ONE TRAY® Warning Letter Closed: An Interview with the Company
Beyond Clean sits down with Dave Billman, COO and Scott Cohen, CEO of Innovative Sterilization Technologies (ONE TRAY®) to talk about their journey, the closure, a new product launch, and a 10 year anniversary.
OFFICIAL COMPANY STATEMENT: Innovative Sterilization Technologies (IST/ ONE TRAY®) is pleased to announce the closure of the FDA Warning Letter. After many years of working with the FDA on this very unique product’s clearance, we are happy our storage claim, which has been there from the beginning, has been acknowledged by the FDA. ONE TRAY® was cleared with a validated 48 hour storage period. We strive to support and educate our customers, as well as the industry, regarding the ONE TRAY® technology and its’ usage.
Explore this page and find more information regarding the closure of the Warning letter plus general educational information on the ONE TRAY® technology. If you would like to reach out to us for any reason, please send us a message below, or call 937.619.0138.
Resources
Articles
The FLASH cycle is known for a no dry time cycle, it achieves sterility in the same degree as terminal or IUSS sterilization.
Organizations recommended abandoning the use of the term “FLASH” sterilization, which is now considered outdated, and replacing it with the term Immediate Use Steam Sterilization “IUSS.”
The FDA asked us to remove the additional performance testing from the IFU because that additional testing was not part of the 2006 Shelf Life clearance.
FAQs
Yes, you should continue to use ONE TRAY® as outlined in the IFU along with following your internal policies and procedures.
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 the 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, 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 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.
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ONE TRAY® has received numerous calls 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 bharmer@onetray.com.
If you have any questions or need to speak to someone, please call 937.619.0138 or email us at info@onetray.com.
In 2006 when the inventor of the ONE TRAY® product received the FDA 510(k) clearance to go to market, he used words that had different meanings back then.
In the 510(K) from 2006 there were words like “use immediately” or “for immediate use” these words did not mean IUSS or Immediate Use Steam Sterilization as we know it today.
Why? Because in 2006 IUSS did not exist. IUSS would not become an industry term until 2011 when the industry put aside the word FLASH and created a new term, IUSS. So in 2006, any references to the word “immediate” did not reference IUSS.
The inventor could not have predicted the future and had no way of knowing when he said the word “immediate” it would be interpreted differently today.
To find your ONE TRAY® Rep you can visit https://onetray.com/customers/distributor-locator and choose your state.
