New regulations on X-ray use: likely implications of draft IRR17 and IRMER18

News Published: 
8 August 2017

Professor Keith Horner, Co-Editor of FGDP(UK)’s Selection Criteria for Dental Radiography, analyses what the draft Ionising Radiation Regulations 2017 and draft Ionising Radiation (Medical Exposure) Regulations 2018 mean for dentists and dental practice teams.

Introduction

The Ionising Radiation Regulations 1999 (IRR99) and Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER2000), which relate to radiation protection, have long been a necessary burden for GDPs. While IRMER2000 deals with patient protection, IRR99 addresses the protection of staff as well as members of the public who are not patients.

The Health and Safety Executive (HSE) is currently finalising the Ionising Radiation Regulations 2017 (IRR17), and the UK Department of Health has recently consulted on draft Ionising Radiation (Medical Exposure) Regulations 2018 (IRMER18). IRR17 will replace IRR99, and IRMER18 will replace both the original IRMER 2000 and the amendments from 2006 and 2011.

The reason for the new regulations is the Basic Safety Standards Directive 2013 (BSSD, also known as European Council Directive 2013/59/Euratom), which all European Union member states are legally required to transpose into their national laws by 2018. This requirement applies equally to the UK and is not affected by the prospect of Brexit, which is not due until March 2019. After two decades, the opportunity has also been taken to make some minor amendments to the regulations which are unrelated to the BSSD.

While at this stage the draft regulations are very general and do not provide the sort of detail specific to particular professions such as dentists, there are a number of changes in areas relevant to the profession.

Implications for general dental practitioners

At this stage, we are still dealing with draft regulations, so look on what follows as highly likely rather than certain content. Probably the most immediate impact of the draft IRR17 is that the existing requirement for dental practices using x-rays to notify the Health & Safety Executive (HSE), on a once-only basis, will change to a requirement for regular registration. While IRR17 is rather short on detail on how this will work, we understand that registration will be online, with a process for this currently in development, and will require the dental practice to confirm that all legal requirements have been addressed, such as a risk assessment and the appointment of a Radiation Protection Adviser (RPA). We also understand that there will be a fee for registering, which is likely to be well under £100, and that re-registration will be required on a regular basis.

Under draft IRR17, there was an intention to designate radiation Controlled Areas based upon a much lower Instantaneous Dose Rate. The implications of this could mean many dental surgeries requiring lead shielding. We have been given to understand by that the medical physicists involved in developing medical and dental guidance notes, however, that the HSE have been persuaded that this would be an unacceptably expensive consequence to a regulation that would provide little practical benefit.

Moving on to the draft IRMER18, the proposed changes are in relation to the reporting of accidental exposures, quality assurance of equipment, appointment of Medical Physics Experts, exposures made to carers and comforters, ‘non-medical’ imaging, Diagnostic Reference Levels (DRLs), training, and possibly in relation to cone beam CT equipment. The impact, however, of most of these looks to be minor for dental practices. Nonetheless, some of the changes are worth some consideration.

The current legal requirement under IRR99 is for dental practices to appoint a RPA and this requirement remains the same under the IRR17. Under the existing IRMER2000, dental practices have to “ensure that a Medical Physics Expert shall be involved in every medical exposure”, but the draft IRMER18 requires that the MPE must be “appointed” by the employer and must meet criteria of competence. In practice, the role of Radiation Protection Advisor (RPA), already required under IRR99, is generally combined with the MPE role. The message is that dental practices should ensure that they have appointed a competent person or organisation to act as both RPA and MPE.

With respect to accidental and unintended exposures, the essential difference in the draft regulations seems to be an explicit requirement that the employer’s procedures must provide that the referrer, practitioner, and patient or their representative are informed of the occurrence of any relevant and clinically significant unintended or accidental exposure, as well as the outcome of the analysis of this exposure.

The draft IRMER18 regulations also give greater emphasis to the duties of the employer in implementing and maintaining a quality assurance programme which must, as a minimum, permit the assessment of dose during normal operation of the equipment. However, when the draft regulations are compared side by side with the current IRMER, there do not appear to be any significant implications for dentists in the requirements for quality assurance.

Draft IRMER18 specifically requires justification of exposures to “carers and comforters”. In a dental context this would mean, for example, a parent supporting a child undergoing an x-ray examination and staying in the controlled area when the exposure is made. The new regulations suggest considering this person during the justification of the X-ray examination and considering the dose that they might receive and informed consent. A sufficient net benefit would need to be established taking into account the direct benefit to a patient, the possible benefits to the carer or comforter and the detriment that the exposure may cause. The practicalities of doing this, particularly in a dental context, will need to be clarified and some guidelines developed. At this stage, it seems only reasonable and ethical that the exposure made to carers and comforters is taken into consideration, so the Faculty is supporting this change.

