Hello Yoram,
I agree that there appears to be a disconnect between cleaning and disinfection. The definition of cleaning is normally the level of organic material removed from a device not necessarily the removal of organisms. Disinfection, of which there are three - low, intermediate and high, refers to a log reduction of organisms e.g., bacteria, fungi, virus and is often represented as a 3 log reduction. Sterilization refers to a 6 log reduction of spore formers. While it doesn't completely address your situation there is a draft FDA guidance document on the FDA site called "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". This guidance provides definitions of cleaning, disinfection and sterilization. It also references the various AAMI TIR documents that address the cleaning and processing of medical devices, and the validation of these processes. Again, this is not exactly what you are doing, but I think these references should give you a better understanding of the differences between cleaning, disinfection and sterilization and the validation of such processes. I think you can use this information to better assess your needs for your situation.
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Christine Anderson
Regulatory Affairs Specialist
Philips Healthcare
Cleveland OH
United States
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Original Message:
Sent: 09-15-2012 05:32
From: Yoram Levy
Subject: Cleaning validation
Thank you for responding.
As far as the standard states if you claim the the product is clean you should validate it for 10-3 degradation,
I don't know about a sifference between clean and disinfect.
I would use the statement "clean for its intended use". please comment.
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Yoram Levy
General Manager
QSite
Binyamina
Israel
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Original Message:
Sent: 09-12-2012 03:16
From: Siegfried Schmitt
Subject: Cleaning validation
I think there is some confusion between cleaning and disinfection
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Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
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Original Message:
Sent: 09-09-2012 10:35
From: Yoram Levy
Subject: Cleaning validation
Cleaning is defined as reduction of 3 log reduction of microbial growth.
We have a single patient item that is in touch with the external part of the body and doen't have to be cleaned, Yet we would like to state that it has been cleaned after manufacturing. The validation would only succeed for 2.5 log. Can we define this part as cleaned after conducting the cleaning process.
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Yoram Levy
General Manager
QSite
Binyamina
Israel
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