A strong case for newAE (Medical Devices) role

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.

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.