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
27/10/2017 MAXTER ENTRAL* ENFit® NASOGASTRIC (NG) FEEDING TUBES. Priority 1 – For Immediate Action For Immediate Action
27/10/2017 CT Imaging of Patients reliant on Electronic Medical Devices Advisory
27/10/2017 MR Imaging of Patients with Implanted Medical Devices Advisory
26/10/2017 VITEK® 2 Gram- Positive Identification Test Kit. Priority 2 – Warning. Warning
19/10/2017 Liko Universal Slingbar 350, Slingbar 450, and Slingbar 600. Priority 2 – Warning Warning
06/10/2017 Mobile Applications in Healthcare - Information Notice Advisory
03/10/2017 Field Safety Notice – September 2017 3rd Party Publications
27/09/2017 ThermoScientific Oxoid CAZ10 CEFTAZIDIME, CT1629B. Priority 2 – Warning. Warning
25/09/2017 Information Notice - Caution when Purchasing Medical Devices Advisory
15/09/2017 Counterfeit NSK Contra Angle Ti-Max Z95L Dental Handpiece - Priority 2 – Warning Warning
14/09/2017 Medtronic MiniMed Infusion Sets. Priority 1 – For Immediate Action For Immediate Action
01/09/2017 FLUOROCELL PLT. Priority 2 – Warning Warning
01/09/2017 Summary of Field Safety Notices - August 2017 3rd Party Publications
22/08/2017 Paraffin-based skin products. Priority 2 – Warning Warning
16/08/2017 OXFORD - DIPPER. Priority 2 – Warning Warning
01/08/2017 Summary of Field Safety Notices - July 2017 3rd Party Publications
14/07/2017 VITEK® 2 Gram-Negative AST cards. Priority 2 – Warning Warning
13/07/2017 Birdie Lifter. Priority 2 – Warning. Warning
13/07/2017 VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards. Priority 2 – Warning. Warning
05/07/2017 NovoPen Echo® and NovoPen® 5 Insulin Pens. Priority 1 – For Immediate Action For Immediate Action