Cleanliness Specifications that apply to non-sterile medical devices

C

czielsdorff

#1
All,

I have been doing a little research and I would like to get some input from other sources. I am looking for some cleanliness specifications or standards that apply to non-sterile medical devices.

We manufacture medical devices and distribute them sterile and non-sterile. I certainly understand that there are several specs and standards regarding sterility levels (SAL, Dose Audits, VDmax, etc) but I am more concerned with non-sterile. We also provide Instructions for Use that clearly state how to sterilize products at the hospital (steam sterilization) when provided non-sterile.

However, we are trying to justify / specify non-sterile cleanliness standards (Particulate Counts, Cytotoxity levels, Total Organic Carbon, etc) and there appears to be no available standards. Basically I am finding that we as a company should pick our own specifications and have some justifcation as to why. Then we need to validate our cleaning process achieves those defined standards.

Is this accurate? Are there available (non-sterile) cleanliness standards for implants (class 2 devices) or instruments? If not, are their industry standard levels that are generally accepted? Or any levels you are willing to share (or have seen in the past)? I am assuming some of this information would be confidential to your company, so I certainly don't want you to give any information you shouldn't.

Sorry for the length of this post, but I am looking for something specific that my searching has not come up with.

Thanks,
Casey
 
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Q

Qualqueen

#3
However, we are trying to justify / specify non-sterile cleanliness standards (Particulate Counts, Cytotoxity levels, Total Organic Carbon, etc) and there appears to be no available standards. Basically I am finding that we as a company should pick our own specifications and have some justifcation as to why. Then we need to validate our cleaning process achieves those defined standards.

Is this accurate? Are there available (non-sterile) cleanliness standards for implants (class 2 devices) or instruments? If not, are their industry standard levels that are generally accepted? Or any levels you are willing to share (or have seen in the past)? I am assuming some of this information would be confidential to your company, so I certainly don't want you to give any information you shouldn't.

Thanks,
Casey
We're an ISO 13485 and 9001 Class 2 supplier also and all I can do is offer our rational for exclusion. As far as I know there is no industry standard level standard for implants that are class 2. Attached is our reasons for the exclusions. Hope some of this helps. View attachment 13485 2003 exclusions.docx
 
C

czielsdorff

#4
We're an ISO 13485 and 9001 Class 2 supplier also and all I can do is offer our rational for exclusion. As far as I know there is no industry standard level standard for implants that are class 2. Attached is our reasons for the exclusions. Hope some of this helps. View attachment 11276
Thanks for the info. The one item that I am interested in is in your rational side for sterilization. It states, "Products are supplied clean to customer's specifications." This is what I am interested in. Is there any non-proprietary information regarding these cleaning specifications you can share? If not, I understand.

Thanks,
Casey
 

chris1price

Trusted Information Resource
#5
Hi

I use to make non-sterile anaesthetic airways which were subsequently sterilised by the user. I am not aware of any standards for cleanliness. We ran routine bioburden tests on finsihed product and assigned our own limits.

We also had to validate that when in the worst case of contamination, that using typical SALs, the user would be able to sterilise them.

Chris
 

Ajit Basrur

Staff member
Admin
#6
Hi Casey,

Probably, you could have a look at ISO 11137 - it offers some valuable info on the non sterile medical devices that would be sterilized later. I agree with Chris that Bioburden is an important indicator in the scenario that you stated.
 
L

Laura Halper

#7
Hi Casey,
Let me add to what Chris has said.

The FDA has a Guidance document for reviewing 510(K)s for sterile devices and for devices which are sold non-sterile where the user must sterilize before use. Here's what it says about the latter:

"For NONSTERILE devices which must be sterilized prior to use or for devices which a sponsor states in the 510(k) that they may be RESTERILIZED:

1.Identify a recommended set or sets of sterilization process parameters (for steam - the cycle, temperature, and exposure time; for EtO - temperature, humidity, gas concentration, exposure time, and aeration cycle).
2.Provide the Sterility Assurance Level (SAL) you intend to meet or met ( <10-6).
3.Identify the sterility validation method that will be used or was used (e.g., AAMI).
4.If the sterilization method is EtO, then identify the maximum residual levels of ethylene oxide, ethylene chlorohydrin and ethylene glycol that will be or were met. These levels must be below those limits proposed in FR 27482 (6/23/78).
5.If provided nonsterile, provide sample package labeling that reflects some type of nonsterile notation.
6.Provide a sample package insert that reflects the sterilization process parameters.
If the process parameters have not been validated, then state that the validation will be completed prior to marketing and that the package insert will be revised to reflect the validated parameters."


So you should use a cleaning process that provides on-going bioburden control such that the validated sterilization procedure can provide the necessary SAL. With gamma irradiation, for example, you determine the sterilization dose based on the bioburden. The requirement for your cleaning process would be that, assuming worst-case bioburden (which will depend on incoming materials, your processing methods and environment), the cleaning process will result in reducing bioburden to the level used in the sterilization validation. You can do this by running some tests using bioburden challenges with your cleaning procedure.

In a nutshell, the cleaning requirements are the same as if you provided the device sterile.

Regards,
Laura
 
C

czielsdorff

#8
All,

Thanks for the informative replies. It seems that you are confirming what I thought; we need to establish our own specifications and verify that they are acceptable (achieving SAL) and then prove that we meet our specifications.

I would like some additional clarification. I understand that bioburden is critical when determining dose levels, but this is really only to make sure that whatever is on the device is dead after sterilization. It is still there, but no longer viable. What about other contaminants that may have an impact on the patient? Pyrogens, oils, cytotoxic chemicals, etc. Do your companies check for these (or others) in addition to the bioburden?

Thanks,
Casey
 
B

brandomenon

#9
The bioburden only covers the low dose portion of a specification (irradiation specific). You absolutely need to test for pyrogens, toxins, etc with respect to setting the maximum tolerated dose for the product. The more you irradiate a product, the more byproducts you will create (especially with plastics). The same is true for EtO - there are residuals on the product that need to be tested for.

Unfortunately, there isn't a simple guideline for setting limits. Typically, whatever you can justify in your submission is the limit. Keeping bioburden low to begin with does have the added benefits of reducing a sterilization cycle (lower dose).
 
C

czielsdorff

#10
What about tests before sterilization? We use gamma radiation, but for parts provided non-sterile, we prescribe steam sterilization (with specific cycle times). From my understanding, these will not result in additional toxins and pyrogens, so we want to check for these before.

Are there specific (i.e. ASTM) test protocols that your companies are using?

Thanks,
Casey
 
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