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Decree of the Ministry of Social Affairs and Health on the medical use of radiation 10.5.2000/42310.5.2000

Chapter 1 Scope and definitions

Section 1 Scope of the Decree

This Decree shall govern the use of ionizing radiation

for the examination or treatment of patients;

for screening and other mass inspection;

in procedures performed on healthy persons or patients participating in scientific research;

in occupational health inspections; and

in medico-legal procedures.

This Decree shall also apply to the radiation exposure of persons who voluntarily and otherwise than as part of their occupation assist a person who is subject to a procedure causing exposure to radiation.

Section 2 Definitions

In this Decree the term:

"a procedure involving exposure to radiation" (hereinafter referred to as a "procedure") shall denote X-ray examination, nuclear medicine examination and treatment, radiotherapy and other investigative and treatment procedure in which the person undergoing the procedure is intentionally exposed to ionizing radiation;

"radiological equipment" (hereinafter referred to as "equipment") shall denote equipment together with ancillary devices, accessories and instruments used in X-ray practices, nuclear medicine practices or radiotherapy;

"radiation dose" shall denote a measurement quantity describing the degree of exposure to radiation, or the radiation dose (the effective dose or equivalent dose) referred to in section 2 of the Radiation Decree (1512/1991) describing the harmful health effects arising from exposure to radiation;

"reference level" shall denote a predetermined radiation dose level in X-ray examinations or an activity level in nuclear medicine examinations, that is not presumed to be exceeded in a procedure performed according to the standards of good practice upon a person of normal size;

"dose constraint" shall denote a predetermined limiting value of the radiation dose arising from a procedure causing exposure to radiation, which should not be exceeded;

"a referral" shall denote an assignment issued by a physician attending to a patient, whereby a unit responsible for the use of radiological equipment is requested to perform a procedure causing exposure to radiation;

"scientific research" shall denote the research referred to in the Medical Research Act (488/1999) that seeks to increase knowledge of the causes of illnesses, and of their symptoms, diagnosis, treatment and prevention, or of the character of diseases in general;

"a medico-legal procedure" shall denote a procedure involving exposure to radiation that is performed on a living person for insurance or legal purposes;

"quality assurance" shall denote all planned and systematic measures that are performed in order to ensure that methods and equipment, and the use thereof, meet specified quality requirements;

"a medical physics expert" shall denote an expert meeting the requirements of training and qualifications prescribed in section 26 of this Decree; and

"a responsible party" shall denote a corporation, enterprise, foundation or institution, or a business or sole trader, that is the holder of a safety licence entitling the use of radiation, or the holder of radiation equipment notifiable to the register referred to in section 20 of the Radiation Decree.

Chapter 2 Justification and optimization

Section 3 Grounds for discretion in justification

The benefit to be gained from radiation exposure shall exceed the detriment thereby caused when assessing, on the one hand, the benefit to be expected from the procedure involving exposure to radiation including the direct health benefit accruing to the person and the benefits accruing to society and, on the other hand, any detriment that may be caused to the person by exposure.

Assessments of benefits and detriments shall give consideration to the available alternative methods for achieving the purpose of the procedure, and to the effectiveness of the said methods, and the advantages and risk factors involved therein.

The justification for a procedure involving exposure to radiation shall be assessed in advance, taking into account the purpose and particular objectives of the procedure and the characteristics of the person subject thereto. Particular attention shall be paid to the justification for radiation exposure in medico-legal procedures and other procedures in which a person is subjected to radiation without the expectation that he or she will derive immediate health benefits from the procedure.

Section 4 General justification of a practice involving exposure to radiation

Any new kind of method of examination or treatment causing exposure to radiation or mode of use of radiological equipment shall be shown in advance to be justified before it is introduced for general use.

The general justification for an existing method of examination or treatment or mode of use of radiological equipment shall be separately evaluated as necessary when any new significant data are obtained on its efficacy or consequences, or a new alternative method causing lower exposure to radiation becomes available whereby the purpose of the practice may be achieved.

