One Tray

Re: One Tray

posted by Trista Carter on Jan 24, 2018 12:34 pm

Bradley,

Can you please send me the email from AORN with the statement about One Tray tcarter@slchospital.org. Thank you.

Re: One Tray

posted by Tracy Tiernan on Feb 7, 2018 5:44 pm

TJC and CMS considers One Tray as IUSS.  They stated that the trays cannot be used for terminal sterilization because of the variation from a standard terminal cycle.  This creates two seperate standards of care. 
 
Tracy Tiernan BS, RN, CNOR

Re: One Tray

posted by Tamara Massengale on Apr 13, 2018 1:05 pm

Hi
Could I  please get the AORN recommendation on one tray? We are thinking about getting one tray at our facility.
Thank you
Mara

Re: One Tray

posted by Bradley Jacobs on Apr 15, 2018 9:20 am

Hello Tamara
I cannot speak to AORN recommendations regarding One Tray, as I do not work for, nor represent AORN. In fact, I believe that AORN made a statement a few months ago regarding the One Tray on this thread.

However, I did have an email exchange last summer with a clinical specialist at AORN regarding the One Tray, and I am happy to forward that email to you. If you send me a private message with your work email address, I will forward the exchange to you. 


 

Re: One Tray

posted by Bradley Jacobs on Apr 15, 2018 9:42 am

FYI: to all of the One Tray enthusiasts:
Last week, I spoke with the FDA compliance officer that oversees the One Tray. It was our 4th conversation in the past year. I want to keep abreast of any potential changes regarding FDA status with the One Tray, and so I reach out to her every few months. As of last week, per our conversation, the One Tray was still ONLY FDA approved for IUSS, and NOT for long term storage of sterile instruments. 

To any IST lurkers: Please address any questions/concerns regarding my posts to me directly. Please leave my employer alone. My employer has NO knowledge of, nor any involvement with, my postings regarding One Tray.  

Re: One Tray

posted by Kellie Switalski on Apr 16, 2018 10:41 am

please forward your one tray conversations to Kellie.Switalski@Franciscanalliance.org

Re: One Tray

posted by Wendy Bellesfield on Apr 16, 2018 4:43 pm

I also would like any information or contact information regarding one try. We have a new SPD manager that is recommending this in place of IUSS. And I am not 100% confident that this can be used to replace IUSS. So I am looking for any information to support this either way. I am just beginning to do some research on this product. Thanks for any input. wlbcnor@hotmail.com

Re: One Tray

posted by Bridget Owen on Apr 17, 2018 10:11 am

What is considerd too much condensate in an IUSS tray ? I have seen 20 + ML in a tray and was told by SPD that it is ok ? This seems to me that the tray would be unsterile.

Re: One Tray

posted by Inger Rao on Apr 18, 2018 1:20 pm

We consider any dampness, any moisture present is an indication of an unsterile TRAY.
INGER C. RAO

Re: One Tray

posted by Bradley Jacobs on Apr 19, 2018 7:54 am

According to the One Tray's 510K predicate approval, it was designed for IUSS. It is my belief that the One Tray performs IUSS functions as well as any other tray designed for IUSS. Because there is NO cooling period, one should expect retained moisture in the tray after sterilization. I cannot speak to how much water is too much, at least in terms of IUSS.

My concern is when the tray is used for Terminal Sterilization, or when the tray will sit on the shelf for an extended length of time. In my opinion, retained water sitting in trays for extended lengths of time is a big issue. The One Tray has not received FDA approval for terminal sterilization. Also, both AORN and AAMI address retained water in trays meant for terminal sterilization in their standards and guidelines.

Re: One Tray

posted by Nina Volz on Apr 20, 2018 11:00 am

That WAS the thinking before ONE TRAY.  They have proven the fluid in the tray is sterile and can be used.  Only with ONE TRAY.

Re: One Tray

posted by Margery Hammond on Apr 21, 2018 4:10 am

The problem with retained moisture in IUSS is that you don't know when it occurred.  Was this condensation that happened when staem initially contacted the instruments?  If so, that puddled water created a cool spot within the set that may not have sustained sterilization temperature for an adequate amount of time.  Did the water happen after the chamber door was cracked and the pack began to cool?  Less of an issue because in theory at least the water would have been sterile.  How can you determine at what point in the process the puddling happened?  If you can definitively pinpoint that time, then you can trust the sterility of items with condensation only.  Otherwise you have to reject all wet packs. 

In terms of shelf life, if the container is fluid impervious the water can't strike through the packaging and the instruments should remain sterile.  But who among us wants to risk introducing that water to the sterile field when opening the set?  It may be sterile, but it can strike through the back table drape and contaminate the whole set-up.

Re: One Tray

posted by Bradley Jacobs on Apr 22, 2018 5:56 pm

The water in the One Tray may be sterile when it exits the sterilizer, but for how long will it remain sterile. Since water evaporates out of the One Tray over a period of several weeks or months, we can assume that the One tray is NOT a sealed system. Also, there's another important consideration. There's been two studies that indicate that rigid instrument trays can lose their integrity with use and over time. There was a really good study that was presented in the AORN Journal in 2008 that indicated 10% (3 out of 30) of the trays used in the study tested positive to bacterial presence when opened. (https://www.ncbi.nlm.nih.gov/pubmed/18451394) The One Tray is not immune to this. By googling "One Tray complaints", one of the things that comes up,(https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm489358.htm) is returns due to issues with the seals of the One Tray(#3 in the fda document above). I am NOT suggesting that One Tray has a problem with seals. Rigid instrument containers get abused with extremes in pressure, temperature, and the honest abuse that comes with use of heavy trays in the surgical environment. Like other rigid instrument trays, One Tray does not seem to be immune to this. When rigid containers lose their integrity, bacteria can migrate inside. If the trays contain water, then the bacteria can breed. I believe this is at the core of why both the AAMI and AORN standards and guidelines speak to retained moisture in trays, and why they should automatically be considered contaminated if the contents are not used immediately. Due to the One Tray's Instructions for Use, the trays do NOT go through a cool down period, and condensation (retained water) is formed. If they are placed on a shelf for an extended length of time, how can anyone know what is happening inside of the trays?

To any IST lurkers: Please address any questions/concerns regarding my posts to me directly. Please leave my employer alone. My employer has NO knowledge of, nor any involvement with, my postings regarding One Tray.  

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