Managing field safety corrective actions

This page is for hospitals and healthcare professionals.

It provides practical information on how to manage field safety corrective actions. 

How are field safety corrective actions notified?

Sometimes, devices can experience issues which may impact their safety or performance.

When device manufacturers identify such issues, they may issue a Field Safety Notice (FSN). 

What is a Field Safety Notice (FSN)?

An FSN is a formal communication sent by the manufacturer to users (e.g. hospitals, healthcare professionals, patients etc.) informing them about a field safety corrective action. 

An FSN typically contains: 

  • Identification of the affected device(s)
  • Description of the problem
  • Potential risks to patients and users
  • Actions the user (e.g. hospital, HCP or patient) must take
  • Instructions for traceability and response
  • Contact details for the manufacturer

What is a Field Safety Corrective Action (FSCA)?

The corrective action outlined within a FSN is called a Field Safety Corrective Action (FSCA). 

The aim of a FSCA is to reduce the risk associated with a device that has already been placed on the market or is in use. 

Examples include:

  • Software updates
  • Changes to instructions for use
  • Device repair or modification
  • Product recall or withdrawal
  • Replacement of affected devices

Managing Field Safety Corrective Actions

It is the responsibility of each individual hospital to manage corrective actions in line with their own quality or risk management protocols. 

If you receive an FSN, we recommend you take the actions outlined below. 

No'

Action

Description

1

Recieve and notify

  • Ensure you have a documented process to receive, review, and implement manufacturer FSNs and FSCAs.
  • Ensure there is a process to notify relevant clinical, technical, and procurement staff.

2

Assess applicability

  • Determine if you possess any affected devices or accessories. Effective traceability systems are essential to locate affected products.
  • Relevant staff should be informed of the issue and any temporary risk-control measures. Internal communication is critical where devices are used across multiple departments.

3

Assess risk

  • Assess patient risk. If devices have already been used, assess whether patients are at risk and whether additional monitoring or follow-up is required.

4

Implement

  • Implement the manufacturer's instructions.

5

Document

  • Document all actions taken. You should maintain records showing receipt of the FSN, identification of affected devices, actions completed, dates and responsible personnel.
  • Manufacturers often request confirmation that the FSN has been received and acted upon. You should return these acknowledgements in a timely manner.
  • After implementing the FSN and FSCA, you should confirm that all affected devices have been identified and addressed.

6

Report

  • Report incidents to the HPRA where required.

Field Safety Notices (FSNs)

Each month, we publish a summary of FSNs affecting the Irish market. 

An FSN informs device users about a safety issue and any actions that need to be taken to reduce the associated risk.

FSNs are important because they help healthcare organisations and users identify affected devices, implement corrective actions promptly, and protect patients from potential harm. 

HPRA safety communications

We also publish HPRA safety communications. 

HPRA safety notices

We publish safety notices on our website. 

You can sign up to be notified when we publish these notices via my alerts. 

We publish 5-10 safety notices per year to raise broader awareness of a specific device issue affecting the Irish market.

If you’re a hospital, HCP or device user, do not wait for us to publish a safety notice to take action. It is important to act promptly if you receive an FSN and corrective action from a device manufacturer. 

Direct to HCP communications

Sometimes, we write directly to hospitals or HCPs. 

This might be because there is a safety issue with a device, and we want to ensure those impacted are aware of it. We may also ask for feedback on how the issue is being managed.