Published: 30 January 2018
From 6 February, providers in England must ensure compliance with the requirements of new Ionising Radiation (Medical Exposure) Regulations.
Background
These Regulations, in part, implement the provisions of Council Directive 2013/59/Euratom dated 5 December 2013 (known as the Basic Safety Standards Directive, or BSSD). The BSSD lays down the basic safety standards for protection against the dangers from exposure to ionising radiation. In particular, the Regulations address the radiation protection of persons undergoing medical exposure and non-medical imaging exposure using medical radiological equipment. The BSSD will be transposed into UK law in early February.
We would like to remind providers in England of their obligations and highlight the main requirements of the new set of Regulations, namely:
The Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R2017)
IR(ME)R2017
IR(ME)R2017 comes into force on 6 February 2018, revoking and replacing the Ionising Radiation (Medical Exposure) Regulations 2000 (IR(ME)R2000) and subsequent amendments, the Medicines (Administration of Radioactive Substances) Regulations 1978 and the Medicines (Radioactive Substances) Order 1978.
The new regulations follow a format similar to IR(ME)R2000, however includes requirements for a number of topics which either were not addressed or addressed to a lesser degree previously. These include:
- Licensing for nuclear medicine
- Non-medical imaging using medical equipment
- Medical physics experts
- Communicating benefits and risks to patients
- Amendment to definitions surrounding "much greater than intended"
Provisions related to equipment and "comforters and carers" included in previous Ionising Radiation Regulations (IRR99) will be transferred to IR(ME)R2017.
Guidance
27 June 2018 update: The Department of Health and Social care has published guidance on the Ionising Radiation (Medical Exposure) Regulations 2017.
ARSAC Licensing has been published by Public Health England.
CQC is working in conjunction with Department of Health and Social Care and the devolved administrations on guidance for accidental and unintended exposures. This will involve amending the MGTI guidance to fit the new definitions within the regulations. In the meantime, please report all accidental or unintended exposures as per your current process referring to PM77 for equipment failures and MGTI guidance for all others.
In the first instance, please contact your local medical physics expert for advice.