The Ionising Radiation (Medical Exposure) Regulations IR(ME)R 2017 (2018 in Northern ireland) came into effect on 6th February 2018 and replaced The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000).
The Regulations are available from The Stationery Office here.
IR(ME) Regulations are flexible and allow a wide variety of practices to be undertaken as long as there is clear justification. Responsibility for compliance with IR(ME)R rests with the employer and all entitled duty holders as defined in the Regulations.
IR(ME)R is legislation aimed at the protection of the patient against the hazards associated with ionising radiation. It is made as criminal law rather than civil law. The main difference being that if there is a breach of civil law then the law seeks to establish fault and award compensation; in criminal law an illegal act is punished, compensation is a secondary issue.
The CQC produces an annual report in line with the requirement of regulation 9. It provides a comprehensive summary of notifications, recommendations for employers and lessons learned from significant events.
i) Employers Procedures
“Employers Procedures” (as required under Schedule 2 of the regulations) – within these Procedures there needs to be clarity around:
ii) Diagnostic Reference Levels
The Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R) require that employers establish and make available to an operator, Diagnostic Reference Levels (DRLs) and undertake appropriate reviews if they are consistently exceeded.
National DRLs can be found here.
Patient dose information and typical effective doses, equivalent periods of natural background radiation and lifetime fatal cancer risks from diagnostic medical exposures is available via Public Health England website.
iii) Guidance has been written by SoR, RCN, RCR and CSP to help those healthcare practitioners registered with a healthcare regulatory body who wish to take on the role of IR(ME)R 'Referrer' within clinical imaging departments. The guidance is available in the policy and guidance document library.
The guidance sets out a policy position on handling this type of request which was agreed by all the contributing organisations and includes legal and professional requirements under IR(ME)R. The IR(ME)R Referrer is required to have a knowledge of IR(ME)R and radiation exposure risks.
Following the publication of this guidance the College of Radiographers developed an IR(ME)R awareness training study day for Nurses and Allied Health Professionals. Similar training is generally available within local diagnostic imaging departments - A typical programme would include: IR(ME)R Referrer Programme.
iv) Examples of IR(ME)R training questions have been written by Maria Murray (Professional Officer for radiation protection) these may be used and modified as required to help radiographic staff gain a better understanding of the IR(ME)R regulations.
IR(ME)R training excercises
v) Guidance for implementing IR(ME)R in radiotherapy is available in the document library here.
This guide will be of benefit to chief executives, medical directors, human resources departments and all professionals involved in the delivery of radiotherapy. This document aims to address a series of frequently asked questions (FAQs) which have come up in formal inspections or have been brought to the attention of the Working Party by its members from their own departments and professions.
vi) Revised IR(ME)R Criteria for Significant Accidental and Unintended Exposures. As of June 3rd 2019, MGTI and PM77 were revoked and new criteria for statutory notifications under Regulation 8(4) were published. The IR(ME)R enforcement authority will no longer accept notifications following MGTI or PM77 so please ensure that SAUE criteria is followed. The new notification webform has been carefully constructed to intuitively follow the new criteria. The form and the associated guidance can be found here.
The enforcing authority for Scotland for the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) is Healthcare Improvement Scotland
Incidents in Wales, which result in a patient receiving a radiation dose "much greater than intended", must be reported, in one of these ways:
By email: [email protected]
Healthcare Inspectorate Wales
Bevan House, Caerphilly Business Park
Van Road, Caerphilly
02920 92 8921
NHS Organisations are also required to inform the Welsh Government of IR(ME)R incidents as part of Serious Incident reporting procedures.
Incidents in Northern Ireland which have gone through a local preliminary investigation and which results in a patient receiving a radiation dose "much greater than intended", must be reported to the Regulation and Quality Improvement Authority
Information about reporting incidents is available on the CQC website.
A link is there which lists what incidents need to be reported in terms of "much greater than intended" and to the HSE for incidents that involve a medical exposure to a patient through equipment failure.
Notifications can be made directly to CQC by using their web-based notification form.