Reporting adverse incidents involving medical devices

MHRA Adverse incident reporting

Reporting adverse incidents involving medical devices

What is a medical device?

Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. This does not include general workshop equipment such as power or machine tools, or general purpose laboratory equipment or aids for daily living. See European Commission guidance MEDDEV 2.1/1 (external link).

What is an adverse incident?

An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons.

For example:

  • a patient, user, carer or professional is injured as a result of a medical device failure or its misuse
  • a patient’s treatment is interrupted or compromised by a medical device failure
  • a misdiagnosis due to a medical device failure leads to inappropriate treatment
  • a patient’s health deteriorates due to medical device failure.

Causes may include: design; poor user instructions or training; inappropriate modifications; inadequate maintenance; and unsuitable storage and use conditions.

Why report?

The information from adverse incident reports can help identify faults with medical devices and may prevent similar incidents happening again.

Who should report?

Anyone may submit an adverse incident report to the MHRA – clinicians, healthcare workers, carers, patients and members of the public. Reports may need to be submitted via, or copied to, medical device liaison officers and/or patient safety managers.

What should be reported?

Any adverse incident involving a medical device should be reported to the MHRA. Some apparently minor incidents may have greater significance when aggregated with other similar reports.

When should an incident report be made?

All incidents should be reported to the MHRA as soon as possible. Serious cases should be reported by the fastest means possible. Initial incident reports should contain as much relevant detail as is immediately available, but should not be delayed for the sake of gathering additional information.

How do I report an incident?

Preferably by using the online forms here. However, you can also send a report by be email or post. Report forms may be downloaded/printed from the website.

What do I do with devices that have been involved in incidents? 

All items should be quarantined if possible. Do not throw them away, repair them or return them to the manufacturer until the MHRA has carried out its own investigation. Do not send medical devices to the MHRA unless you have been specifically requested to do so by MHRA.

What does the MHRA do when it receives a report?

The details are recorded on a database and a triage process completed by device specialists and clinical advisers. That assessment determines whether an investigation is undertaken directly by the MHRA (‘specialist’ investigation) or by the manufacturer on the Agency’s behalf (‘monitored’ investigation). Other incidents are recorded for trending and surveillance purposes only - a one-off incident in one healthcare establishment, when combined with information of several others, may identify the need for focussed awareness training or for the amendment of manufacturer's usage instructions. All reports are acknowledged and reporters advised of the nature and outcome of the investigation.

Trigger levels

Where possible, the MHRA attempts to identify trends within the adverse incident reports that we receive via manufacturers, clinicians and members of the public. Trigger levels are frequently used by the device specific specialist teams within the Agency to signal problems that could potentially be more widespread. When a trigger is highlighted, this initiates a further examination of the reported details and commonality can then be established. The non-active cardiovascular device team (the team that monitors events related to devices such as stent-grafts, IVC filters and peripheral stents) has set trigger levels purposely low, this is currently three (3) reports concerning the same type of problem with the same make and model device over a three month period. Although single reports have on occasion (by themselves) enabled the MHRA to bring about changes to the design or instructions for use of a device, multiple reports enable us with much more leverage when working with manufacturers to initiate change.

How long does the investigation take?

On average, 50% of monitored investigations are concluded within 10 weeks and 50% of specialist investigations within 21 weeks.

Medical Device Alerts (MDAs)

MDAs are the MHRA’s prime means of communicating important safety information to medical device users in health and social care.

The Central Alerting System (CAS) and the role of medical device liaison officers (MDLOs) 

The Central Alerting System is the medium through which MDAs are issued to the NHS. Each NHS trust and social services department has an MDLO. Their key roles are to co-ordinate the effective reporting of adverse incidents involving medical devices, and the dissemination of MDAs.

For general enquiries about adverse incidents involving medical devices contact our Adverse Incident Centre: [email protected] or 020 3080 7080.

Incidents occurring in Scotland, Northern Ireland and Wales
Each devolved administration has its own guidance on reporting adverse incidents, available on the respective websites.
Northern Ireland (external link)
Scotland (external link)
Wales (external link)

BSIR Guidance can be seen here