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Reporting IRMER incidents

Categories:
  • Organisations we regulate

What to report

Exposures "much greater than intended" (MGTI), occurring otherwise than as a result of equipment failure, must be reported to us. This is required under regulation 4(5).

Details of what constitutes an MGTI exposure can be found in guidance published on the Department of Health website.

Read the much greater than intended (MGTI) guidance.

Read the HSE guidance on equipment used in connection with medical exposure.

When to report an IR(ME)R incident

You should tell us about an Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) incident as soon as practicable after your preliminary investigation has confirmed that the exposure was MGTI or you have decided that a voluntary notification is worthwhile.

We normally expect notifications should be made within two weeks of the exposure taking place. We are happy to receive notifications where you do not yet have every item of information we ask for. We will ask you to provide it during the subsequent investigation.

Please feel free to contact us by phone or email if you believe the incident is a serious one or merits urgent notification.

How to make an IR(ME)R notification

Please make the notification using the incident report form.

IR(ME)R incident report form

If you wish to bookmark the form, please use this page and not the link for the form itself as this can result in a duplication of the IRMER reference number generated by the form.

Once you submit the form you will receive an automatically generated email acknowledgement including an IRMER notification reference number. Please use this number in all subsequent dialogue with us. Please contact us if you do not receive this confirmation email.

What happens next?

Once you have made the notification you will shortly be contacted by the IR(ME)R team with their initial triage into the incident.

Although the lead role in progressing notifications is taken centrally by the IR(ME)R team, the Compliance Inspector responsible for your organisation will have access to the investigation and its progress and may contribute where appropriate.

We may also sometimes arrange a more informal visit to a medical exposure provider to discuss notifications in general or seek assurances on a particular matter arising from a notification.

In rare circumstances, if we receive a notification that we believe requires a detailed investigation we will visit on-site and discuss the incident face-to-face with relevant staff which we refer to as a 'reactive' inspection.

As part of the investigation, we expect to be informed as to how the organisation has learnt from the incident through root cause analysis and local governance arrangements together with details of remedial action taken with the aim of preventing similar incidents occurring in the future.

Within your investigation report we seek evidence of the following points:

  • Internal governance.
  • The incident being fed back into risk management.
  • The patient being informed or the reasons why not.
  • Senior management being informed.
  • An action plan with management oversight to conclusion.

How is the notification closed?

When we have completed our investigation into an incident and we are satisfied to close the notification we will do so by way of sending a formal closure email to the organisation’s Chief Executive Officer copied to the individual who originally submitted the notification.

The letter makes mention that the notification has been closed on the assumption that any recommendations or remedial action have, or are being, followed through.

What if equipment malfunctions cause the exposure?

There may be situations where the patient over-exposure was solely the result of equipment malfunction. In these circumstances, the Health and Safety Executive (HSE) must be notified under the Ionising Radiation's Regulations 1999.

You should ask your Radiation Protection Advisor (RPA) for advice or find out more from the HSE directly.

More information about the HSE's work can be found on its website and you can make a notification to their ionising radiation team by email.

If there is a safety or performance issue involving the equipment, you should follow the adverse incident reporting process managed by the Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with their guidelines.

Find out more about the MHRA on the Medicines and Healthcare products Regulatory Agency (MHRA) website.

Last updated:
19 December 2016