Medical device safety information produced by the MHRA
The MHRA publishes several types of information about medical devices on GOV.UK
National Patient Safety Alert
The MHRA is accredited to publish National Patient Safety Alerts (NatPSA) for medical devices and medicines. These alerts are sent to the NHS in England. The devolved administrations of Northern Ireland, Scotland and Wales have the option of distributing in their territories.
NatPSA are:
- written by the MHRA
- targeted at senior management in healthcare organisations for system-wide action
- sent to the healthcare sector through the Central Alerting System
- published on GOV.UK for action and information
NatPSAs are published only for the most serious issues that will impact on patient safety and there are strict criteria that must be met for an alert to be issued.
These criteria are set by the National Patient Safety Alerting Committee (NaPSAC), which is chaired by the National Director of Patient Safety at NHS England. The committee is formed of all alert-issuing bodies in the NHS, but currently only the MHRA and NHSEI are allowed to issue NatPSAs.
General information can be found here
The MHRA NatPSAs are published on this page.
When an issue does not meet the criteria for a NatPSA, but still needs to be broadcast, we can issue a different kind of communication.
Device safety information
This type of communication:
- is written by the MHRA
- has a target audience normally made up of healthcare professionals but may sometimes be directly relevant to patients
- is published on GOV.UK for action and information
The MHRA may directly inform specific organisation that we know have a particular device or contact organisations such as professional bodies or charities directly to inform them of new information relevant to their area of expertise and interest.
See this page for published information.
When a manufacturer becomes aware of an issue with a medical device that they make, they must tell their customers what actions to take, using a field safety notice (FSN). The actions are referred to as ‘field safety corrective actions’ (FSCAs).
Field safety notices (FSNs)
FSNs:
- are written by manufacturers of medical devices, not by the MHRA
- target audience is the manufacturer’s customers
- are published on GOV.UK for information only
If a healthcare organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from the MHRA.
See this page for FSNs that affect medical devices in the UK.