Section 5 Assessment of justification at place of use

Particular attention shall be paid to the justification of a practice involving exposure to radiation when development of a method of examination or treatment involving exposure to radiation is planned or when an alternative method involving lower exposure to radiation becomes available whereby an adequate outcome of examination or treatment may be achieved. If necessary the opinion of the competent ethical committees shall be sought.

If the practice cannot be shown to be justified, then it shall either be prohibited or restricted to special situations in which its use for an individual procedure is justified based on a case-specific assessment.

Section 6 Scientific research

The plan of research for a scientific investigation shall assess the radiation exposure caused to the subjects of investigation and shall show justification for it, having regard to the provisions of section 4 of the Medical Research Act (488/1999). Particular attention shall be paid to presenting and justifying the dose constraint for persons who are not expected to derive immediate health benefits from the radiation exposure caused by the research.

When the persons participating in the research are patients who are expected to derive health benefits from procedures involving exposure to radiation, the radiation doses caused by the procedures shall be individually planned.

It shall be a condition of beginning the research that the competent ethical committee, after hearing experts in the medical use of radiation, issues a statement supporting the said research. The opinion of the medical subcommittee of the

Advisory Board for Radiation Safety shall be obtained when necessary.

The implementation of the research and the procedures to be followed therein shall be governed by the provisions of the Medical Research Act.

Section 7 Health inspections pertaining to work

If a procedure involving exposure to radiation is necessary for examining the state of health of an employee or applicant for employment showing no symptoms, then the justification for the procedure shall be assessed on the basis of the particular health demands pertaining to the work in question, also having regard to prior information on the state of health of the person to be examined. The radiation exposure caused by the procedure shall be kept as low as reasonably achievable.

Section 8 Medico-legal procedures

Assessment of the justification for a medico-legal procedure shall be the responsibility of the responsible physician prescribed in section 39 of the Radiation Act. If the physician does not perform the procedure in person, then it shall be performed only by a person specially trained to perform the procedure under the supervision of a physician.

The radiation exposure caused by the procedure shall be kept as low as reasonably achievable. The recording and storage of information concerning the procedure shall be governed by the provisions of the Act on the Status and Rights of Patients (785/1992) and by the regulations issued pursuant thereto pertaining to patient documents.

The examination of a person suspected of a criminal offence shall be governed by the provisions of the Coercive Criminal Investigation Means Act (450/1997) pertaining to a search of a person. The lawful conditions in this respect shall be assessed and determined by the competent authority, which shall issue a written warrant for a search of the person.The examination of a person suspected of a criminal offence shall be governed by the provisions of the Coercive Criminal Investigation Means Act (450/1997) pertaining to a search of a person. The lawful conditions in this respect shall be assessed and determined by the competent authority, which shall issue a written warrant for a search of the person.

Section 9 Grounds for optimization

When planning the medical use of radiation it shall be an objective to avoid unnecessary radiation exposure of persons to be examined and treated. The general factors to be considered for this purpose shall be:

the selection of equipment;

the performance of procedure involving exposure to radiation so as to produce adequate diagnostic information or an effective outcome of treatment;

the determination of patient doses and measurement of the activity of radiopharmaceuticals to be administered to patients; and

quality assurance.

Section 10 Limitation of radiation exposure of voluntary assistants

Dose constraints shall be used as necessary to limit the radiation exposure of the voluntary assistants referred to in paragraph 2 of section 1 hereof. The assistant shall have attained the age of 18 years. A pregnant woman may not be used as an assistant.

Before the procedure is performed the assistant shall be advised about exposure to radiation and the significance thereof. Particular attention shall be paid to guiding and protecting the assistant so that the radiation exposure caused thereto is kept as low as reasonably achievable.

The Radiation and Nuclear Safety Authority shall issue instructions on the use of dose constraints and protection.

Section 11 Protection during use of radiopharmaceuticals

When a radiopharmaceutical is used for the treatment or examination of a patient, then the patient may be discharged only when the radioactive substance in the body no longer causes unreasonable exposure to radiation to persons in the vicinity of the patient.

