Medical Exposure (Ionising Radiation) Regulations, 2012 (ionisingradiation)

L.N. 353 of 2012

PUBLIC HEALTH ACT

(CAP. 465)

Medical Exposure (Ionising Radiation) Regulations, 2012

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

Public Health Act, the Minister of Health, the Elderly and

Community Care has made the following regulations:-

(1) The title of these regulations is the Medical

Exposure (Ionising Radiation) Regulations, 2012.

(2) The scope of these regulations is to transpose Directive 97/

43/Euratom.

The Superintendent of Public Health shall have the power

to enforce these regulations.

In these regulations, unless the context otherwise requires

"adequate training" is the term used to ensure that both

practitioners and persons performing the practical aspects, have the

necessary requirements to carry out their duties. These requirements

include the need for

(a)

the registration with the relevant Health Care

Professions Regulatory Council in terms of Health Care

Professions Act as applicable;

(b)

initial training with any qualification; and

(c)

proven experience and ongoing training;

"approval" means the process whereby the employer entitles

different persons to act in the different aspects of medical exposures;

"the Board" means the Radiation Protection Board as

constituted by regulation 9 of the Nuclear Safety and Radiation

Protection Regulations;

"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; optimisation; 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 prescribers, 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 standard

sized 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” means any natural or legal person who has the legal

responsibility under Maltese law for a given radiological installation;

"experience" means the activity accomplished in specific areas

under the direct supervision of an approved individual in that specific

area and includes the performance of work in that specific area, but

does not include time spent during organised training;

"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;

"medical physics expert" means an expert in radiation physics

or radiation technology applied to exposure, within the scope of these

regulations, whose training and competence to act in a specific area of

practice is recognised by Superintendent of Public Health, 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 required by law in force at the time;

"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 4(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 health care professional registered with a

regulatory body as defined by the Health Care Professions Act, who

is authorised by the employer to take clinical responsibility for an

individual medical exposure;

"prescriber" means a medical doctor, dentist or other registered

healthcare professional who is authorised, in accordance with the

employer’s procedures, to refer individuals for medical exposure to a

practitioner;

"qualification" means the written testimony of the education

and, or training carried out;

"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;

"radiographer" shall have the meaning as ascribed by the Health Cap. 464.

Care Professions Act;

"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 Application.

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.

All medical exposures shall be effected under the clinical Justification.

responsibility of a practitioner.

(1) Practitioners are to justify medical exposures in

advance and may only authorise a medical exposure if due

consideration is given to

(a) the specific objectives of the exposure and the

characteristics of the individual involved;

(b) the total potential diagnostic benefits or the total

therapeutic benefits it produces;

(c)

the direct health benefits to the individual and the

benefits to society;

(d)

the individual detriment that the exposure might

cause;

(e)

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 4(1)(d)

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

ethics committee.

(3) Exposure referred to in regulation 4(2) shall show a

sufficient net benefit, taking into account also the direct health

benefits to a patient, the benefits to individuals referred to in

regulation 4(2) and the detriment that the exposure might cause.

(4) An exposure that cannot be justified shall be prohibited.

(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

prescribers and, or practitioners, and persons performing the

practical aspects;

(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 4(1)(d), including the

use of dose constraints;

(i)

procedures for the giving of information and written

instructions as referred to in regulation 20;

(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 as far as reasonably

achievable;

(l)

procedures for the carrying out of clinical audit as

appropriate.

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

procedures referred to in sub-regulation (1) are complied with.

(3) In the case where the employer is also the practitioner, 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 and shall

make available to prescribers the relevant radiation doses for

each type of medical exposure;

(b) quality assurance

programmes

for

standard

operating procedures;

(c)

diagnostic reference levels for radiodiagnostic

examinations falling within regulation 4(1)(a), (b), (c) and (e)

having regard to European diagnostic reference levels where

available;

(d) dose constraints for biomedical and medical

research programmes falling within regulation 4(1)(d) where no

direct medical benefit for the individual is expected from the

exposure;

(e)

appropriate guidance and dose constraints for

exposure of individuals referred to in regulation 4(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.

