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®.
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: email@example.com
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.
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
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.
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.
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. 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®.
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.
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).
The key difference is that the manufacturer typically performs validation, and the user typically performs user verification. It is very common that Central staff use these two concepts interchangeably and they should not. The goal for a user is to be able to replicate the predetermined specifications that were found in the IFUs of the sterilizer, the medical device and the packaging system. As the above definition explains, the user records the results that have been obtained during their verification process.
The U.S. Food and Drug Administration (FDA) places the primary responsibility for developing and validating methods for effective reprocessing of a reusable medical device on the manufacturer of the device. The manufacturer is expected to validate that the device can be cleaned and disinfected or sterilized adequately to allow the device to be reused. As outlined in FDA (2015), the manufacturer must test and validate any labeling claims of fitness for reuse that are provided in the written instructions for the handling, cleaning, disinfection, packaging, and sterilization of medical devices in a health care facility. To demonstrate compliance with label claims, manufacturers of cleaning agents must validate that their cleaners provide the expected level of soil removal and determine its materials compatibility. (AAMI TIR12 and AAMI TIR30 address the issues related to manufacturers’ validation testing for cleaning of medical devices.)