One Tray

One Tray

posted by Jonathan Pitner on May 23, 2016 6:33 pm

I am curious if anyone has any experience with or exposure to the One Tray from Innovative Sterilization Technologies.  It is a tray used with IUSS and is advertised as meeting all requirements of a normal sterilization cycle.  Here is one of their advertisements:

ONE TRAY® Sealed Sterilization Containers allow clinicians to rapidly process surgical instrumentation in response to unpredictable demand using the same preparation protocol and reliable performance as popular "filtered vent" containers. ONE TRAY® is 510(K) cleared to sterilize a 25-pound load in a pre-vacuum cycle at 270 degrees F in just four minutes.

Here's another:

Get the benefits of immediate-use steam sterilization without the risks with the ONE TRAY sealed sterilization container system from Innovative Sterilization Technologies. ONE TRAY terminal vented containers allow you to process instruments with a 4-minute pre-vac cycle—no dry or cool time required. The circulation pattern assures complete, rapid dispersal of saturated steam throughout the container. Compliant with all AORN and AAMI recommendations.

Re: One Tray

posted by Mary Baldwin on May 24, 2016 8:50 am

Thank you
 

Re: One Tray

posted by Susan Banschbach on May 31, 2016 9:16 am

Yes, we have One tray to avoid immediate use sterilization. It works well.

Re: One Tray

posted by Paul Lamb on Jun 1, 2016 11:31 am

We use a container from Aesculap that has a filter in the lid. It also needs only 4 minutes @ 270 Prevac. Do not be deceived by the 4" claim though because it still takes time for the autoclave to come up to temp and pressure and then to exhaust the steam. With the autoclaves we have the cycle time is a little over 15"

Re: One Tray

posted by Amy Steele on Jun 2, 2016 1:45 pm

We utilize One Tray in our facility and have eliminated all "flash" cycles thanks to it!
Amy Jo Steele, BS, RN

Re: One Tray

posted by Jacalyn Thomas on Nov 3, 2016 2:01 pm

If One Tray is not considered IUSS, how is the process being documented or is it? Does anybody use it for implants? What makes One Tray different from other rigid containers that are recommended for IUSS, like the FlashPak, that makes it not considered IUSS? How is the OR staff expected to know what vendor trays are validated and which ones are not? I appreciate any clarification you can give me.
Jackie

Re: One Tray

posted by Paula Nania on Nov 7, 2016 7:41 am

Hi Jackie,
its nice to hear from you. One tray is a sticky wicket. I commented on it as being IUSS. A rep contacted me and was very threatening. AORN is disturbingly quiet about this. My advice would be to follow Mfg rec. They guarantee a shelf life of 30 days. The burden of proof is on them. Hope you and hubby are enjoying your new life.

Re: One Tray

posted by Kathryn Johnson on Jan 9, 2018 11:22 am

Good Morning!
I have been approached several times by the rep of One Tray to purchase these and he has even involved some of my powerful surgeons to campaign for this system to be purchased.  I have been holding back to see what discussions will come about and would love to have, in print, the recommendations from AORN regarding the One Tray.  Can someone direct me to where that might be?

Thank you,
Kathy Johnson, RN, BSN

Re: One Tray

posted by Bradley Jacobs on Jan 9, 2018 12:20 pm

Hello Kathryn
I just sent you a private message with my email address. I am happy to forward my conversation with AORN regarding the OneTray. In the email exchange, AORN made a very clear statement regarding One Tray, and its usage.
Also, please be advised that per the FDA compliance officer who overseas IST, the FDA has NOT approved OneTray for terminal sterilization. Any usage beyond 48 hours post sterilization would be off-label.

Re: One Tray

posted by Michelle Sloan on Jan 10, 2018 1:42 pm

HI. DO you mind to please send me your comments from AORN on this subject?
Thank you!

Re: One Tray

posted by Margaret Hendrix on Jan 10, 2018 7:49 pm

Hi Bradley, my facility is thinking about switching to OneTray, I would like to know what kind of information you found, and where you found it. Thanks

Re: One Tray

posted by mary eaves on Jan 10, 2018 9:09 pm

could you also forward me the information on one trays.  thanks you  cathereineeaves@texashealth.org

Re: One Tray

posted by Bradley Jacobs on Jan 11, 2018 8:46 am

On March 13th, 2006, The FDA gave a 510K predicate approval for the One Tray. The 510K approval number is K052567. For those who are not familiar with the FDA approval process, a predicate approval allows a company to obtain FDA approval for a product without the extensive testing usually required, but stating that their product is equivalent to other products on the market. By googling “FDA 510K” and K052567, the first PDF should show a copy of the actual 510K, and also lists the equivalent containers. Under the heading “Intended Use”, the company states” The ONE TRAY Sealed Sterilization Containers are intended to be used for rapid sterilization of instruments or instrument sets in flash cycles.” Later in this form, the company states in two different sections that the ONE TRAY is substantially and functionally equivalent to the predicate devices, as well as stating that they have the same intended uses and the same performance attributes. If you look at the list of predicate devices, it is obvious that they are all FLASH pans or rigid containers used for IUSS. As a side note, the company began making the claim that the trays met or exceeded both AORN and AAMI standards and guidelines.
 
