Advisory AS18/07: Reprocessing of reusable medical devices in health service organisations

Advisory details

Purpose

To describe the minimum requirements for health service organisations’ compliance with Action 3.17 (formerly Action 3.14 in the 2017 NSQHS Standards) to relevant national or international standards for reprocessing of reusable medical devices in health service organisations.

Issue

Action 3.17 of the 2021 amended National Safety and Quality Health Service (NSQHS) Standards states:

Where reusable equipment, instruments and devices are used, the health service organisation has:

1. Processes for reprocessing that are consistent with relevant national and international standards, in conjunction with manufacturers’ guidelines
2. A traceability process for critical and semi-critical equipment, instruments and devices that is capable of identifying

• the patient
• the procedure
• the reusable equipment, instruments and devices that were used for the procedure.

The Australian Standard AS/NZS 4187 is the national standard commonly used by hospitals and day procedure services to meet the requirements in Action 3.17. Standards Australia released AS/NZS 4187:2014: Reprocessing of reusable medical devices in health service organisations in 2014 and it became operational in December 2016.

Standards Australia’s AS/NZS 4815:2006 - Office-based health care facilities—Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment is commonly used in office-based practice. This standard is still operational and is not covered by this Advisory.

In response to concerns raised by health service organisations and state and territory health departments the Commission has reviewed the implementation of AS/NZS 4187:2014 and revised the compliance timeframe requirements. This revised Advisory specifies the minimum requirements needed to comply with Action 3.17 in the NSQHS Standards.

To comply with the requirements of Action 3.17 previous versions of this advisory have required health service organisations to:  

• Complete a gap analysis against the requirements of AS/NZS 4187:2014 and develop a detailed implementation plan, however named.

Requirements

The implementation plan should be finalised by 31 December 2023 and include:

• A strategy to identify and manage any current and emerging risks associated with the compliance gap(s)
• The timeframes and actions required to address the compliance gap(s) for:
  • Segregation of clean and dirty activities
  • Design of storage areas for sterile stock
  • Replacement of AS/NZS 4187:2014 non-compliant cleaning, disinfecting and sterilising equipment
  • Monitoring requirements for water quality
• Executive endorsement

By 31 December 2024, the Commission expects organisations to comply with relevant national or international standards for:

• effective segregation of clean and dirty activities
• storage of sterile stock in compliant shelving
• cleaning, disinfecting and sterilising equipment
• monitoring water quality

For health service organisations moving into new facilities, redeveloping facilities or with planned and funded redevelopment due for completion after 31 December 2024, extensions to these requirements can be sought from the Commission. These will be assessed on a case-by-case basis. Extension submissions must include:

• Gap analysis and risk remediation documents
• Implementation plan including timelines
• Evidence of approval from the organisation’s executive or governing body.

As part of the submission process, regulator support will be sought. It is recommended applicants check licensing agreements to establish if applications and approvals for capital works are also required by the state or territory regulator.

The process flow diagram outlines the steps that the Commission will follow when an extension request related to this Advisory is received.

Submissions can be made, but cannot be progressed unless final plans with executive approval are provided.

Whenever an organisation commences occupation of a new build, the new facility must be compliant with relevant national or international standards for the segregation of clean and dirty activities.

Accrediting agencies are required to review evidence that:

From January 2023, the organisation has completed a gap analysis to determine its current level of compliance with the relevant national or international standards for reprocessing reusable medical devices in use by the health service organisation and has implemented systems to remediate risk for identified gaps

• From January 2024, the organisation has a detailed plan
• From January 2025 the plan is implemented
• From January 2025, where the plan has not been implemented an extension to the requirements set out in this advisory has been sought from the Commission.

From 1 January 2025, Action 3.17 is to be rated met with recommendations in organisations that are still working towards full compliance and an extension request has been sought from the Commission for:

• segregation of clean and dirty activities
• storage of sterile stock in compliant shelving
• cleaning, disinfecting and sterilising equipment
• monitoring water quality

Assess and rate health service organisations compliance with Action 3.17 in accordance with the requirements set out in this advisory.