Kimberly clark and One Step wrappers

[nancy42]

We were just informed by Kimberly Clark that their ONE STEP WRAPPERs are not compatible for sterrad. Even though Sterrad company says yes. Any input on this?
Nancy.Gusler@LPNT.net

[Harvey Johnson]

Lots of rumors flying around the past few days about KC wrap, event related sterility and sterrad issues.
Call your KC rep for the facts, they have the documentation to counter the rumors and will email a copy to you.
ASP directs it is OK to use KC wrap, being they are the manufacturer of the machine and have done the testing, should be enough evidence the wrap is approved for use.

[Kristopher]

Since Kimberly-Clark is the original manufacturer of the wrap then it is up to them to do the appropriate testing in Sterrad systems. ASP may have approved the one-step wrap to be used in their systems, but KC still needs to have the appropriate 510(K) clearance through the FDA.
Are we supposed to go about business as usuall even though KC has yet to get proper FDA approval to use their one-step wraps in Sterrad systems?

[Harvey Johnson]

Let's not get too excited..... I am not aware of any adverse events occurring over KC wrap......my business will be as usual.....
Talk with your KC rep, they have the facts.
I received the following this morning, it might help:

Here is an excerpt from the draft FDA guidance for sterile packaging dated March 2002.

C. Maintenance of Package Integrity
An important characteristic of a medical sterilization packaging system is its ability to maintain the sterility of the enclosed medical device under labeled shelf life, transport, and storage conditions. Microbial barrier properties of sterilization packaging should be evaluated after exposure to storage conditions and environmental stresses expected for finished packaging systems. Data should demonstrate that the enclosed devices are sterile and the integrity of the packaging systems during shelf life, transport, and storage is maintained.
Performance testing should be conducted to evaluate the stability of the packaging systems after stressing by simulating labeled shelf life, transport, and storage conditions. After stressing the packaging system, physical testing or microbial challenge testing should be conducted to determine the microbial barrier properties. Physical test data for pouches should show that the physical parameters for seal strength and whole package integrity are still within the original package integrity specifications.

Note that it is still posted on FDA’s website as a draft guideline, so they have not yet adopted it, but it does represent their thinking on this topic. One good thing in this draft is that FDA states that a manufacturer does not need to submit a new 510(k) for an extension of its shelf life claims for sterile packaging if they use the same test methodology that was accepted by FDA in the original cleared 510(k). This means that KC wouldn’t have to resubmit when they have evidence to support a shelf life longer than 30 days – that will allow them to make the claims without FDA review delays.

Reference site:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073304.pdf