Reprocessing of re-usable medical devices

Cleaning, disinfecting and sterilising re-usable medical devices and equipment provides an essential foundation for delivering safe and good-quality care. The National Safety and Quality Health Service (NSQHS) Standard 3, Preventing and Controlling Healthcare Associated Infections, requires health service organisations to comply with the requirements and demonstrate evidence of meeting the actions relating to reprocessing of re-usable medical devices.

The release of the Australian Standard and New Zealand Standard (AS/NZS) 4187:2014, Reprocessing of reusable medical devices in health service organisations, presented health service organisations with a number of challenges, including the cost, applicability and timeframe for implementing the recommendations in the standard. In response, the Australian Commission on Safety and Quality in Health Care issued an advisory to health service organisations and accrediting agencies. The advisory acknowledges the need for health service organisations to plan for the operational changes and capital investment that may be required to update or change sterilising equipment and meet water quality requirements. This advisory, A16/03, is available on the commission’s website.

A number of resources to support organisations with implementation and assessment of compliance for reprocessing re-usable medical devices are being updated.

For many health service organisations, the reprocessing of re-usable medical devices is a core function that enables operating theatre and procedural services to continue. To ensure effective sterilising services, an organisation must plan for future service requirements and the resources necessary to meet AS/NZS 4187:2014.

In many health service organisations, there are no direct lines of reporting between sterilising services and the executive. Organisations might consider reviewing governance and reporting arrangements between the executive and the sterilising services to ensure that the requirements for safe patient care are being met and information flow is effective. It is the role of the governing body to assure itself that the education of the workforce providing, and relying on, reprocessing of re-usable medical devices is appropriate, and there is access to relevant standards, guides and reference materials.

There are governance and policy issues associated with reprocessing of re-usable medical devices that should be considered when implementing the recommendations in AS/NZS 4187:2014. These issues include how health service organisations can:

• work with sterilising managers to plan future requirements and to provide the scope of services needed to meet future demands
• support the development, review and approval of policies, procedures and protocols
• ensure that there is a quality management system that reports on the services provided for reprocessing re-usable medical equipment, instruments and devices
• have a system to allow for tracking of re-usable medical devices to identify the patient, procedure and items used when needed
• provide appropriate continuing education and professional development to ensure currency of knowledge for the workforce
• ensure the workforce has access to AS/NZS 4187:2014 and other relevant references and guides.

The reprocessing of re-usable medical devices is an essential activity in many organisations and requires planning, resourcing and an appropriately trained workforce to undertake this activity and to demonstrate compliance with the requirements of national and international standards.

References

1. Reprocessing of reusable medical devices in health service organisations: https://www.safetyandquality.gov.au/publications/advisory-a1603-reprocessing-of-reusable-medical-devices-in-health-service-organisations/
2. AS/NZS 4187:2014: http://infostore.saiglobal.com/store/details.aspx?ProductID=1773923
3. NSQHS Standard 3, Preventing and Controlling Healthcare Associated Infections: https://www.safetyandquality.gov.au/publications/safety-and-quality-improvement-guide-standard-3-preventing-and-controlling-healthcare-associated-infections-october-2012/

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