Sterilizing Safety Pins

[doc7592]

I had an issue this weekend. A maternity nurse wanted smaller safety pins than the one we currently buy sterile. Someone went to Walmart and purchased gold safety pins and gave them to SPD to process.
This is an ongoing battle with the dept. When I took over as manager in Nov.
we were sterilizing everything(glass syringes, needles, rubber bands, safety pins, bulb syringes) I could go on. I need a easy to read document to show these nurses that we cant do this. I stopped my staff, but have angry Docs since then. HELP:confused:

[Cindy Bee]

We have sterilized our safety pins on a 2x2 gauze inside a peel pack in ETO. and now in Sterrad. No known problems or issues in 17 yrs. My question is why are you not doing these items anymore is it a liability question? You need to have a good leg to stand on when your aggravating the docs.
Good luck,
Cindy

~!~Do it right or dont do it at all ~!~

[HRJohn]

This may be of help:

http://www.fda.gov/cdrh/ohip/guidance/1333.html

The FDA considers us to be 'manufacturers' if we sterilize single use items without possessing and following specific manufacturers' instructions for the item.

As such, we would be required to extensively test and prove both sterility assurance and compatibility with the material being sterilized.

Obviously, that is way beyond the capablility of most of us,

And we are also assuming the liability for both the sterility and the product itself when we do this . :eek:

.

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[has]

This thread was WAAAYYY back in 2006, but I am in the EXACT situation. Anybody have an updated reply to this? The link for the FDA does not work. The doc wants to know why, why, why????? Our policy is-no instructions, no sterilization. Not good enough for him. :(

[Harvey Johnson]

The reason can be found in AAMI ST 79 section 7.2.2 "Manufacturers' Instructions".
"If there are no specific instructions in the labeling, then the manufacturer should be contacted directly to provide the documented method".
The Joint Commission is now also asking personnel for written instructions for processing items during their surveys.
AAMI and Joint Commission aside, if you "open the window" for that Doc, before you know it you will be processing craftsman tools, wood handled screw drivers, home made block and tackle pulley systems, etc.... with everyone asking "well, you did it for the other Doc" reasoning.
Stick to your policies, you are in the right....they will get the message soon enough.

[cpdguy]

You can buy them already sterilized so you do not have to worry. I stocked them all the time ( when I was working in CSSD). It was worth the small cost and I had them ready. Contact me if you want the name of the company ( note it is not my company) off line.

[kmarsh]

I have had similar issues in regards to penrose drains, ace bandages, and other items that were being processed or reprocessed with hydrogen peroxide because some misinformation had been being given to the processing staff. When I came on board, we got letters and e-mails from the product manufacturer's indicating that sterility assurance was not guaranteed with hydrogen peroxide. With this information readily available to inquiries, we have successfully moved away from this practice and found pre-packaged, sterile items for replacements. AAMI and AORN are valuable resources to quote and having manufacturer's guidlines readily available, will generally quiet the complaints. I have also found that having working relationships with the quality assurance folks and infection control are valuable assets when doing the correct processes are contrary to old habits and new requests that do not conform to accepted practice. Stick to your guns...you are right.