SAL (Sterility Assurance Level) for High Level Disinfection vs. Sterilization

[Broccoli]

Hi,

I read somewhere that the SAL for High Level Disinfection is 10^-3 verses a SAL of 10^-6 for sterilization. Now I can't find the source and I am wondering if I was dreaming.

Does anyone know if for a FDA class II medical device if a tested SAL level of <10^-3 (but not <10^-6) is sufficient for claiming High Level Disinfectability?

Thanks!

 

[Marc]

Re: SAL for High Level Disinfection vs Sterilization

For those of us with inquiring minds who are not in this field, what is SAL?

 

[harry]

Re: SAL for High Level Disinfection vs Sterilization

For those of us with inquiring minds who are not in this field, what is SAL?

Sterility Assurance Level

 

[harry]

Re: SAL (Sterility Assurance Level) for High Level Disinfection vs Sterilization

Check this: Directory of open access journals - The limits of sterility assurance

Proceeding from this, we would like to make the following suggestions for tiered SAL values, adjusted according to the respective sterilization task: * SAL 10–6 for heat-resistant pharmaceutical preparations (parenterals), suggested term: “Pharmaceutical sterilization”, * SAL 10–4 for heat-resistant medical devices, suggested term: “High-level sterilization”, * SAL 10–3 for heat-sensitive re-usable medical devices, under the precondition of a validated cleaning efficacy of >4 lg increments, suggested term: “Low-level sterilization”.

 

[MIREGMGR]

Are you referring to using a germicide with a High-Level-Disinfectant indication that also has a Sterilant indication, under its required Sterilant use-conditions?

Two FDA reference documents:

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants

In the latter document, the following statement appears:

"A SAL cannot be inferred for a device sterilization claim based on this recommended testing protocol."

(FDA's emphasis.)

 

[WilliamS]

The FDA has clear guidelines for validation of "sterility" (10-6) and HLD (10-).

I've worked for 2 medical device companies (not Pharm) who's products fall into one or both of these areas. Both have validated there processes and passed FDA Audits.

There's no need to try and rename these "levels of sterility assurances. It should be remembered that even at 10-6, there is the mathimatical probability that there will be one non-sterile package.

 

[Broccoli]

Thank you WilliamS
Could you please check the first line of your response again and tell me what the power of HLD you were trying to enter was?

The FDA has clear guidelines for validation of "sterility" (10-6) and HLD (10-).

Also, do you have a reference for this?

Thank you !

 

[dendrenn]

Hi Broccoli, I realise that this is probably coming a little late for you but as I came across your post while I was looking for this information myself, I thought I would leave my findings for future reference.

I don't have sufficient 'Cove' experience to post you the link directly but if you Google the 'CDC Guideline for Disinfection and Sterilization in Healthcare Facilities', in it you will see that:

The FDA definition of high-level disinfection is a sterilant used for a shorter contact time to achieve a 6-log10 kill of an appropriate Mycobacterium species.

This on the face of it looks like an equivalent requirement to that of sterilisation i.e. a SAL of 10^-6, but I believe it is the fact that a mycobacterium species is used for validation that makes the difference; high-level disinfection is not required to kill anything beyond mycobacteria e.g. bacterial spores:

Unlike sterilization, disinfection is not sporicidal. A few disinfectants will kill spores with prolonged exposure times (3?12 hours); these are called chemical sterilants. At similar concentrations but with shorter exposure periods (e.g., 20 minutes for 2% glutaraldehyde), these same disinfectants will kill all microorganisms except large numbers of bacterial spores; they are called high-level disinfectants.