PDF 555 KB
Provides the mandatory requirements in relation to the effective and efficient strategic asset planning, asset lifecycle tasks, use and management of SA Health
Version 1.0 approved 03 December 2023
The Asset Management: Biomedical Technology Managing Risk Guideline (PDF 1,226KB) provides a framework for controls and possible treatments to manage and mitigate risks of biomedical technology, whether by Biomedical Engineering (BME) or other parties within SA Health.
Specific information applies to that not under BME management with a method for determining assurance level required for management of biomedical technology and estimating resourcing requirements, particularly when historical records are inadequate and management shifts to an in-house biomedical technology service group.
The Biomedical Technology Guidelines support the Asset Management Policy by setting consistent practice for managing biomedical technology and medical-related devices.
These policies and guidelines on based on principles from three Standards:
AS/NZS 3551 Management programs for medical equipment
AS/NZS ISO 9001 Quality management systems – Requirements, and
ISO 13485 Medical devices – Quality management systems-Requirements for regulatory processes.
SA Health applies consistent asset management principles over the asset lifecycle (acquiring, managing, maintenance and disposal) for delivery of health services and ensure assets are appropriate, available, safe, used effectively, functioning correctly, and compliant with relevant laws, regulations and standards.
This guideline applies to all employees and contractors of SA Health; that is all employees and contractors of the Department for Health and Wellbeing (DHW), Local Health Networks (LHNs) including state-wide services aligned with those Networks and SA Ambulance Service (SAAS).