Medical devices management
annual saving of £500,000 on consumables, resulting in a net saving of £100,000 in the first year and an anticipated £3.1 million over the devices’ seven-year lifespan. This demonstrated unequivocally that procurement conduct is the primary policy area influencing all other aspects of medical device management.
l Training inconsistencies and patient safety: The uncontrolled proliferation of device models directly compromised training effectiveness. Staff, including permanent and agency personnel, frequently relied on self-certification or informal “cascade training” from peers, leading to questionable competency, particularly concerning high-risk devices. This systemic weakness was a documented contributor to medical device-related incidents and near-misses.16 The challenges in medical device training, particularly in scaling training management and ensuring competency validation, remain a significant industry concern. 18,19 The original research highlighted that “the influence of the operator on the effective and safe application of medical technology is generally underestimated,” citing studies where a high percentage of incidents were due to incorrect operation and maintenance rather than equipment failure.10 l Impact of redesign: Standardisation, driven by improved procurement, profoundly simplified training logistics. Reducing infusion pump models from 18 to 3 enabled comprehensive, organised training across the entire organisation within a three-month period, a task that would have otherwise required 18 months. This ensures that staff are adequately trained on the specific devices they use, directly mitigating the risk of misuse and patient harm.
l Maintenance Inefficiencies: The wide variety of equipment models placed an undue burden on the maintenance department. Technicians required a broader range of diverse spare parts, more extensive technical training, and a larger library of service manuals. Furthermore, user errors stemming from inadequate training frequently led to unnecessary service calls, wasting valuable technician time and reducing the availability of critical equipment for clinical care. The original case study noted specific CQC spot- check findings from 2009, which uncovered “soiled mattresses, poor clinical practices, mould growing in suction machines and out-of-date medical equipment,” directly illustrating the consequences of poor maintenance practices.10
Stakeholder Engagement
Successful Strategy
Plan Key factors that create a successful medical devices management strategy
l Impact of redesign: Standardisation significantly improved maintenance efficiency. Technicians developed deeper expertise on fewer models, leading to a reduction in spare parts inventory and a decrease in unnecessary service call- outs. This, in turn, improved equipment turnaround time and increased device utilisation rates, potentially allowing for a reduction in the overall inventory size required.
l Strengthening governance and accountability: The case study highlighted a prevalent “tick-box” mentality towards policy adherence, coupled with a perceived lack of ownership among some management tiers. The independent AE (MD) involvement, integrated with the participatory AR methodology, fostered a greater sense of ownership and accountability across the organisation. The CQC’s emphasis on proper maintenance and use of equipment.9
underscores the ongoing
need for robust governance. l Impact of redesign: The redesigned policy, with procurement strategically positioned at its core, and the continuous, active engagement of the MDC, ensured that regulatory requirements (CQC, NHS Resolution) were not merely met on paper but were effectively embedded into daily practice. This provided senior management with robust external verification of their oversight and the tangible effectiveness of their policies, thereby strengthening the overall clinical governance framework.
Discussion: the value proposition of the Authorising Engineer (Medical Devices) The compelling findings in this paper strongly support the critical need and immense value of an Authorising Engineer (Medical Devices) (AE (MD)) role within NHS Trusts. The AE (MD)
functions as a vital external check, providing expert, unbiased insights that yield multifaceted benefits: l Bolstering patient safety: By independently identifying and mitigating latent risks across the entire medical device lifecycle, from strategic procurement to safe disposal, the AE (MD) directly contributes to reducing avoidable patient harm. This is crucial given the continued incidence of device-related injuries and deaths globally and within the UK.
l Ensuring regulatory compliance: The AE (MD) provides credible external validation that a Trust’s medical device management system adheres to national legislation and guidance (e.g., MHRA 2021,11
evolving UK MDR), thereby
safeguarding the organisation’s reputation and mitigating the risk of regulatory penalties.
l Optimising financial investments: Through driving standardisation and efficient procurement practices, the AE (MD) facilitates significant cost savings and ensures better utilisation of costly medical assets, contributing to long-term financial sustainability.
l Enhancing operational efficiency: By streamlining processes, reducing device downtime, and improving staff competency, the AE (MD) contributes to smoother clinical operations and improved patient throughput.
l Driving strategic organisational impact: By providing strategic recommendations based on expert analysis and benchmarking, the AE (MD) empowers Trusts to adopt a proactive, learning-oriented approach to medical device management, fostering continuous improvement and organisational resilience in the face of evolving healthcare demands.
The success of the case study in transforming policy and practice through collaborative action research, led by an expert AE (MD) ‘equivalent’ serves as a compelling model for how the IHEEM accredited AE (MD) can contribute to a safer,
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