Hospitals globally face persistent challenges in medical device management, impacting patient safety, operational efficiency, and financial sustainability. This paper draws insights from a seminal doctoral case study conducted within an NHS Trust, which explored the transformative potential of a collaborative, expert-led intervention in medical device management policy. The study identified systemic issues such as fragmented procurement, inconsistent training, and siloed departmental operations, directly contributing to avoidable patient harm and escalating costs. Findings demonstrate that an independent, expert-driven approach, analogous to the role of an Authorising Engineer (Medical Devices) (AE (MD)), can effectively identify latent risks, drive comprehensive policy redesign, and foster a culture of continuous improvement. This would result in significant benefits — including substantial cost savings, enhanced patient safety, improved staff competency, and strengthened clinical governance, thereby positioning the AE (MD) as a vital strategic asset for NHS Trusts in an increasingly complex regulatory and technological landscape.
The enduring challenge of medical device management
Medical devices are foundational to contemporary healthcare delivery, underpinning diagnostics, therapeutic interventions, and patient rehabilitation. However, their escalating volume, diversity, and technological complexity, present formidable management challenges for healthcare organisations globally. Reputable international and national bodies, including the National Audit Office (NAO), National Patient Safety Agency (NPSA), Medicines and Healthcare products Regulatory Agency (MHRA), NHS Resolution (formerly NHS Litigation Authority), and the World Health Organization (WHO), have consistently documented critical issues stemming from suboptimal medical device management. These issues directly impact patient safety, and contribute significantly to escalating healthcare costs.
The persistence of these challenges is starkly evident in recent data, demonstrating a continuing issue over the past two decades. As early as 2004, an NPSA report highlighted ‘uncontrolled purchasing and device management, in the absence of competency-based training’, as significant contributing factors to incidents.1 The Care Quality Commission (CQC), in its 2010 report, even listed device management as one of the worst-performing areas of NHS management.2 This historical context is reinforced by more recent figures: a comprehensive global investigation by the International Consortium of Investigative Journalists (ICIJ) in 2018, ‘The Implant Files’, linked poorly tested or faulty medical devices to over 1.7 million injuries and nearly 83,000 deaths globally over a decade, highlighting systemic failures in regulatory systems and transparency.3,4 In the UK, NHS Resolution reported total clinical negligence payments of £2.87 bn in 2023/24, with a significant portion of claims directly or indirectly linked to equipment issues,5 underscoring the tangible impact of device management failures.
Continuing equipment incidents
Furthermore, analysis of NHS ‘Never events’ data for 2024/25 indicates a continuing presence of incidents involving equipment, reinforcing the fact that device-related harm remains a persistent concern.6 The MHRA continues to report adverse incidents involving medical devices, including beds and associated equipment, with serious cases leading to injury and death, thereby emphasising the critical importance of appropriate staff training, correct use, and adequate service and maintenance.7 These figures, alongside ongoing challenges in medical device vigilance and the increasing complexity of devices — including Software as a Medical Device (SaMD), underscore the fact that suboptimal medical device management has been a continuing issue over the past two decades.8
The UK government’s proactive response, exemplified by the introduction of new Health and Social Care Act Regulations, including CQC Regulation 15 (Premises and Equipment), aims to address patient safety concerns related to medical devices.9 This regulation specifically mandates that equipment used by service-providers must be clean, secure, suitable, properly used, and properly maintained. Yet, despite these clear regulatory mandates, practical implementation at the organisational level often lags, creating a persistent disconnect between policy intent and operational reality. I would suggest that an independent, expert oversight function, such as the Authorising Engineer for Medical Devices, AE (MD), is crucial for bridging this implementation gap, and driving sustainable, transformative improvements in medical device management across the NHS.
The case for independent oversight
The concept of an Authorising Engineer (AE) is firmly established in other high-risk domains within healthcare infrastructure, such as medical gases and decontamination, where independent experts provide essential assurance of compliance and safety. The Institute of Healthcare Engineering and Estate Management (IHEEM) AE (MD) role — which officially ‘went live’ on the IHEEM governance platform in early June — extends this critical independent oversight to the highly complex and rapidly evolving domain of medical devices. This independence is paramount because internal audit functions, while valuable, can sometimes be constrained by organisational politics, resource limitations, or inherent biases stemming from familiarity with existing practices. The persistence of medical device incidents, and the escalating costs of negligence, as evidenced by recent data, underscore the critical need for this external, unbiased layer of scrutiny.
The financial incentive for robust management is also significant; as noted in the original doctoral work, an NHS Trust could achieve substantial discounts (£ millions) on its NHS Resolution annual contributions (similar to insurance payments) by demonstrating up-to-date, implemented, and monitored policies.10 The total provision for future clinical negligence claims was £58.4 bn at 31 March 2024.
