Specifically, staff at hospitals are facing a pink versus blue problem. The 3M Comply Hydrogen Peroxide Chemical Indicator 1248 uses blue to indicate an unprocessed device and pink to indicate a sterilized device. Meanwhile, the Aesculap MD334 Process Indicator Card uses pink/magenta to signal an unprocessed device and blue to indicate a sterilized device.
Said FDA: “There is no standard color to indicate validated sterilization. Each manufacturer has developed its own color scheme to validate the sterilization process, and the colors vary among manufacturers even though many are validated for the same cycle conditions.”
FDA said there are no reports of injuries at this time. The agency is urging hospital staff to increase staff training and have staff check indicator colors listed in the manufacturer’s instructions.
The FDA is meanwhile collaborating with sterilization system manufacturers to improve product labeling and explore standardization of the colors.
Sterilizing N95 masks for reuse has become an important strategy as the COVID-19 pandemic rages on.
The DoD has awarded a $415 million contract to provide 60 Battelle Critical Care Decontamination Systems that use vaporized hydrogen peroxide to decontaminate as many as 80,000 N95 respirator masks each day for reuse.
Steris (NYSE:STE) Advanced Sterilization Products, Stryker (NYSE:SYK), and Sterilucent are among the companies receiving EUAs involving use of hydrogen peroxide sterilizers on N95 and N95-equivalent respirators.