European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018

• Jurisdiction: Ireland
• Citation: IR SI 256/2018
• Year: 2018

ARRANGEMENT OF REGULATIONS

PART 1

PRELIMINARY

1. Citation

2. Interpretation

3. Responsibility for functions under Directive

PART 2

REQUIREMENTS IN RELATION TO MEDICAL EXPOSURES

4. Referrers

5. Practitioners

6. Undertaking

7. Justification of practices

8. Justification of medical exposures

9. Optimisation

10. Responsibilities

11. Diagnostic reference levels

12. Dose constraints for medical exposures

13. Procedures

14. Equipment

15. Special practices

16. Special protection during pregnancy and breastfeeding

17. Accidental and unintended exposures and significant events

18. Estimates of population doses

PART 3

MEDICAL PHYSICS EXPERTS

19. Recognition of medical physics experts

20. Responsibilities of medical physics experts

21. Involvement of medical physics experts in medical radiological practices

PART 4

EDUCATION, INFORMATION AND TRAINING

22. Education, information and training in the field of medical exposure

PART 5

COMPLIANCE AND ENFORCEMENT

23. Interpretation of Part 5

24. Authorised persons

25. Inspections

26. Compliance notice

27. Prohibition Order

28. Provision of information to the Authority

PART 6

OFFENCES AND PENALTIES

29. Offences

30. Penalties

31. Summary proceedings may be brought by Authority

PART 7

AMENDMENT, REVOCATIONS AND TRANSITIONAL PROVISIONS

32. Amendment of Health Act 2007

33. Amendment of European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004

34. Revocations

35. Transitional provisions

S.I. No. 256 of 2018

EUROPEAN UNION (BASIC SAFETY STANDARDS FOR PROTECTION AGAINST DANGERS ARISING FROM MEDICAL EXPOSURE TO IONISING RADIATION) REGULATIONS 2018

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 15th January, 2019.

I, SIMON HARRIS, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Council Directive 2013/59/EURATOM of 5 December 20131 , as affected by Corrigendum to Council Directive 2013/59/EURATOM2 , insofar as it relates to medical exposures, hereby make the following regulations:

PART 1

PRELIMINARY

Citation

1. These Regulations may be cited as the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018.

Interpretation

2. (1) In these Regulations—

“Authority” means the Health Information and Quality Authority;

“clinical responsibility” means responsibility of a practitioner for individual medical exposures, in particular, justification; optimisation; clinical evaluation of the outcome; cooperation with other specialists and staff, as appropriate, regarding practical aspects of medical radiological procedures; obtaining information, if appropriate, on previous examinations; providing existing medical radiological information or records to other practitioners or the referrer, as required; and giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate;

“compliance notice” means a notice served pursuant to Regulation 26;

“Directive” means Council Directive 2013/59/EURATOM of 5 December 20131 as affected by Corrigendum to Council Directive 2013/59/EURATOM2;

“ethics committee” means an ethics committee established or recognised under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ) for the purposes of Regulation 8(2);

“medical exposure” means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research;

“medical physics expert” means an individual having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to medical exposure, whose competence in this respect is recognised by the Minister pursuant to Regulation 19(2);

“Minister” means the Minister for Health;

“new type of practice” means a practice of a class or type which was not carried out in the State before the coming into operation of these Regulations;

“practical aspects of medical radiological procedures” means the physical conduct of a medical exposure and any supporting aspects, including handling and use of medical radiological equipment, the assessment of technical and physical parameters (including radiation doses), calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals, and image processing;

“practitioner” means a person, being a member of one of the classes of persons referred to in Regulation 5, who has clinical responsibility for an individual medical exposure;

“prohibition order” means an order served pursuant to Regulation 27;

“radiation protection adviser” means an individual or a body, having the knowledge, training and experience needed to give radiation protection advice in order to ensure the effective protection of individuals, which meets such criteria of competence as may from time to time be specified in writing by the Environmental Protection Agency;

“Register of Medical Physics Experts” means the register established and maintained by the Minister pursuant to Regulation 19(1)(b);

“referrer” means a person, being a member of one of the classes of persons referred to in Regulation 4(1), who is entitled to refer an individual for medical radiological procedures to a practitioner;

“undertaking” means a person or body who, in the course of a trade, business or other undertaking (other than as an employee), carries out, or engages others to carry out, a medical radiological procedure or the practical aspects of a medical radiological procedure.

(2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

Responsibility for functions under Directive

3. (1) The Authority is designated as the competent authority in the State for the purposes of Articles 55, 60, 63, 76, 77, 96, 104 and 105 of the Directive, insofar as those Articles relate to medical exposures.

(2) The Minister is designated as the competent authority in the State for the purpose of recognition of competence of medical physics experts under Article 79(1)(d) of the Directive.

(3) In exercising their powers and carrying out their functions under these Regulations and the Directive, the Authority and the Minister—

(a) shall comply with the transparency requirements of Article 77 of the Directive, and

(b) may obtain advice from appropriate third parties and may pay such parties for such advice.

(4) The Authority shall co-operate with the Environmental Protection Agency in the carrying out of the Agency’s functions under the Directive, in particular in relation to the withdrawal of authorisation, registration or licences as appropriate, and may share data with the Agency for that purpose.

PART 2

REQUIREMENTS IN RELATION TO MEDICAL EXPOSURES

Referrers

4. (1) A person shall not refer an individual for medical radiological procedures to a practitioner unless the person referring (“the referrer”) is—

(a) a registered nurse or registered midwife within the meaning of the Nurses and Midwives Act 2011 (No. 41 of 2011) who meets the standards and requirements set down from time to time by the Nursing and Midwifery Board of Ireland in relation to the prescribing of medical ionising radiation by nurses or midwives,

(b) a registered dentist within the meaning of the Dentists Act 1985 (No. 9 of 1985),

(c) a registered medical practitioner within the meaning of the Medical Practitioners Act 2007 (No. 25 of 2007),

(d) a person whose name is entered in the register established and maintained by the Radiographers Registration Board pursuant to section 36 of the Health and Social Care Professionals Act 2005 (No. 27 of 2005), or

(e) a health care professional registered with the General Medical Council of the United Kingdom, and practising medicine in Northern Ireland, who is entitled in accordance with his or her employer’s procedures to refer individuals for exposure to a practitioner.

(2) A person shall not carry out a medical radiological procedure on the basis of a referral from a person other than a referrer.

Practitioners

5. A person shall not take clinical responsibility for an individual medical exposure unless the person taking such responsibility (“the practitioner”) is—

(a) a registered dentist within the meaning of the Dentists Act 1985 (No. 9 of 1985),

(b) a registered medical practitioner within the meaning of the Medical Practitioners Act 2007 (No. 25 of 2007), or

(c) a person whose name is entered in the register established and maintained by the Radiographers Registration Board pursuant to section 36 of the Health and Social Care Professionals Act 2005 (No. 27 of 2005).

Undertaking

6. (1) Subject to paragraph (2), an undertaking shall notify the Authority, no later than one month before commencing practices, of the proposed commencement, in such form and manner as may be prescribed by the Authority from time to time.

(2) An undertaking which, on the commencement of these Regulations, is carrying out practices shall notify the Authority, no later than 3 months after the commencement of these Regulations, of such activity, in such form and manner as may be prescribed by the Authority, and may continue such activity pending said notification.

(3) An undertaking shall provide for a clear allocation of responsibilities for the protection of patients, asymptomatic individuals, carers and comforters, and volunteers in...