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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
03/11/2023 Summary of Field Safety Notices - October 2023 Advisory
24/09/2020 LAP-BAND Adjustable Gastric Banding System and Accessories. Priority 3 – Advisory Advisory
24/06/2020 Lifeguard LG20, LG50, LG55. Priority 2 - Warning Advisory
17/06/2020 ACTIV.A.C.™ Therapy Units. Priority 2 – Warning Advisory
08/06/2020 Caution When Purchasing Thermometers Advisory
13/03/2020 Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy Advisory
11/03/2020 Programmable Ventriculo-Peritoneal (PVP) / Programmable Cerebrospinal Fluid (CSF) Shunts. Priority 3 – Advisory Advisory
17/06/2019 Electro–Surge Limited Devices used in Electrosurgery Advisory
02/08/2018 HIV Self-tests - Information Notice Advisory
29/01/2018 HPRA Information Notice - Food Intolerance Testing - 2018 Update Advisory
24/01/2018 Animas Vibe Insulin Pumps. Priority 3 – Advisory. Advisory
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
06/10/2017 Mobile Applications in Healthcare - Information Notice Advisory
25/09/2017 Information Notice - Caution when Purchasing Medical Devices Advisory
09/02/2017 Caution when Purchasing Dental Devices Online - Information Notice Advisory
09/12/2016 CME T34 Ambulatory Syringe Pumps. Priority 3 – Advisory Advisory
10/11/2016 Accu-Chek Aviva Combo, Accu-Chek Mobile bGM system, Accu-Chek Spirit Combo, Accu-Chek Spirit and Spirit Combo insulin pump. Priority 3 – Advisory Advisory
12/05/2016 Counterfeit Prime & Bond NT Refill - Priority 3 - Advisory Update Advisory
29/04/2016 LOVEXOK One Step Pregnancy (HCG) Test Strips. Priority 2 – Warning Advisory
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