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

2. 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

3. Look Familiar

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

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

7. 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

8. 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

9. 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

10. 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

11. 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