ACSQHC Advisory #A16/03 – Reprocessing of Reusable Medical Devices in Health Service Organisations

Megan Reilly

Action 3.16.1 of the National Safety and Quality Health Service (NSQHS) Standards states:
“Compliance with relevant national or international standards and manufacturer’s instructions for cleaning, disinfection and sterilisation of reusable instruments and devices is regularly monitored”.
The Australian Standard AS/NZS 4187 is the national standard most commonly used to meet the requirements in Action 3.16.1.
AS/NZS 4187:2014 replaces AS/NZS 4187:2003 and becomes operational in December 2016. Standards Australia has withdrawn AS/NZS 4187:2003.
The Commission is seeking expert advice on implementation issues from jurisdictions, and will update Advisory #A16/03 once strategies have been agreed.  Australian Commission Safety in Quality in Health Care

To comply with the requirements of Action 3.16.1, where health service organisations apply AS/NZS 4187:2014 health service organisations will need to:
a) complete a gap analysis to determine the current level of compliance with AS/NZS 4187:2014 and document the findings
b) document a detailed implementation plan specifying timeframes to enable full implementation of AS/NZS 4187:2014 over a five year period, from December 2016
c) implement the plan and demonstrate progress toward implementation

Accrediting agencies are required to:
a) assess progress on implementation at each accreditation assessment
b) rate Action 3.16.1 met only in health service organisations that demonstrate progress towards full implementation as set out in their implementation plan for AS/NZS 4187:2014