I am having a hard time determining what sterilization standards to validate our reusable medical device to. Years ago we used ANSI/AAMI ST35 and ST46. Now we have been told to use ST67, 77 and 79.

Is there any way to comfortably determine which standard is applicable?

I am having a hard time determining what sterilization standards to validate our reusable medical device to. Years ago we used ANSI/AAMI ST35 and ST46. Now we have been told to use ST67, 77 and 79.

Is there any way to comfortably determine which standard is applicable?
I'm sure that I can help, but need more information. What sterilization method are you using? Are you reprocessing for the customer, or providing instructions for them to do it themselves? Do you propose cleaning and disinfection steps in addition to sterilization? What CDC category are your products in critical, semi-critical or non-critical? What markets are you selling into?

Reusable products have multiple stages of validation above and beyond the "usual" ISO sterilization series (ISO11135/ISO11137/ISO17665), including the minimum information to be provided to the end user, pre-treatment requirements (partial disassembly etc.), cleaning, disinfection, sterilization, packaging, drying, inspection & testing, storage blah blah...

If you can give me the info I can tailor a more specific response,

Jimmy

Jimmy,

Thanks for your help! I have answered most of your questions and look forward to your response.


What sterilization method are you using? steam autoclave 135 degrees 3.5 minutes
Are you reprocessing for the customer, or providing instructions for them to do it themselves? we provide the instructions so they can do it themselves
Do you propose cleaning and disinfection steps in addition to sterilization? cleaning is a wipe down with an appropriate cleaner & disinfection is using a surface disinfectant
What CDC category are your products in critical, semi-critical or non-critical? non-critical (I think so - the instrument should not touch mucosal membranes but will be held while an attachment touches the mucosal membrane. The most it might touch is a lip. Bodily fluids could splatter on the instrument))
What markets are you selling into? dental offices
Pretreatment Requirements: disassemble the one part to be sterilized and place in pouch

The equipment box should be cleaned and disinfected, and the instrument should be cleaned, disinfected and sterilized. We are not selling it as "sterile".

Thanks, that helps to narrow it down. I think I would hedge your CDC classification and go with semi-critical because of the possible oral contamination route - this should have no effect on you as you have chosen sterilization anyway, although you technically only require HLD.

I recommend that your first port of call is AAMI TIR12:2004 which gives guidance on the design, testing and labeling of reusable medical devices. This document guides you through the expectations of decontamination, disinfection and sterilization.

ANSI/AAMI ST81 is the US standard covering resterilizable medical devices, specifically targeted at the labeling and literature provided to the customer to allow them to reproduce the validated methods you originally employed to clean, disinfect and sterilize the devices. (ISO17664 is similar)


As for the other standards you mention:

ST67 is the Grandfather of sterilization documents, and really just tells you what sterility assurance level you require.
ST77 is all to do with containment devices for MD disinfection and is only relevant is you are using a manual cleaning method, or noxious chemicals
ST79 is a standard aimed at informing a hospital device reprocessing department how to reprocess devices safely. It can be a useful reference for you to design your devices so they can be reprocessed using a standard methodology. (ST79 incorporates ST33, 35, 37, 42 and 46 into a single large document which explains why you have been redirected)
For your steam sterilization process I recommend that you follow ISO17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Former Designation: AAMI ST25) which should tell you all you need to know.

By the way, I applaud your decision to use a 135 degrees C for 3.5 minutes; I like the high temp, short time approach as it puts less stress on the device and has a much higher degree of sterility assurance (your cycle is equivalent to 87 minutes at 121 degrees)

Let me know if this helps, or if you need more information

Jimmy

Jimmy,

Your response is wonderfully informative. I now have a building block. Next step - lots of reading. :)

Thanks for everything.