Before discharge the patient and any person attending thereto shall be furnished with proper protection instructions, which shall also be provided in writing. The instructions shall provide necessary information on the radiation exposure caused by the radiopharmaceutical and practical instructions to prevent unnecessary exposure of persons coming into contact with the patient.

Chapter 3 Procedures

Section 12 Issuing of referrals

A physician issuing a referral shall have access to recommendations pertaining to customary procedures causing exposure to radiation for the purpose of assessing the procedures. The recommendations shall include information on the radiation doses caused by the procedures.

The referral must clearly state the examination or treatment indication.

Section 13 Assessment of justification for procedures

A physician issuing the referral shall assess the justification for a procedure causing exposure to radiation. For this purpose the physician shall as far as possible procure the necessary information on earlier examinations and treatment, and if necessary shall consult experts before issuing the referral.

A physician issuing a referral shall submit the information pertaining to the assessment of justification to the unit responsible for performing the procedure and to a physician issuing a statement.

A physician who is responsible pursuant to section 39 of the Radiation Act for a procedure involving exposure to radiation shall be required to verify the justification for the procedure. If, on the basis of his professional knowledge and experience, the said physician does not consider the procedure to be justified, then he or she shall negotiate as necessary with the physician who issued the referral with respect to the factors in the individual case pertaining to the assessment of justification before making a final assessment.

If the physician responsible for the procedure involving exposure to radiation thereafter continues to consider that the procedure is unjustified, then the procedure shall not be performed.

Section 14 Instructions for performance of procedures

The premises in which each item of radiological equipment is used shall be furnished with written instructions on the performance of customary procedures intended for the persons using the equipment.

Section 15 Expertise in medical physics

A medical physics expert shall be involved in radiotherapy dose planning, quality assurance and activities pertaining to radiation protection.

A medical physics expert shall be available when performing isotope treatment or examinations.

Expertise in medical physics shall be used in X-ray practice when planning and monitoring radiation protection, optimization, quality assurance and radiation dose measurement.

Section 16 Reference levels

Properly determined reference levels shall be introduced for X-ray and nuclear medicine examinations when such are available. The reference levels for the most general examinations shall be issued by the Radiation and Nuclear Safety Authority.

Section 17 Measurements and comparison of results

Radiation doses caused by X-ray examinations shall be regularly measured or numerically assessed. The activity to be administered to the patient in nuclear medicine examinations shall be measured using an activity meter.

Dose and activity data shall be recorded and shall be systematically compared to reference levels.

If a reference level is found to have been repeatedly exceeded, then the reasons for this shall be investigated and necessary measures shall be taken to reduce exposure to radiation.

Section 18 Quality assurance programme

Quality assurance activities shall be defined in writing in a quality assurance programme. Special attention shall be paid to quality assurance activities for procedures causing large radiation doses, procedures concerning children, and screenings involving exposure to radiation referred to in chapter 8 hereof.

A quality assurance programme shall include the principles for preventing in advance errors or mishaps from which radiation doses may arise unintentionally. Special attention shall be paid to preventing mishaps when planning quality assurance in radiotherapy.

Section 19 Self-assessment of activities

A responsible party shall promote self-assesment by those taking part in the medical use of radiation with a view to improving the activity. If necessary evaluation may be performed in association with an external expert invited to support evaluation.

The performance and reporting of evaluation may be governed by procedures corresponding to those used in external clinical auditing.

Chapter 4 Clinical audits

Section 20 Obligation to audit

The clinical audits prescribed in section 39 c of the Radiation Act shall be arranged so that they complement self-assessment of activities in an expedient manner. The objective shall be for the practice of a responsible party involving exposure to radiation to be audited in all essential respects at intervals not exceeding five years.

Clinical audits may cover the whole of the medical use of radiation for which the responsible party is responsible or a specified part thereof. Clinical audits shall be performed by qualified and experienced experts who are independent of the responsible party.

Practices in which X-ray equipment is used solely for dental X-ray imaging may be governed by the self-assessment of activities referred to in section 19 hereof.

