10. Reprocessing of reusable medical devices and other devices in general practice

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Infection prevention and control guidelines
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Last revised: 12 Jun 2026

Documentation


The practice needs to document its reprocessing policies and procedures. These need to address, at a minimum, the categories in Table 10.3.

Reprocessing activities need to align with existing relevant practice policies, such as work health and safety, training, response planning, immunisations).

Table 10.3 Documented reprocessing procedures

Category

Inclusions

Procurement and equipment
  • Purchasing of reusable medical devices and reprocessing equipment, including instructions for use
  • Qualification of equipment, including reusable medical devices and reprocessing equipment

Collection and cleaning
  • Collection of used reusable medical devices from their point of use
  • Cleaning of reusable medical devices prior to disinfection and/or sterilisation

Inspection and preparation
  • Inspection, assembly, and testing (where applicable) of reusable medical devices prior to disinfection
  • Inspection, assembly, testing (where applicable), and packaging of reusable medical devices prior to sterilisation

Processing and sterilisation
  • Loading and unloading of equipment used to reprocess reusable medical devices (eg washer-disinfector)
  • Disinfection and sterilisation of cleaned reusable medical devices

Validation and monitoring
  • Validation and routine control of cleaning, disinfection, and sterilisation processes, including rationale for assigning a particular reusable medical device to a specific product family and processing category
  • Routine monitoring and control of cleaning, disinfection, and sterilisation processes

Traceability and release
  • Traceability of reprocessed semi-critical reusable medical devices
  • Release of reusable medical devices after reprocessing

Storage and handling
  • Handling, transport, and storage of reprocessed reusable medical devices
  • Handling of specialised, loaned, and trial reusable medical devices

Maintenance and cleaning
  • Cleaning of reprocessing equipment and the reprocessing area
  • Periodic preventive maintenance (eg calibration) of reprocessing equipment

Incident management
  • Actions to be taken in the event of a biological or chemical spill or exposure
  • Control of non-conforming reusable medical devices
  • Recall of reusable medical devices

Quality and compliance
  • Review of deviation reports and other indicators of quality or procedural problems

 


Practice records need to include, at a minimum:

  • The patient-level traceability of sterilised items The patient-level traceability of sterilised items is in accordance with criterion CG9.F in the Standards for general practices (6th edition)
  • Purchase and equipment records, including all reusable medical devices and reprocessing equipment
  • Monitoring records for reprocessing equipment (routine checks and performance verification)
  • Cleaning, disinfection, and sterilisation process records
  • Microbiological surveillance testing results (where applicable)
  • Cleaning records for both reprocessing equipment and the reprocessing area
  • Training and competency records for all practice team members involved in reprocessing
  • Staff rosters or allocation logs identifying responsibility for each reprocessing activity
  • Maintenance records for reusable medical devices (where applicable) and for all reprocessing equipment
  • Installation, operational, and performance qualification documents for reprocessing equipment (where applicable)
  • Deviation or incident reports, and (where applicable) records of corrective or preventive actions taken
  • Recall records for reusable medical devices (where applicable)


Software that controls or monitors cleaning, disinfecting, and sterilising needs to work as intended and be tested if any changes impact its function.

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