Overview – Reprocessing reusable medical devices

Area

Prior practice/guideline

New/clarified guideline (aligned to AS 5369)

National standard referenced

AS/NZS 4187:2014 and AS/NZS 4815:2006

AS 5369 – Reprocessing of reusable medical devices and other devices in health and non-health related facilities

Informally guided

These guidelines are explicitly aligned to Australian Standard AS 5369

Framework

General instructions only

Risk-based approach where each practice needs to document a structured risk assessment for reprocessing

Risk assessment is now a documented, auditable requirement under the Standards for general practices (6th edition) criterion CG9.E

Cleaning equipment

Manual cleaning is acceptable

Washer-disinfector is required for pre-cleaning (manual cleaning alone no longer sufficient, except when the manufacturer advises)

Ultrasonic cleaning

Optional

Remains an optional step before washer-disinfector

Dedicated area

Separation between clean/dirty zones required

Dedicated or clearly segregated area required; layout and workflow must prevent contamination and be documented

Initial treatment timing

“Promptly after use” (undefined)

Ideally within 1 hour, no later than 4 hours after use

Training

Staff must be competent

Structured, documented training and competency assessment required; formal qualifications are not mandatory.

Practices need to ensure that training, supervision, and competency assessment are delivered and overseen by a competent person.

Traceability

Strongly encouraged

Explicit requirement to record device tracking, batch/cycle numbers, and patient linkage

Validation

Annual validation of steriliser only

Validation applies to all reprocessing equipment, including washer-disinfector, with defined monitoring intervals

Outsourcing

Allowed to any external provider

Must be a hospital or an accredited facility (including accredited general practice), or co-located site that surveyors can access

Environmental impact

Mentioned briefly

Emphasis on sustainability and considering environmental impact of resources and processes

Section of reprocessing guidelines

Key information – This is a high-level summary of requirements and recommendations made throughout this section of the IPC Guidelines. You can view further rationale, detail and examples within the full corresponding sections.

Classification for reprocessing devices

• Most devices used in general practice are classified semi-critical or non-critical.
• The process for cleaning, sterilising and storing a reusable medical device is based on its classification.

Quality systems and staff competency

• The practice needs to document its reprocessing policies and procedures.
• For each reusable medical device, practices need to check the information provided by the manufacturer for the required validated processes for cleaning, disinfection, packaging (if required), and sterilisation.
• The practice owner and manager need to support the implementation of all policies and procedures for the reprocessing of reusable medical devices at the practice.
• Staff involved in reprocessing must meet the following requirements, with training and oversight provided by a competent person
  A competent person:

  • has demonstrated expertise in reprocessing procedures, relevant standards, and infection control principles
  • is familiar with applicable guidelines, including national standards and local protocols
  • is capable of identifying risks, correcting unsafe practices, and ensuring compliance with best practice
  • is authorised or recognised by the practice as suitable to train, supervise, and assess others in reprocessing tasks.

  Competency is not defined by job title alone. A person may be considered competent through a combination of formal qualifications, extensive experience, and/or completion of recognised training in reprocessing and infection control.

  :
  • Documented training – Staff must receive structured education led by a person with demonstrable expertise in reprocessing practices, either through in-house training or external courses.
  • Supervision – Staff must be supervised by a competent person during training and initial practice.
  • Competency assessment – Staff must undergo regular, documented assessments by a competent person to confirm they can perform reprocessing tasks safely and correctly.
• Training must be delivered and overseen by a competent person.

⚠️ Formal nursing or sterilisation qualifications are not required to perform reprocessing activities. However, the quality and credibility of training, supervision, and assessment are critical. These need to be delivered and monitored by a person who is competent in reprocessing practices.

Risk-based approach

• To apply a risk-based approach effectively, practices need to adopt a structured risk management process that supports the safe and consistent reprocessing of reusable medical devices. The steps include:
  • Appointing a reprocessing team
  • Developing a process flow
  • Risk analysis
  • Risk evaluation
  • Risk control
  • Evaluation of overall residual risk
  • Risk management review
  • Finalising and implementing the risk analysis

The Risk-based approach section of these guidelines provides detail and examples of how to adopt a structured risk management process that supports the safe and consistent reprocessing of reusable medical devices.

