Load Control labels

[CanadianTech2]

Is there a specific standard that states that a processed item without a load sticker is considered contaminated and should then be re-processed? I've read in the Central Services textbook (7th edition) from Purdue that an item 'should' have a load control label and further down the page it says the item 'must' have a load control label. :confused: CT

[allis]

Is there a specific standard that states that a processed item without a load sticker is considered contaminated and should then be re-processed? I've read in the Central Services textbook (7th edition) from Purdue that an item 'should' have a load control label and further down the page it says the item 'must' have a load control label. :confused: CT

This is a very good question, and I also would like to hear what others think! Before saying an " item without a load sticker is considered contaminated and should then be re-processed", we need to ask why an item needs a sticker. My facility uses stickers only for the purpose of recalling. Does anyone use stickers for a different purpose? I am confused too!

[sunshine]

We use the sticker only for recall purposes. We do write the date processed on the tape. We would not reprocess if an item did not have a sticker.

[stoney704]

How can you recall an item if it doesn"t have a load sticker on it?

[Harvey Johnson]

Why wouldn't you take the time to reprocess an item that either didn't have or lost the load sticker?
The time to reprocess is time well spent rather than taking more time to back track in the OR if when opened, the item's internal integrator indicates not sterile.
AAMI ST 79 Section 10.3.1 addresses lot control numbers:
"Each item or package intended for use as a sterile product should be labeled with a lot control identifier."

[stoney704]

You nailed it right on the head with the AAMI standard. The lot control number is needed for sterile items intended for use. Now if an institution has an automated traking system the lot number is already in the barcode that identifies that tray, which is specific and unique. This is and probaly the only way to move from actual stickers. What are your thoughts?

[allis]

How can you recall an item if it doesn"t have a load sticker on it?
In my facility, we don't count on stickers to recall items. We are using the ABACUS SYSTEM by Priority One. It's a wonderful tool to us!

[CanadianTech2]

AAMI ST 79 Section 10.3.1 addresses lot control numbers:
"Each item or package intended for use as a sterile product should be labeled with a lot control identifier."

There it is! The 'should' not the 'shall'. Managers can spot that at ten paces.

[Harvey Johnson]

I'm not sure what you are trying to say, CT2?
All of AAMI is recommendations for best practice, not requirements, so you will see wording suggesting "should" or "shall" or "must" in place of "required".
Legislating required practices in the U.S. is up to the FDA, CDC, OSHA, etc.

[CanadianTech2]

What I am commenting on is that at my facility, a should is not held to the same level as a shall. For me, common sense should prevail, especially if a 'should' recommendation can be accomplished with very little time, money and/or effort. Just to give you a round figure example . . . we have ten processed items on our shelf and one without a load sticker . . . I would say common sense would be to reprocess it but since the recommendation is a 'should' then it is this facility policy to leave it as is.

[Harvey Johnson]

I appreciate the reply, have read it three times and..I......I....
(I guess I should {or shall?} brush up on my Canadianese)....;)

[Chuck Hughes]

Dear CanadianTech2,

As a member of IAHCSMM, AAMI and CSA, allow me to chime in on this discussion. Harvey is correct in that AAMI documents use the word "should" to express a recommendation; however, these recommenations are adopted by ANSI as our American National Standards which means they reflect best practices. Adhering to standards is important for any organization as they reflect the values of that organization. I trust your facility strive to support best practices and therefore, I suggest you present it that way to peers. That being said, you may not be aware that the updated Canadian Steam document Z314.3-09 published in March of 2009 states..."Packages shall be labelled with sterilizer load identification information, including i. sterilizer number, ii load number of that sterilizer, and iii sterilization date. In CSA Standards, "shall" is used to express a requirement, "should" is used to express a recommendation, "may" is used to exprss an option and "Can" is used to express possibility or capability.

If you would like to discuss this issue further, I welcome the opportunity and can do so offine.

Cheers,

Chuck Hughes
GM/Lead Educator
SPSmedical Supply Corp.
1-800-722-1529 www.spsmedical.com

[CanadianTech2]

Thank you very much, Mr. Hughes, for your detailed answer. It does get difficult following standards, recommendations, best practices, etc. especially when one is educated by an American institution (Perdue) while trying to formulate an up-to-date standards documention here in Canada for our own facility. Yes, we are trying to use all the aformentioned documentation and it can get slippery with the wording at times.

On a side note, I recently read some documention that states "Each item intended for use as a sterile product must be labeled with a lot control number, a control date for stock rotation, and the following statement: 'Product is not sterile if packaging is open, damaged, or wet. Please check before using.' This is referred to as an AAMI draft. Does anyone attach this statement to every item their facility processes? CT