(8) The employer shall ensure persons performing the

practical aspects as detailed in regulation 19 and practitioners have

the appropriate qualification and experience.

(9) The employer shall facilitate the continuing education and

training of employees.

(10) The employer shall have readily available updated

documentation on the qualification and appropriate level of training

requirements needed by the persons who carry out the practical

aspects of each specific procedure.

(11) When the employer acts as either the practitioner or the

person performing the practical aspects or concurrently, he is

responsible accordingly.

The employer shall approve individuals to act in different

aspects of certain types of medical exposures.

(1) The employer shall establish a procedure as required Employer to

by regulation 7(1)(b) to identify the appropriately qualified persons establish

procedure.

entitled to act in their different capacities.

(2) The employer shall maintain lists of individuals that he has

approved as prescriber, practitioners and persons performing the

practical aspects. The lists shall clearly specify any limitations of his

approvals for individuals.

(1) Employers shall ensure that individuals considered Employer to

for approval under these regulations shall have the sufficient verify

of employees.

education and adequate training. Documentation of prior approval

may be used by an employer as evidence for approval for comparable

functions of approval.

(2) Documented evidence of qualification and experience and

continuous education shall be kept by employer and shown to the

Board on request.

(3) To be considered for approval, the individual shall satisfy

the employer’s minimum criteria for the applicable approval being

sought.

(1) The employer is responsible to ensure that any Employer to

individual whose work relates to medical exposure is approved by adopt

vetting.

ensuring that the necessary requirements for that individual have been

met.

(2) Each employer shall maintain on record all personnel

qualifications and shall include

(a)

name of the individual;

(b) approval area, namely: practitioner, person

performing the practical aspects of medical equipment for

medical purposes; person performing the practical aspects for

other purposes;

(c)

qualification certificates to demonstrate training

(both academic and practical);

(d) examination results if applicable (including vision

examinations pursuant to regulation 10 of the Minimun Health S.L. 424.14

and Safety Requirements for Work with Display Screen

Equipment Regulations) and their expiry;

(e)

documentation of any continuing professional

development;

(f)

contract or signed statement of employment of the

individual to act in the approved capacity.

(3) A new employer may approve an individual to work in the

same capacity provided that

(a)

the individual has proof of prior approval, and

(b) the individual was working in the same capacity in

the last six months.

(4) Individuals not meeting the requirements referred to in

sub-regulation (3) are to receive the appropriate training including

examination if applicable.

The employer’s approval shall be deemed revoked when

(a)

employment is terminated, or

(b) preliminary investigations for accidents indicate

gross individual negligence, or

(c)

approved work has not been carried out for six

consecutive months.

The persons performing the practical aspects, practitioner

and the prescriber shall comply with the employer’s procedures.

Prescribers shall

(a) ensure and document that the medical exposure of

the patient is warranted based on the medical indications;

(b)

make reference to referral criteria;

(c)

refer the patient to a practitioner, providing adequate

clinical details;

(d) state on each individual referral the clinical question

to be answered;

(e)

where practical, seek to obtain previous diagnostic

information or medical records relevant to the planned exposure

and consider this data to avoid unnecessary exposure;

(f)

seek the outcome of the exposure and act on the

(g)

comply with the employer’s procedures.

Prescribers shall have the following qualifications and Prescribers’

qualifications

experience

and experience.

Qualification

Registered medical doctors, or dentists, or

Practitioners when additional exposures are clinically

indicated

Experience

No initial experience needed.

(1) Without prejudice to regulation 21(4)(e), the Duties and

practitioner shall select equipment and methods to ensure that, for requirements

practitioners.

each medical exposure, the dose of ionising radiation to the individual

undergoing the exposure, is as low as reasonably achievable 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 regulation 4(1)(a),

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

(2) The practitioner shall sanction medical exposures.

(3) The practitioner shall take clinical responsibility for

medical exposure.

(4) The practitioner shall make arrangements to satisfy

himself that the individual medical exposure as prescribed is justified,

by ensuring that there is sufficient net benefit by this exposure for the

patient, the benefit to comforters and carers against the detriment that

the exposure might cause. This should be based on his knowledge of

the hazard associated with the exposure and the clinical information

supplied by the prescriber.

