Guidance on Cleaning & Sterilization of an FDA Class II Medical Device

Hi all:

I believe a re-validation of the cleaning and sterilization procedures for our device is in order.

A brief description of our device before proceeding with my questions:
1. FDA Class II
2. Semi-critical device (may contact broken skin or mucosal membranes)
3. Provided to end user in non-sterile condition
4. We provide customer with cleaning and high-level disinfection/sterilization instructions
5. Customer may use either autoclave or cold soak sol'n for disinfection/sterilization
6. We also provide a brief (but not all inclusive list) of products that may be used for cleaning and high-level disinfection/sterilization

My questions are: what standards are out there to validate your cleaning and sterilization procedures to and what must we validate (cleaning, high level disinfection, steam, and sterilization?? And secondly, what 3rd parties may do this validation on our behalf? Lastly, is it necessary for our company to clean the device before it is sent to the customer?

Thanks,
Ash

Re: Guidance on Cleaning & Sterilization

aoldendo said:

Hi all:

I believe a re-validation of the cleaning and sterilization procedures for our device is in order.

A brief description of our device before proceeding with my questions:
1. FDA Class II
2. Semi-critical device (may contact broken skin or mucosal membranes)
3. Provided to end user in non-sterile condition
4. We provide customer with cleaning and high-level disinfection/sterilization instructions
5. Customer may use either autoclave or cold soak sol'n for disinfection/sterilization
6. We also provide a brief (but not all inclusive list) of products that may be used for cleaning and high-level disinfection/sterilization

My questions are: what standards are out there to validate your cleaning and sterilization procedures to and what must we validate (cleaning, high level disinfection, steam, and sterilization?? And secondly, what 3rd parties may do this validation on our behalf? Lastly, is it necessary for our company to clean the device before it is sent to the customer?

Thanks,
Ash

Click to expand...

oops let me read this again!

Re: Guidance on Cleaning & Sterilization

Validation of the sterilisation/decon of a reusable medical device is a nightmare, or at least it is in the UK. This is because each hospital uses it's own equipment and cleaning fluids/agents. They all have their own processes which use different systems and different cleaning fluids/agents. I have come across two types of hospitals...

1. Hospitals that read your instructions, then refuse to process the items until you validate using their system
2. Hospitals that don't care what your instructions say and just do it their own way.

I have yet to come across the third group...hospitals that follow the manufacturers instructions, unless they do it by accident



there...rant over...

With regards to standards, I don't believe there are any international ones; individual hospitals may have their own - the NHS in the UK has HTM's regarding decontamination and sterilisation.

As for validation; in a generic way, the simplest approach is to dirty your product with hard to kill bacteria; clean it using your methods and demonstrate that it no longer has any of that bacteria on it.

Sterigenics in the UK has offered this service to me before; they have international sites-I don't know where you are based. I'm unaware of any other companies, but I imagine there must be quite a few.


(I am not affiliated with sterigenics, I have used their services before but not for decontamination validation work)

edit: extra bit of advice from personal experience... you may be looking at the US market for now, but what about in the future. The "standard" autoclave cycles are different between the UK and US (I presume it varies in other countries)....Validate to the worst case...lowest temperature, shortest time therefore anything at a higher temperature or longer time will also be validated!

aoldendo said:

Hi all:

I believe a re-validation of the cleaning and sterilization procedures for our device is in order.

A brief description of our device before proceeding with my questions:
1. FDA Class II
2. Semi-critical device (may contact broken skin or mucosal membranes)
3. Provided to end user in non-sterile condition
4. We provide customer with cleaning and high-level disinfection/sterilization instructions
5. Customer may use either autoclave or cold soak sol'n for disinfection/sterilization
6. We also provide a brief (but not all inclusive list) of products that may be used for cleaning and high-level disinfection/sterilization

My questions are: what standards are out there to validate your cleaning and sterilization procedures to and what must we validate (cleaning, high level disinfection, steam, and sterilization?? And secondly, what 3rd parties may do this validation on our behalf? Lastly, is it necessary for our company to clean the device before it is sent to the customer?

Thanks,
Ash

Click to expand...

Hi,

You may want to take a look at ISO 14937, 17665-1&2, 20857 and 25424.

As a general approach, FDA would require you validate any labelling claims (including marketing verbal ones and sometimes implied ones) regarding cleanliness / sterility [SAFETY]. You probably can't cater for all possible uses and misuses at the end-user level, but to be on the safe side you could preclude some methods which you can't / don't want to validate. Whether or not this would be a good marketing approach is a different issue... As Pkost has mentioned hospitals have their own approaches and styles and not all of them are rational...

I'm not sure that these companies provide this type of service, but I would have checked with NAMSA in the USA or MDT in Germany (I'm affiliated with neither). I'm sure there are a few more out there, just run a web search.

Lastly, If you claim your product is supplied "clean" (a clear definition of this term must be in place) then I reckon yes, you should validate it, as it would be impractical to verify cleanliness of each and every released unit. Otherwise, make sure you state in the IFU that the cleanliness is not guaranteed and the user is required to clean the product BEFORE first use.

Cheers,
Ronen.

Does anyone know where I might find acceptance criteria for particulate matter after either a manual or automated cleaning of a reusable medical device? I know USP has a monograph, but is that not only for pharma use?
Thank you.