1) Detail the preparation and use of the germicide including type of acceptable diluent, the
method of activation or dilution, and the acceptable covered container(s) for (re)use of
the germicide (e.g., stainless steel, plastics, heat bath, etc.).
2) Provide general instructions for cleaning devices in preparation for sterilization or high
level disinfection. Refer the user to the reusable device labeling for the manufacturer’s
recommendations for device decontamination.
3) Provide the directions for sterilization and/or high level disinfection of cleaned devices in
the prepared solution. Inform the user of the necessary elements for the sterilant/high
level disinfectant to be effective:
· clean the devices thoroughly
· immerse the devices in the solution
· use a solution that is at or above the minimum recommended or effective
concentration of the active ingredient(s)
· use the solution according to the Directions for Use
4) Provide detailed rinsing and neutralizing instructions, when needed, including the type of
rinse and duration and/or volume of rinse necessary to remove residues as determined
from testing. Define the quality of the rinse water, such as pH, presence of dissolved
organic material, water hardness, microbial content, and temperature, in the labeling.
State any factors in the rinse water that could interfere with adequate removal of
germicide residues from devices.
5) Provide directions for reuse of the solution, if applicable. Direct the user to monitor the
solution before each use for the minimum recommended or effective concentration(s) of
the active ingredient(s), time, pH, and temperature, as applicable. Emphasize the need
for monitoring the concentration of the active ingredient(s) of the germicide preparation
before each use and that the decision to use the germicide product should be based on
the concentration of the active ingredient(s) and not the days in use. Include a