Which of the following types of medical items requires sterilization if they are to be used during patient care?

Shared patient equipment and the healthcare environment must undergo routine cleaning and disinfection as required as part of the standard or transmission-based precautions. The choice of products for cleaning and disinfection is an important one; effectiveness of the product, suitability for the surface and practicality must all be considered.

Shared patient equipment

Shared patient care equipment that comes into contact only with intact skin such as IV pumps, blood pressure monitors and wheelchairs is classified as non-critical under the Spaulding classification. Non-critical equipment requires cleaning, at a minimum, between patients.

Disinfection of non-critical equipment is not routinely required unless the equipment has come into contact with blood or body fluids, or patients with multi-resistant organisms [PDF, 150KB] or Clostridioides [Clostridium] difficile [PDF, 137KB].

Product requirements for cleaning or disinfection of patient care equipment

Most patient care equipment meets the definition of a medical device as per the Therapeutic Goods Act 1989. The definition of a medical device is very broad and includes a range of items from wound dressings to blood pressure monitors, and from catheters to hospital beds.

Any equipment, instrument, device, apparatus, material or other article used for the diagnosis, prevention, monitoring, treatment or alleviation of disease [among other inclusions] is classified as a medical device. The regulation of medical devices is overseen by the Therapeutic Goods Administration [TGA].

Specific requirements apply for the regulation of products intended to be used to clean and disinfect medical devices. Cleaners intended to be used on medical devices must be ‘included’ in the Australian Register of Therapeutic Goods [ARTG] before they can be supplied in Australia, and are themselves regulated as a Class I Medical Device. Disinfectants intended to be used on medical devices must also be ‘included’ in the ARTG, and are regulated as a Class IIb Medical Device.

The healthcare environment

As per the Australian guidelines for the prevention and control of infection in healthcare, local risk assessment should determine the appropriate product, method and frequency of cleaning of the healthcare environment.

Some situations require disinfection of the environment in addition to cleaning, for example:

  • management of outbreaks of communicable diseases in health facilities [PDF, 195KB]
  • management of multi-resistant organisms [PDF, 150KB]
  • management of patients with Clostridioides difficile infection [PDF, 137KB].

Local risk assessment may identify additional situations requiring disinfection of the healthcare environment.

Hospital-grade disinfectants with specific claims including antibacterial cleaning wipes, fluids or powders must be listed on the ARTG as 'other therapeutic goods'.

Additional considerations when choosing a method for cleaning or disinfection

Items or surfaces must be clean for disinfection to be effective, sole reliance on a disinfectant without physical cleaning is not recommended. When disinfection is required, surfaces or items should always be physically cleaned with a detergent solution followed by or combined with a disinfectant.

When choosing a method for cleaning or disinfection of shared clinical equipment there are a few considerations, such asit is important to consider:

  • equipment manufacturers should provide instructions for reprocessing, including the method to be used and compatible chemicals
  • material compatibility of cleaning/disinfectant products with the equipment
  • appropriateness of the method or disinfectant product for the target organism or local epidemiology
  • potential for reduced susceptibility to chemical germicides
  • cleaning and disinfection products must be used according to manufacturer’s instructions, including the required contact times for disinfectant products and any recommended rinsing process.

For further information refer to Chapter 3 of the Australian guidelines for the prevention and control of infection in healthcare.

Disinfection is defined as a procedure, the result of which is transient and that eliminates or kills microorganisms and/or deactivates undesirable viruses that are carried by inert contaminated environments.

From: Gastrointestinal Endoscopy in Practice, 2011

Disinfection, Sterilization, and Control of Hospital Waste

John E. Bennett MD, in Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, 2020

Definition of Terms

Sterilization is defined as the complete elimination or destruction of all forms of microbial life and is accomplished in health care facilities through either physical or chemical processes. Steam under pressure, dry heat, ethylene oxide [ETO] gas, hydrogen peroxide gas plasma, vaporized hydrogen peroxide, hydrogen peroxide with ozone, and liquid chemicals are the principal sterilizing agents used in health care facilities. Sterilization is intended to convey an absolute meaning, not a relative one. Unfortunately, some health professionals and the technical and commercial literature refer to “disinfection” as “sterilization” and items as “partially sterile.” When chemicals are used for the purposes of destroying all forms of microbiologic life, including fungal and bacterial spores, they may be called chemical sterilants. These same germicides used for shorter exposure periods may also be part of the disinfection process [i.e., high-level disinfection].

Disinfection describes a process that eliminates many or all pathogenic microorganisms on inanimate objects, with the exception of bacterial spores. Disinfection is usually accomplished with the use of liquid chemicals or wet pasteurization in health care settings. The efficacy of disinfection is affected by a number of factors, each of which may nullify or limit the efficacy of the process. Some of the factors that affect both disinfection and sterilization efficacy are the prior cleaning of the object; the organic and inorganic load present; the type and level of microbial contamination; the concentration of and time of exposure to the germicide; the nature of the object [e.g., crevices, hinges, and lumens]; the presence of biofilms; the temperature and pH during the disinfection process; and in some cases the relative humidity of the sterilization process [e.g., ETO].

By definition, then, disinfection differs from sterilization by its lack of sporicidal property, but this is an oversimplification. A few disinfectants will kill spores with prolonged exposure times [e.g., 3–12 hours] and are calledchemical sterilants. At similar concentrations but with shorter exposure periods [e.g., 12 minutes for 0.55% ortho-phthalaldehyde [OPA]] these same disinfectants will kill all microorganisms with the exception of large numbers of bacterial spores and are calledhigh-level disinfectants. Low-level disinfectants may kill most vegetative bacteria, some fungi, and some viruses in a practical period of time [

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