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

Release of reusable medical devices following reprocessing

Infection prevention and control guidelines
Download PDF
      10. Release of reusable medical devices following reprocessing
  1. Figures
  2. Glossary
  3. Links
  4. Relevant standards
  5. Acknowledgements
  6. Disclaimer
  7. Search

Last revised: 12 Jun 2026

Release of reusable medical devices following reprocessing


Before moving an instrument to the next stage of cleaning, disinfecting, or sterilising, the practice needs to check that the previous stage has been done properly.

A device needs to be clean before it can be disinfected or sterilised.

Always check that the equipment used has run its cycle correctly. This includes reviewing cycle printouts or digital records.

There should be a clear system in place to identify processed (ready for use) and unprocessed (dirty) instruments.

When a device can be released for use

A device can only be released for patient use when it has passed all relevant checks – it is clean, sterilised, and its packaging is intact. Table 10.25 outlines the minimum criteria that need to be met at each phase of reprocessing. A device can only be released for patient use once all criteria across all applicable stages have been met. Skipping or partially completing any stage applicable to a reusable medical device renders the device non-compliant.

Table 10.25 Minimum criteria for releasing reusable medical devices

Stage of reprocessing

Release criteria

Manual cleaning

Device is visually clean and dry.

Automated cleaning

Device is visually clean and dry and cycle records match process settings.

Thermal disinfection (heat-based)

Device is visually clean and dry, and cycle records confirm the correct temperature and time were reached.

Packaging – Sealable pouches/reels (PSBS)

Packaging is the right size, labelled correctly, intact, and includes a chemical indicator that has changed to the correct colour.

Moist heat sterilisation (with drying)

Cycle records confirm the correct time, temperature, and pressure were reached. External chemical indicators show the correct colour change. Packs are dry and intact. Data-logged information or a printout is checked for every load (an on-screen display alone is not sufficient). Chemical indicators inside the steriliser show the correct result. Process challenge devices, where used, show the expected result.

⚠️ All listed criteria across all applicable stages need to be met before a device can be released for patient use. If any requirement is not met, the device is considered non-compliant and needs to be quarantined and managed under the formal procedure.


If any of the requirements are not met, the device is considered non-compliant.

These non-compliant devices need to be quarantined and dealt with under a formal procedure for handling such issues (this is a quality control measure to prevent use of faulty items).

 

Recording and retention of reprocessing data

The practice needs to maintain reprocessing records for each washer-disinfector and steriliser in use. These records may be kept in a digital tracking system or in a structured log format, depending on the practice’s setup.

What to record for each sterilisation cycle

Table 10.26 outlines all items that needs to be recorded for every sterilisation cycle.

Table 10.26 What to record for every sterilisation cycle

Item

Detail

Date

When the cycle was run

Steriliser ID

If the practice has more than one steriliser

Load number

Unique number to identify each cycle/load

Load contents

A general description (eg “minor surgical pack x 2”)

Name of person who prepared the load

For traceability

Cycle results

Pass/fail status

Chemical Indicator result

Confirm Class 1 CI colour change occurred

Additional indicators used

Record any biological or other indicators used, and their results

Sterile barrier system condition

Confirm packs are dry, intact, seals undamaged

Name or initials of person who released or rejected the load

For accountability

Comments

Record any faults or anomalies and corrective action taken

A printout from the steriliser should be attached to the logbook or verified digitally. If a data logger is used, confirm the parameters were correct and record this check in the log.

Sterilisation records need to be retained in accordance with state and territory legislation.

Review and release

After each cycle, the staff member responsible for releasing the load needs to:

  • review the cycle record (printout, data logger, or onscreen display)
  • verify time, temperature, and pressure parameters met validated specifications
  • confirm this review in the record or logbook with a name or initials.

Do not release the load if:

  • cycle parameters are not met
  • chemical or biological indicators fail
  • there is visible moisture, damage, or any fault with the sterile barrier.

Any deviation needs to be reported to the appropriate supervisor, recorded, and followed by corrective action in accordance with the practice’s non-conformance procedure.


Once reusable medical devices have been sterilised, they need to be handled, stored and transported in ways that protect their sterility until they are used. Poor storage or handling can damage the sterile barrier system and allow contamination, even if the sterilisation process was successful.

Table 10.27 Handling, transport and storage of reprocessed reusable medical devices

General storage requirements
  • Sterilised devices need to be kept clean, dust-free and dry.
  • Do not store them near or under sinks, above sterilisers, or on open shelving.
  • Suitable storage options include:
    • Clean, sealed cupboards or drawers.
    • Enclosed shelving units (with sliding doors closed).
    • Sealable plastic containers with plastic dividers (avoid cardboard, which sheds fibres).
  • Avoid exposing items to sunlight, which can weaken some packaging (eg laminated pouches).
  • Drawers need to be deep enough to prevent damage when opening and closing.
  • Access to sterile stock should be limited to trained staff with clean hands.
  • Always close cupboard doors and container lids after use.

Sterile barrier system integrity
  • Protect packs with plastic dust covers or containers, especially for items that are stored long-term.
  • Handle pouches gently and never use rubber bands or other items that could damage packaging.
  • If a pouch or pack becomes wet (eg splashed water), it is no longer considered sterile and need to be reprocessed, starting with cleaning.
  • Unwrapped sterilised instruments cannot be stored as sterile stock – they need to be used immediately or rewrapped and reprocessed.

Stock rotation
  • Use a consistent system such as “use from the front, restock at the back” or “use from the left, restock from the right.”
  • Check and rotate stock regularly to avoid prolonged storage.
  • Items that have not been used in 12 months should be considered for reprocessing.
  • Check pouches every 2–3 months for brittleness, moisture, or damage.
  • If brittle, reprocess the item (including cleaning to remove possible dust).

Environmental conditions for storage
  • Store sterile stock in rooms with:
  • Temperature: 18°C to 25°C.
  • Relative humidity: 35% to 70%.
  • Controlled ventilation.
  • These conditions help prevent microbial growth and protect package integrity.

Transporting between sites

If devices are moved between locations (eg offsite procedures), the method of transport need to:

  • maintain the sterile barrier system
  • keep sterile and non-sterile items separate
  • protect items from physical damage and moisture
  • use containers that are cleanable, labelled, and appropriate for transport.

Advertising