FDA seeks to standardize sterilization indicators

WASHINGTON — The FDA warned that N95 masks from 3M and Aesculap use different colors to indicate that a device has been sterilized, which might lead reprocessing staff to mistakenly re-release contaminated devices.

“During the COVID-19 pandemic, health care facilities are rapidly adopting conservation practices, including decontaminating disposable compatible N95 and N95-equivalent respirators for single-user reuse,” the agency explained in a letter to health care providers. However, “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.”

For example:

  • The 3M Comply Hydrogen Peroxide Chemical Indicator 1248 uses blue to indicate an unprocessed device and pink to indicate a sterilized device.
  • The Aesculap MD334 Process Indicator Card uses pink/magenta to indicate an unprocessed device and blue to indicate a sterilized device.

While the agency has not received reports of injuries associated with these sterilization indicators, the FDA recommended that health care facilities and reprocessing staff carefully review instructions from the manufacturer for the specific indicator bar or card they are using and know what the colors mean. In addition, the FDA suggested enhancing staff training on the indicators for all sterilization systems used in the facility, including incorporating visual reminders of how each color indicator responds to vaporized hydrogen peroxide — the FDA included examples of how these visuals might look in their letter.

Meanwhile, “[t]he FDA is collaborating with manufacturers of sterilization systems to improve product labeling and explore standardization for colors used to indicate sterilization,” the agency wrote. “The FDA will continue to keep health care providers, manufacturers, and the public informed of new or additional information.”

The FDA asked health care providers to report any adverse events associated with these sterilization indicators:

John McKenna, Associate Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,926,192,927,725,928