Kimberly Clark Wrappers

[lemmons]

I am trying to find an alternative for Kimberly Clark wrappers since they are only validated for 270/4minute cycle. Can anyone recommend a wrapper that they are using that meets their needs for extended cycle trays? The size of wrapper needed is 54 x 72. Thank you in advance for any help with this.

[Donna Arnholt]

I have a letter from kimberly-clark dated 8-14-2007 addressing the issue of extended cycles and their wrappers. Kimguard was tested with extended exposure times up to thirty-minutes using prevac @ 275. Strength, barrier, lint, and repellecny were tested and compared to the commonly used three minute exposure time. No negative performance differences were found.
donna

[mklane62@gmail.com]

There is a great deal of updated information out there from K-C and it is even more constricting than the information that was originally disseminated. An alternative to K-C is Gemini Wrap from Medline or Asepti-Wrap from EcoLabs.

[Harvey Johnson]

Are any other alternative wraps validated and FDA approved for extended cycles?

[mklane62@gmail.com]

To my knowledge - no. KC wrap has been in my radar for quite some time, and when KC came out with their newest IFU that is just casually placed in their product box, I had all the ammunition I needed in order to quit using the product.

[Harvey Johnson]

I guess if KC wrap has "been on your radar for quite some time" you must have issues other than the latest directives.
And what type of instructions will come with the other mfr's wraps?
Are you really gaining anything by switching?
My point is KC is the first mfr so far to be called on the carpet by the FDA regarding validated cycle times and required to place the IFU as part of their compliance.......
If you have knowledge either of the two wrap mfrs you are recommending have IFU's citing extended cycle validations (and approved by the FDA), please share with us.
Otherwise, I suggest you do as multiple agency best practices recommend with any mfr's wrap; perform validations and record in detail your processes to assure conditions have been met (and maintained) for sterility.

[lemmons]

Thank you for the response. With the new DFU that state only 270/4 min. and EtO I was concerned with all the extended cycles and gravity cycles. I will look at the other wrappers or the validation process.

[mklane62@gmail.com]

I have plenty of documentation and in fact, KC was not "the first mfr so far to be called on the carpet by the FDA regarding validated cycle times and required to place the IFU as part of their compliance........" Their citing had to do with the selvedge they put into the wrap. If one took the wrap and looked at it closely it is easily noted that there are holes. Then if one looked at it under a microscope on the selvedge edge it would be even easier to see why there was an issue, and in fact still is an issue.

The wrap being marketed by EcoLab is actually manufactured by ARJO Wiggins a French Company that has the majority of the European Market, and who manufactures the filters that we (all of us using disposable filters) are using from Aesculap.

I'm merely saying that there are alternatives and there are quite a few of us looking at alternatives; however, we continue to monitor the predicate devices.

[Harvey Johnson]

Selvedge....hmm, that's a new one for me. Looking up the definition, selvedge is the finished edge of woven material.... I don't recall that being an issue with the FDA and Kimberly Clark.
All multi layered wrap must have filtration in the design.... it is after all a sequential layered filter, which allows sterilant penetration, and isn't manufactured to be a solid shell containment device.
Reading the warning letter:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048253.htm
doesn't mention edges or holes, rather the unapproved modification of the layers as an issue.
The KC response letter also does not address the issue of edges or holes: http://www.ncahcsp.org/Misc/KC_Customer_Letter_June_4.pdf
Please cite references from your plenty of documentation so we all may be enlightened?

[cpdguy]

Harvey, as aways great CSSI work. I have not been abe to find anythig dealing with
"selvedge" ; but we all know that is the key to the one step, how it is sealed.

Best source is just to call KC up ( one of the users) and ask if this information is true.

Here in the MidWest we say getting in writing.