Reprocessing of reusable medical devices

Note: This action is only applicable if your healthcare service uses critical reusable equipment, instruments and devices in the provision of health care.

Reusable medical devices are used in health care for diagnostic and treatment purposes for patients and must be reprocessed according to their intended use and manufacturer’s instructions. A reusable medical device must be included on the Australian Register of Therapeutic Goods before they can be supplied in Australia.

Where reusable equipment, instruments and devices are used , the healthcare service must minimise infection risks to patients and the workforce by ensuring adequate identification of, and procedures for, reprocessing reusable medical equipment. This includes cleaning, disinfection and sterilisation of reusable medical devices, equipment and instruments used, as well as processes and records to identify the patient, procedure and reusable equipment, instruments and devices that were used. 

Critical medical equipment, instruments and devices are items that confer a high risk for infection if they are contaminated with microorganisms and must be sterile at the time of use. They include any objects that enter sterile tissue or the vascular system, because any microbial contamination could transmit disease. 

Healthcare services must ensure that processes for reprocessing are consistent with the relevant Australian Standard. Where multiple Australian Standards may be applicable, the healthcare service should adhere to the standard most appropriate for their service context. 

In developing processes for reprocessing, consider:

• Whether the healthcare service has the facilities and the ability to reprocess the required reusable equipment, instruments and devices on site? 
• Whether sterilising services should be centralised or shared with another service?
• Are specialised reprocessing techniques required for some reusable medical devices (for example, low-temperature sterilisation or ethylene oxide) and are processes in place to achieve this? 
• Could the purchase of commercial, pre-sterilised single-use items help to meet the healthcare service’s needs? 
• Could an external sterilising service be contracted to provide reprocessing services for critical equipment, instruments or devices? See the Australian Guidelines for the Prevention and Control of Infection in Healthcare for a description of critical items.
• If services are contracted, are activities such as contract development, documentation and record keeping conducted in consultation with key groups, including
  • an identified position with responsibility for the service’s sterilising 
  • senior management
  • the clinical workforce
  • consumer representatives.

If reprocessing of reusable equipment is to be carried out on-site, policies, procedures and protocols should include:

• Ensuring that the environment and infrastructure consists of enough dedicated space to safely carry out all the required steps for reprocessing 
• Maintenance and replacement schedules for reprocessing equipment 
• Appropriate storage to maintain the integrity of reprocessed equipment, instruments and devices before use, in all areas where they are stored 
• Decontamination and safe packaging for transporting reusable equipment, instruments and devices from clinical areas that may be located away from the sterilising services 
• A process for fault or variance reporting that includes responsibility, actions and risk management strategies 
• Document control and record-keeping processes that allow data to be retrieved at any time 
• Environmental controls, including water quality, air handling, access, maintenance schedules and cleaning activities 
• Consumables, including packaging materials and personal protective equipment (PPE) 
• Suitably trained members of the workforce who are available for sterilising services, and wherever decontamination of used reusable equipment, instruments or devices is undertaken 
• Use of an incident management and investigation system to report any incidents relating to the reprocessing of reusable equipment, instruments and devices. Review the incident management and investigation system in the healthcare service to identify any variation between practice and policy, procedure or protocol and act to rectify the risks.

• Is there a process for identifying and registering the reusable equipment, instruments and devices that need to be reprocessed?
• How does your healthcare service ensure that reprocessing of reusable medical equipment, instruments and devices follows relevant standards and manufacturer’s instructions? 
• How does your healthcare service identify which reusable equipment, instruments and devices have been used during the care of a patient? 
• What mechanism does your healthcare service have in place to recall those patients at risk of acquiring an infection as a result of the reusable equipment, instruments and devices used?
• How are the sterile stock and reprocessed equipment, instruments and devices transported, stored and maintained?

• Identify the healthcare service’s need for reusable critical equipment, instruments and devices.
• Develop and implement a process for the reprocessing of reusable critical equipment, instruments and devices used in the healthcare service. This process must
  • be consistent with the relevant Australian Standard and manufacturer’s instructions
  • describe how the healthcare service will record and identify (if required) the patient, procedure and reusable equipment, instruments and devices that were used for the procedure 
  • identify situations when processes may need to be reviewed
  • determine how additional controls for novel and emerging infections may be identified and incorporated.
• These processes may also be required for the reprocessing of semi-critical equipment, in accordance with the relevant Australian Standard, for example, where high-level disinfection of a semi-critical medical device is required. 

• The type and comprehensiveness of evidence used is dependent on each healthcare service context. The content and complexity of the policies and processes will likely depend on the size of the healthcare service, but could include:
• Policies, procedures and/or protocols for processing reusable equipment, instruments and devices that are consistent with relevant national or international standards and manufacturer’s instructions for use 
• Examples of agreements or contracts in place to manage reprocessing services that include safety and quality measures such as incident and performance monitoring 
• A register of reusable medical devices
• Access to, or copies of, manufacturer’s instructions for each device
• Records that verify equipment installation, operation and reprocessing is consistent with the relevant national or international standards 
• Maintenance schedules for equipment used to reprocess medical equipment, reusable instruments and devices are monitored and reviewed 
• Registers of staff training and competency assessments
• Audits to ensure the integrity of sterile stock integrity and supply 
• Relevant documentation where reports on cleaning, disinfection and sterilisation processes are reviewed and discussed 
• Risk assessments where there are deviations in the requirements of relevant standards and the manufacturer’s instructions 
• Policies or procedures that specify which procedures should be used for single-use items 
• Policies or procedures for the use of reusable items that reflect relevant risk management strategies to ensure safe clinical practice and determine when, for which procedures and/or where reusable items should be used 
• Register or record of patients who have had procedures using reusable equipment, instruments and devices.

Commission resource

• Addendum NSQHS Standards Accreditation Workbook 2021 Infection Prevention and Control Standard – provides users with updated information on reflective questions and examples of evidence for the 2021 Preventing and Controlling Infections Standard within the NSQHS Standards. Principles and strategies are broadly applicable.

Other resources

• National Health and Medical Research Council in collaboration with the Commission: Australian Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) Section 3.1.4 Reprocessing of reusable medical devices – developed to specifically support improved infection prevention and control in acute health settings and  provides a risk management framework to ensure that the basic principles of infection prevention and control can be applied to a wide range of healthcare settings.
• Standards Australia: Catalogue of Australian Standards – Standards Australia is the nation’s peak non-government, not-for-profit standards organisation.