Dive Brief:

• FDA issued a warning letter to Innovative Sterilization Technologies over the promotion of a tray for sterilizing reusable medical devices, the agency disclosed Tuesday.

• Regulators cleared the product, called One Tray, for use in the flash sterilization of devices that are to be used immediately after undergoing the cleaning process.

• However, the FDA warning letter, which was published on Tuesday, accuses IST of promoting the product as a "terminal sterilization container," leading the agency to warn of a threat to patient safety.

Dive Insight:

Flash sterilization, also known as immediate use steam sterilization, rapidly sterilizes instruments for immediate use. Devices that undergo this form of sterilization may retain some moisture. However, they are unlikely to become contaminated as there is little time for microbial communities to develop in the moisture before the device is used.

In terminal sterilization, devices are sterilized in their final storage container. A variant of terminal sterilization permits the storage of devices even if they retain moisture from the sterilization.

FDA mitigates the greater potential for contamination of terminally sterilized devices by requiring the products that facilitate the procedure to clear a higher evidence bar. The agency has accused IST of marketing its One Tray online as terminal sterile storage, with and without retained moisture, despite its 510(k) clearance only covering flash sterilization. FDA sees that as a problem.  

"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," FDA wrote.

Examples of the language that triggered the FDA warning letter include "offers an option to eliminate Immediate Use Steam Sterilization" and "addresses retained moisture concerns." In FDA's view, the statements indicate IST has made major changes or modifications to the intended use of One Tray without filing a new premarket submission to enable the agency to assess safety and effectiveness. 

FDA said its inspectors raised these concerns with IST during a 2015 inspection of the company's facility, which led to a 2016 warning letter centered on manufacturing and quality failings. As a result of the prior exchanges, FDA thinks IST is "aware that terminal sterile storage and terminal sterile storage with retained moisture both represent major changes or modifications."

The agency sent the latest warning letter to IST in March and gave it 15 working days to reply. FDA made the warning letter available online on Tuesday.