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Lessons Learned from FDA Citations on Cleaning, Disinfection, and Sterilization.

The Food and Drug Administration (FDA) regularly inspects healthcare facilities to ensure that they are following proper cleaning, disinfection, and sterilization procedures. When the FDA finds violations, it issues citations.

A review of FDA citations can provide valuable insights into the common mistakes that healthcare facilities make in these areas. By learning from these mistakes, healthcare facilities can improve their cleaning, disinfection, and sterilization practices and reduce the risk of patient infection.

Here are some of the most common mistakes that healthcare facilities make in cleaning, disinfection, and sterilization:

  • Not following manufacturer instructions. Healthcare facilities should always follow the manufacturer instructions for cleaning, disinfecting, and sterilizing equipment. These instructions are based on the manufacturer's testing and are designed to ensure that the equipment is properly cleaned, disinfected, and sterilized.

  • Using outdated or contaminated cleaning solutions. Cleaning solutions should be replaced on a regular basis to ensure that they are effective. Contaminated cleaning solutions can spread bacteria and other pathogens, which can increase the risk of patient infection.

  • Not cleaning equipment thoroughly. Equipment must be cleaned thoroughly to remove all dirt, debris, and microorganisms. Improper cleaning can leave behind residues that can harbor bacteria and other pathogens, which can increase the risk of patient infection.

  • Not using the correct disinfectant. The type of disinfectant used must be appropriate for the type of surface or equipment being cleaned. Using the wrong disinfectant can be ineffective or even harmful.

  • Not allowing equipment to air dry after cleaning. Equipment must be allowed to air dry completely after cleaning to prevent the growth of bacteria and other pathogens.

  • Not properly storing cleaned and disinfected equipment. Cleaned and disinfected equipment must be stored in a clean, dry, and protected environment to prevent the recontamination of surfaces.

By avoiding these common mistakes, healthcare facilities can improve their cleaning, disinfection, and sterilization practices and reduce the risk of patient infection.

In addition to avoiding these mistakes, healthcare facilities should also implement a comprehensive cleaning, disinfection, and sterilization program. This program should include the following elements:

  • Written procedures. Written procedures should be developed for all cleaning, disinfection, and sterilization activities. These procedures should be clear, concise, and easy to follow.

  • Training. All staff who are responsible for cleaning, disinfecting, and sterilizing equipment must be trained on the proper procedures. Training should be ongoing to ensure that staff are up-to-date on the latest procedures and techniques.

  • Equipment and supplies. Healthcare facilities must have the proper equipment and supplies to clean, disinfect, and sterilize equipment. This includes cleaning solutions, disinfectants, and sterilization equipment.

  • Monitoring and evaluation. The cleaning, disinfection, and sterilization program should be monitored and evaluated on a regular basis to ensure that it is effective. This includes reviewing records, conducting audits, and collecting feedback from staff.

By implementing a comprehensive cleaning, disinfection, and sterilization program, healthcare facilities can reduce the risk of patient infection and improve the quality of care.


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