FDA Warning Letter

The FDA disclosed on Tuesday, August 20, 2019 that they had issued a warning letter on March 20th of this year. The warring letter expressed significant concerns by the FDA about 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 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 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..”5 On Thursday, August 22, 2019 this Press Release was issued: Press Release7 1 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-sterilization-technologies-llc-524761-03202019 2 Op. Cite. 3 Op. Cite. 4 Innovative Sterilization Technologies ‘One Tray®’ website 5 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-sterilization-technologies-llc-524761-03202019 6 Innovative Sterilization Technologies, LLC, Press Release, August 22, 2019, Dave Billman, Chief Operating Officer 7 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-sterilization-technologies-llc-524761-03202019