Cleaning and disinfecting shared patient care equipment
Shared patient equipment that is to be reused must undergo reprocessing - cleaning, disinfection and/or sterilisation. The minimum level of reprocessing for reusable instruments and equipment is determined by the degree of risk for infection involved in the use of the items and manufacturer instructions. The National Safety and Quality Health Service (NSQHS) standards require health service organisations to have adequate identification of, and procedures for, reprocessing reusable medical equipment. These processes must be consistent with relevant national and international standards, in conjunction with manufacturers’ guidelines. 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.
Detailed information regarding the reprocessing of reusable medical devices is available in:
- Australian/New Zealand Standard 4815:2006 Office-based health care facilities—Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment
- Australian/New Zealand Standard 4187:2014 Reprocessing of reusable medical devices in health service organisations.
Both standards will be replaced by AS 5369 Reprocessing of reusable medical devices and other devices in health and non-health related facilities when it is published.
Shared patient equipment
The Spaulding Classification System provides a system to determine, based on intended use, the level of reprocessing necessary for shared patient equipment/reusable medical devices.
Category | Definition | Level of reprocessing required |
|---|---|---|
Critical | These items confer a high risk for infection if they are contaminated with any microorganism and must be sterile at the time of use. This includes any objects that enter sterile tissue or the vascular system, because any microbial contamination could transmit disease. | Require cleaning followed by sterilisation. |
Semi-critical | These items come into contact with mucous membranes or non-intact skin, and should be single use or sterilised after each use. If this is not possible, high-level disinfection is the minimum level of reprocessing that is acceptable. | Require cleaning followed by high-level disinfection at a minimum. Sterilisation of these items is strongly recommended. |
Non-critical | These items come into contact with intact skin but not mucous membranes. | Require cleaning and this can be followed by low or intermediate level disinfection. |
Disinfection of non-critical equipment is not routinely required unless the equipment has come into contact with blood or body fluids, or patients with organisms of significance (PDF 580 kB) or Clostridioides (Clostridium) difficile (PDF 519 kB) or during an outbreak (PDF 822 kB).
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. Cleaning products 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. Products for cleaning medical devices that do not claim to be a medical device disinfectant or sterilant are regulated as Class I Medical Devices. Products intended to be used on medical devices that make disinfectant or sterilant claims are regulated as Class IIb Medical Devices.
For further information refer to: