompatible with traditional sterilization methods.¹⁴

Q: What does the Joint Commission say about the use of a biological indicator?
A: Although the Joint Commission does not specify the use of biological testing, the Joint Commission expects each hospital’s clinical and practice settings to follow the recommended standards and guidelines established by AAMI and AORN, which are the organizations that provide regulatory guidance to healthcare facilities regarding infection prevention and control. AAMI and AORN recommend that a biological indicator be used for sterility assurance.^15,16 The Joint Commission aims to determine whether a facility has a thorough, organization-wide infection prevention and control plan in place that is in compliance with the relevant guidelines.

View the Webinar

If you were unable to attend the live broadcast of the webinar, it is now available for on-demand. VIEW HERE.

Nancy Chobin serves as a consultant for ASP. For information about ASP alternatives, please visit www.ASPJJ.com/alternatives.