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 IFU. 

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 IFU. 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

It is recommend to follow 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 additional reprocessing instructions (i.e. Dry time, Storage etc.)

No.

Retained moisture is normal and expected and does not compromise the sterility of any instruments. In addition, the sloped floor addresses the issue of retained moisture. By virtue of this design, the sloped floor directs any retained moisture away from the filtered vents towards the center collection area. Each vent is surrounded by a gasket which forms a fluid proof seal when the SMS filter elements are secured in place by the interlocking filter cover. Additionally, the location of the vents on the sloped portion of the floor reduces the risk of contamination by directing moisture away from the filter elements. The sloped floor prevents moisture from coming into prolonged contact with the filter element, thereby ensuring the protective fluid proof performance of the ONE TRAY® hydrophobic filter elements and the sterile integrity of the contents. The efficient vapor exchange performance and ratio of filtered vents to the internal volume of the container effectively minimize condensation.

ONE TRAY® should not be considered a wet pack as long as the IFU was followed and there were no other sterilization issues.

Source: Annex O AAMI ST79:2017 

Reusable medical devices intended for reprocessing by steam sterilization are generally constructed using corrosion resistance materials with corrosion resistant finishes, such as anodization, electropolishing or passivation. These devices, in their routine use and reprocessing, are repeatedly subjected to significantly greater oxidative challenges than storage with retained moisture in an ambient environment.

It is important to note that despite the lack of drying, the reusable medical devices are not subjected to long term storage in a high moisture environment. While there is some moisture initially present at the bottom of the ONE TRAY®, the reusable medical devices are elevated via the deck plate that keeps them above physical contact with water. While it is possible that the water vapor content within the tray will be slightly elevated (typical storage conditions allows for up to 75% humidity), IST has conducted studies that demonstrate that all moisture at the bottom of the tray has evaporated in 3 – 5 days. Therefore, the reusable medical devices are not subjected to long-term storage in a high moisture environment.

Retained moisture in the bottom of the ONE TRAY® after the conclusion of the process, and not in direct or prolonged contact with the instruments, will have no detrimental or corrosion-promoting effect on the stainless steel instruments in the container. The sterilization process itself, involving a combination of high temperature and high humidity, is itself far more promoting of corrosion than the subsequent presence of retained moisture in the vicinity of the instruments.

In conclusion, the exposure to moisture in this case is minimal, presenting an oxidative challenge which is, to the best of our knowledge, similar to other challenges metallic surgical reusable medical devices are designed to regularly survive. Even if corrosion should occur, safety measures to check for significant corrosion prior to use are already in place and the clinical risk of corrosion is minimal.

The validated performance of ONE TRAY® is in effect ONLY with the exclusive use of ONE TRAY® components, filters, and tamper evident locks.

No.

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

Yes.

Follow the ONE TRAY® IFU with specific attention to the inspection checklist.

2.131 Validation: Documented procedure performed by the device manufacturer for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. (AAMI ST79:2017, page 11)

2.129 User Verification: Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met. (AAMI ST79:2017, page 10).