Sterilizable Medical Device Requirements

[Nancy Allen]

Hello and Happy New Year to All,
Not sure if this is the correct forum - this is really a pretty specific question, but if anyone has any experience, I'd appreciate your thoughts. We sell class 1 devices that are used to position patients in the operating room. One is sterilizable. We are looking to distribute a sterilizable case (class 2) that is maunfactured by another company which we would like to market with our device. In order to sell them together, what must we do?
Is it necessary to validate the sterility of the combination? Would it be considered a "kit"?
Thanks Much!

 

[MIREGMGR]

In spite of this question being in the ISO 13485 forum, I assume from the cited classifications that you're focusing on US FDA requirements. EC requirements are similar, though more complicated.

Yes, this will be a kit. You will be both a kit packer and the manufacturer of one of the kit components. You must appropriately fulfill both roles.

If you sell a product (in this case, a kit) that claims or implies sterilizability by the user, you must validate the specified sterilization method and document that specification for the customer. (Which might consist of referencing an appropriate standard that their process must meet.)

If you've been selling the Class I device as user-sterilizable, you already should have sterilization validation data for it. You will only need to re-run parts of that validation with your kit's sterilization case instead of (I assume) a user-supplied case or other method of device-holding.

 

[Nancy Allen]

In spite of this question being in the ISO 13485 forum, I assume from the cited classifications that you're focusing on US FDA requirements. EC requirements are similar, though more complicated.

Yes, this will be a kit. You will be both a kit packer and the manufacturer of one of the kit components. You must appropriately fulfill both roles.

If you sell a product (in this case, a kit) that claims or implies sterilizability by the user, you must validate the specified sterilization method and document that specification for the customer. (Which might consist of referencing an appropriate standard that their process must meet.)

If you've been selling the Class I device as user-sterilizable, you already should have sterilization validation data for it. You will only need to re-run parts of that validation with your kit's sterilization case instead of (I assume) a user-supplied case or other method of device-holding.

Thanks so much for your response. Yes, I was focusing on the FDA requirements, though we are also ISO13485 certified. Everything you say makes sense. I did receive some updated information from our marketing group - the intention is to sell the items separately (not kitted), which makes life a lot easier. I expect, though, that if we are marketing foe use with out product, we stuill need to do the strilization validation...... We have not been sellling a case with our product. It is the requests that have initiated this project!