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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
01/07/2009 Field Safety Notice Monthly Summary Sheet - July 2009 3rd Party Publications
18/06/2009 ‘First Steps’ Medicine Feeder Recall
27/04/2009 Safe and Effective Use of Bench-top Steam Sterilisers Advisory
23/04/2009 AidFast, 1st Aid & Powerplast Digital Thermometers Warning
20/04/2009 Exact Couch Top Warning
20/04/2009 Spacelabs Ultraview Digital Telemetry Transmitter Model 90478 Warning
02/04/2009 Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S Advisory
05/09/2008 Blood Component Bags and Transfusion Giving Sets Warning
29/07/2008 Safe and Effective Use of Bench-top Steam Sterilisers 29.07.2008 Advisory
10/06/2008 Disposable Infusion Devices Advisory
15/04/2008 Clinitest® hCG Cassette Pregnancy Test Kit Recall
02/04/2008 Coopers Walking Frames Advisory
01/02/2008 Baby Beets Fetal Doppler Warning
31/01/2008 H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory Warning
24/01/2008 IntraStent Unmounted Balloon Expandable Stent Recall
17/10/2007 Medical Devices Recommended by Healthcare Institutions for Use in a Community Setting Advisory
15/10/2007 Recall of Medtronic Sprint Fidelis Defibrillation Leads Recall
27/07/2007 EVAQUA Breathing Circuits Warning
27/07/2007 Scholl Freeze Verruca and Wart Remover Warning
27/07/2007 Mini Lift Stand Aid Warning
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