Non-sterile reusable surgical instruments - FDA sterilization requirement

#1
Hi everyone!
My device is a reusable stereotaxic screw for temporary fixation to the bone for surgical navigation.
It is made of stainless steel 630 and is provided non-sterile.

After reading FDA guidance, I'm still very confused what sterilization validation is needed. Is the reprocessing validation enough? Or should I provide a large sample size to validate the initial sterilization (this is what I learned from the lab)?

Somehow in my opinion the reprocessing validation is enough for the device, and I hope to avoid unnecessary tests. But I'm new to the industry worrying about making mistakes.:bonk:
I would be grateful if anyone could help. :thanx:
 
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monoj mon

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#2
Or should I provide a large sample size to validate the initial sterilization
If your device is expected to be sterilized by the user then you will need to provide a validated method of sterilization in the IFU. And for that you will need to validate the sterilization method first hand, with appropriate amount of sample size.
I hope to avoid unnecessary tests
I am afraid you cannot avoid it. It's your device, and you cannot expect the user to know how to sterilize the device without reading a single word about it in the IFU.

With our re-usable devices we usually provide multiple (if possible) validated sterilization methods which are readily available at the hospital setting as well as multiple re-processing methods so that users have the liberty to choose any one of it and still remain confident on the sterility of the device.
 

planB

Super Moderator
#3
CreamXX,

for devices distributed in the US, reprocessing consists of at least the two processes cleaning and sterilisation. You are expected to validated each of these two processes and associated labelled instructions independently.

Being new to the industry, you may want to seek professional support, because these validation activities might be quite complex. There are consultants as well as certified and accredited test houses around that support you with putting together a sound validation protocol.

Hope this helps,
 
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