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
01/07/2011 Field Safety Notice Monthly Summary Sheet - June 2011 3rd Party Publications
27/06/2011 Medicine Feeders (incl. spoons, droppers, syringes, and pacifiers/soothers) Advisory
17/06/2011 Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons* & Flents Paediatric Urine Collectors * Includes ‘Duffy Dog’ and ‘Kyle Crocodile’ Medicine Spoons Recall
15/06/2011 Explorer Loop 4 Wheeled Rollator Recall
13/06/2011 Millennium Oxygen Concentrator Advisory
13/06/2011 Contec Devices including Pulse Oximeters, Patient monitors, Ambulatory Blood Pressure Monitors, Spirometers, Pocket fetal dopplers, B-Ultrasound Diagnostic Systems, ECG's Advisory
09/06/2011 Patient Monitor CMS7000 Advisory
03/06/2011 Field Safety Notice Monthly Summary Sheet - May 2011 3rd Party Publications
01/06/2011 ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Dropper Advisory
26/05/2011 Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers) Advisory
23/05/2011 Zoll AED Plus Defibrillator Advisory
13/05/2011 Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen Advisory
12/05/2011 Ondal Acrobat 2000 (AC2000) Advisory
09/05/2011 Field Safety Notice Monthly Summary Sheet - April 2011 3rd Party Publications
13/04/2011 Safe Use of Blood Glucose Monitoring Systems Advisory
08/04/2011 Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units Recall
07/04/2011 Field Safety Notice Monthly Summary Sheet - March 2011 3rd Party Publications
05/04/2011 Installation and Compatibility of Medical Devices Advisory
01/04/2011 BHM Medical Inc. Hoists Advisory
11/03/2011 IMB Safety Notice: Liftmaster 160 (AA8974), Liftmaster 190 (AA8943) Advisory