News / September 9, 2019
The FDA disclosed on Tuesday, August 20, 2019 that they had issued a warning letter to Innovative Sterilization Technologies (IST) on March 20th of this year. The warring letter expressed significant concerns by the FDA about IST’s promotion of One Tray for “terminal sterile storage and terminal sterile storage with retained moisture.”1
If your healthcare facility is using One Tray for anything other than its FDA approved use, your facility could be “in violation of the Federal Food, Drug, and Cosmetic Act.”(2) The FDA has only approved One Tray to hold reusable medical devices while they are flash sterilized for immediate use (IUSS). According to the FDA warning letter, the use of One Tray for terminal sterile storage and/or terminal sterile storage with retained moisture “could result in patient illness, injury, or death.”3
One Tray was initially cleared by the FDA for use in the ‘flash’ sterilization of devices that are to be used immediately after undergoing the decontamination and cleaning processes. For the past several years the One Tray sterilization container system has been marketed as a way to significantly reduce reprocessing time.
According to IST, healthcare facilities can “Process loaner, consignment, & high turn hospital owned instrumentation in a fraction of the time it takes with blue wrap or traditional rigid containers. One Tray® provides ‘One Standard of Care’ by eliminating the need for Immediate Use Steam Sterilization (IUSS).4
The sterilizer manufacturer AAMI guidance document, ST8, defines “flash” sterilization as an unwrapped surgical instrument tray containing (1) Non Porous metal Items or (2) Porous metal items. The replacement application, IUSS, has always meant, as defined by AAMI ST79 and related AAMI IUSS guidance documents, the use of a containment device. The intended use of a healthcare sterilizer today is for the steam sterilization of some sort of containment device (wrap/container) and that requires a cleared vacuum cycle.
The term “flash” sterilization was born many decades ago before instruments were wrapped prior to putting them into a steam sterilizer. When unwrapped surgical instruments were removed from a steam sterilizer they were super-hot (270+ degrees). The latent heat in the instruments emerging from the super-hot sterilizer caused the moisture to evaporate “in a flash” and disappear. The decades-old term “flash” sterilization should probably be removed from use by healthcare and regulatory authorities in favor of the more accurate term, IUSS.
The FDA’s warning letter specifically accuses IST of promoting the product as a “terminal sterilization container” and not simply for ‘flash’ sterilization as originally approved by the FDA. The first paragraph of the FDA’s warning letter states that:
“The United States Food and Drug Administration (FDA) has learned that your firm, Innovative Sterilizations Technologies, LLC, is marketing the ONE TRAY Sealed Sterilization Container (One Tray), a rigid reusable sterilization container classified under 21 C.F.R. 880.6850, in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). One Tray is intended to hold reusable medical devices while they are flash sterilized for immediate use. However, as described below, your firm is marketing the product for two different intended uses outside of its original clearance: terminal sterile storage and terminal sterile storage with retained moisture. These intended uses raise new questions of safety and effectiveness not addressed by the original clearance, including, but not limited to, an increased risk of microbial contamination. For example, medical devices terminally stored with retained moisture in One Tray may be used in surgeries, and, if contaminated or improperly sterilized, could result in patient illness, injury, or death. Your firm has not provided evidence to FDA to substantiate the safety and efficacy of these uses, and FDA is currently unaware of any data or literature that supports your firm’s claims related to the safety and efficacy of terminal storage with retained moisture. Further, to date, FDA has not cleared or approved a rigid reusable sterilization container with an intended use for terminal sterile storage with retained moisture. The lack of evidence and potential increased risks raise public health concerns because the marketing creates a misleading impression that FDA has evaluated the safety and effectiveness of One Tray for these new uses.”5
On Thursday, August 22, 2019 IST issued this Press release:
Dayton, OH August 22, 2019 — Innovative Sterilization Technologies, LLC (“IST” or the “Company”), developer of the ONE TRAY® rigid sterilization container, is announcing today in this release that the Company is in receipt of a Warning Letter from the U.S. Food and Drug Administration (FDA), dated March 20, 2019 but posted publicly by the Agency on August 20, 2019. FDA’s Warning Letter alleges a number of differences between the ONE TRAY®’s 510(k) clearance and the uses for which the device is currently marketed. IST has been inspected by FDA multiple times over the last six years. In every instance, IST was transparent and cooperative, fully addressed FDA questions, and resolved inspectional observations. Throughout the warning letter, FDA has made multiple statements that are false and/or inaccurate.6
If your facility is using One Tray, please be sure and share this blog and link to the FDA’s Warring Letter with your facility’s Infection Control Manager, your OR manager and your Risk Manager. As the FDA points out in their warring letter, unapproved use of One Tray “could result in patient illness, injury, or death.”7
Elmed Incorporated is an American* manufacturer and distributor providing the medical industry and its many specialties with quality products.
Elmed Incorporated is a wholly owned American company and is not associated with any other “Elmed” company based outside the United States.