Why Patient Safety Must be Your Top Priority
September 17th marks World Patient Safety Day.
A day to celebrate the pioneering technology developed to improve the quality and quantity of patients’ lives. But this day also serves as a harsh reminder of when this doesn’t happen - when patients can be left with devastating, even irreparable harm.
As defined by NHS England, patient safety is the ‘avoidance of unintended or unexpected harm to people during the provision of healthcare’. By this, responsibility does not rest solely on front-line clinicians in hospital and primary care. It sits equally with OEMs, CDMOs and everyone else involved in the design and manufacturing of a medical innovation.
The vast majority of health tech companies target what WHO classifies as NCDs – non communicable diseases. Long term, chronic conditions like respiratory failure, diabetes and cardiovascular problems all fall under this, with them all typically requiring 24/7 monitoring.
So, if healthcare professionals face such rigorous scrutiny and accountability, it only makes sense that their technical counterparts should receive the same. In come the FDA and MHRA - two globally renowned regulatory bodies solely dedicated to ensuring these devices undergo ruthless testing to be fit for purpose.
Yet with FDA’s recall list surpassing 1,100 in 2025, with a leading cause being device failure, it’s clear not enough is being done. The MHRA matches with a similar story of software issues emerging as the primary cause and device failure following close second. Both categories are critical for the successful running of a medical appliance. Unlike human clinicians who can be afforded grace and adapt in real-time, life-saving technology does not have the luxury of this second chance.
To begin bridging this gap, it starts with redefining what is safe.
Manufacturers must continuously stress test their products year-round. This requires a more rigorous risk assessment and longer, dedicated time in clinical trials before approving products fit for widespread clinical use. A more collaborative research and development team must be established too, working alongside clinicians, biomedical engineers and anatomists to investigate the root cause of failures before they reach the patient. Companies developing AI and software must ensure strong cybersecurity measures are in place to prevent data leaks and predict complications before they occur, with contingency plans ready.
The human body will forever be unpredictable and the margin for error may never reach zero. But the closer we strive, the more resilient our technology becomes, and the safer patients’ lives will remain.
Pavanpreet Gohani - Biomedical Editor
Sources:
4. https://www.who.int/campaigns/world-patient-safety-day
5. https://www.england.nhs.uk/patient-safety/
6. https://www.techbriefs.com/component/content/article/54187-doc-9786
https://www.pharmacymagazine.co.uk/news/dramatic-rise-seen-in-medicine-recalls