In the Instructions for Use (IFU), the company states that their trays do NOT require a cool down period after being autoclaved. In 2006, this was fine, because flash trays do not require a cool down period, as they are used immediately. The lack of an established cooling period results in condensation inside of the rigid containers. Again, not a big deal if the tray will be used immediately.
 
However, the company now markets the OneTray for terminal sterilization, making the claim that it can sit on a shelf forever, even though there is retained water inside. When their sales reps were at my hospital, they claimed that they had FDA approval(510K) for terminal sterilization. As of October 2017, the OneTray has not received FDA approval for terminal sterilization. I know this, because I called and spoke with the compliance officer at the FDA that oversees the OneTray…twice. According to a OneTray sales rep I recently spoke with, the company is presently claiming that they do not need a new 510K for terminal sterilization. They attribute this claim to some obscure rule at the FDA that says that implant manufacturers can establish their own expiration dates on their packaging. I argue that this rule does not apply to the One Tray, because a rigid instrument container that is constantly and repeatedly heated to over 270 degrees, after being subjected to extreme pressure changes(vacuum), is not the same thing as a one-time use disposable package used for implants. But what do I know, I’m just a nurse…..a nurse that took a LOT of chemistry and physics classes.​
 
Anyways, after some discussions, AORN clearly stated in an email to me, that due to the retained water inside of the OneTray, that AORN approves of the OneTray for IUSS, but not for terminal sterilization. I agree with their conclusion 100%. For what it's worth, AAMI has not made that statement. Instead, they simply say that they do not comment on specific products, and to read their guidelines. The company that makes OneTray is still stating "ONE TRAY® meets the guidance  recommendations of AAMI and AORN" on their website. I am happy to forward the email exchange I had with the experts at AORN. Please send me a private message request with an email address I can respond to.

Re: One Tray

posted by Virginia Reilly on Jan 12, 2018 10:46 am

Hi Bradley, I am interested in the information you received regarding ONE TRAY.  Could you send it to me please. @ VReilly@skagitvalleyhospital.org.

Re: One Tray

posted by ORNurseLink Manager on Jan 12, 2018 6:31 pm

AORN does not endorse or recommend any company’s products or services.  AORN does not in fact have a position on the ONE TRAY device and its sterilization system, and we apologize for any confusion that may have resulted from comments or summaries in this discussion chain.  ONE TRAY is an FDA-cleared device and, like all devices, AORN’s sole recommendation is to use it according to manufacturer’s instructions for use. AORN is not aware of any evidence that ONE TRAY does not perform as intended or that it presents any hazard to patients or personnel. Costs and operational aspects of adding ONE TRAY to a facility’s store of sterilization containers is a facility-specific decision.

We recommend users review the ONE TRAY FDA 510K Summary at https://www.accessdata.fda.gov/cdrh_docs/pdf5/k052567.pdf.  For additional questions we recommend users reach out directly to ONE TRAY manufacturer, IST Sterilization. 

AORN Headquarters

Re: One Tray

posted by Melody Gillette on Jan 13, 2018 4:21 pm

Thank you for providing this info. These threads do tend to get off track occasionally. Many still believe AORN has specific statements on things like this. The guidelines are just that. The references are very helpful when making decisions for your facility.

Re: One Tray

posted by Jennifer Misajet on Jan 14, 2018 12:32 pm

I read this thread with interest- I think regardless of what the vendor says, or what AAMI does not say etc. there is a fundamental issue missing here for me- Cleaning & Disinfection.  If an item is not properly cleaned & disinfected following IFU prior to any method of sterilization in any wrap or container it won't be sterile.  Bioburden is the concern at all times.  Delayed reprocessing, inadequate cleaning & disinfection can lead to biofilm which "protects" pathogens from the sterilization process. 
Here is what I always think of
Can the item be effectively cleaned & disinfected?- lots of issues here in many specialties
Has the mfg of what you are containerizing validated their product with this produc/ cycle & included it in the IFU?
Are you fully documenting the process including any biologic testing - start to finish?

Re: One Tray: concept is great, but system not user-friendly

posted by Pat Guzzo on Jan 14, 2018 12:36 pm

The facility where I work uses this exclusively for 'point-of-use' sterilization. It DOES take longer to run than a regular flash cycle (annoying when a single instrument for immeidate use is needed!) but the biggest complaint is the amount of time it takes to prepare the tray. Three separate filters must be installed, and they are awkward (the locking mechanism is very difficult to engage. The filters must be new for each run,but there is no indicator on the filters so it is impossible to tell if they have been used previously. There is no place to easily install the plastic 'lock' so that breaking it indicates that the tray has been opened after sterilization.  As the trays aren't stored (without 'supervision') for any length of time, this feature isn't used, but best practice would certainly be to have this safety feature in place.