(5) The practitioner, where practical, shall seek to obtain

previous diagnostic information or medical records relevant to the

planned exposure and consider this data to avoid unnecessary

exposure.

(6) The practitioner shall comply with the employer’s

procedures.

Practitioners shall have the following qualification and Practitioners’

qualifications

and experience.

experience

Qualification

Medical doctors who are on the Specialist Registers held by

the: Medical Council for Radiology; Radiotherapy; Nuclear

Medicine, or

Medical doctors who are on the Specialist Register held by

the Medical Council for Cardiology, Gastrenterology,

Respiratory Medicine, Rheumatology Orthopaedic Surgery

and Surgery while carrying out interventions, or

Dental surgeons, or

Registered Radiographers

Experience

At least one month on the job experience under the

supervision of an approved practitioner, excluding dental

surgeons.

No initial experience for dental work performed by dental

surgeons.

The physical conduct of any of the exposures referred to in

regulation 4(1) and the administration of radio-pharmaceuticals may

be delegated by the employer or the practitioner, as appropriate, to

one or more individuals authorized by the Superintendent of Public

Health to act in this respect.

(1) As the practical aspects of different procedures for

medical exposures carry different levels of risk, both to the person

performing the practical aspects and to the patient, the Board has

categorised medical exposures as shown in the below table. This

categorisation is being done in relation to persons performing the

practical aspects only

Risk Level

Type of medical exposure

High

Radiotherapy

Brachytherapy

Nuclear Medicine (diagnostic and therapeutic)

Interventional Radiology Fluoroscopic Techniques

CT

Mammography

Medium

General Diagnostic Radiography

Dental Radiography

Low

Low output Diagnostic Radiography (e.g. bone density)

(2) Persons performing the practical aspects shall have the

following qualification and experience as detailed below

(a)

Persons performing the practical aspects of radiation

producing medical equipment for medical purposes

High Risk

Qualification

Practitioners, or

Procedures

Surgeons during surgery provided a

registered

radiographer

is

in

attendance during the procedure.

Experience

First time registered radiographers

shall have at least three months on the

job training under the supervision of

a registered radiographer approved to

work in the specific area.

Medium Risk

Qualification

Practitioners, or

Procedures

Dentists for dental medical exposures

Experience

First time registered radiographers,

Practitioners, excluding dentists,

shall have at least one month on the

job training under the supervision of

an approved individual in the specific

area.

No initial experience for dental work

performed by dental surgeons’

specific area.

Low Risk

Qualification

Practitioners, or

Procedures

Other persons

approved

under

regulation 18

Experience

No

initial

experience

for

practitioners.

Persons

approved

by

the

Superintendent of Public Health shall

have two months on the job training

under the supervision of a

Practitioner.

(b) Persons

performing

the

practical

aspects

administering sealed or unsealed radioactive sources for

medical exposure purposes

Brachytherapy

Qualification

Radiotherapist/oncologist

on

specialist register or Radiographer

(Therapy) as per code of practice

issued by Council for the

Professions Complementary to

Medicine

Experience

One month or several procedures of

on the job training under the

supervision of an approved

individual in the specific area.

Therapeutic

Qualification

Nuclear Medicine Physician on

Nuclear Medicine

specialist register, or

registered Medical Doctor directed

by the Nuclear Medicine Physician

on specialist register.

Experience

One month or several procedures

on the job training under the

supervision of an approved

individual in the specific area.

Diagnostic

Qualification

Nuclear medicine physician on

Nuclear Medicine

specialist register, radiographer or

other individuals as approved under

regulation 18 directed by the

nuclear medicine physician on the

specialist register

Experience

One month on the job training

under the supervision of an

approved individual in the specific

area.

(c)

Persons performing the practical aspects of other

aspects of medical exposures

Gamma Camera

Qualification

Nuclear medicine physician on

specialist register, or

registered radiographer or

other suitably qualified individuals

under the direct supervision of the

nuclear medicine physician on

specialist register or radiographer

Experience

Three months on the job experience

under the supervision of Nuclear

medicine physician on specialist

register, or

registered radiographer.

