Validation of cleaning, disinfection and sterilization method

kormach

Starting to get Involved
Hello,

I am wondering if you could share your thoughts about the validation of cleaning, disinfection and sterilization method (acc. ISO 17664-1). We have non-sterile devices but intended for sterilization before first and each use (class: I and IIa). We outsourced the validation of sterilization but it seems to be "not enough"... We spent a lot of money on a document that is useless.
My biggest concerns:
- Where does this obligation come from?
- If the devices are reusable, should they undergo multiple number of cleaning, disinfection and sterilisation cycles?
- Did you use an accredited laboratory? Is it neccessary?
- Which labs in central Europe do you recommend? [in terms of approach to the client, but also prices] (our location: Poland)

We have to have it under the MDR, but we are also thinking of going to the FDA market.

Any advices will be helpful. Thank you in advance.
 

EmiliaBedelia

Quite Involved in Discussions
Who told you that it was "not enough"? Why was it not enough? From your description it sounds like you only did sterilization and not cleaning - sterilization validation is necessary but not sufficient on its own, so I don't think your document is necessarily "useless" The concern here would be that if your device has been used, it may have debris/residue from the procedure (eg, if it is a surgical instrument, it may have blood or tissue on it). The user would need to clean off any debris prior to sterilization. So, you need to validate the instructions for both.

The obligation to validate a cleaning/disinfection/sterilization method is because this is part of the intended purpose of the device, so it needs to be fully tested. There are several general safety and performance requirements that directly relate to sterilization and cleaning. it is your responsibility as the manufacturer to provide 1) a design that CAN be safely sterilized and 2) instructions for suitable cleaning and disinfection.

Reusability is a big issue for MDR. if you prescribe a certain use life for the device, you need to show that it can be fully cycled that many times, including sterilization and cleaning. You will also need to provide instructions for inspecting and verifying the device before use so that the user can identify whether they

The lab you use needs to be qualified to perform the testing that you are contracting them for. Accreditation is probably the easiest way to do this. They should be on your ASL though if they are providing services like that.

No recommendation on labs, but do note that this IS a big issue for MDR and FDA, and you should definitely address these concerns as thoroughly as possible now to avoid any rework later. Here is a helpful guidance from FDA on this topic: https://www.fda.gov/media/80265/download
 

kormach

Starting to get Involved
Who told you that it was "not enough"? Why was it not enough? From your description it sounds like you only did sterilization and not cleaning - sterilization validation is necessary but not sufficient on its own, so I don't think your document is necessarily "useless" The concern here would be that if your device has been used, it may have debris/residue from the procedure (eg, if it is a surgical instrument, it may have blood or tissue on it). The user would need to clean off any debris prior to sterilization. So, you need to validate the instructions for both.

The obligation to validate a cleaning/disinfection/sterilization method is because this is part of the intended purpose of the device, so it needs to be fully tested. There are several general safety and performance requirements that directly relate to sterilization and cleaning. it is your responsibility as the manufacturer to provide 1) a design that CAN be safely sterilized and 2) instructions for suitable cleaning and disinfection.

Reusability is a big issue for MDR. if you prescribe a certain use life for the device, you need to show that it can be fully cycled that many times, including sterilization and cleaning. You will also need to provide instructions for inspecting and verifying the device before use so that the user can identify whether they

The lab you use needs to be qualified to perform the testing that you are contracting them for. Accreditation is probably the easiest way to do this. They should be on your ASL though if they are providing services like that.

No recommendation on labs, but do note that this IS a big issue for MDR and FDA, and you should definitely address these concerns as thoroughly as possible now to avoid any rework later. Here is a helpful guidance from FDA on this topic: https://www.fda.gov/media/80265/download
Thank you EmiliaBedelia for your thoughts.

"not enough" mean without prior cleaning and disinfection steps, report without reference to standard and without few crucial aspects from the standard... :(
 

EmiliaBedelia

Quite Involved in Discussions
That makes sense.... unfortunately yes, it sounds like the protocol was not exactly sufficient to meet the requirements. You MAY have some option to work with an expert to come up with a way to bridge the gap, but it really really depends on the specifics and you need a real expert to help with your situation.
 

Vetty007

Involved In Discussions
Hi,

validation is a very big topic here in Germany and with different approaches, depending on the device and use. Thus, without knowing the device, its hard to say something more concrete. Even I would question, if you really mean or need a sterilization of the device for reuse or if disinfection would be enought. The general requirement is to reprocess a device, so that it won't be a source of infection and for that it doesn't have to be sterile, but depending also on the invasiveness of the device. Regarding multiple reprocessing, the amount of it needs to be defined and tested, also in terms of the material compatibility incl. possibly leachables, alterations of the material etc. and in the end it may limit the duration of use.

Esp. if you want to go to USA, I would definitely use an accredited lab. I don't know, if its allowed to give recommendations for a lab here? Also, without knowing the device and if reprocessing requires sterilization or only cleaning and disinfection, which BTW leads to the question which disinfectant you will use/recommend (which chemical will be compatible with your device), makes it hard to give a recommendation - validation is different, for these different ways of reprocessing...... Also you carefully need to define the disinfectant or better different active substance groups, to not limit to just a few products.

In general I would orient on DIN EN ISO 15883-1/2/4 regarding the requirements that should be met for reprocessing and validation of it. Missing prior cleaning and disinfection is honestly unbelivable as its an absolute standard and prerequisite for sterilization - even if the rest is absolute perfect, if this is missing, you don't read further and you know, that there is no knowledge regarding reprocessing
 
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