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®.
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 you can:
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
It is recommended 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 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.
Our IFU says FLASH because our intended use must reflect language used in the 2006 510(k)clearance. In 2006, when ONE TRAY® was cleared by the FDA, a steam sterilization cycle of 4 minutes at 270 degrees with no dry time per AAMI ST37:1996 was called a FLASH cycle. This terminology changed in 2011, however FDA has advised us that our labeling and claims language STILL must reflect our cleared 2006 intended use, therefore, our IFU still has to say FLASH. The FDA, during the warning letter correspondence, confirmed ONE TRAY®’s clearance contained a validated 48-hour storage period and has agreed to usage in the company’s labeling. Innovative Sterilization Technologies (IST) attempted to remove the antiquated term “FLASH” without success. During the process, the FDA stated that “a key distinction of Immediate Use Steam Sterilization (IUSS) is that it cannot and should not be stored.” Follow the ONE TRAY® IFU for use.
No. IST does not provide policies for use in a facility. Healthcare facilities should develop their own policies and procedures using the ONE TRAY® IFU and applicable industry recommended practices.
The latest version of our IFU can be found here: onetray.com/IFU.
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®.
No, the FDA does not provide a document like that. The 510(k) document is a static document. The application was submitted in 2005 and 2006 with the clearance being granted to go to market in 2006. The FDA cleared the ONE TRAY® product with a validated 48-hour storage period. When IST acquired the ONE TRAY® product the company continued to test the product to prove the ONE TRAY® product could maintain sterility at various points in time.
The additional performance testing the company conducted was under the guidelines published on the FDA website at that time. During our various inspections with the FDA we advised the Agency that we followed their guidelines for extending a shelf life when a shelf life already existed. The FDA even suggested for our IFU, that we separate the original testing for the 510(k) from the additional performance testing, which we did. Then the FDA came back and asked us to remove the additional performance testing as to not be misleading to the end user. The additional performance testing was outside the 510(k) clearance of 2006.
ONE TRAY® was cleared by the FDA with a validate 48-hour storage policy, facilities should follow their own internal policies as it relates to storage. If you have any further questions, please contact us at 937.619.0138 or visit onetray.com/contact. Follow the ONE TRAY® IFU for use.
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.)
ONE TRAY® has received information from customers stating that their facility is being cited by a surveyor as part of an accreditation assessment. Upon further discussion, we often see that the commentor is a consultant working with their facility who is not an actual surveyor. In any event, chances are this citation or statement reflects a misunderstanding of the use of ONE TRAY®.
If it is an actual survey, then the first question should be “what are you citing us for?” Secondly, “what information can you provide to support your position?” Attempt to have a polite yet confident and professional conversation that what is being cited is a discrepancy. Explain your position, but then seek out the individual that you report to make him/her aware of what is transpiring.
The areas of concern for a surveyor/inspector are usually:
- Moisture in the tray
- Elimination of dry time in the medical device manufacturer’s IFU
- Storing a tray beyond 48 hours
- Calling the tray IUSS
- and Sterilizing implants in a ONE TRAY®
If you do not have the explanation for any of the listed areas, we can provide that for you. To correct the inaccurate information, ONE TRAY® will need the consultant’s name, the organization’s name, and the date that the conversation occurred. Contact ONE TRAY® before your next survey occurs and be prepared! Remember, we are also available if you would like to reach out to our VP of Clinical services Barbara Ann Harmer, MHA, BSN, RN (with 25 years experience in surveying) DURING a survey for further explanation. She can be reached at firstname.lastname@example.org.
If you have any questions or need to speak to someone, please call 937-619-0138 or email: email@example.com.
Follow the ONE TRAY® IFU For Use.