EBME Expo 2025
Why medical equipment governance can’t be ignored
Professor John Sandham, Chair of the EBME Expo, provides an insight into the hidden threats in healthcare, arising from the misuse or failure of medical equipment. EBME Expo will shine a light on the importance of medical equipment governance and how we can drive improvement, going forward.
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.
Figure 1. MHRA receives thousands of adverse incident reports each year, involving HeathTech.
The cost of complacency 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,
3,500,000 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 500,000 0
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). This is not an isolated national problem, either.
BMJ Finding 2,866,693 device malfunctions 1,552,268 injuries
In the United States, a National Institutes of Health (NIH) study revealed that more than 17% of adverse event reports involving deaths were misclassified by the Food and Drug Administration (FDA) – the body responsible for regulating devices in the US. (NIH, 2021).3
In other words,
hundreds – perhaps thousands – of deaths that should have prompted urgent safety alerts were buried by inaccurate or delayed reporting.
13,587 deaths Device malfunctions Injuries Figure 2. BMJ Medical device research - FDA Data 2018 to 2022 Deaths
Understanding the systemic gaps These failures are not usually due to a single mistake. They occur within systems that lack transparency, proper training, consistent policy enforcement, or investment in oversight. The recurring issues fall into several categories: 1. Design and manufacturing defects - Devices that are rushed to market, inadequately tested in real-world scenarios, or manufactured with subpar materials that are prone to failure. The MHRA and FDA both routinely issue safety alerts and recalls, but often after harm has already occurred.
2. Inadequate training - Frontline medical staff June 2025 I
www.clinicalservicesjournal.com 23
t
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68
