Standards · Standard or regulation
MHRA Yellow Card and FSN system
UK reporting of adverse incidents with medical devices
In plain words
What it covers.
The UK route for reporting problems with medical devices to the MHRA. Healthcare staff and the public report adverse incidents through the Yellow Card scheme; manufacturers must report serious incidents and issue field safety notices (FSNs) for corrective actions. The MHRA and the National Patient Safety Alerting system tell hospitals what to do.
Who uses it: All healthcare staff, medical device safety officers, clinical engineers and manufacturers.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Yellow Card adverse incident reports
- Manufacturer vigilance reporting
- Field safety corrective actions (FSCA) and FSNs
- National patient safety alerts
- Local incident reporting links
- Device quarantine for investigation
Key points
What engineers need to know.
- Report any incident where a device caused or could have caused harm, including near misses.
- Keep the device and its accessories in quarantine, unaltered, for investigation.
- A field safety notice tells users what the manufacturer is doing and what they must do.
- Hospitals must confirm every affected device is found and actioned, and record it.
- National patient safety alerts have deadlines and must be closed with evidence.
- Reporting builds the national picture: one hospital's near miss may be another's pattern.
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