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) 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:

• Processes for reprocessing that are consistent with relevant national and international standards, in conjunction with manufacturers’ guidelines
• 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.

Standards Australia is currently finalising AS 5369: Reprocessing of reusable medical devices and other devices in health and non-health related facilities to supersede both AS/NZS 4187:2014 and AS/NZS 4815:2006.

AS/NZS 4187:2014 and the draft AS 5369 state that water may be treated by a variety of methods, as determined by local water quality and the types of devices being processed. These methods include softened, filtered, demineralized or reverse osmosis. The addition of a suitable disinfectant may also be required at various stages of the process.

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.

Requirements

Health service organisations replacing inoperable or obsolete reprocessing or water filtration equipment, are to ensure when replacing equipment it is compliant with the relevant national or international standards. Health service organisations should:

• Assess their local water conditions, reprocessing methods, types of devices being processed and equipment replacement needs when deciding on the most suitable water treatment options
• Closely monitor their water quality for reprocessing in accordance with the requirements of AS/NZS 4187:2014.

Whenever a health service organisation commences occupation of a new build, the new facility must be compliant with the relevant national or international standard for reprocessing of reusable medical devices.

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

• Effective segregation of clean and dirty activities
• Storage of reprocessed medical devises.

Where the requirements for segregation and storage of reusable medical devices cannot be met by 31 December 2024, extensions can be sought from the Commission. These will be assessed on a case-by-case basis. Extension requests 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 extension request process, regulator support will be sought. It is recommended applicants check with the relevant state or territory licensing regulator and seek their agreement to the proposed changes where an approval in principle (AIP) is required.

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 here, but cannot be progressed unless final plans with executive approval are provided.

Accrediting agencies are required to review, assess and rate health service organisations compliance with Action 3.17 in accordance with the requirements set out in this Advisory. That is, review evidence that:

• From January 2023, a gap analysis has been undertaken. Where risks were identified, ensure there is evidence these risks are monitored and mitigation strategies are in place until the organisation is fully compliant with relevant national or international standards for reprocessing of reusable medical devices
• From January 2023, health service organisations replacing inoperable or obsolete reprocessing or water filtration equipment must do so with equipment that is compliant with the relevant national or international standard for reprocessing of reusable medical devices
• From 1 January 2025, Action 3.17 is to be rated met with recommendations in organisations that:
  • are still working towards full compliance
  • have been granted an extension by the Commission to work toward full compliance with:
    • segregation of clean and dirty activities
    • storage of reprocessed medical devices.