Image Processing

Qualification

Basic academic and, or technical

qualification to the satisfaction of

the practitioner supervising the

activity.

Experience

Supervision by practitioner.

(d) Persons performing the practical aspects of radiation

producing medical equipment for non medical purposes

Quality Control

Qualification

Medical physics experts, or

Procedures

radiographers, engineers, or

persons specifically trained to carry

out the quality control of the

relevant equipment.

Experience

At least nine months on the job

experience under the supervision of

an approved QC individual or 300

hours of continuous training in

quality control.

Installation and

Qualification

Engineers

or

technicians

Maintenance

specifically

trained

by

the

manufacturer in the areas that are

needed to carry out their duty or

trained by other engineers/

technicians certified competent by

the manufacturer

Experience

One month experience under the

supervision of an experienced

installer.

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

diagnosis with radioactive medicinal products, the employer’s instructions

information.

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) All doses due to medical exposure for radiological

purposes except radiotherapeutic procedures referred to in regulation

4(1) shall be kept as low as reasonably achievable consistent with

obtaining the required diagnostic information.

(2) The optimisation process shall include the selection of

equipment, the consistent production of adequate diagnostic

information or therapeutic outcome as well as the practical aspects,

quality assurance including quality control and the assessment and

evaluation of patient doses or administered activities.

(3) Practitioners and persons performing the practical aspects

shall be personally and professionally responsible for their respective

aspects of optimisation as defined in these regulations.

(4) In complying with the obligations under these regulations,

the practitioner 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 reasonably achievable;

(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)

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 achievable and consistent with the intended

radiotherapeutic purpose of the exposure;

(f)

where appropriate, females 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

(g) 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.

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

examination without an image intensification or equivalent technique.

(6) Fluoroscopic examinations without devices to control the

dose rate shall be limited to justified circumstances.

(7) Individuals who participate in biomedical and medical

research projects referred to in regulation 4(1)(d) shall participate

voluntarily and shall be informed about the risks of such exposure.

The employer shall ensure that a medical physics expert is: Medical physics

experts.

(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 advice on matters relating

to radiation protection concerning medical exposure, as

required, in all other radiological practices.

The role of the medical physics expert shall be to give Medical physics

experts’ role.

advice on or perform the following

(a)

Dosimetry, including

-

advising employer on radiation doses

delivered to patients and diagnostic reference levels, and

-

establishing adequate protocols to ensure

accurate patient dosimetry, and

-

confirmation that the prescribed dose is the

dose delivered, and

-

methods to optimise patient dose (the medical

physics expert should consider and review all aspects

leading to a medical exposure to aim to reduce unnecessary

patient doses), and

-

surveys of radiation equipment and the

environment.

(b)

Quality assurance, including

-

acceptance testing, and

-

constancy testing, and

-

advising on when equipment should be taken

out of clinical use or returned back into clinical use.

(c)

Advise the employer on the purchase of new

equipment and its installation requirements.

(d)

The development and use of equipment.

(e)

Other matters relating to radiation protection

concerning the medical exposures not limited to patient

exposure and may include radiation protection of staff, public

and the environment.

(f)

Advise the employer on training needs for all

categories of staff involved in the Medical exposure process.

Medical physics experts shall meet the following criteria

(a)

training as recommended by The European

Federation of Organisations for Medical Physics at the level of

M.Sc.; and

(b) two years full time work experience supervised by a

person who meets the requirements of paragraph (a) and who

has at least two years experience within that sub-speciality

(radiotherapy, nuclear medicine, radiology); and

(c)

from three years after the publication of these

regulations, a minimum further two years work in sub-speciality

(radiotherapy, nuclear medicine, radiology) with continued

professional development.

Requirements for continued professional development for

medical physics experts shall meet the continued professional

development requirements stipulated by Superintendent of Public

Health.

(1)

The employer shall ensure

(a) that practitioners, those individuals mentioned in

regulations 18 and 22 have adequate theoretical and practical

training for the purpose of radiological practices, as well as

relevant competence in radiation protection;

(b) the organization of training related to these

techniques and the relevant radiation protection requirements.

