Ionising Radiation Medical Exposure Regulations, 2004

L.N. 472 of 2004

THE PUBLIC HEALTH ACT, 2003

(ACT NO. XIII OF 2003)

Ionising Radiation Medical Exposure Regulations, 2004

IN exercise of the powers conferred by article 26 (m) of the Public

Health Act, 2003, the Minister of Health, the Elderly and Community

Care has made the following regulations>-

(1) The title of these regulations is Ionising Radiation Title and scope.

Medical Exposure Regulations, 2004.

(2) The scope of these regulations is to transpose Directive

97#43#Euratom.

The Superintendent of Public Health shall have the power to Enforcement.

enforce these regulations.

In these regulations, unless the context otherwise requires>

Interpretation.

“adequate training” means training which satisfies

requirements for theoretical knowledge and practical experience

as determined by the Board. Such training shall be commensurate

with the functions and the specific area of practice of practitioners

or operators, as appropriate<

“the Board” means the Radiation Protection Board as

constituted by article 3 of the Nuclear Safety and Radiation

Protection Regulations, 2003<

“child” means a person who has not yet attained the age of 18

years<

“clinical audit” means a systematic examination or review of

medical radiological procedures which seeks to improve the quality

and the outcome of patient care through structured review whereby

radiological practices, procedures and results are examined against

agreed standards for good medical radiological procedures, with

modification of practices where indicated and the application of

new standards if necessary<

“clinical responsibility” means the responsibility regarding

individual medical exposures attributed to a practitioner, notably>

justification, optimization, clinical evaluation of the outcome,

cooperation with other specialists and staff, as appropriate,

regarding practical aspects< obtaining information, if appropriate,

of previous examinations< providing existing radiological

information and, or records to other practitioners and or referrers,

as required< giving information on the risk of ionizing radiation to

patients and other individuals involved as appropriate<

“diagnostic reference levels” means dose levels in medical

radiodiagnostic practices or, in the case of radio-pharmaceuticals,

levels of activity, for typical examinations for groups of

standardsized patients or standard phantoms for broadly defined

types of equipment. These levels are expected not to be exceeded

for standard procedures when good and normal practice regarding

diagnostic and technical performance is applied<

“dose constraint” means a restriction on the prospective doses

to individuals which may result from a defined source, for use at

the planning stage in radiation protection whenever optimisation

is involved<

“employer” shall have the same meaning as assigned to

radiation employer in the Nuclear Safety and Radiation Protection

Regulations, 2003<

“equipment” means equipment which delivers ionizing

radiation to a person undergoing a medical exposure and equipment

which directly controls or influences the extent of such exposure<

“exposure” means the process of being exposed to ionizing

radiation.<

“health screening” means a procedure using radiological

installations for early diagnosis in population groups at risk<

“individual detriment” means clinically observable deleterious

effects that are expressed in individuals or their descendants, the

appearance of which is either immediate or delayed and, in the

latter case, implies a probability rather than a certainty of

appearance<

“inspection” means an investigation by the Board or any

authorised person or persons or any body corporate established by

or under any law, on behalf of the Board to verify compliance

with these regulations<

“medical physics expert” means an expert in radiation physics

or radiation technology applied to exposure, within the scope of

these regulations, who holds a science degree or equivalent and

who is experienced in the application of physics to the diagnostic

and therapeutic uses of ionising radiation and whose training and

competence to act in a specific area of practice is recognised by

the Board< and who, as appropriate, acts or gives advice on patient

dosimetry, on the development and use of complex techniques and

equipment, on optimisation, on quality assurance, including quality

control, and on other matters relating to radiation protection,

concerning exposure within the scope of these regulations<

“medical radiological procedure” means any procedure

concerning medical exposure<

“medico-legal procedures” means procedures performed for

insurance or legal purposes without a medical indication<

“occupational health surveillance” means the medical

surveillance for workers as specified by Occupational Health and

Safety Authority by virtue of the General Provisions for Health

and safety at Work Places Regulations, 2003<

“operator” means any person who is entitled, to carry out

practical aspects<

“patient dose” means the dose, concerning patients or other

individuals undergoing medical exposure<

“patient dosimetry” means the dosimetry concerning patients

or other individuals undergoing medical exposure<

“practical aspects” means the physical conduct of any of the

exposure referred to in regulation 5 (1) and any supporting aspects

including handling and use of radiological equipment, and the

assessment of technical and physical parameters including radiation

doses, calibration and maintenance of equipment, preparation and

administration of radio-pharmaceuticals and the development of

films<

“practitioner” means a medical doctor, dentist or other health

professional, who takes clinical responsibility for an individual

medical exposure and whose training and competence to act in a

specific area of practice is recognised by the Board<

“referrer” means a medical doctor, dentist or other health

professional recognised by the Board, who is entitled, in accordance

with the employer’s procedures, to refer individuals for medical

exposure to a practitioner<

“quality assurance” means all those planned and systematic

actions necessary to provide adequate confidence that a structure,

system, component or procedure will perform satisfactorily

complying with agreed standards<

“quality control” is a part of quality assurance and means the

set of operations (programming, co-ordinating, implementing)