An AE (MD) brings an unbiased, external perspective that is vital for identifying subtle, latent risks and systemic gaps that internal teams — regardless of their competence — might inadvertently overlook. Their specialised, up-to-date knowledge of legal frameworks, evolving regulatory expectations (e.g., MHRA 2021 guidance), emerging UK Medical Devices Regulations [UK MDR]), and industry best practices, enables a critical, in-depth evaluation across the entire medical device lifecycle. This external validation transcends a mere compliance check; it can be profoundly innovative, fostering benchmarking against leading practices, and introducing advanced solutions for risk mitigation and efficiency that may not be apparent from within the Trust’s immediate operational context. Such an independent role is key to unlocking new paradigms for policy and practice.11,12
Methodology: a model for AE (MD) engagement
The insights presented are derived from a doctoral case study conducted within a large London NHS hospital. This research employed an Action Research (AR) methodology, led by an ‘insider-consultant-researcher’ (a role directly analogous to an AE (MD)). This participatory approach involved close, iterative collaboration with a multidisciplinary team of participants from all levels of the organisation, including procurement, clinical, maintenance, and governance functions.
The investigative AR process unfolded through nine cyclical phases (Input, Action, Output), allowing for a deep, contextual understanding of existing challenges, and the co-creation of an improved medical device management policy model.10 Qualitative methods, including semi-structured interviews, participant questionnaires, and extensive document review (e.g., Medical Devices Committee minutes, internal policies, and regulatory documents), were employed to gather rich data. This methodology serves as a practical blueprint for how an AE (MD) can engage with a Trust to achieve systemic, sustainable change, fundamentally emphasising collaboration and shared ownership.13,14
The case study revealed several critical areas where existing practices led to significant inefficiencies, increased risk, and substantial financial burdens. The intervention, guided by the AE (MD) ‘equivalent’, led to profound transformational findings across the medical device management system, as follows:
Fragmented procurement as a central problem: A paramount finding was that poor or uncontrolled procurement practices formed the root cause of many subsequent systemic issues. The hospital’s previous acquisition model, characterised by over 100 departmental budget lines and diverse funding sources (capital, revenue, charitable donations), fostered an unmanaged proliferation of device models. For example, the infusion device technology group alone featured 18 different models in use, creating significant cost and safety implications.1,15 This ‘silo mentality’10 inherently hindered standardisation and effective cross-departmental collaboration. The ongoing challenge of device proliferation and lack of standardisation continues to be a concern, as highlighted in recent industry reports on quality challenges in medical devices.15
Impact of redesign: By strategically redesigning procurement policy to centralise purchase requests and mandate Medical Devices Committee (MDC) approval for standardisation, the Trust achieved remarkable results. A targeted infusion pump project, which successfully reduced 18 disparate models to just 3, yielded an annual saving of £500,000 on consumables, resulting in a net saving of £100,000 in the first year, and an anticipated £3.1 m over the devices’ 7-year lifespan. This demonstrated unequivocally that procurement conduct is the primary policy area influencing all other aspects of medical device management.
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 with 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.17,18 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
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.
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.12
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.
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 underscores the ongoing need for robust governance.9
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 for, 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:
- 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.
- 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 2021,7 evolving UK MDR), thereby safeguarding the organisation’s reputation, and mitigating the risk of regulatory penalties.
- 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.
- 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.
- Driving strategic organisational impact: By providing strategic recommendations based on expert analysis and benchmarking, the AE (MD) empowers Trusts to adopt a proactive, learning-orientated 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, more efficient, and more compliant, healthcare environment.
Conclusions
The complexities of medical device management in NHS Trusts pose significant challenges, directly impacting patient safety, costs, and operational effectiveness. This paper unequivocally demonstrates that a structured, independent, and expert-led intervention, analogous to the Authorising Engineer (Medical Devices) role, is not merely beneficial, but represents a strategic imperative. By rigorously focusing on systemic issues, particularly the pivotal role of procurement, and by fostering multidisciplinary collaboration, an AE (MD) can drive the development and implementation of best practice policies that yield tangible improvements in patient safety, enhance financial stewardship, and build organisational resilience. The profound insights from this research provide a robust foundation for advocating the wider adoption of the AE (MD) role across the NHS, ultimately contributing to a safer, more effective, and more sustainable, healthcare system for all.
John Sandham
John Sandham DProf, CEng, FIHEEM, MIET, is a British Chartered Engineer, Fellow of IHEEM, and an entrepreneur with over 35 years’ experience in healthcare technology management. He has successfully built multiple businesses in clinical engineering and property development. John holds a Doctorate in Medical Devices Management, and has authored over 300 educational articles. An Honorary Professor at the University of Warwick, mentoring postgraduate students, and a Visiting Senior Research Fellow at Middlesex University, he chairs the Annual EBME Expo, and serves as an executive advisor to MTS Health (a Sodexo company). He is also dedicated to improving global healthcare access as Chairman of My Bridge International and a Trustee of the Amalthea Trust.
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