This article has been updated with a statement from Innovative Sterilization Technologies.
The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes.
Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical devices while they are sterilized. In its March 20, 2019, letter, released today, the agency said the company is marketing its product for two different intended uses outside of its original clearance — terminal sterile storage and terminal sterile storage with retained moisture.
One Tray is 510(k)-cleared to sterilize a 25-pound gross weight load in a four-minute pre-vacuum steam sterilization cycle at 270°, according to the company’s website.
“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,” the agency said. “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.”
The FDA said the company has not provided evidence to substantiate the safety and efficacy of these uses and is unaware of any data or literature that support the company’s claims related to the safety and efficacy of terminal storage with retained moisture.
The agency said it has not cleared or approved a rigid reusable sterilization container intended for use as 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,” it said.
In a statement released today, Innovative Sterilization Technologies said the FDA’s warning letter included “multiple statements that are false and/or inaccurate.” The company also said that it had cooperated fully with the agency’s inspectors, that it appealed the warning letter on March 28 and that the agency denied its appeal on August 15.
“IST firmly maintains that its currently marketed indications for use are within the scope of FDA’s original clearance and that FDA’s current position reflects a change in the Agency’s original position upon which clearance was based,” the company said. “Specifically, the 510(k) notice for the One Tray device (K052567) included a validated storage period following processing without a dry time and with retention of residual moisture within the device. The One Tray 510(k) summary posted on FDA’s website also specifically lists “shelf life” testing of the device and the sterile instruments it holds without a dry time based on performance testing relied upon for clearance. Subsequent to clearance, IST extended the shelf life in accordance with FDA guidance regarding modifications to cleared devices. FDA investigators reviewed these extensions to shelf-life during every FDA inspection with no issues identified.”
The company also said it has not received and is unaware of “any reportable adverse events related to the retention of residual moisture within the device following a sterilization cycle. Based on this undisputed fact and the company’s extensive testing data, IST is confident that continued use of the One Tray within its cleared and marketed indications for use does not pose a risk of harm to patients.”
“We followed FDA guidance as written. FDA’s actions and post hoc interpretation of the clearance that it issued to IST in 2006 are arbitrary and capricious and we are willing to do whatever it takes to make this right,” added CEO Scott Cohen. “We are confident that the One Tray clearance under which our product has been marketed for many years included a validated and FDA- cleared storage claim. We also maintain that the company’s actions in extending the One Tray’s cleared storage period following FDA guidance documents for medical device shelf life and the same test methods used to establish the cleared shelf life period were entirely appropriate.”
The company said it is pursuing additional appeals to the FDA commissioner’s office through the Office of Scientific
Integrity, “while also preparing for legal action against the FDA, if necessary.”