Validation Required? Disinfection of wearable patches for unbroken skin

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
We sell wearable patches for unbroken skin. Our auditor cited ISO section regarding contamination control of returned patches we RMA for investigations of failures because we had them sent directly to us from the users. We contracted an expensive disinfection house to do the work for us. We are thinking of bring the work in house and disinfecting the patches ourselves. Assuming we use the same methods the contractor did will we have to validate the disinfection process? This in no way affects users of our product.
 
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yodon

Staff member
Super Moderator
#2
Setting standards / regulations aside for the moment, how will you know if your disinfection process actually works? I'd want to just for the sake of the employees!

That aside, it would seem that it would at least marginally fall under the scope of (executing the) QMS as part of the process of investigation. And you don't want returned product contaminating your good product so it may be broader than just the disinfection process itself.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
Couple more items. This is an R&D lab. No production occurs here. The lab we get these disinfected at now takes two solutions and wipes the patch down and air dries it. If we copied that process would we need to validate that?
 

JoshuaFroud

Involved In Discussions
#4
HI Ed

I would say unless the disinfection lab you previously used is nice enough to send you the validation data demonstrating that your process is effective then I would strongly recommend validating your disinfection process. At the end of the day this is very close to a health and safety issue more than quality.

Do you believe the patches coming back to be contaminated with anything in specific? or is the disinfection premptive?
 

JoshuaFroud

Involved In Discussions
#6
Unfortunately, I would suggest not. Validation is not a proof of concept; it is evidential proof that what you are doing, in that specific location, with your specific methods is effective at the task defined.

When I was working as an analytical chemist we would take methods from the pharmacopoeia to test for impurities and still validate them. As while they are pharmacopoeia defined and recognised methods there is no proof they will work on my equipment, in my lab without the validation to demonstrate it.

You could risk assess and justify why you are not conducting validation of your disinfection process using examples of similar processes in similar industries and put that against the risk to your operators based on the expected contaminants and further mitigated by PPE. This may be enough to satisfy the auditor.

At the end of the day, it is the health of your employees you are taking a chance on by not validating your cleaning process. It only takes one person inoculating themselves with something and the world of pain that will cause to justify all of the cost and time of validating a cleaning process.
 

planB

Super Moderator
#7
Ed,

adding the perspective of a class III AIMD manufacturer who also investigates returned (explanted) devices after inhouse disinfection:

Occupational safety is not the core focus of ISO 13485, but product /patient safety. Don't get me wrong: your employees' health is very important and you should take all measures to protect your employees from exposure to infectious material. It should just no be in the main focus of your ISO auditor.

Anyway, validating your disinfection process is quite simple:
  1. You need a microbiological lab that inoculates your product with a defined number of a representative microorganism. The number depends on your desired log reduction, e.g. 10exp3 up to 10exp6.
  2. You provide them with your disinfection procedure, which contains detailed step-wise instructions
  3. The microbiology labs performs the disinfection procedufre based on your instructions
  4. The microbiology lab performs a bioburden test on both the positive inoculated controls as well as on the disinfected devices.
  5. Comparing these results will retunf the log-reduction power of your disinfection process
In addition to establishingh this validated disinfection procedure at your site, you should take additional safety measure measure, such as mandatory wearing of gloves/goggles, disinfection procedures for equipment as as well as hands of personnel; establish also emergency procedures in case of contamination/contact with potential infectuous material or disinfection media.

HTH,

Gerhard
 
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