Passivation of Medical Devices

Q

QA Memphis

#1
In 1997 the FDA sent a Warning Letter to SUA Martin GmbH & Co. In item #3b it stated " There is no changing interval prrceedures for the ultrasonic bath solution, where an excessively dirty solution can decrease the cleaning effect and increase the risk of corrosion on the insturments."

What is the trend in industry to prevent a finding like this in their facility?

Here is a link to the Warning Letter
http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1997/UCM065223.pdf
 
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J

JaxQC

#2
In essence it usually boils down to getting credit for what you’re already doing. You’d be looking at documenting and having evidence that you are …
1) defining what to do (what should they be doing)
2) justifying how you arrived at what you defined (what’s the rational)
3) proof or evidence you are doing it (why should they believe you did it)
4) Training (who and why are they qualified to be doing it)

In their case it could have been avoided if they documented when they should flush (empty) their tanks (DEFINE what). I would go with a gage check rather than just saying once a week) Say a conductivity meter of 20uS (microSeimen) check. (DEFINE when) Why is this an acceptable frequency to change the tank??- because validation testing showed that they would get an xxx passing reading on cytotoxicity and thus passing (JUSTIFY). Then document that they are actually doing it. Simple check sheet, signed/dated when they do it (EVIDENCE). I’m doing these type validations now but they all fall into this type of criteria check questions. They auditor wants to see that on a certain date which qualified, trained individual (TRAINING) did what they should have done. The response “we must have done it since we always do what we are supposed to do” doesn’t quite cut it.
After you get into it I would bet that you will find information you were not aware of and that need to be addressed. Hope this helps.
 
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