white cotton gloves

[anna grayson]

Is anyone currently sterilizing white cotton gloves for use by a surgeon during a surgical procedure? The gloves will not be worn under the sterile non-latex gloves, but rather over the gloves during a point in a procedure and then removed.

I informed the OR nurse that there are many reasons why it cannot be done. from the who and how will they be washed and dried to not having sterilization instructions, to the possibility of causing granuloma's from the lint- she agrees, but the surgeon keeps insisting that another hospital use to do this all the time.
Any suggestions?

[jrc]

I have never been asked to sterilize cotton gloves, but this kind of situation goes on with so many things.

Assuming you are in the United States, I would find the kind of gloves the surgeon wants and contact the manufacturer for cleaning and sterilization instructions. If they give them to you, great! If you cannot get those instructions, then it is not approved by the FDA to be used in that manner. No FDA Approval = No Use of That Item.

Stick to your principles and to federal regulations. Remember, you have control over what gets sterilized in your department.

[anna grayson]

Thank you for your quick response and support inmy position that unless an item comes with cleaning and sterilization instructions- it doesn't get sterilied.
Have a great week

[jrc]

We all go through the same thing with countless items. Somebody wants some nonmedical device sterilized, or they want a medical device sterilized even though it has not been approved by the FDA to be used in that manner. I had a surgeon who wanted reusable blood pressure cuffs sterilized, and I had to say I could not do it. My favorite nonmedical device I saw sterilized is toothpicks in the cap of a saline bottle :confused:

What it all comes down to is this: in the United States, any manufacturer of medical devices must submit an application to the FDA for a new device. The application must demonstrate that the manufacturer has validated the device is safe under the specific conditions of use listed. This includes reprocessing and reuse instructions. If the FDA approves it for use, it is only in the specific way described on the application. If the manufacturer has not validated the device is safe after reprocessing, then, obviously, the FDA has not approved it for use in that manner. If you reprocess the item, you become the de facto manufacturer of the reprocessed device and assume all liability for its safety. That is not a position you want to take.

[sonny1388]

I agree completely with both jrc. It is always a difficult situation to be in when you get the argument "We have always done it that way" or "This other hospital would do that for me"especially from a physician. It is hard for people to grasp that just because we have done it in the past doesn't mean that it is okay. The easiest way I have found is to pull copies of the documentation saying that you can't do it. Then it's not your word against theirs anymore, it's a legal issue. I have not had any problems after that.

[jrc]

The easiest way I have found is to pull copies of the documentation saying that you can't do it. Then it's not your word against theirs anymore, it's a legal issue. I have not had any problems after that.
I keep a copy of the FDA regulations booklet 21 CFR 820 for that purpose.