Biocompatibility for endoscope external handle/grip

#1
Class 2 endoscope medical device has a flexible lower insertion portion into the human body and upper body which is a grip/handle controlled by the surgeon wearing a glove. The grip/handle is made from plastic which has no contact to the human body. Does it count as indirect contact if the surgeon holds the grip/handle while touching the flexible insertion part during human body entry? Does the grip/handle requires biocompatibility?
 
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#3
Yes, i did read through the ISO 10993-1. Under attachment G: Glossary, contact, i'm unable to identify whether the grip hold is under non-contact or indirect contact. The surgeon will hold the grip with gloves on and it will not be in contact with patient. What i am not sure is if the surgeon touches the grip and touches the insertion part(which enters patient body), does it count as indirect contact?

• Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue)
• Non-contact – term used for a device or device component that has no direct or indirect contact with the body (e.g., stand-alone software or database), and for which no biocompatibility information would be needed other than confirmation that there is no contact with the human body
 

Ronen E

Problem Solver
Moderator
#4
It's a risk assessment issue.

I tend to think that standard surgery practices do not allow the surgeon to touch anything and then touch the device part that penetrates the patient's body (especially if it's surgically invasive, i.e. does not just go into the gastrointestinal tract, etc.). If that wasn't the case, it would have been necessary to assess a whole array of scenarios where the surgeon touches all kinds of objects and then the invasive device. I can't, however, confidently dismiss the issue because I don't know enough about OR practices, and I also guess they vary from place to place.

I would document to issue in the risk management file (hopefully being able to dismiss this scenario as unlikely). If you wanted more predictability you could ask the FDA about it in a Q-Sub, but it seems a little disproportional with the issue, and it might take too long. You could ask them informally, but the answer will be pretty much worthless - they make sure to not commit to anything they say/write outside a formal process.
 
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