The draft IRMER18 also includes the category of “non-medical imaging exposures”, replacing the term “medico-legal exposures” used in IRMER (2000). Non-medical imaging is defined as “any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed”, and an example in the dental context might be radiological imaging for the purpose of preparing legal reports. Another example is the use of dental radiographs for age assessment for population groups such as refugees and asylum seekers - a practice which goes against FGDP(UK)’s radiography guidelines, which has been condemned as unethical by the British Dental Association and Royal Colleges in the UK, and for which many dentists may not be indemnified, but which may nonetheless still be happening in the UK at the request of public authorities. The new regulations will require that employers have a procedure in place for non-medical exposures. This means a bit more paperwork, and therefore gives another reason for GDPs not to perform such exposures in the first place.

The draft IRMER18 also defines “adequate training” for practitioners and operators. In response to the consultation, we commented upon the content of this training as listed in Schedule 4. We have recommended the inclusion of “non-medical imaging” into the topic list, as this term will be unfamiliar to most dentists and, as already noted, has been given prominence in the draft regulations. We have also suggested the addition of “Fundamentals of radiological interpretation” into the “adequate training” syllabus, an item which was also absent from IRMER 2000. The good news for dentists is that there is otherwise little change in the content of this list from that in the current regulations, so it would seem unlikely that dentists will feel an immediate need to attend a new IRMER course as a result of the updated requirements. Dentists will also be pleased to know that the roles and duties of “referrer”, “practitioner” and “operator” as defined and used in the draft regulations have not changed.

We will, however, be keeping our eyes on the possible implications of a section on “Estimates of population doses”. This states that “The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures, taking into consideration, where appropriate, the distribution by age and gender of the exposed population and, when so requested, must provide it to the Secretary of State”. While in hospital practice all exposures are currently recorded when radiological examinations are performed, this is probably not the case in general dental practice, and it seems likely that in future attention will need to be given to this. However, we will need to see whether this will mean anything more in practice than recording the exposure factors used for dental x-ray examinations.

From my reading of the draft IRMER18, one uncertainty relates to whether dental cone beam CT equipment, an increasingly common technology in dental practices, is classifiable as “computed tomography equipment”. In the draft, there is a section relating to equipment installed after the regulations take effect, which says: “Equipment used for… computed tomography must have the capacity to transfer, to the record of a person’s examination, information relating to relevant parameters for assessing the dose.” While it seems likely that there was no intention to include dental cone beam CT equipment under this requirement, there must be a possibility that the regulations might be interpreted as doing so. If this happens, then guidance will be needed on how the regulations will translate into the dental context.

What next?

Once finalised, IRR17 will take effect on 1 January 2018 and IRMER18 on 6 February 2018, both applying to England, Wales and Scotland. Separate regulations will be produced later for Northern Ireland, and dentists there should continue to comply with IRR(NI)2000 and IRMER(NI)2000 until these are implemented.

While the root cause of the changes is EU legislation, as the regulations will be laid down in UK law, the updated requirements will continue to apply to dentists after Brexit unless and until a specific decision is taken thereafter to alter them.

Dentists need not be alarmed by the revised legislation, but they do need to understand and prepare for them, and the FGDP will be here to guide you. Following finalisation, we will be making some minor updates to the online version of Selection Criteria for Dental Radiography.

A draft Approved Code of Practice is expected in October 2017, though on its own we should not expect this to be particularly helpful for dentists. While Medical and Dental Guidance Notes are also expected to be published around May 2018, this will still leave the profession in limbo for 4-5 months after the regulations have taken effect, and we cannot be sure that they will give dentists the “user-friendly” guidance they would value. In the meantime, we hope that your RPA will be keeping you informed about the new regulations and their implementation.

It is our understanding, disappointingly, that there are no current plans for government to produce a specific guidance document for dental practitioners, or even an update of the dental-specific guidance which the profession has had since 2001 in relation to the current regulations. If such guidance is not forthcoming from government, this is something the Faculty will look to develop for the benefit of the profession.

The draft IRR17 can be found via this link, and the draft IRMER18 here.

Acknowledgement

Thanks to Dr Mark Worrall, Department of Medical Physics, Ninewells Hospital and Medical School, Dundee, and member of the Medical and Dental Guidance Notes panel with responsibility for Diagnostic Radiology, for providing helpful information.