Agents for reprocessing

• Use TGA-listed cleaning/disinfection agents.
• Avoid household or corrosive cleaners.
• Maintain a register of agents and safety data sheets.
• Consider environmental impact and sustainability.

Disposable materials used in the sterilisation process

• Use validated sterile barrier systems (pouches, wraps).
• Include Class 1 chemical indicators.
• Use demineralised water for sterilisation.
• Store packaging materials properly.

Managing the area for reprocessing for reusable medical devices

• Practices need to:
  • have a designated area for reprocessing reusable medical devices that is physically separated In line with the current relevant standards, "separated" refers to the physical and functional segregation of clean and contaminated workflows to minimise cross-contamination risk. from treatment and administration areas
  • establish a workflow pattern that prevents contamination of clean (pre-sterile and sterile) areas.
• Ideally, the practice has a dedicated room for reprocessing.
• Shared spaces are acceptable only if physical and functional separation is maintained.

Process definition

• Personal protective equipment is to be worn during reprocessing and may require changing between stages.
• Use labelled, leak-proof containers for transport.
• Wipe/rinse immediately after use.
• The interval between use and reprocessing should be as short as possible, ideally within 1 hour, and never longer than 4 hours.
• Depending on the risk categorisation of the reusable medical device, the cleaning method can involve:
  • the use of an ultrasonic cleaner followed by automated cleaning using a washer-disinfector
  • the use of a washer-disinfector that may incorporate an ultrasonic cycle
  • manual cleaning, with subsequent use of the above.
• Packaging: Use correct size, label, and seal properly.
• Sterilisation: Use steam under pressure; monitor cycles.
• Drying: Allow packs to cool and dry fully before handling.
• Unloading: Inspect each pack. If any are wet, damaged, or have compromised seals, they are not sterile and must be reprocessed.

⚠️ Manual cleaning alone is not acceptable unless the device’s instructions for use specifically prohibit automated cleaning.

Validation

• Validation applies to all stages of reprocessing and is required:
  • when new equipment is installed
  • when equipment is repaired, moved, or upgraded
  • annually (minimum)
  • when changes affect the sterilisation process
• All validation steps must be documented and retained for quality assurance and accreditation. Maintain:
  • technician validation reports
  • calibration certificates
  • staff competency records
  • challenge load diagrams and cycle data.

Routine monitoring and control

• For every cleaning and sterilisation cycle, the practice needs to record:
  • equipment used
  • the date of sterilisation
  • load number
  • packs/items in the load
  • cycle settings (time, temperature, dosage, etc.)
  • who performed the task
  • visual inspection results.
• Results recorded by printout or a data log need to be viewed after each cycle before sterilised items can be released for use.
• Class 1 chemical indicators need to be used on:
  • every pack in every load, or
  • the tray of unwrapped items.

Release of reusable medical devices following reprocessing

• Confirm all stages completed: Cleaning, disinfection, sterilisation, and packaging need to meet validated criteria.
• Inspect packaging to ensure packs are dry, intact, sealed, and labelled correctly.
• Check indicators and records. Review chemical indicators, cycle printouts or data logs, and confirm sterilisation parameters were met.
• Record the release decision with name/initials in a logbook or digital system.
• Quarantine non-compliant items. Wet, damaged, or failed items must be reprocessed and documented.
• Protect sterility post-release, storing and transporting items in clean, sealed containers to maintain sterility until use.

Keeping reprocessing equipment working effectively

• Service equipment annually (including steriliser, washer-disinfector).
• Use qualified technicians for servicing, calibration, and validation.
• Keep records of all maintenance, checks, and repairs.
• Follow recommended timeframes for servicing and calibration.

Outsourced and offsite instrument handling

• Practices can consider using offsite sterilisation when in-house reprocessing is not feasible. Acceptable providers include:
  • accredited general practices, hospitals, or commercial services
  • co-located reprocessing facilities (must be assessable during accreditation).
• Loaned instruments need to be fully reprocessed before use, even if packaging is intact.
• Shared reprocessing services must follow guidelines and be supported by formal agreements.
• Practices using reusable medical devices for offsite procedures need to ensure pre-cleaning/treatment is done immediately after use and sterility is maintained during transport. Policies must cover safe handling and traceability.
• Legal and insurance cover is essential when reprocessing for other facilities – consult your insurer or medical defence organisation.