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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:

Field safety notices (FSNs), published by manufacturers.
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.

Order by:

Show:

Date	Title	Type
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
04/03/2011	Field Safety Notice Monthly Summary Sheet - February 2011	3rd Party Publications
23/02/2011	Counterfeit Medical Devices	Advisory
04/02/2011	Counterfeit Medical Devices 04.02.2011	Advisory
03/02/2011	Field Safety Notice Monthly Summary Sheet - January 2011	3rd Party Publications
21/01/2011	Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors	Advisory
06/01/2011	Field Safety Notice Monthly Summary Sheet - December 2010	3rd Party Publications
22/12/2010	Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors 22.12.2010	Advisory
21/12/2010	Safe Use of Insulin Pens	Advisory
17/12/2010	Installation and Compatibility of Medical Devices 17.12.2010	Advisory