For several years Innovative Sterilization Technologies, LLC (IST), the developer of the ONE TRAY® rigid sterilization container has promoted extended storage after a zero dry time steam sterilization cycle. On March 20, 2019, the FDA issued IST a Warning Letter CMS#524761 related to off-label promotion of its product. This letter was made public on August 21, 2019 on the FDA’s website.
The FDA issues Warning Letters when manufacturers significantly violate FDA regulations. It is a communication reserved for serious violations, and the FDA does not issue these letters without considerable discussion.
A lack of IST’s receipt or awareness of reportable adverse events related to the retention of residual moisture within the device following a sterilization cycle does not mean that adverse events have not occurred.
It also does not mean that the retention of residual moisture within the device following a sterilization cycle does not pose a risk of harm to patients. This is why FDA review and clearance of sterilization containers is so important. It is also why continuous testing of sterilization containers to new standards is so important.
As a rebuttal, on August 22, 2019, IST released a press release disputing the FDA Warning Letter.
IST mentions extensive testing, but does not specify this testing.
There is no mention of “terminal sterile storage” or “terminal sterile storage with retained moisture” in the Instructions for Use found in the 510(k) Summary of Safety and Effectiveness (K052567, ONE TRAY® Sealed Sterilization Container). It does mention, “immediate use".
IST states, “IST did not validate the ONE TRAY® for a flash sterilization cycle nor did IST seek clearance for such use.” However, their Intended Use listed in the 510(k) Summary of Safety and Effectiveness (K052567, ONE TRAY® Sealed Sterilization Container) states, “The ONE TRAY® Sealed Sterilization Containers are intended to be used for rapid sterilization of instruments or instrument sets in flash cycles.” There are other mentions of “flash sterilization” in the document, including in the Indications for Use.