What is the HPRA’s role?
We protect patients and members of the public by ensuring that the medical devices used in our hospitals, care centres and in our homes meet safety and quality standards. Our role is to watch over the safety of medical devices and to check new information that becomes available. That way, any action needed to improve safety can be quickly taken.
What is a device safety issue?
A device safety issue is any unexpected problem with a device that may affect your health or cause or contribute to an injury. Typical safety issues with devices include an incorrect test result, a problem with a device, or a device not working.
What can I do?
You can report a device safety issue to us using our online reporting system, by post, or by telephone. You can submit a report for yourself or for someone in your care.
Why should I report to the HPRA?
When you submit a report, you give us information that can help to make medical devices safer for others.
Every report counts and helps to make medical devices as safe as possible.
What information is needed to make a report?
When making a report, we ask that you provide as much detail as possible. However, you can still report even if some information is missing or unknown.
At a minimum, please include
- Your name and contact information.
- Details to help identify the medical device, and batch/lot number if known
- Name of the manufacturer and supplier, if known.
- A description of what went wrong with the device.
You can also share additional relevant information. For information on how to report a medical device safety issue click here
What happens when I report to the HPRA?
When you submit a report to us, we: -
- Review your report.
- Let you know we received it.
- May contact you for more information about your experience.
Reports can help to find new safety issues or trends and are used together with all new information about the medical device.
Making a report to the HPRA does not mean that the medical device caused the safety issue. However, it is important to share the information with the HPRA so it can be looked at.
For more information on how we keep medical devices as safe as possible for patients and members of the public, click here
If you are worried about your health or the health of someone you care for, it is really important to speak to your doctor, pharmacist, or nurse. The HPRA cannot give medical advice.
What should I do when buying a device online or using a device at home?
The HPRA has also published information on a range of topics relevant to patients and members of the public including
- Buying medical devices online
- Buying medical devices for personal use
- Medical devices in the home
To access this advice for patients and members of the public click here
HPRA patient forum
We have established a Patient Forum for dialogue and exchange of information on topics relevant to patients and the public. The forum is based on a partnership approach to empower patients, so their experience and perspectives are heard, acknowledged and actioned to bring about improvements in the regulation of health products.
For information on the HPRA’s Patient Forum click here