intended to maintain or to improve quality. It covers monitoring,

evaluation and maintenance at required levels of all characteristics

of performance of equipment that can be defined, measured, and

controlled<

“radiological” means pertaining to the radiodiagnostic and

radiotherapeutic procedures and interventional radiology or other

planning and guiding radiology<

“radiological installation” means a facility containing

radiological equipment<

“radiodiagnostic” means pertaining to in vivo diagnostic

nuclear medicine, medical diagnostic radiology, and dental

radiology<

“radiotherapeutic” means pertaining to radiotherapy including

nuclear medicine for therapeutic purposes.

(1) These regulations shall apply to the following medical

exposures>

(a) the exposure of patients as part of their own medical

diagnosis or treatment<

(b) the exposure of individuals as part of occupational health

surveillance<

(c) the exposure of individuals as part of health screening

programmes<

(d) the exposure of healthy individuals or patients

voluntarily participating in medical or biomedical, diagnostic or

therapeutic research programmes<

(e) the exposure of individuals as part of medico-legal

procedures.

(2) These regulations shall also apply to exposure of

individuals helping, other than as part of their occupation, in the support

and comfort of individuals undergoing medical exposure.

(1) All medical exposures shall be effected under the clinical Justification.

responsibility of a practitioner.

(2) No new type of practice involving medical exposure

shall be adopted unless authorised by the Board.

(3) Existing types of practices involving medical exposure

shall be reviewed by the Board whenever new evidence about their

efficacy or consequences is acquired.

(1) No practitioner may authorise a medical exposure unless Conditions

justifying medical

he has given due consideration to>

exposures.

(a) the specific objectives of the exposure and the

characteristics of the individual involved<

(b) the target volumes intended for a radiotherapeutic

purpose which volumes are individually planned taking into

account that doses of non-target volumes and tissues shall be as

low as practicable and consistent with the intended radiotherapeutic

purpose of the exposure<

(c) the total potential diagnostic benefits or the total

therapeutic benefits it produces<

(d) the direct health benefits to the individual and the

benefits to society<

(e)

the individual detriment that the exposure might cause<

(f) the efficacy, benefits and risks of available alternative

techniques having the same objective but involving no or less

exposure to ionising radiation.

(2) Any medical exposure in terms of regulation 5(1)(d)

requires the prior approval of the Board acting on the advice of an ethics

committee.

(1) The employer shall ensure that written procedures for

medical exposures are in place and shall include>

(a) procedures to identify correctly the individual to be

exposed to ionising radiation<

(b) procedures to identify individuals entitled to act as

referrer or practitioner or operator<

(c) procedures to be observed in the case of medico-legal

exposures<

(d) procedures for making enquiries of females of

childbearing age to establish whether the individual is or may be

pregnant or breastfeeding<

(e) procedures to ensure that quality assurance programmes

are followed<

(f) procedures for the assessment of patient dose and

administered activity<

(g) procedures for the use of diagnostic reference levels<

(h) procedures for medical and biomedical research

programmes as referred to in regulation 5(1)(d), including the use

of dose constraints<

(i) procedures for the giving of information and written

instructions as referred to in regulation 11(1)<

(j) procedures for the carrying out and recording of doses

for each medical exposure including, where appropriate, factors

relevant to patient dose<

(k) procedures to ensure that the probability and magnitude

of accidental or unintended doses to patients from radiological

practices are reduced so far as reasonably practicable.

(l) procedures for the carrying out of clinical audit as

appropriate.

(2) The employer shall take steps to ensure that the written

procedures are complied with by the practitioner and the operator.

(3) In the case where the employer is concurrently

practitioner or operator, he shall comply with these procedures himself.

(4) The employer shall ensure that written protocols are in

place for every type of standard radiological practice for each equipment.

(5) The employer shall establish>

(a) referral criteria for medical exposures, including

radiation doses, and shall ensure that these are available to the

referrer<

(b) quality assurance programmes for standard operating

procedures<

(c) diagnostic reference levels for radiodiagnostic

examinations falling within regulations 5(1)(a), 5(1)(b), 5(1)(c)

and 5(1)(e)having regard to European diagnostic reference levels

where available, which levels must be approved by the Board.

