FDA Medical Device Reprocessing Guidance - Validation

acro14

Starting to get Involved
#1
Hi,

FDA has issued a guidance for the reprocessing of medical devices. There a validation of the cleaning process is required. How you can handle that in a time efficient-manner?
we have a fabric whose cleaning and disinfectiion process has to be validated. Can you rely on data from the detergent manufacturer or rely on formulations specific to the fabric or a manual?
As the cleaning process has to be performed by a home user (in the laundry) a validation could not be able to reproduce real conditions, i.e. we cannot put hundreds of detergents under test. Has anybody an idea?
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
> FDA has issued a guidance for the reprocessing of medical devices

It's still a draft if you refer to this - and actually applies to health care settings, not home use:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm252999.htm


> Can you rely on data from the detergent manufacturer or rely on formulations specific to the fabric or a manual?

No, you (usually) cannot - except your detergent manufacturer can provide you with evidence that allows you to adopt your fabric into the detergent manufacturer's reprocessing validation.

>As the cleaning process has to be performed by a home user (in the laundry) a validation could not be able to reproduce real conditions, i.e. we cannot put hundreds of detergents under test. Has anybody an idea?

You may want to employ a common detergent and find out its active ingredient(s). You could then refer in your IFU to the active ingredient(s) instead of a specific detergent trade mark.

Generally, you will have to label instructions that a home user will be able to follow, so you will have to think of validating real-world /usable conditions.

HTH,

Gerhard
 
#3
Ok - a little removed from the above but - I have a non-sterile (does not need to be sterilized), non-implantable, transient use device which can be used in healthcare facilities or in the home use environment. This device should be wiped down with alcohol wipes between multiple users and wiped down intermittently(as needed) with one user. I have a hard time saying this is reprocessed per the FDA usage of the word "reprocessed medical device". Your comment is appreciated.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Ok - a little removed from the above but - I have a non-sterile (does not need to be sterilized), non-implantable, transient use device which can be used in healthcare facilities or in the home use environment. This device should be wiped down with alcohol wipes between multiple users and wiped down intermittently(as needed) with one user. I have a hard time saying this is reprocessed per the FDA usage of the word "reprocessed medical device". Your comment is appreciated.
Why would you say it's not "reprocessed"?

Reprocessing: Validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization.
 

KMac

Registered
#5
I have a question that relates to the title of the thread if appropriate.

We are looking to conduct cleaning and sterilization validation for our reusable medical devices. I am having some issues finding any reference to the requirements of the certification of the test house providing the validation. The FDA guidance referred to in the title of this thread gives no mention of the certification requirements of the test house conducting the validation.

I am wondering if anyone can help me understand what the test requirements for doing cleaning and sterility assurance validations are? Whether a GLP or equivalent test house is necessary to complete this testing, or would a non-certified test facility be sufficient?

I anyone knows of any guidance or regulations specific to this, I would be grateful.

Thanks,
 
#6
hi in this scenario (use of thread) you can define on the label the methods of reuse, "to obtain the best result for reuse using " (* manufactured preferred way of / tested method).
Also, define a method to identify its discard (eg. cuts in the thread) and for best results reusability life of XXXX times under defined conditions.
Another way is to sell add alcohol wipe to your packaging and earn extra.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I have a question that relates to the title of the thread if appropriate.

We are looking to conduct cleaning and sterilization validation for our reusable medical devices. I am having some issues finding any reference to the requirements of the certification of the test house providing the validation. The FDA guidance referred to in the title of this thread gives no mention of the certification requirements of the test house conducting the validation.

I am wondering if anyone can help me understand what the test requirements for doing cleaning and sterility assurance validations are? Whether a GLP or equivalent test house is necessary to complete this testing, or would a non-certified test facility be sufficient?

I anyone knows of any guidance or regulations specific to this, I would be grateful.

Thanks,
The key to the answer to your question is in the ISO standard(s) that covers the relevant sterilisation method (e.g. Gamma) and its validation. Cross that with the scope of the relevant FDA standard recognition.

That should get you started in the right direction.
 
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