A story caught my attention this week. Thousands of NHS patients were exposed to potential infection risk during surgical procedures because a supplier failed to adequately document calibrations for sealing equipment and sterilisation sensors.
Not a deliberate act of negligence – but a failure of process assurance. 150 NHS trusts. A mass recall. Disruption to operations already under pressure.
The detail that struck me: the products underwent a sterilisation process. But the minimum assurance levels couldn’t be verified. The documentation wasn’t there to prove it worked.
Sound familiar?
In my work as a Clinical Safety Lead in NHS digital transformation, I see a version of this regularly.
Technology suppliers who find assurance processes too onerous. Who want to move fast, push updates, resist regression reviews.
And I genuinely understand the pressure they’re under – development cycles are indeed costly, timelines are tight, and clinical safety frameworks can feel frictional rather than foundational.
I’ve worked hard to continuously recalibrate our approach – proportionate, risk-based, balanced.
But there is always pressure to go further, to relax standards, to trust that things will probably be fine.
Here’s what I know:
If we push safety assurance further down the development chain, we don’t eliminate the risk. We just lose our ability to manage it.
By the time a problem surfaces in a live clinical environment, the levers to enforce change are few and the patient is already in the room. We are playing catch-up trying to mitigate the issue, contain the impact, and inevitably it’s a quick fix.
The Medline recall wasn’t about a catastrophic technical failure. It was about undocumented calibration. A process gap. Exactly the kind of thing assurance exists to catch – before it reaches the patient.
That patient is always in my thinking. It’s why I won’t stop holding that line, even when it’s the harder position to defend.