ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit

P

Pataha

#1
Hi all,

I have been reading for awhile and could not help but register to comment and even though, I do lose mt train of thought. I have found this forum very handy and thought provoking.
Now, I had a recent ISO 13485:2003 CMDCAS audit and recieved and NCR for my ETO Sterilization Validation Process. This validation approach has been audited by the FDA every time they audit. And I understand that from Health Canada's Medical Device Regulation Section "17. A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used shall be validated."
My current process is for an Annual Validation with an Independent UTAH based Lab that is no way related to my Contract Sterilizer and follows ISO 11135:1994 and EN550. Plus my Contract Sterilizer has evidence of conforming to ISO 11135:1994 and EN 550.
The Auditor wants us to do Validation more often, yet when pressed for the reference that requires this, they backed off and went with "just show that you are doing what you state you are doing."
Which I thought I showed them when they were here.

So I am looking for suggestions on how to clear this NCR. We believe that the Auditor may have confused ETO requirements with GAMMA. We, also, have gone the appeals approach and it was bounced back. :bonk:

Thank you for your help.
Craig.
 
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DannyK

Trusted Information Resource
#2
I am not an expert on sterilization techniques. I did not see any Health Canada specifications regarding frequency of validation.

You should ask the auditor and registrar to show you the requirement.

The registrar should have an appeals process and if it was bounced back, ask to speak to their medical device manager and if you do not get satisfaction to the President.


Danny
 
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