Workshop on implementing AS/NZS4187:2014
On 24 September 2019, the Australian Commission on Safety and Quality in Health Care (the Commission) hosted infection control and sterilisation experts, representatives of health service organisations and governments at a workshop on the National Safety and Quality Health Service (NSQHS) Standards requirements for reprocessing reusable medical devices.
Participants from the public and private sector across the acute, community, dental sectors and policy areas attended.
The workshop was convened to discuss issues health service organisations have identified with implementing the Standards Australia standard AS/NZS4187:2014: Reprocessing of Reusable Medical Devices in Health Service Organisations.
Workshop participants first heard from Mr Tim Cole, Manager of the Sterilizing Department of South Eastern Local Health District, who outlined the development of AS/NZS4187:2014 and how he had approached implementation of AS/NZS4187:2014. His key message was that ongoing and comprehensive monitoring is essential along with effective quality improvement systems.
Margaret Banks, Director of the Commission’s National Standards program reported on the results of a survey that asked health service organisations about implementing AS/NZS4187:2014. The Commission received over 470 responses to the survey and the results showed:
- Over 90% of respondents had completed a gap analysis as required by Advisory AS18/07
- Approximately 30% of organisations reported they currently comply with AS/NZS4187:2014, with an additional 50% expecting to comply by 2021.
- Most organisations (90%) identified implementation issues.
Participants recognised current sterilisation practices do not meet best practice and agreed AS/NZS4187:2014 and the standards that it references did provide a useful framework for improving the safety and effectiveness of processes for cleaning, disinfecting and sterilising reusable medical devices. Participants agreed simple guidance documents were required to assist health service organisations accurately interpret and apply these standards.
Workshop participants identified a range of strategies to support health service organisations comply with AS/NZS4187:2014 including:
- Clarifying and documenting the governance arrangements for sterilising service units
- Providing in-service and/or access to external training for sterilising technicians
- Developing interpretive and guidance documentation to support a better understanding of the requirements of AS/NZS4187:2014
- Implementing monitoring requirements for water quality as specified in the Standards Australia Amendment 2 to AS/NZS4187:2014
- Adopting a risk-management approach to the implementation of the requirements of AS/NZS4187:2014, prioritising high risk areas
- Using the organisations quality improvement systems to identify, implement and monitor improvements in safety and quality systems in the sterilising service unit. This may include adopting quality improvement systems such as ISO 13485: Medical devices—Quality management systems—Requirements for regulatory purposes
- Including sterilisation services unit equipment on the organisation’s preventative maintenance program.
It was agreed that the Commission would review Advisory 18/07 using the feedback provided by the workshop participants to clarify the requirements health service organisations must meet to comply with the requirements of NSQHS Standards Action 3.14.
The Commission is currently working with stakeholders to develop the final advisory. Further advice will be released publicly in November 2019.
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