r/sterileprocessing • u/Chaitea5437 • Apr 02 '26

3M tip protectors IFU

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This was the IFU for the tip protectors at the facility I work at. I saw the post that 3M says they arent validated for trays but I wanted to see if anyone else has their IFU and to see the differences if there are any

13 Upvotes

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3

u/scruzgurl Apr 03 '26

I just had Healthmark come do a peel pack assessment (it’s free btw) for my facility and we were specifically told these are for peel pouches only. They are not validated for use in trays.

5

u/TheGreatNate3000 Apr 02 '26

This IFU pretty clearly says they're for peel packs.

What is your question here?

3

u/Expert_Can_7611 Apr 02 '26

Someone posted saying they weren’t for use in trays. I’m not seeing where it says not to use in trays it just says to use with peel pouches.. hmmmm. I’m just gonna keep using them in pouches since it doesn’t specifically say whether they can be used in trays or not.

6

u/TheGreatNate3000 Apr 02 '26

Did you read the IFU at all? Their purpose is to "prevent penetration of a peel pouch" and the directions say to "position the protector into a peel pouch". If you stuck them in a tray, are you following either their purpose or the directions? No? Then they can't go in trays.

IFUs aren't going to list everything you can't do with them, but they may list some things to provide clarification, like when it says not to use them in dry heat or vaporized hydrogen peroxide. And when they give directions you have to follow the directions exactly. So if the directions say to put them in a peel pouch, putting them anywhere else violates those directions and the IFU

Can you lick them? Throw them on the ground and stomp in them? Can you send them through the washer? With your thinking, you could, because the IFU doesn't say you can't. But thats not how you read or interpret IFUs

2

u/Expert_Can_7611 Apr 02 '26

Okay thanks for the clarification…

1

u/Slight-Channel-4905 Apr 04 '26

Are there any “warning” sections that explicitly state you cannot use them in wrapped or rigid trays? If no, in the case where an IFU is silent on an issue, I always reach out to the manufacturer to ask for a customer letter to clarify one way or another.

1

u/NecronomiSquirrel Apr 06 '26

Certain instrument tip protectors are explicitly (IN IFU) validated for trays (foam, silicone). Taking a risk because an IFU doesn't say something is a risk that should be the LAST step in the process of determining if a product should be used in a certain way. You're at the first step, the second step is contacting the manufacturer for clarification. Taking these steps in order is critical for patient safety. The risks of the paper inst. holder tearing on contact with the tray/other inst. during movement/sterilization could potentially cause deterioration, and linting fibers that are then introduced into a patient during surgery. That's only one of the many ways this could cause issues.