Field Safety Notices & MHRA Communications
This section outlines important clarification from the
Medicines & Healthcare Products Regulatory Agency (MHRA)
Changes to the way MHRA issues safety information
The MHRA has changed the way it issues safety information to healthcare providers. It stopped issuing Medical Device Alerts (MDAs) in September 2020.
This page describes the different communications that the MHRA now publishes.
For the most serious issues that will impact on patient safety, the MHRA is accredited to issue National Patient Safety Alerts (NatPSAs). There are very strict criteria that must be met for these alerts to be issued. For example, safety issues in NatPSAs will be more likely than not to cause a death or disability in a year. Consequently NatPSAs will be issued less frequently than MDAs were.
‘Device safety information’ pages are published for issues that do not meet NaPSAC criteria. These are listed here (where previously issued MDAs are also listed).
Note that the advice in published MDAs will remain valid until and unless they are archived.
Those who wish to receive National Patient Safety Alerts and Device safety information will need to subscribe. Those who were signed up to receive Medical Device Alerts will not receive the new publications and will need to sign up again.
Introducing National Patient Safety Alerts gives general information on National Patient Safety Alerts.
It is important that medical device users continue to read and act on the advice contained in Field Safety Notices, which are issued directly by device manufacturers. These are sent directly to those affected but they can also be found on gov.uk here
This page outlines MHRA expectations of manufacturers for FSNs and how MHRA review them.
On average around 2 FSNs are issued in the UK on CIEDs per month. It is therefore important that centres pay urgent attention to any FSNs they receive, act straight away and do not ignore them. This includes responding to the manufacturer’s request for confirmation that the message has been received and understood.
Who is Responsible for implementing Field Safety Notices?
It is the medical device manufacturer that is legally responsible for identifying when they need to undertake field action to address a safety risk with their devices. They should always issue a Field Safety Notice (FSN) when they do so to explain what they are doing and why.
For cardiac implantable electronic devices (CIEDs) companies usually target their FSN to all customers or centres they can identify who received the devices or are managing affected patients. So some FSNs, affecting many patients, go to a large number of UK pacing centres, while others may be targeted to only a few.
It is important that medical device users continue to read and act on the advice contained in Field Safety Notices, issued directly by device manufacturers. To keep up to date with weekly released FSNs these can be found on gov.uk here