(2) Individuals undergoing relevant training programmes may

participate in practical aspects for the procedures mentioned in

regulation 18 provided that they are constantly under direct

supervision.

The Superintendent of Public Health shall take all those Equipment.

steps he may consider necessary to avoid the unnecessary

proliferation of radiological equipment.

(1)

The employer shall ensure that

Employer’s

responsibility

for equipment.

(a) all radiological equipment in use is kept under strict

surveillance regarding radiation protection;

(b) an up-to-date inventory of radiological equipment

for each radiological installation is available;

(c)

appropriate quality assurance programmes including

quality control measures and patient dose or administered

activity assessments are implemented by the holder of the

radiological installation; and

(d) necessary measures are taken to improve inadequate

or defective features of the equipment.

(2) The employer shall also adopt specific criteria of

acceptability for equipment in order to indicate when appropriate

remedial action is necessary, including, if appropriate, taking the

equipment out of service.

The Board shall require the employer to provide a copy of EC Declaration

of Conformity

the EC Declaration of Conformity, issued by the manufacturer.

requirement.

A device showing the quantity of the radiation produced by New equipment.

the equipment shall be required for new equipment, where

practicable.

Upon installation of the equipment the supplier/installer Installation

shall perform installation tests (also often referred to as critical tests) tests.

to ensure that all the safety features and warning devices of the

equipment are functioning. During installation, the manufacturer’s

instructions for use must be followed. These tests shall be performed

whenever new, second hand, refurbished and relocated equipment has

been installed, as well as after major maintenance has been

performed. Installation test results shall be kept by the employer and

made available to the Board whenever so required.

(1) Within their quality assurance programme, Quality control

employers shall also have quality control systems for radiological systems.

equipment and its ancillary equipment that they are responsible for.

(2) Quality control systems shall include the following tests

(a)

acceptance tests;

(b)

constancy tests.

(1)

Acceptance tests need to be carried out

(a)

on installation of equipment;

(b) within six months of the publication of these

regulations for all other existing equipment not covered by the

above;

(c)

after relocation or major modifications have been

made to existing equipment;

(d) after major adjustments of functional parameters,

repairs or maintenance have been performed;

(e)

components or sub-assemblies have been added,

modified, replaced or removed.

(2) Acceptance testing must be carried out in accordance with

international standards.

(3) Test results shall be compared to and meet the specified

tolerances. In the absence of such, as in the case of aged equipment,

then European Union Criteria for acceptability may be used.

(4) The records for such testing shall be kept for the lifetime of

the equipment and made available to the Board whenever these are

requested.

(5) After the installation and acceptance testing are carried

out, the test reports and any other relevant documentation has to be

passed on the Board. The Board will then review the test results and

any other information that is deemed necessary.

(6) The information to be supplied to the Board with regard to

acceptance tests that have been performed is as follows

(a)

full equipment details including

-

type of equipment

-

manufacturer

-

model

-

serial numbers

-

year of manufacture

-

year of Installation

-

for x-ray equipment: Max KV. Max mA

-

location of equipment;

(b)

particulars of the test

-

reason for performing test

-

person or persons performing test

-

date of test

-

name of standard followed

-

specified

tolerances,

manufacturers’

specification and other reference documents if appropriate

-

details of test equipment used, including

calibration dates;

(c)

previous tests

-

details of any on-site/factory tests performed

by manufacturer and results of such tests;

(d)

for each of the required parameters tested the report

shall include

-

test procedure followed

-

measured values

-

manufacturers’

specification

for

that

parameter

-

if no manufacturers’ specification available,

the reason why and which value the measured value was

compared to

-

statement if the equipment passes that

parameter.

(1) The responsibility to ensure that the equipment is fit

for clinical use resides with the employer.

(2) The clinical use of equipment prior to clearance from the

Board is prohibited.

(1) Immediately after an acceptance test has indicated

that the functional performance of the equipment is satisfactory, an

initial constancy test, or a series of initial constancy tests, shall be

carried out to establish the baseline values (values obtained to be used

as reference for future tests).

