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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
25/04/2016 Cross Reactivity Of Fulvestrant in Estradiol Assays. Priority 3 – Advisory. Advisory
07/04/2016 Risk associated with Wall mounted and Ceiling mounted Devices. Priority 3 – Advisory Advisory
08/01/2016 Manufacturer Field Safety Notices & HPRA Safety Notices. Priority 3 – Advisory Advisory
06/11/2015 New Format of HPRA Safety Notices. Priority 3 – Advisory Advisory
21/05/2015 Interference Of N-Acetylcysteine (NAC) with Enzyme-based Assays Used following Paracetamol Overdose. Priority 3 - Advisory Advisory
15/05/2015 Medtronic Synchromed II Implantable Infusion Pump Systems Advisory
24/03/2015 HPRA Information Notice - Food Intolerance Testing Advisory
13/03/2015 Invacare Leo®, Orion® and Comet ® Scooters. Priority 2 – Warning Advisory
23/02/2015 Information Notice - Medical devices supplied by Atrium Medical (Maquet) Advisory
05/02/2015 Counterfeit Toshiba Ultrasound Transducers - Priority 3 - Advisory Advisory
02/02/2015 Medical Devices in the Home. Priority 3 – Advisory Advisory
06/11/2014 Insulin Infusion Pumps. Priority 3 – Advisory Advisory
11/08/2014 ArjoHuntleigh lifting poles with an adjustable strap and handle. Priority 3 – Advisory Advisory
06/08/2014 Magnetic Resonance Imaging Safety. Priority 3 – Advisory Advisory
25/06/2014 “Intended Purpose” of a Medical Device. Guidance for healthcare settings -Priority 3 – Advisory Advisory
23/06/2014 Alaris® SmartSite® Needle-Free Valve. Product Reference: 2000E7D. Priority 2 – Recall Advisory
05/06/2014 Accu-Chek® Mobile blood glucose monitoring system Priority 2 – Warning Advisory
15/05/2014 Illegal “iCARE” self test kits. Priority 2 – Warning Advisory
09/05/2014 pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0 Priority 2 – Warning Caution In Use Advisory
06/05/2014 Kryo range of freezers. Priority 2 – Warning Advisory
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