Outsourced and offsite instrument handling

When offsite sterilisation may be used

• Consider offsite sterilisation when in-house sterilisation is not feasible.
• Options include:
  • An accredited external reprocessing provider, such as another accredited general practice, hospital, or commercial service
  • A co-located reprocessing facility within a shared or multi-site setting.

Provider requirements

• The practice needs to have evidence that the offsite provider is compliant with current standards.
• For co-located facilities, compliance needs to be verified – surveyors need to be able to assess these facilities during on-site accreditation.

Documentation requirements

A clear and precise documented agreement needs to be in place that outlines:

• the accreditation standard for the facility/service
• scope of the reprocessing service
• responsibilities for each stage of reprocessing (pre-treatment, cleaning, packaging, sterilisation)
• safe transport procedures for reusable medical devices (if applicable)
• traceability and tracking system
• evidence of up-to-date calibration and validation of reprocessing equipment.

Practical considerations

• Offsite reprocessing may result in slower turnaround times.
• Practices may need additional sets of reusable medical devices to maintain clinical flow.
• The number of sets required depends on usage patterns and turnaround time.

Risk management

• Practices performing procedures outside the practice, including house calls or visits to aged care facilities, need to have risk-based policies and procedures to maintain sterility during transport.
• Offsite infection prevention and control protocols need to ensure:
  • safe management and disposal of sharps and used single-use devices
  • use of standard precautions to prevent exposure to blood and body substances.

Segregation and containment

• Sterile and non-sterile devices need to be kept separate in appropriately labelled, cleanable containers.

Initial pre-treatment at the offsite location

• Remove visible soil using damp or dry low-lint/linen-free wiping.
• Rinse if required.
• Apply a TGA-registered instrument pre-treatment product if needed for transport.

Tracking and traceability

• All reusable medical devices used off-site need to be logged to enable tracing and tracking.

If a general practice provides a reprocessing service for another practice or healthcare facility, it needs to ensure that this arrangement complies with these guidelines. The practice could consult its medical defence organisation to confirm the medico-legal implications of providing reprocessing services to other practices.

A documented agreement needs to be in place to:

• clearly outline the scope and expectations of the reprocessing service
• define tracking and traceability systems to monitor the movement of reusable medical devices between facilities
• implement processes to preserve the sterility of reprocessed items during storage and transport back to the receiving practice or facility.

Shared reprocessing reusable medical devices, when done safely and in accordance with best practice, offers a more environmentally sustainable alternative to single-use items by reducing waste and conserving resources.