Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) has become aware of the potential for health care facility staff that reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of medical devices because there is no standard indicator color to indicate a sterilized device.

The FDA recommends that health care facility staff review the manufacturer’s instructions for their indicators. 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.

There have been no injuries reported to the FDA associated with the use of these indicators.