(d) dose constraints for biomedical and medical research

programmes falling within regulation 5(1)(d)where no direct

medical benefit for the individual is expected from the exposure<

(e) appropriate guidance and dose constrains for exposure

of individuals referred to in regulation 5(2).

(6) The employer shall review diagnostic reference levels

and shall ensure corrective actions are taken when such levels are

consistently exceeded>

Provided that the employer keeps a record of these levels,

which record is also submitted to the Board.

(7) Where the employer knows or has reason to believe that

an incident has or may have occurred in which a person, while

undergoing a medical exposure was exposed to ionising radiation to an

extent much greater than intended, the employer shall make an

immediate preliminary investigation of the incident and, unless that

investigation shows beyond a reasonable doubt that no such

overexposure has occurred, the employer shall forthwith notify the Board

and make or arrange for a detailed investigation of the circumstances of

the exposure and an assessment of the dose received.

The practitioner and the operator shall comply with the

employer’s procedures.

Without prejudice to regulation 7(1)(b), the operator and

practitioner shall select equipment and methods to ensure that for each

medical exposure the dose of ionising radiation to the individual

undergoing the exposure is as low as reasonably practicable and

consistent with the intended diagnostic or therapeutic purpose and in

doing so shall pay special attention to>

(a)

quality assurance< and

(b) assessment of patient dose or administered activity< and

(c) adherence to diagnostic reference levels for

radiodiagnostic examinations falling within regulations 5(1)(a),

5(1)(b), 5(1)(c) and 5(1)(e) as set out in the employer’s procedures.

(1) In the case of patients undergoing treatment or diagnosis

with radioactive medicinal products, the employer’s procedures shall

provide that, where appropriate, written instructions and information

are provided to>

(a) the patient, where he has capacity to consent to a

treatment or diagnostic procedure< or

(b) where the patient is a child who lacks capacity so to

consent, the person with parental responsibility for the child< or

(c) where the patient is an adult who lacks capacity to

consent, the practitioner shall decide in the best interest of the

patient.

(2) The patient shall be informed how the doses can be

restricted as far as reasonably possible in order to protect persons in

contact with him.

(1) In complying with the obligations under these

regulations, the practitioner and the operator shall ensure optimisation

of the medical exposure and shall pay special attention to>

(a) the need to keep doses arising from medico-legal

exposures as low as practicable<

(b) medical exposures of children<

(c) medical exposure as part of a health screening

programme<

(d) medical exposures involving high doses to the patient<

(e) where appropriate, female in whom pregnancy cannot

be excluded and who are undergoing a medical exposure, in

particular if abdominal and pelvic regions are involved, taking into

account the exposure of both the expectant mother and the unborn

child< and

(f) where appropriate, females who are breastfeeding and

who are undergoing exposures in nuclear medicine, taking into

account the exposure of both the female and the child.

(2) No person shall, in the case of fluoroscopy, carry out an

examination without an image intensification or equivalent technique>

Provided that examinations without devices to control the dose

rate shall be limited to justified circumstances.

The employer shall ensure that a medical physics expert is> Expert advice.

(a) closely involved in every radiotherapeutic practice other

than standardised therapeutic nuclear medicine practices<

(b) available in standardised therapeutic nuclear medicine

practices and in diagnostic nuclear medicine practices<

(c) involved as appropriate for consultation on optimisation,

including patient dosimetry and quality assurance, calibration of

equipment, and to give advise on matters relating to radiation

protection concerning medical exposure, as required, in all other

radiological practices.

It shall be the duty of all persons to comply with any General duty.

requirement or duty prescribed on them by these regulations and to

render all assistance to and co-operate fully, by all possible means, with

the Board or its duly authorised officers.

(1) Any breach of any provisions of these regulations shall Enforcement.

be deemed an offence.

(2) Any action taken by the Board with respect to these

regulations shall be deemed to have been taken on behalf of the

Superintendent of Public Health.

(3) In any proceedings for an offence under these regulations

consisting of a failure to comply with a duty or requirement, it shall be

for the accused to prove that it was not practicable to do more than was

in fact done to satisfy any of the requirements under these regulations.

It shall be the duty of the Board to prescribe rules in

consultation with the Superintendant of Public Health on any matter

regarding>

(a)

radiological equipment<

(b) training of employers, practitioners, referrers and

operators<

(c) duties of employers, practitioners, referrers and

operators<

(d) qualifications of, practitioners, referrers, and any other

experts < and

(e) on any other matter concerning these regulations or as

prescribed by the European Community.

The Ionising Radiation Medical Exposure Regulations, 2003

2003. are hereby repealed.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press