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Incidents where patients, staff or members of the public receive accidental or unintended doses of radiation may arise as a result of equipment malfunction, operator error or a failure to follow standard procedures. It is the responsibility of the Employer to ensure that such incidents or accidents are properly investigated and, where appropriate, reported to the relevant authority in accordance with legislation. Healthcare Improvement Scotland (HIS) [1] is the relevant authority for notification of incidents involving patients, under The Ionising Radiation (Medical Exposure) Regulations 2017 [2], while incidents involving staff or members of the public are regulated under The Ionising Radiations Regulations 2017 [3] and reportable to the Health and Safety Executive (HSE) [4]. It is also recommended that near-miss incidents are investigated.

Immediately consult your Radiation Protection Adviser (RPA) or Medical Physics Expert (MPE), if it is suspected that a member of staff, the public or a patient has received an accidental or unintended dose of radiation.

Carry out an immediate preliminary investigation and report the incident to the relevant authority if it cannot be established beyond reasonable doubt that the exposure does not meet the relevant criteria for reporting.

  • Where the incident involves exposure of a patient, HIS [1] must be notified if the accidental or unintended dose is considered ‘ significant’ as defined in ‘Significant Accidental and Unintended Exposures under IR(ME)R’ [5]. If notification is required, it should be made no later than 2 weeks after discovering the incident.
  • Where the incident relates to overexposure of a member of staff, HSE [4] must be notified if the dose results in the dose limit being exceeded.

Carry out a detailed investigation of any notifiable incident in conjunction with your RPA or MPE, to:

  • establish the circumstances of the incident including how it happened;
  • estimate the magnitude of the dose;
  • identify the failure which led to the incident;
  • determine the actions required to prevent a similar incident in future.

Submit the detailed investigation report no later than 12 weeks after the incident to HIS [1] (for patient exposures) or to HSE [4] (for staff exposures).

In addition to notifying the relevant authority, inform Health Facilities Scotland (HFS) [6] of incidents relating to failure of x-ray equipment.
NB: Purely private dental practices (those with no NHS patients, including children) should report such incidents to the Medicines and Healthcare Products Regulatory Agency (MHRA) [7]; HFS can also be notified as a courtesy.

Retain investigation reports in the Radiation Protection File or patient notes

  • The ‘Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment’ recommend retaining reports of significant incidents involving patients for at least 5 years, or at least 30 years for clinically significant incidents [8].
  • For incidents involving members of staff or the public, the Ionising Radiations Regulations 2017 [3] require retention of immediate investigation reports for at least 2 years and detailed investigation reports for at least 30 years.

An example Employer’s Procedure on Incident Reporting (EP10) to describe the practice’s approach to accidental or unintended exposures of patients can be downloaded via Written Procedures and Protocols.

Sources of information

  1. Healthcare Improvement Scotland
  2. The Ionising Radiation (Medical Exposure) Regulations 2017
  3. The Ionising Radiations Regulations 2017
  4. Radiation Notifications. Health and Safety Executive
  5. Significant accidental and unintended exposures under IR(ME)R. Guidance for employers and duty-holders (Version 2) (2020) Care Quality Commission (PDF)
  6. Report an Incident. Health Facilities Scotland
  7. Medical Devices Adverse Incident Centre. Medicines and Healthcare products Regulatory Agency
  8. Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment (2nd Edition) (2020) Faculty of General Dental Practice (UK)