We are in a similar situation We have an FDA class 2 device that is to be used in abdominal organ surgeries. We have several components of the device that will be in the sterile field, and one of those components will briefly be in contact with the patient. We are not supplying the products sterile, however, we need to give instructions to the end user as to how to clean and sterilize these items. We will be validating using both STERRAD and EO sterilization. I am currently reviewing ISO 17664, and I see that disinfection is referenced. Is it necessary to use a disinfectant when you are following the cleaning process with sterilization? The cleanser we validated specifically stated that it is not a disinfectant. Also, must we be specific in our instructions to the end user as to how to package these items prior to sterilization (single peel pouch, double peel pouch, instrument tray wrapped with 2 sterilization wraps, etc), or is that too specific? Also, if we are specific, all ways of packaging must be performed during the sterilization validation, correct? I appreciate any advice/input!

We are in a similar situation We have an FDA class 2 device that is to be used in abdominal organ surgeries. We have several components of the device that will be in the sterile field, and one of those components will briefly be in contact with the patient. We are not supplying the products sterile, however, we need to give instructions to the end user as to how to clean and sterilize these items. We will be validating using both STERRAD and EO sterilization. I am currently reviewing ISO 17664, and I see that disinfection is referenced. Is it necessary to use a disinfectant when you are following the cleaning process with sterilization? The cleanser we validated specifically stated that it is not a disinfectant. Also, must we be specific in our instructions to the end user as to how to package these items prior to sterilization (single peel pouch, double peel pouch, instrument tray wrapped with 2 sterilization wraps, etc), or is that too specific? Also, if we are specific, all ways of packaging must be performed during the sterilization validation, correct? I appreciate any advice/input!

Hi there,

I recommend that you contact Jimmy from the above responses. He is very knowledgable.:D

Hi g1853,

According to the FDA (US Food and Drug Administration (1996) "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance" Office of Device Evaluation - Appendix 1) HLD is for use when a device cannot be sterilized, so cleaning followed by sterilization, OR cleaning followed by HLD, not cleaning then HLD, then sterilization (Sections 3 and 6g). The key differentiator is the sterility assurance level required (HLD is 10^-3, sterilization is 10^-6). In both cases you have to demonstrate that cleaning removes a suitable test soil rendering the device ready for sterilization (AAMI TIR30 is best guide for test soils and cleaning validation)

As to your second question - yes you need to be specific, but you also need to ensure that any wrap/packaging you specify is readilly available to the hospital/reprocessing unit. Thus the use of Steriwrap is commonly specified, but the use of a vacuum-forming packaging machine is beyond their capabilities. You are absolutely right - you need to validate all packaging configurations that you specify, especially with the two sterilization methods you propose, which are very dependent on gaseous penetration.

Let me know if you want more info on this, I am happy to help,

Regards,

Jimmy

Thanks for the info, great forum. I'm an engineer that's manufacturing a semi-critical mucosal contact single-use disposable. I've found lots of info on how reusable devices are to be processed, but does anyone have insight on the initial as-supplied Sterility assurance level for a semi-critical disposable(non-resuable)? After reading AAMI ST67, our device falls under HLD by Spaulding category, SAL 10(-3) by AAMI ST67 category, not true SAL10(-6) sterility, so can't be labeled sterile/isn't required to be sterile. So are all these "non-sterile" devices ( tongue depressors through urinary catheters) sold/supplied with an SAL10(-3) or are they "just clean"? I'd appreciate any insight

I assume from your location that your regulatory context is primarily FDA, even though this is the 13485 forum.

FDA Guidance K90-1 addresses sterilization processes. It specifies that the standard SAL for all devices is 1E10-6, except those which contact only intact skin for which 1E10-3 is acceptable. The FDA normally distinguishes skin from oral mucosa, so I think it's clear that oral mucosal contact would require 1E10-6.

I think, then, that the only question regarding a product is whether it's an FDA medical device, or a non-device.

To pick one of your example products, tongue depressors definitely are devices; they fall into FDA regulation 880.6230, product code FMA, Class I, which encompasses such devices in either sterile or non-sterile form. They're mostly exempted from GMPs if non-sterile; not exempted if sterile.