Welcome to Devices Adverse Incident
When reviewing the data presented within these webpages it is important to read the essential guidance here to ensure that you do not misinterpret the data.
Adverse incident transparency scope/plans:
The first stage of our adverse incident transparency plan is to provide this electronic summary information.
In due course, the Medicines and Medical Devices Act will allow, via subsequent statutes, for MHRA to increase the amount of detail included in information released to the public about actual or potential serious adverse incidents. This will allow MHRA to release details about the specific device, the incident and the conclusions of the manufacturer’s investigations.
Purpose:
The MHRA’s core role is the regulation of products, rather than clinical practice or the provision of healthcare.
No effective medicine or medical device is completely free of risk. As a regulator, our work must be underpinned by robust and fact-based judgments to ensure that the benefits of using any one device justify the risks. Decisions are not always straightforward. They are inevitably based on data which includes a range of individual experiences, either of benefit or risk.
The process:
MHRA receives reports of adverse incidents with medical devices from several different sources, including members of the public, healthcare professionals, manufacturers and suppliers. All reports of an adverse incidents are added to the adverse incident database.
When an incident report is received from a healthcare professional or members of the public it is logged onto the database and sent on to the manufacturer. The manufacturer must investigate and submit a formal report for every incident which meets the vigilance reporting criteria.
Note: Patients and members of the public have the option to remain anonymous when we share their report with the manufacturer.
The MHRA uses trending activities to monitor adverse incidents and determines when there may be a need to seek further investigation and/or action by the manufacturer.
Essential context for understanding adverse incident data on medical devices
A Yellow Card report of an adverse incident does not necessarily mean there is an actual fault with the device. An adverse incident may be the result of a pre-existing medical condition, or the device may not have been used as intended. Similarly, a report on a severe injury or death does not necessarily mean it was caused by the device malfunctioning.
The data can be particularly useful in helping to identify potential device safety issues. However, this information does not present a complete overview of the potential problems associated with specific devices. Conclusions on the safety and risks of devices cannot be made just on the data shown here.
For comprehensive information about the risks of particular devices, you should refer to the instructions for use, or ask your doctor, nurse, or healthcare professional.
Each adverse incident report adds to our knowledge of how devices perform once they are on the market, further enhancing our safety and surveillance activities. Therefore, we encourage members of the public to report any adverse incident through the Yellow Card website.
When reviewing these data, please remember that:
· Due to limited information about how many people have used a particular type of device without having a problem, the likelihood of having a problem with a device cannot be estimated from the data shown here.
· People should submit Yellow Card reports even if they only have a suspicion that the device may have caused the problem. Just because there is an adverse incident report in the database, does not necessarily mean that the device has caused the problem.
· It may be difficult to tell the difference between something that has happened naturally and an adverse incident. Sometimes adverse reactions can be part of the condition being treated rather than being caused by a device.
· Many factors must be considered when assessing whether a device has caused a reported adverse incident. When monitoring the safety of devices, MHRA staff carry out careful analysis of these factors.
· It is not possible to compare the safety of different devices by comparing the numbers presented in these data sets. Reporting rates can be influenced by many factors including the seriousness of the adverse incident, their ease of recognition and the extent of use of a particular product. Reporting can also be stimulated by promotion and publicity about a product.
If you are concerned about the device you are using, you should contact your GP, the health professional who prescribed it or contact the NHS via the routes listed below.
- NHS 111 in England and Scotland on 111 (textphone 18001 111)
- NHS Direct Wales/Galw IECHYD Cymru on 0845 46 47 (textphone 0845 606 46 47)
- NHS Northern Ireland
You should not stop using your device without first talking to your health professional.
General statements on adverse incident reports involving medical devices:
- A report of an adverse incident does not mean that the medical device caused the incident.
- The reason for reporting can be just a suspicion that an incident was caused by a device or the way in which it was being used.
- Manufacturers must report to MHRA incidents involving their device where there was a death or serious deterioration in health or the potential for these events. However, manufacturers do also send us reports in cases of minor or no injury.
- It is not compulsory for healthcare professionals to report incidents directly to MHRA but we strongly encourage this.
- The information we hold on our database is not a full picture of all the device-related incidents that happen, it is just a snapshot.
- Therefore, our data should NOT be used to make a judgement on the safety of a particular type of medical device or how likely it is to be involved in an adverse incident.
Questions & comments
The MHRA continually reviews these pages, however if you have any questions or comments please do not hesitate to share your feedback via the ‘Contact Us’ page.