(2) Constancy testing shall be carried out in accordance with

international standards.

(3) A constancy test is to be carried out at regular intervals, the

frequency of which will be in accordance to the relevant international

standard, and immediately after preventive and corrective

maintenance. A constancy test shall also be carried out when

malfunction of equipment is suspected.

(4) These results shall be kept at the practice and made

available to the Board whenever so requested.

(5) The records for such testing shall be kept for three years

from the last date of entry and made available to the Board whenever

these are requested.

(6) These tests are to be performed as often as the standard

stipulates and shall not exceed two years.

(1) If any of the tests show that the equipment has or is

producing doses higher than acceptable levels for medical exposures,

or a malfunction has occurred that could effect patient dose, it shall be

removed from clinical use and shall be reported to the Board.

(2) Acceptable levels are deemed the tolerances specified in

the manufacturers’ specifications or the current European Union

criteria whichever is the most stringent.

(3) If the equipment is deemed to be redundant, with no

intention of scrapping, then the employer shall remain responsible for

accounting for that equipment and if the equipment is sold, leased or

given to another approved employer, the Board shall be notified prior

to this happening.

(1) The employer shall have procedures for bringing the

equipment back into clinical use following any event referred to in

regulation 36(1).

(2) Once the employer is satisfied that the equipment is fit to

be put back into clinical use (after ensuring that tests were performed

to ensure this), he is then bound to inform the Board.

(3) Clearance shall only be issued after the Board reviews all

documentation pertaining to the tests mentioned above.

(4) All equipment used for testing shall be routinely re-

calibrated according to its instructions for use; in the absence of any

specified re-calibration period, the equipment calibration period shall

not exceed a period of two years.

(1) Any records generated through the quality assurance Quality records.

or quality control systems that provide documentary evidence of the

operational performance of the equipment are to be kept by the

employer and shall be made available to the Board whenever these

are requested. These records shall be kept on site and maintained in

accordance with the provisions of this regulation.

(2) Acceptance test records and baseline value records shall be

kept for the lifetime of the equipment.

(3) Other test records shall be kept for a minimum of three

years from last date of entry.

(1) The employer shall take all reasonably practicable Prevention of

steps to prevent failure of radiation equipment where such failure equipment

failure.

could result in exposure of patients to ionising radiation greater than

intended.

(2) If the employer becomes aware of potential defects in

equipment during use, he will need to assess, in consultation with the

supplier (or, where relevant, the service agent or original

manufacturer) and the medical physics experts and the qualified

expert, in terms of the Nuclear Safety and Radiation Protection S.L. 365.15

Regulations, if appropriate, whether any further action is necessary.

(3) The employer shall have a contingency plan for responding

to equipment failures or malfunction. Following equipment failure

and subsequent repair, the employer shall consider the likelihood and

consequences of recurrence before returning the equipment to clinical

use.

(1) Employers shall ensure that appropriate radiological Special

equipment, practical techniques and ancillary equipment are used for practices.

the medical exposure

(a)

of children,

(b)

as part of a health screening programme,

(c)

involving high doses to the patient, such as

interventional radiology, computed tomography or radiotherapy.

(2) In the case of the medical exposures referred to in sub-

regulation (1), special attention shall be given to the quality assurance

programmes, including quality control measures and patient dose or

administered activity assessment.

(1)

Any breach of any provisions of these regulations

shall be deemed an offence.

(2) 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.

The Superintendent of Public Health, in consultation with

the Board, may issue guidance documents on any matter regarding

(a) equipment

used

in

connection

with

medical

exposures;

(b) training of practitioners, prescribers and persons

performing the practical aspects;

(c)

duties of employers, practitioners, prescribers and

persons performing the practical aspects;

(d) qualifications of practitioners, prescribers and any

other expert; and

(e)

on any other matter concerning these regulations.

These regulations have been notified in terms of Directive

98/34/EC, as amended by Directive 98/48/EC, as transposed by the

Notification Procedure Regulations.

The Ionising Radiation Medical Exposure Regulations,

2004 are hereby revoked.

2004.

2004. €2.16