x-ray film

[anna m grayson]

Can anyone tell me where I can find in writing why x-ray film cannot be sterilized?
I called the company years ago and they told me they would not do it nor recommend it because it could distort the film. I also know that it has not been cleared by the FDA for sterilization- since the manufacturer never applyed to have it cleared by the FDA. They did not send me anything in writing to confirm this.
It has been awhile since that last incident, and lo and behold its back again.
This time I am told it is "only being used as a marker on the sterile field"----
I tried to explain the reasons why it cannot,(maybe I should have said should not), be sterilized, and he basically told me that it is my thinking that is the cause for patient safety issues. That I am making an issue out of something that shouldn't be. I understand his frustration, since this is one of many old "poor" practices of the past, but I need to show proof- in writing, why xray film cannot be sterilized.
:confused:

[jrc]

Someone asking you for a written declaration that something cannot be sterilized is approaching the situation in a backward manner. We could not possibly have such a written proscription for every item we cannot sterilize. Instead, we have written instructions indicating something is safe for use after sterilization. That is the 510(k) submitted by the manufacturer and approved by the FDA. We are bound by the Food, Drug, and Cosmetic Act, the Safe Medical Devices Act, AAMI/ANSI standards, AORN standards, and internal policies to follow the manufacturer's instructions for use. Any other use is off-label, and is forbidden.

We all face this issue every day (for me it's toothpicks instead of x-ray film), but the answer is the same. Unless the manufacturer has gotten it approved to be used in that way, we cannot sterilize it.

[New CSD Tech]

What about combs and toothbrushes? One department in my hospital sometimes gas sterilizes them.

[jrc]

What about combs and toothbrushes? One department in my hospital sometimes gas sterilizes them.
Can you get written instructions from the manufacturers on how to sterilize them properly? If so, follow those instructions. If not, you can't sterilize them.

This time I am told it is "only being used as a marker on the sterile field"----
Maybe I'm misunderstanding the purpose, but it seems to me they could just use a surgical ruler.