Identify any personal protective equipment that must be worn, facilities that must be used,
and any other precautions the user should take to safely use the product. Include all
materials, devices and other agents, such as cleaning agents that are not compatible with the
germicide. Include statements similar to those shown below:
1) “Clean devices thoroughly prior to disinfection or sterilization to remove all blood and
patient material that may inactivate the active agent. If all material is not removed, the
germicide may not be effective and infection in the next patient may result.”
2) “Rinse devices thoroughly following disinfection or sterilization to remove toxic residues.”
3) “DO NOT use with the following heat-sensitive devices: [List any heat-sensitive devices
that have been shown to be incompatible with the product.] Testing has shown that
TRADE NAME is not compatible with these devices”
4) “DO NOT use with the following materials: [List materials that have been shown to be
incompatible with the product.] Testing has shown that TRADE NAME is not compatible
with these materials”
5) “DO NOT use with any heat-stable devices. Due to the inherent limitation of using liquid
chemicals for sterilizing medical devices, TRADE NAME is limited to reprocessing only
critical devices that are heat-sensitive and incompatible with other sterilization methods.”
6) “DO NOT use beyond XX days even if the concentration of the active agent(s) is above
the Minimum Recommended (or Effective, as applicable) Concentration as indicated by the recommended monitoring system. Do not rely solely on days in use. Use patterns may
reduce the established reuse life of the liquid chemical sterilant. The concentration of the
active ingredient should be evaluated before each use with an appropriate chemical
indicator.”