PRODUCT FAMILY – Another Perspective David McNamara CSSD ANUM North West Private Hospital BRISBANE 2018

ISO17665 Part 3 ……………….. Sterilization of health care products -- Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization Abstract Aim Identified Issues Validations Actions Review and Review Summary

Look Familiar

Product Family… Preamble What are your issues? How did you manage before? I will provide another way to approach this neccessity

Product Family…Aim Action undertaken at a HSO: Types of RMD IFUs Your equipment Your limitations Manufacturer IFU review - updates

Identified Issues / Risk Contamination from incorrect / insufficient processing Potential for occurrence at your HSO Cleaning regime compliance to Manufacture’s IFU Validation – who sets your profile Review of how you will access new RMD Circulation of results to Clinical staff in OT

Validation Review what you use Review what you will use Compliance processing review to Manufacturer’s IFU Request to Manufacturer to any variation / review to current IFU’s Suppliers there to help you Conducting validations has changed

Product Family …………. Actions Remember to make it easy for all senior staff to understand Contact other HSO re their methods Establish layout / matrix as basis Review to ensure your process reflects new equipment Product Family may be different for different equipment e.g. sterilizers

Review – did I mention? Document Consult Cleaning Process compliant with IFU’s Suppliers deferring to Manufacturer’s IFU’s Testing Regime to continue Consult with your peers

T.O.E. Probe … Summary Review research / articles when presented Demonstrate / identify local risk Escalate to relevant Committee as Risk Seek Manufacturer’s Imput Continue testing to show + or – results Quality Report activity Know your Team has done a good job