6.3 Risk Assessment of Contaminated Items Using the Spaulding Classification of Equipment Decontamination

In 1968, Earle H. Spaulding invented a reasonable approach to disinfection and sterilization of patient-care items and devices based on the degree of risk of infection from these items.

According to the Spaulding classification, health care providers must evaluate the following four factors when determining the risk of repurposing a medical device:

  1. The critical, semi-critical, or non-critical nature of the item or device.
  2. The number of bacteria, microbes, viruses, or prions present on the item or device.
  3. The potential of microorganisms (virulence) to cause infection.
  4. The body site where the item or device would be used.

The Spaulding classification method was created in the 1950s to assist people in determining which disinfection method was best for various types of reusable devices depending on the threat of infectious disease to a patient.

Medical devices were divided into three risk categories by Spaulding:

  • High risk (critical)
  • Intermediate risk (semi-critical)
  • Low risk (non-critical).

However, later an additional category of minimal risk items was incorporated into Spauldings original classification for items.

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