Changes to the Ionising Radiation Regulations in 2018
Dental practitioners have an ever-increasing burden of compliance to shoulder. Included in the growing list of industry protocols that have to be followed are the latest Ionising Radiation Regulations, which came into force on the 1st January 2018 – at the point when the Ionising Radiation Regulations 2017 (IRR17) replaced IRR99. The Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER) have also been revised, and the updated versions came into force on the 6th February 2018. IRR17 introduces a three-point risk-based system of regulatory control – “notification” (for low level risk activities), “registration” (for the operation of radiation generators) and “consent” (for the highest risks).
As general dental practitioners use x-ray generators, they will be required to apply in the “register” category (Level 2). Henceforth, all employers at dental practices that work with dental x-ray equipment are required to register. This applies even if they have previously notified HSE of their work with dental x-ray equipment. There is a fee of £25 per registration, which may include details of one or more practices where applicable.
This is a one-off registration so there is no requirement to annually renew, but if there are any material changes to the practice – for example, if you relocate or change the practice name – you may need to re-register.
There will also be a requirement to record and analyse events that cause the contingency plan included in the local rules to be enacted, and it will be mandatory to state what measures, if any, are needed to prevent a reoccurrence of any such event.
Further changes include additions of two additional key topic areas to be included in the local rules, which are now as follows:
- details of the management and supervision of the work;
- procedures for ensuring staff have received sufficient information, instruction and training;
- the dose investigation level;
- identificational summary of any contingency arrangements relating to reasonably foreseeable accidents;
- name or names of the appointed radiation protection supervisor or supervisors;
- identification and description of the designated control area and areas;
- an appropriate summary of the working instructions relating to the work with x-rays, including the written arrangements relating to non-classified persons entering or working in designated control areas; and
- procedures are also required that estimate the doses to members of the public.The proposed changes under IRMER18 will deal with non-medical imaging, which, in broad terms, covers situations where exposure does not bring an immediate health benefit to the individual exposed (e.g. health screening or reviewing treatment previously carried out).If you operate as two separate entities (e.g. as a limited company and a sole trader), and you share one set of radiation equipment, the HSE would require two registrations, as the fact that you share equipment would be irrelevant.There are also additional employer’s procedures to follow, such as that the employer must collect dose estimates from medical exposures under radio diagnostic procedures, and provide it to the Secretary of State – although guidance is yet to be issued. In addition to the above, the patient or their representative should be provided with adequate information as to the benefits and risks associated with dosage, prior to an exposure taking place. The referrer, practitioner, and the individual or the representative exposed, must be informed of the occurrence of clinically significant, unintended or accidental exposure, and the outcome of the analysis of this exposure – appropriate treatment must then be given. In relation to the sale and purchase of dental practices, the new regulations will inevitably lead to some further due diligence enquiries.
With over 20 years experience specialising in providing specialist legal services to the dental profession, Goodman Grant have the knowledge and expertise to assist in this regard. The professional team will carry out extensive due diligences checks into the financial, commercial and legal position of a business, so practitioners can avoid any pitfalls. A well-advised buyer should ensure that the appropriate procedures have been adopted and that the practice is duly registered as part of the due diligence, prior to purchase. We have covered a broad summary of changes to the Ionising Radiation Regulations and it is not intended to be exhaustive. Practitioners can seek further details at www.hse.gov.uk/radiation/ionising/. Equally, practitioners with any queries should seek appropriate advice. Regulations are frequently updated, so it is important to be prepared for any changes in order to ensure you remain compliant, for the benefit and safety of you and the patients you treat.