 

Re: One Tray

posted by Leigh Bartlett on Jan 15, 2018 9:50 am

We have been using the OneTray for some time for immediate use, quick turnaround of instruments when an unanticipated turnaround is needed.  From the thread of discussion, a few things that we do in order to be as safe as we can be according to the IFU, etc. are:  1. We have not been able to find enough documentation to feel comfortable using for implant trays - specifically.
2. We do not "store" on the shelves in them... however, I believe that they could be. 
3. Yes, there may be some water in the bottom of the tray but with the filter system, it is sterile water and not able to "wick" from the tray in order to contaminate the instruments. 
4. It does not eliminate the dedicated time to thoroughly clean and disinfect them, but it does save time with the sterilization cycle for sure. 
These trays have been a great asset to our organization when needed. 

Re: One Tray

posted by Barbara Nishimiya on Jan 15, 2018 1:41 pm

We have been using the One Trays for a few years now.  I'm concerned that they may not be approved for terminal sterilization after reading some of the blog posts. The rep came in and met with management and they assured us they were approved for terminal sterilization. 
 

Re: One Tray

posted by Carmen Bouchard on Jan 15, 2018 4:49 pm

Please send me the information carmenbo@baptisthealth.net
thank you

Re: One Tray

posted by Myra Eleby-Hankerson on Jan 16, 2018 10:43 am

Please send me info on the above as well to mjay30@aol.com

Re: One Tray

posted by Dave Nichols on Jan 16, 2018 10:47 am

Seems like there is alot of misleading/ unfactual information being discussed. Looks like AORN directly addressed some of the items in a post on January 12th, 2017


posted by
ORNurseLink Manager on Jan 12, 2018 6:31 pm
 
AORN does not endorse or recommend any company’s products or services.  AORN does not in fact have a position on the ONE TRAY device and its sterilization system, and we apologize for any confusion that may have resulted from comments or summaries in this discussion chain.  ONE TRAY is an FDA-cleared device and, like all devices, AORN’s sole recommendation is to use it according to manufacturer’s instructions for use. AORN is not aware of any evidence that ONE TRAY does not perform as intended or that it presents any hazard to patients or personnel. Costs and operational aspects of adding ONE TRAY to a facility’s store of sterilization containers is a facility-specific decision.

We recommend users review the ONE TRAY FDA 510K Summary at https://www.accessdata.fda.gov/cdrh_docs/pdf5/k052567.pdf.  For additional questions we recommend users reach out directly to ONE TRAY manufacturer, IST Sterilization. 

AORN Headquarters

Re: One Tray

posted by Bradley Jacobs on Jan 16, 2018 12:25 pm

Thank you for the support I've received via private emails. I appreciate it very much.

I believe that one of the disconnects that exists with the OneTray, is that some nurses are familiar with AORN's recommended standards, and AAMI's Guidelines, and some nurses are not familiar with them. Both organizations are very clear when it comes to retained water in rigid sterilization containers. It's been ingrained in many of us, that any tray that has retained water, if not used immediately, should be considered contaminated. To the best of my knowledge, both AORN and AAMI have not reversed this doctrine in their respective standards and guidelines.

It's unfortunate that IST has not participated in this thread. At least one of their employees is a member of AORN, and used to be an OR nurse. It would be nice to have a nice, civil debate about this product. I have several concerns that their sales reps have not been able to address.

Re: One Tray

posted by Rebecca Roe on Jan 17, 2018 10:49 am

We use the ONE Tray, like the ONE TRAY and see the benefits of the ONE tray over FLASHPAK and other rigid container systems for IUSS.  That being said, your facilitiy and your Infection Prevention experts will need to review the 510K specifications.  It is a different type of filter and filtration system than other rigid filtered containers.  So there is a learning curve. Your facility has to make it's own determination how you will use this product based on your instrumentation needs, volume, vendor situation, prior IUSS rates, and determine if you can buy more instruments, or support the continued expense of a FLASHPAK system which in and of itself is problematic.
 
​ONE TRAYs selling point is that it has the possibility of storage which that has been increased over time since validation exercises have been carried out over the past two years.  It is up to your facility whether you will use it in this way.  Even some of the rigid container systems that are used for IUSS can be processed and kept for 24 hours, so it seems that your comfort level with the product, learning system IFUs and developing your own experiments to validate the advertisements can lead to a better understanding of how to address monitoring expiration dates of storage, event related documentation, temperature, condensation and other issues in this specialized tray system.  

​Bottom line.  If you don't feel comfortable with the system, don't use it. There are other alternatives. Its just another tool in the toolbelt. My request is that you test the science.  Things are progressing now to such a point in technology that we have to have a spirit of inquiry and investigate fully to a valued conclusion. .  If that can't be done, then don't worry about using it-continue on with what you are doing.
Rebecca B. Roe, BSN, RN, CNOR

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