- NSW Auditor-General’s Report: Performance Audit – Medical equipment management in NSW public hospitals, May 2017
The NSW Auditor General found that: “Only about half the items of equipment included in our sample had testing and maintenance completed according to scheduled intervals or within 30 days of the scheduled date. These intervals were set under the Australian/ New Zealand Standard 3551 ‘Management programs for medical equipment’, which requires regular testing and maintenance of biomedical equipment to ensure it is safe and suitable for clinical use.”
While AS/NZS 3551 may have stipulated a 30-day time frame for completing maintenance within the scheduled date in its previous 2004 version, it no longer specifies any time frame for completing maintenance in its current 2012 version. Instead it states in section 6.7.2 When assessment and testing are delayed: “Where medical equipment is identified as beyond its anticipated re-assessment date, the responsible organization [i.e., hospital] shall be advised that service and testing are overdue. The medical equipment shall be made available at a mutually acceptable time to the clinical user and the service entity to allow assessment of the medical equipment to bring it into compliance.”
An open-ended “mutually acceptable time” for the hospital and the service entity may not be acceptable to ensure the safety of patients. Since the standard does not require that the decision to delay be appropriately approved and documented (justification, approver with management responsibility), it is likely that nobody will feel accountable for maintenance delays.
The audit report also found that: “The information systems used to record service histories of biomedical equipment were inefficient and inadequate for effective planning, monitoring and reporting of testing and maintenance. The implementation of a state-wide asset management system, Asset and Facilities Management Online (AFM Online), which will replace existing systems, has experienced delays. In addition, hospitals did not maintain adequate oversight of testing and maintenance that was outsourced to external contractors.”
Inefficient and inadequate information systems for medical equipment management coupled with slack requirements in AS/NZS 3551:2012 are a very bad combination indeed, likely to result in poor maintenance practices and adverse events.
It is not clear why the 30-day time frame for completing maintenance within the scheduled date was removed from AS/NZS 3551:2012. This change is not even listed in the PREFACE on page 2 of the standard along with other “principal differences”; is it really such a negligible change?
- Victorian Auditor-General’s Report: Efficiency and Effectiveness of Hospital Services – High-value equipment, February 2015
The audit of the Victorian Auditor General’s examined the effectiveness and efficiency of planning, delivery and utilisation of high-value imaging equipment in Victorian public hospitals such as CT and MR, and found that public CT and MR imaging services “are not being managed economically, efficiently or effectively across Victoria”.
The report concludes that: “Poor medical equipment asset management practices in public health services exacerbate a lack of planning at the health-system level. None of the six public health services visited had an asset management plan that included imaging equipment. The health services could not communicate to the department—or clearly identify—what their future imaging needs would be over the medium to longer term. This means that although future demand is set to increase, it is not clear at either the health-system or health-service level how that demand might best be met.”
The Auditor General’s report does not mention the AS/NZS 3551 standard at all, but the Victorian Department of Health refers to AS/NZS 3551:2004 in its Medical equipment asset management framework – Parts A and B of 2014 and Part C of 2012. Section 4.2 Maximise the effective life of the asset states: “The maintenance requirements of specific items are determined by the original equipment manufacturer guidelines (as described in the service or maintenance manual) and Australian and New Zealand Standard (AS/NZS) 3551 — Technical management programs for medical devices.”
It is not clear whether the maintenance and management programs for medical equipment have been audited by the Victorian Auditor General at all.
- Western Australian Auditor General’s Report: Management of Medical Equipment, May 2017
This audit assessed whether the management of medical equipment in public hospitals is efficient and effective. The audit report points out that: “Medical equipment can be technically complex and require specialist expertise to use, maintain and repair. It generally has an expected life of between 5 and 10 years depending on the type of equipment. The actual life will also depend on a wide range of factors including how often it is used, how reliable it is and how well it is maintained. The unavailability or failure of equipment can present significant risks to patients, staff and service delivery – risks that the health system needs to manage. Individual health service providers and hospitals are responsible for managing their own equipment, including planning, acquisition, maintenance, repair and disposal.”
The audit report concludes: “Equipment failure or unavailability due to repair or maintenance rarely has a serious impact on patient care. However, it does cause incidents and inefficiencies. The risk of adverse events was also increased because preventative maintenance for 16% of equipment we sighted was not done on time, and yet the un-serviced equipment remained available for use. Keeping to maintenance schedules is even more important as 36% of equipment we sighted across our 8 sample hospitals had exceeded its expected life.”
The AS/NZS 3551 is not mentioned in the audit report at all, however the Western Australian Department of Health’s policy for the management of medical equipment of 2019 quotes AS/NZS 3551:2012 as the underlying basis for compliance.
The current approach of State health policies in relation to medical equipment management and maintenance practices appears to be particularly inward looking, with little or no acknowledgement of international best practices like those described in the:
- international standard ISO 55001:2014 Asset management – Management systems;
- international standard IEC 62353:2014 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment;
- WHO Health technology management resources, encompassing a series of guides published since 2011 (see Figure), including:
- Procurement process resource guide
- Medical equipment maintenance programme overview
- Computerized maintenance management system