Useful Terms


Adverse incident. An event that causes, or has the potential to cause, unexpected or unwanted effects, involving the safety of patients or other persons.   More information on adverse incident reporting is available from:


Central alerting system.  The system through which the Medicines and Healthcare Products Regulatory Agency (MHRA) issues Medical Device Alerts (MDAs) to the NHS.


Conformitee Europeanne (CE) mark.  Most medical devices (excluding custom-made devices) cannot be used before a CE mark is issued.  A CE mark can only be issued when a device has been deemed to be acceptably safe by an independent body.  The independent bodies are appointed and regulated by the MHRA.


Field Safety Notice.  This is a communication sent from a medial device manufacturer to the products users.  A full list of these is issued every week by the MHRA:


National Reporting and Learning System is a database run by the NPSA which includes patient safety incidents collected through local reporting systems.  The data is analysed by clinicians and safety experts in order to identify common risks and opportunities to improve patient safety. Feedback and guidance is then provided to improve patient safety.  For more information see:


Medical Device Alert.  These are warnings distributed via the Department of Health and are valid for 5 years or until they are withdrawn.  These can be found at:


Serious Incident Reporting and Learning Framework (SIRL).  A national framework produced by the NRSL Provides guidance for the investigation and dissemination of findings from Serious Incidents for Investigation (formerly known as Serious Untoward Incidents).