Medical devices management
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 billion 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,11
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
1. Investigate 2. Act
Action research
3. Observe 4. Refine
l Back to 1.
an independent role is key to unlocking new paradigms for policy and practice.12,13
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, 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.14,15
Key findings and transformational impact 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: l 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. 1,16 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.17 l 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 three, yielded an
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www.clinicalservicesjournal.com I August 2025
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