Welcome to the Devices Transparency pages

Accept these caveats and then we'll show you the data

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 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.

·         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 where there is minor or no injury.

·         It is not compulsory for healthcare professionals to report incidents directly to MHRA but we strongly encourage this.



The process

Reports of adverse incidents with medical devices come to the MHRA from several different sources, including members of the pubic, healthcare professionals, manufacturers

When we receive a report of an adverse incident from a healthcare professional, a patient or a member of the public, we send these on to the manufacturer of the device*.

This means that the adverse incident data that manufacturers then send us, and that forms part of this transparency pilot, will include reports from healthcare professionals, patients and members of the public.

 

*Patients and members of the public have the option to remain anonymous when we share their report with the manufacturer.

 

We will then have context for the data, similar to Drug Analysis Profiles:

At the top of each page of data:

These data sets are an overview of all UK device adverse incidents reported by manufacturers. It is important to note that reported adverse incidents have not been proven to be related to the device and should not be interpreted as a list of known problems. The MHRA encourages the use of Yellow Card data; however, to ensure that it is interpreted in the correct way please refer to the guidance at the bottom of this page (text below).

Essential context for understanding adverse incident data on medical devices

These data contain information from the final reports (following investigation) from manufacturers. This includes reports received by MHRA from healthcare professionals and members of the public that were sent on to the manufacturer.

The data can be very useful in helping to identify possible 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

When using these data, you should remember that:

·         The likelihood of having a problem with a device cannot be estimated from the data shown here. This is because we have limited information about how many people have used the device without having a problem.

·         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 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 [PM2] 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.