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Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at devicesafety@hpra.ie.

 

 

HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing devicesafety@hpra.ie.

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.

 



Date Title Type
04/02/2019 Nebuliser masks. Priority 1 – For Immediate Action For Immediate Action
01/02/2019 Eleganza de Luxe. Priority 2 – Warning Warning
01/02/2019 Summary of Field Safety Notices - January 2019 3rd Party Publications
30/01/2019 VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards. Priority 2 – Warning Warning
28/01/2019 Graseby Syringe Drivers (MS16A & MS26) - Update. Priority 2 – Warning Warning
23/01/2019 MiniMed™ Mio™ Advance Infusion Sets. Priority 1 – For Immediate Action For Immediate Action
16/01/2019 Raindrop Near Vision Inlay. Priority 2 – Warning Warning
03/01/2019 Summary of Field Safety Notices - December 2018 3rd Party Publications
21/12/2018 Dash 3000/4000/5000, Solar 8000M/i, Solar 9500, B20i/B40i and CARESCAPE B450/B650/B850 patient monitors. Priority 2 – Warning Warning
18/12/2018 CoaguChek Test Strips for Self-Testing and Point of Care Use. Update. CoaguChek XS PT Test PST, CoaguChek XS PT Test, CoaguChek PT Test. Priority 2 – Warning Warning
04/12/2018 Summary of Field Safety Notices - November 2018 3rd Party Publications
01/11/2018 Summary of Field Safety Notices - October 2018 3rd Party Publications
24/10/2018 HeartStart FRx, HeartStart HS1 (Home) and HeartStart HS1 (OnSite) AEDs. Priority 2 – Warning. Warning
23/10/2018 MiniMed 640G Insulin Pump. Priority 1 – For Immediate Action. For Immediate Action
18/10/2018 ConvaTec Suction Catheters, Gastro-enteral Tubes, Intermittent Urology Catheters and Urine Drainage Bags Recall
16/10/2018 T34 Ambulatory Syringe Pumps -Update. Priority 2 – Warning Warning
16/10/2018 SureSigns VS,VM & VSV Patient Monitors & Viewing Stations. Priority 2 – Warning Warning
15/10/2018 CoaguChek Test Strips for Self-Testing and Point of Care Use – Update. Priority 1 - For Immediate Action For Immediate Action
01/10/2018 Summary of Field Safety Notices - September 2018 3rd Party Publications
24/09/2018 T34 Ambulatory Syringe Pumps -Update. Priority 2 – Warning Warning
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