The SoR has thanked the Department of Health and Social Care for their collaborative and inclusive approach working with stakeholder organisations and government bodies to review The Ionising Radiation (Medical Exposure) Regulations 2017.
The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2024 came into force on 1 October 2024. They are available to view at: https://www.legislation.gov.uk/uksi/2024/896/regulation/2/made.
By working with stakeholder organisations and government, The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2024 enhance regulatory frameworks in England, Scotland and Wales.
New amendments will ensure the radiography workforce has a robust system within which professionals can confidently deliver patient and service user exposures that are appropriate, safe and effective.
'Supporting the highest quality care'
Charlotte Beardmore, executive director of professional policy, welcomed the updates to the legislation, and the opportunity together with other stakeholders to input expertise into this review.
She said: “The legislation responds to the changing context, recognising the developments in technologies and ensuring that the law surrounding the use of ionising radiation supports the highest quality care and outcomes for patients.
“The legislation also supports safe professional development of the workforce underpinned by appropriate education and training, with a detailed scope of practice."
In Northern Ireland existing arrangements continue with analysis of the amendments to follow.
Lynda Johnson, professional officer for clinical imaging and radiation protection, added: “We welcome these carefully considered amendments and it is our view that none of the new requirements require significant change to working practices and will support the radiographic workforce to deliver the highest quality services.
“The amendments enforce existing good practice and support future developments in the use of medical radiological equipment and assistive software. We encourage everyone working with ionising radiation to make themselves familiar with the changes.
Services may wish to note the following amendments:
Clinical evaluation
Clarification of the interpretation of ‘evaluation’ to ‘clinical evaluation’ meaning interpretation of the information resulting from an exposure, including the outcome and implications
Diagnostic and dose reference levels
The inclusion of dose reference levels in radiotherapeutic practices for typical localisation or verification exposures for groups of standard-sized individuals or standard phantoms for broadly defined types of equipment and an extended requirement in regulation 6. (c) Employer’s duties: establishment of general procedures, protocols and quality assurance programmes where the exposure does not involve interventional radiology procedures to have regard to “international and national diagnostic reference levels and local dose surveys” where available.
Conducting and making use of local dose surveys is required throughout the amendments which is a positive step and will in turn support the development of National Diagnostic and Dose Reference Levels.
Regulation 12. (3) (c) requiring the operator to ensure exposures are as low as reasonably practicable consistent with the intended purpose now explicitly includes interventional radiology practices, in case of doubt where previous wording referred to radiodiagnostic examinations.
To understand more about diagnostic and dose reference levels please see our recorded webinar Diagnostic Reference Levels and Dose Reference Levels: What are they and how should I use them?
Equipment
Expansion of the interpretation of equipment including software which:
(a) delivers ionising radiation to a person undergoing exposure;
(b) directly controls or influences the extent of such exposure; or
(c) directly assists an operator in carrying out a clinical evaluation
Clinical evaluation is defined as a practical aspect of an exposure (regulation 2). The operator is responsible for each practical aspect (regulation 10. (4)). Clinical evaluation remains an operator role and software can directly assist an operator so it is our view that equipment or software cannot be considered the operator.
In regulation 15. (2) Equipment: general duties of the employer there is an additional requirement for employers to draw up and keep up to date an inventory for equipment that is software, and there are specific details in 15(2A).
Practitioners and justification of exposures
A small but impactful change to the meaning of “practitioner” (remember this is the IR(ME)R duty holder definition of practitioner NOT the education and development level of radiographer practitioner). This has changed from:
“A registered health care professional who is entitled in accordance with the employer’s procedures to take responsibility for an individual exposure to a registered health care professional who is entitled in accordance with the employer’s procedures to take responsibility for “the justification of” an individual exposure.”
Co-operation between employers
A new requirement 6A Employer’s duties: co-operation between employers. This is a requirement familiar to services considering compliance with The Ionising Radiations Regulations 2017 where regulation 16 requires employers to exchange information necessary to ensure the radiation safety of employees.
For the purposes of IR(ME)R the requirement is for employers to cooperate with each other to exchange or make accessible information on the exposure, or potential exposure to an individual. This underpins the collaborative work that is developing across imaging networks and in community diagnostic centres.
Taking appropriate action
In regulation 7. Employer’s duties: clinical audit the requirement is clarified to include the taking of appropriate action in relation to audit findings.
This is further enforced under regulation 8. Employer’s duties: accidental or unintended exposure which requires the employer to take appropriate action in relation to events involving or potentially involving accidental or unintended exposures proportionate to the radiological risk posed by the practice.
Duties of the practitioner, operator, and referrer
SoR is pleased to see the previous regulation 10 (1) requiring the practitioner and the operator to comply with the employer’s procedures is extended to include the referrer.
Optimisation and consent
The requirement of regulation 12. (4) Optimisation for medical or biomedical research programmes, is clarified so employer’s procedures must provide that consent to take part is given or where appropriate, consent is given on behalf of the individual.
In 12. (6) where patients are undergoing treatment or diagnosis with radioactive substances, the employer’s procedures around capacity and consent now include provision for a patient who is a child who lacks competence to consent. It is recommended that this amendment is carefully considered and employers procedures around both IR(ME)R and consent are reviewed.
A new regulation 12. (10) is introduced to require capacity and parental responsibility to be read in relation to the different legislations in England, Scotland and Wales.
Two New Employers Procedures
Schedule 2 now includes two additional requirements for employers to include procedures:
(o) for the carrying out of clinical audit, and for any appropriate action to be taken in accordance with regulation 7; and
(p) for making, amending and cancelling any referrals for exposure.
Adequate training
Schedule 3 has been improved to reflect, as a minimum, current entry level theoretical knowledge, and the requirements for practical experience relevant to specific areas of practice.
Implications for services will be different according to the service delivered but it is recommended that the amended requirements are considered when assessing skill mix and safe staffing arrangements. Helpful distinction is made between diagnostic radiology, nuclear medicine and radiotherapy requirements.
Licence fees
Where radioactive substances are to be administered:
- A new employer licence fee has increased from £250 to £298
- Amendment or renewal of an existing licence has increased from £200 to £244
There remains no fee for individual practitioner licences.
The SoR welcomes feedback on the amendments as we continue to update professional body guidance to reflect the changes.
To join the SoR radiation protection forum, a safe on line space for peer discussion and learning, please contact Lynda Johnson [email protected] or Julie Rankin [email protected]
The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2024 come into force on October 1 2024. They are available to view here.
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