Reprocessing, Cleaning, Disinfection and Sterilization Validation

#1
Hi,

I am looking for guidance on Reprocessing, Cleaning, Disinfection and Sterilization Validation for Class I and Class I reusable Surgical Instruments.

The standard i am using for IFU is ISO 17664. I need to know if automatic cleaning and disinfection is a must or is it optional?

If we do validation of manual cleaning and disinfection, will it be enough to comply with requirements of new MDR.

Will appreciate any guidance provided.

P.S If anyone here can recommend a Lab to provide above services at a good cost?
 
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twanmul

Involved In Discussions
#2
I think that this would be better moved to the Medical Devices section of the forum; European Medical Device Regulations. They will be better to help. I wouldn't be able to comment on whether that HS was appropriate or what you should/shouldn't do. Sorry
 

shimonv

Trusted Information Resource
#3
I am not a subject matter expert on this topic, but from what I've in the reusable surgical instrument arena - the instruments are supplied with manual and automatic cleaning options. The MDR does not dictate manual and automatic cleaning validation. I suspect it comes from customer (Hospital) requests which became industry practice.

I welcome inputs from other members...

Shimon
 

planB

Trusted Information Resource
#4
Akrambilal,

if automated cleaning/disinfection is feasible then - at least in the European Union and the US - then this is the strongly preferred method. Consequently, you would have to provide solid justification why you label a manula process if your device(s) could technically also be subjected to an automated process.

Lab: make sure the lab is accredited to the test methods you intend to use. There are quite some European (and US) labs around that offer reprocessing validations at about the same price. Anything specific you are looking for?

HTH,

Gerhard
 

TheMightyWife

Involved In Discussions
#5
I agree, automatic cleaning and sterilisation method is preferred, therefore worth investing in (especially when products are supplied to NHS).
 
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