Sterilization and Disinfection of Patient Care Items

Sterilization and disinfection of patient care items is a critical component to all medical and dental facilities. Understanding that there are different types of patient care items can help your company know how to best keep your patients and staff safe from cross contamination. Medical and dental instruments/devices are labeled by the manufacturer as either reusable or single use. Reusable devices have instructions from the manufacturer for cleaning, disinfection, or sterilization. Single-use devices do not have instructions for reprocessing and should be properly discarded after every use.

The Spaulding classification is the traditional way to reprocess medical and dental devices. EH Spaulding states that how an instrument or device is processed depends on how that instrument is used. The approach is based upon the degree of risk for transmitting infections if the device is contaminated at the time of use. There are three classifications of instruments: Critical, Semi-critical, and Non-critical.

Critical instruments are those that enter sterile tissue or the vascular system. They penetrate soft tissue, teeth, or bone and have the greatest risk of transmitting infection. Medical items that are classified as critical are surgical instruments. Dental instruments that are classified as critical are hygiene scalers and burs. These are a few examples but remember that any device/instrument that enters sterile tissue is classified as critical. The CDC states that all critical instruments should be cleaned and sterilized by heat before use. If they cannot be heat sterilized, they are considered single use items.

Semi-Critical instruments contact mucous membranes or non-intact skin. They DO touch mucous membranes but don’t enter the vascular system. Semi-critical instruments have a lower risk of transmitting infection. If a Semi-critical instrument is heat stable, it should be heat sterilized before use. If it is not heat stable, at a minimum it would require high-level disinfection. Many dental Semi-critical items are heat tolerant; therefore, they would be cleaned, and heat sterilized between uses and before use on another patient. Examples include mouth mirrors and handpieces. Medical devices that are deemed semi-critical are endoscopes. Flexible endoscopes are not heat tolerant and therefore would undergo a cleaning process and high-level disinfection. There are rigid endoscopes which are heat tolerant and available, these should be autoclaved. When a Semi-critical instrument cannot be heat sterilized or high-level disinfected, they are considered single use items.

Non-critical is the last in the classification approach. Non-critical items are those that contact intact skin but not mucous membranes. These pose the least risk of transmitting infection. Non-critical items should be low or intermediate level disinfected between use. Whether to use low or intermediate level disinfection would depend on the nature and degree of contamination. If the item is visibly soiled with blood or other potentially infectious material, the item is cleaned, and an EPA-registered hospital disinfectant is adequate. Examples of Non-critical items include a blood pressure cuff, pulse oximeter, or radiograph tube head.

To reiterate: all Critical and Semi-critical instruments should be cleaned to remove all blood and other potentially infectious material, packaged, and, when possible, heat sterilized between use. They should remain packaged until point of use. Semi-critical instruments that cannot be heat sterilized should be high-level disinfected.

Medical and dental devices are sterilized or high-level disinfected utilizing FDA-cleared sterilant or high-level disinfectants and EPA-registered disinfectants. Manufacturer’s instructions must be followed when utilizing the disinfectants. Practices should follow the directions regarding concentrations and exposure time for disinfection.

Some key recommendations for cleaning, disinfection, and sterilization of devices are as follows:

  • Ensure that reusable devices/instruments are cleaned and reprocessed prior to use on another patient.
  • Reusable devices should be cleaned, reprocessed, and maintained according to manufacturer’s instructions for use.
  • Health care personnel (HCP) should be trained prior to being assigned responsibilities in instrument processing. The training should be hands-on with step-by-step guidance.
  • Manufacturer’s instructions should be available and followed.
  • Assure HCP wear and have access to appropriate personal protective equipment when handling and reprocessing contaminated instruments.

Sterilization and disinfection of medical devices, instruments, and equipment should be a top priority for all healthcare facilities. This will keep both your patients and employees safe.

If your company needs help with Infection Control, TMC is proud to announce that we are rolling out an Infection Control Program to help you with all your needs. Be on the lookout for our emails and information about this exciting new program!