Why medical equipment governance can’t be ignored

Medical devices are the silent backbone of modern healthcare. From defibrillators and infusion pumps to MRI machines and surgical tools, they touch every aspect of patient care. Medical IT and artificial intelligence (AI) are being improved, and engineered into medical devices and systems. But while these technologies have revolutionised medicine, their improper use, malfunction, or poor design can — and frequently does — lead to devastating consequences.

The dangers are not speculative or rare. According to the World Health Organization (WHO), unsafe healthcare — including the misuse or failure of medical equipment — contributes to over three million deaths globally each year (WHO, 2022).¹ The figure is staggering and shines a light on a critical issue that is often underestimated or overlooked: governance and safety monitoring of medical devices.

The failure of medical equipment may sound like a technical problem — an unfortunate glitch in the system. But behind each malfunction is a patient, a family, and often, a tragedy that could have been prevented. The UK's Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medical devices across the NHS and private healthcare systems, receives thousands of adverse incident reports every year (MHRA, 2024).² These incidents aren't limited to rare, obscure devices. Many involve commonly used equipment and include failures due to design flaws, inadequate maintenance, or human error. The consequences? Serious injury or death. (See Figure 2).