Ionising radiation regulatory changes for 2018 – The impact on dental practices
Dental practitioners have long been subject to regulation in relation to the maintenance and use of their x-ray equipment, but a new regulatory regime is shortly to come into force. This results from an EC directive, but as the UK will remain an EU member until at least March 2019 and the regulation is being passed into UK law well before that date, the new regime will continue to apply notwithstanding Brexit.
Immediate change – Registering with the HSE
Previously, the Ionising Radiation Regulations 1999 meant that any employer (a term widely defined so as to include a sole practitioner or principal of a dental practice) using ionising radiation had to give a one-off notification to the Health and Safety Executive (HSE) that this was the case.
Under the new Ionising Radiation Regulations 2017, which came into force on 1 January 2018 and which replace the 1999 regulations, such an employer must register online with the HSE and pay a £25 registration fee.
Re-registration will also be required where there is a ‘significant change’ in the information supplied on initial registration. Initial registration must be effected between 1 January and 5 February 2018, so the timescale for compliance is a very short one. The new regulations also create an obligation to notify the patient and others of any accidental or unintended exposure.
Further changes – New medical exposure regulations
When the 1999 regulations were issued, they were followed by specific further regulations in relation to medical exposure set out in the Ionising Radiation (Medical Exposure) Regulations 2000. These will shortly be replaced by the Ionising Radiation (Medical Exposure) Regulations 2017, which come into force on 6 February 2018.
The new medical exposure regulations mirror the previous regime’s requirements for:
- Justification of each exposure
- Written procedures and protocols to be in place
- Staff training
- Quality assurance
- Clinical audit
However, they enhance them. For example, justification of exposure will also need to include any exposure on the part of a patient’s ‘carers or comforters’. In addition, they will introduce a new requirement for each employer to obtain a licence from Public Health England or equivalent bodies in Scotland and Wales.
Medical and dental guidance notes
The HSE is expected to issue medical and dental guidance notes on the Medical Exposure Regulations, but it is unlikely that this will happen before 6 February, when they come into force.
Until the guidance notes become available, practitioners would be well-advised to refer to the commentaries on the new legislation and its implications for dental practice issued by FGDP(UK).
For more information or guidance, please contact:
T. 029 2034 3035
This briefing is for guidance purposes only. RadcliffesLeBrasseur LLP accepts no responsibility or liability whatsoever for any action taken or not taken in relation to this note and recommends that appropriate legal advice be taken having regard to a client's own particular circumstances.