Field Safety Notices & MHRA Communications

This section outlines important clarification from the
Medicines & Healthcare Products Regulatory Agency (MHRA)

Who is Responsible for implementing Field Safety Notices (FSN) and Medical Device Alerts (MDA)?

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.

Always act on any FSN you receive, straightaway. Do not ignore them.

MHRA will only issue a further safety communication linked to an FSN in extremely rare circumstances.

WHAT IS A FIELD SAFETY NOTICE & WHY THEY ARE IMPORTANT

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, and don’t wait for a separate communication from MHRA. This includes responding to the manufacturer’s request for confirmation that the message has been received and understood.

IMPORTANT CLARIFICATION

Please ensure you read this page carefully. It contains important clarification from the Medicines and Healthcare Products Regulatory Agency (MHRA)

Field Safety Notice: MEDTRONIC

Medical Device Alert: MEDTRONIC

Field Safety Notice: MEDTRONIC

For a Subset of Medtronic Dual Chamber Pacemakers (Jan 2019)

Medical Device Alert: BOSTON SCIENTIFIC

Field Safety Notice: BOSTON SCIENTIFIC

Field Safety Notice: ABBOTT

Field Safety Notice: ABBOTT

Information About Cybersecurity Update (Aug 2017)
Wave

Improving and extending lives by treating arrhythmias

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