Establishment of penetration time on medical device product families based on ISO 17665-3 during performance qualification of steam sterilization

Mr Roel Beltran Castillo1

1Macquarie University Hospital, Macquarie University, Australia

Introduction:  Reusable medical devices (RMDs) significantly differ in material construction and geometric configuration; ISO 17665-3 provides information in grouping RMDs in order to cater to the demand of every unique device. The need to establish penetration time at equilibrium throughout the RMD surfaces during performance qualification based on product families is necessary to ensure sufficient exposure to sterilization is delivered; process lethality is established. This study aims to provide an on-site investigation on the credibility of ISO 17665-3. Is it really necessary to comply with standards to meet lethality of sterilization process?

Methods: RMDs are grouped according to designation of product family based on ISO 17665-3. The most difficult to sterilize item/s in each product is chosen as a master product. This master product is used as part of the reference load on the performance requalification of the steam sterilizer. The most challenging item of identified resistance (based on ISO 17665-3) in the master product is chosen for the study of penetration time. A thermometric measuring device attached to a software reader will be strategically located on the chosen medical device surface. This provides information of penetration time establishing time lapse to attain lethal plateau.

Results: The material construction and complexity of RMDs is directly related to resistance of heat transfer. This confirms the ISO 17665-3 approach grouping medical devices into families of similar penetration resistance in order to attain temperature required.

Conclusion: Establishment of RMDs penetration time during annual performance qualification will address the reprocessing requirements attain sterilization lethality.


Responsible for the provision of Sterilisation and Infection Control Services to Macquarie University Hospital. In particular supports activities of the Operating Suite, Angiography/Endoscopy Unit, the Intensive Care/Coronary Unit and all hospital wards. The role ensures that quality, evidence based practice and cost effective service are delivered within a safe patient and team environment.

Set up a new CSSD at The Chris O’Brien Lifehouse and eventual Manager in 2013 -2015

Currently Teaching Sterilizing at TAFE NSW Randwick Health Precinct.

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