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Published on 10 June 2024

Safety Alerts

What is a safety alert?

  • a safety alert is a communication that highlights newly identified or under-recognised risks that need urgent action to prevent serious or fatal harm.
  • failure to act on safety alerts can be detrimental to patient safety.
  • safety alerts vary in their format and content.
  • IRIC issues safety alerts through the Incidents and alerts Safety Officer Network (ISON). You can check to see if you have received the safety alerts issued by IRIC.

Type of safety Alerts

Field Safety Notice

A Field Safety Notice (FSN) is a communication issued by the manufacturer directly to their customers highlighting safety concerns about a medical device. The FSN details the product failure and the necessary action to be taken to reduce the associated risks with the medical device. Field Safety Corrective Actions (FSCAs) may include a product recall, update to instructions for use, service and repair requirements or software upgrade, etc.

Failure to act on a manufacturer’s Field Safety Notice can be detrimental to patient safety.

The MHRA publishes a list of Field Safety Notices that have been distributed by manufacturers to their customers on their website each week.

Scottish alert formats

IRIC publishes safety alerts in response to an adverse incident investigation or when UK wide alerts may need to be adapted for use in Scotland. Scottish formats include the Safety Action Notice (SAN) and Safety Information Message (SIM). Check you have received our safety alerts.

The MHRA publishes Device Safety Information (DSI) on their website and IRIC publishes this in Scotland as MHRA Device Safety Information (MDSI).

View Scottish alert formats.

UK alert formats

UK alert formats include the Estates & Facilities Notice and National Patient Safety Alert.

The Estates & Facilities Notice (EFN) is issued in response to safety issues involving the fabric of NHS buildings or the facilities within them. They involve UK wide collaboration and publication.

View Estates & Facilities Notices (EFN).

The National Patient Safety Alert (NatPSA) is published when there is a serious risk to patient health ie. death or disability involving medical devices or medicines. They may be published by the MHRA, NHS Patient Safety, UK Health Security Agency and other agencies.

View National Patient Safety Alerts (NatPSA).