ISO Accreditation/ACHS Standard 3 Compliance Results: 3.16 – pass with Merit; 3.17 – pass with Merit; 3.18 – pass with Merit The Macquarie University Hospital ( untold) Story

Roel Castillo 1

CSSD  Manager, Macquarie University Hospital, Macquarie University, NSW, Australia



The Sterilizing Services Department is responsible for compliance to Standard (part of) 3.8, 3.16, 3.17 & 3.18. With the publication of the new AS 4187 compliance is literally more challenging. This presentation focuses on how MUH SSD managed to comply with the current AS 4187:2003 and parts of AS 4187:2014


3.16: Revalidation of related equipment with specific focus on ISO 17664. Product grouping based on penetration time/temperature relationship for sterilization of RMDs. Extensive monitoring of equipment and environment. HLD printout validations. ATP monitoring on equipment, RMD and surface. Policies/procedures/workflows/contingencies. Project plan for full compliance to AS 4187:2014
3.17: Utilization of a traceability system for compliance purposes
3.18: Training, education, in services and assessment of competencies. Visuals


3.16: The penetration time data reveals different RMDs require varying times to reach surface temperature equilibrium. To ensure lethality of process, penetration time must be added to sterilisation exposure/holding time.Required holding times as per IFU (ISO 17664-companies) or based on tests in situ has been implemented. Lethality of the process is established. RO water, additional monitoring now in place, project plan continues.
3.17 Tracking system has been underutilized and is now progressing to full utilization not only for traceability but compliance.
3.18 Updated staff on all 17 technician competencies. Morale, confidence and competency of staff is very recognizable


Announced audits may be challenging, but having time to prepare and sufficient effort helps a lot. Harder challenges lie on the new AS 4187:2014 and operational implications attached to its full implementation.

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