No.

ONE TRAY® is not an IUSS container because it was cleared with defined shelf life/storage. This is a misunderstanding amongst surveyors because although ONE TRAY® can provide the speed of IUSS, we are cleared with a defined storage period and therefore NOT an IUSS container per industry definition.

“The difference between IUSS and terminal steam sterilization lies in the sterile barrier system’s US Food and Drug Administration clearance and IFU for immediate use versus terminal sterilization and storage for later use… Manufacturers’ IFU for some containment devices may indicate they are acceptable for terminal sterilization and may not require drying after the sterilization process.”

 – Erin Kyle, DNP, RN, CNOR, NEA-BC, Editor-in-Chief for Perioperative Practices, AORN. AORN Journal, October, 2018, Volume 108, No. 4, pages 455-456.

It is important to note that the author acknowledged that there is a packaging system that provides terminal sterilization and does not require a dry time.  AORN cannot mention any product’s name because it could be construed as support of that product.

Check out our podcast with Beyond Clean as we discuss surveying and the impact to users of ONE TRAY®: https://onetray.com/2020/04/03/beyond-clean-features-one-tray-on-a-podcast-about-our-disruptive-technology/

Yes.

The FDA classifies implants as a medical device and ONE TRAY® is intended to be used for the sterilization of temperature tolerant medical devices, surgical, supplies, single instruments, multiple instruments or an instrument set.

Medical Device defined within the FDA states: “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory, intended for use in the diagnosis of disease and other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals…”

IST recommends that ONE TRAY® is used in accordance with its intended use and following the specifications for sterilization of each of the medical devices placed in ONE TRAY®.

Source Link:

https://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm

ONE TRAY® sealed sterilization containers are guaranteed for the life of the product to be free of functional defects in workmanship and materials when used in accordance with their indications for use. If you want to take advantage of our lifetime warranty there are a few ways to do that:

Visit this link and fill out the RTF (Return Authorization Form): https://onetray.com/customers/

Call our office: 937.619.0138

Email our info line: info@onetray.com

Yes.

The use of the word “terminal” is clearly defined and used by and throughout many industry documents (i.e. AAMI, AORN, etc.). The key word in these definitions is the ability to be stored.  The FDA requires medical device manufacturers to use language which is consistent with the language of 21CFR 880.6850. Per 21CFR 880.6850. The word “Terminal” and “IUSS” are industry definitions not FDA definitions.

The ONE TRAY® Sealed Sterilization Container is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used within 48 hours from sterilization.

We recommend following the OEM or device IFU for exposure time and temperature for each device sterilized. The manufacturer has performed the validation for sterility.  Follow the ONE TRAY® IFU for dry/cool time and storage.

No.

Retained moisture is normal and expected in a ONE TRAY® and does not compromise the sterility of the medical devices. Specifically, ONE TRAY® is designed in a manner such that all fluid flows away from the filters that cover the vents. In addition, the sterilized medical devices within the ONE TRAY® are supported by the deck plate above and away from any retained moisture.

ONE TRAY® is not considered a wet pack and therefore does not need to be rejected as long as the IFU was followed and there were no other sterilization issues.

Source: Annex O AAMI ST79:2017 

No.

In order to estimate the potential corrosion risk for the medical devices, it is first important to understand the length and temperature of exposure to moisture. Studies demonstrate that any moisture in a ONE TRAY® evaporates in 3-5 days and despite the lack of drying, the medical instruments are not and should not be subject to long term storage in a high moisture environment (maximum of 48 hours). While there is some moisture present in the bottom of the tray, the medical devices are elevated by the deck plate which keeps them above physical contact with the moisture.  Reusable medical devices intended for reprocessing by steam sterilization are generally constructed using corrosion resistant materials and finishes such as anodization, electropolishing or passivation.

Yes.

The performance of ONE TRAY® was exclusively validated with the use of ONE TRAY® components, filters, and tamper evident locks. IST cannot guarantee performance of ONE TRAY® with other manufacturer’s products and has not validated its performance with other manufacturer products. We recommend that you follow your internal policies for the additional replacement of components required for processing.

No.

IST does not provide policies for use in a facility. Healthcare facilities should develop their own policies and procedures using the ONE TRAY® current IFU and applicable industry recommended practices.  The latest version of our IFU can be found here: www.onetray.com/customers

We recommend periodic review of your policies to ensure consistency with the indicated use of ONE TRAY®.

Remember to go back and see if any of your current policies address “following the IFU of medical devices” as you may need to revise them to note that there may be an exception when using ONE TRAY®.

Yes.

The tray is still good if each disposable ONE TRAY® filter completely covers the grooved channel surrounding the perforated areas. You should confirm that the notched end of each of the filter covers is properly oriented with the correct set of the retention posts.

Shelf life is defined by recognized industry standards as “the period of time during which the item is considered safe to use.”

The labeling on your in-house sterilized items will have a sterilization date on the package but no expiration date. If you are using expiration dating, a sterilization and an expiration date will be found on a package. Per industry practices and guidelines, the facility should follow their internal policies and procedures for storage and transport for, and the release of, sterilized medical devices.