The Principles of Medical Device Decontamination

Spaulding Classification

Level of micro- biocidal action

Decontamination method

Medical Device examples

Use

High

Medical devices that breach the

Kills all microorganisms

Sterilisation

Surgical Instruments,

(Critical)

implants, urinary catheters, cardiac catheters, needles

skin or mucous membrane, or enter a sterile body cavity Medical devices in contact with mucous membranes or non-intact skin Medical devices in contact with intact skin

Intermediate

Kills most microorganisms, except high numbers of bacterial spores Kills vegetative bacteria, fungi and lipid viruses

Sterilisation or Disinfection

Anaesthetic equipment, flexible endoscopes, vaginal specula

(Semi Critical)

Low

Disinfection

Blood pressure cuffs, stethoscopes, electrocardiogram leads

(Non Critical)

Table 9.1 - Spauldings Classification

These disinfectants have advantages and disadvantages, most notably differing in their biocidal performance and material compatibility. They must be used in accordance with the manufacturer’s instructions for use and only on medical devices with which they are compatible. Aldehydes are known protein fixatives, hence their use is less prevalent today due to concerns of fixing proteins on poorly cleaned medical devices. This became particularly relevant with concerns over transmissible spongiform encephalopathies (TSEs) such as variant Creutzfeldt Jacob Disease (CJD), where the infectious particle is a protein. Disinfectants used in medical device decontamination should also be free-rinsing, because disinfectant residuals may cause compatibility problems with subsequent medical device processing steps, and biocompatibility issues such as cytotoxicity in patients.