For a class 1 device if you state in the IFU, Technical file or design history file that the device is autoclavable, do you need to conduct bioburden by a outside test lab on the device to justify that statement? Is there anything public that could be used instead as justification?:confused:

A few years ago, we had a device that the user was expected to autoclave between uses. To validate the method, we exposed the device to a blood mixture laced with high numbers (>106) of spores. These were then washed and autoclaved and shown to be sterile. We did a bioburden count a device that had been used clinically and compared it to the bioburden on the test device to show that the device would be sterile in the worst case.

Without doing the tests, I dont think there is any other way of validating the process.

When validating a device for multiple uses after user cleaning and re-sterilization, when the device has mechanical joints and other internal cavities and is exposed in normal use to typical protein-containing biological contaminants, does the required validation encompass only the sterilization process?

We don't do multiple-sterile-use devices, so I don't have any relevant experience, but I've been under the impression that the device maker has some degree of responsibility for guiding the end user in the entire process of getting the device to sterile condition before re-use. My understanding has been that that includes cleaning as well as the autoclave process. Cleaning of dried proteins within mechanical joints, as far as I know, is non-trivial because of the lack of means for verification. Is my understanding correct, and if so, what impact does that have on the validation process?

Absolutley right, making sure the device still works after repeated cleaning and sterilisation is frequently more difficult than the sterility.

Is this nessesary for each device type or each family of the device?

For example: we make 4 kinds of widgets, does each kind need its own validation?

Is this nessesary for each device type or each family of the device?

For example: we make 4 kinds of widgets, does each kind need its own validation?

We make many dimensional variants of many design-classes of disposables. For our third-party,multi-pallet, industrial-scale EtO sterilization process, we determine (and document the process for determining) our Process Challenge Devices and Process Challenge Load Locations.

I'd think that in your validation process, the Process Challenge Device concept would be applicable as well.

Absolutley right, making sure the device still works after repeated cleaning and sterilisation is frequently more difficult than the sterility.

The potential mechanical effects of unremoved contaminants in joints could become significant, but actually I was referring to possibly not being able to validate a sterilization process if unremoved contaminants could be present but undetected in joints or cavities.

You are right, contamination can reduce the effectiveness of the sterilisation. We tested worst case products within a family, usually largest and smallest.