Section 21 Performance of audits

The subjects of clinical audits shall include the following:

specification of powers and responsibilities;

referrals and recommendations guiding the issuing thereof;

the practice and information flow observed in assessing justifications;

instructions and practices pertaining to the performance of procedures involving exposure to radiation;

equipment for examinations and treatment;

radiation doses arising from procedures and the examination and treatment results achieved;

the quality, recording and flow of information pertaining to procedures;

staff training;

the definition and application of quality assurance activities; and

self-assessments of activities, assessment results and the use of results.

Audits shall employ available information and experience of good medical practices. The comparison with proven good practices shall be of particular importance when the number of procedures performed is large, when the radiation exposure caused by a single procedure is of considerable magnitude, or when the persons subjected to procedures are unusually sensitive to radiation.

Section 22 Audit report

The audit report shall be addressed to the responsible party. The report shall present the essential observations made in the audit, the assessments and conclusions drawn on their basis, and the recommendations of the party performing the audit for development measures.

Chapter 5 Training and qualification requirements

Section 23 Issuing of a referral for procedures involving exposure to radiation

A physician who issues referrals for procedures involving exposure to radiation shall have basic knowledge of the health effects of ionizing radiation and of the radiation exposure of the patient in the course of the said procedures. If demonstration of such knowledge was not part of the basic studies of the physician, then the knowledge may be demonstrated through separate radiation protection training meeting the requirements of content imposed by the Radiation and Nuclear Safety Authority.

Section 24 Responsibility for procedures

A physician responsible for a procedure involving exposure to radiation shall possess qualifications consistent with the character of the procedure for assessing the justification and optimization thereof, and also for contributing to the interpretation of the results of the procedure. The responsible party shall be responsible for meeting the qualification conditions, and the general qualification requirements to be considered when assessing these shall be:

Radiotherapy: a specialist in oncology or other specialist qualified for radiotherapy in his specialty

Nuclear medicine: a specialist in clinical physiology and nuclear medicine or other specialist qualified in nuclear medicine

X-ray examinations and interventional radiology: a specialist in radiology. Other specialist responsible for procedures performed using X-ray equipment shall possess the knowledge of radiation protection necessary for procedures performed in his or her specialty. When radiation protection has formed no part of the studies of a physician the required knowledge may be demonstrated through the radiation protection training referred to in section 23 hereof

Dental X-ray examinations: a dentist or other physician with basic knowledge of the health effects of ionizing radiation and of the exposure of the patient to radiation.

A physician other than those referred to in the foregoing who is responsible for procedures shall possess basic knowledge of the health effects of ionizing radiation and of the exposure of the patient to radiation in the procedure concerned.

Section 25 Performance of procedure involving exposure to radiation

The qualification requirements prescribed in section 24 hereof for a physician responsible for procedure shall apply when a physician performs a procedure involving exposure to radiation.

A radiographer may independently perform an X-ray imaging according to a referral. Under the supervision of a physician responsible for procedure other professional health care staff may assist in the use of X-ray equipment for the use of which they have been properly trained.

A person who has been trained in dental X-ray may perform dental X-ray imaging according to the instructions of a physician.

Any other person participating in the performance of procedure involving exposure to radiation shall possess training and experience in accordance with the nature of the said assignment, having regard to the provisions of this Decree.

Section 26 Medical physics expert

A medical physics expert shall have completed separately prescribed specialization training as a hospital physicist including qualification pursuant to section 18 of the Radiation Act as a radiation safety officer in the general use of radiation in the medical sector.

A physicist or another person who has completed an appropriate university qualification and approved by the Radiation and Nuclear Safety Authority, who has qualified pursuant to section 18 of the Radiation Act as a radiation safety officer in the general use of radiation in the medical sector, and who possesses the familiarity and experience required for expert duties in X-ray practice may serve in the duties referred to in paragraph 3 of section 15 hereof in X-ray practice.

Section 27 Supplementary training

Radiation protection shall be included in an expedient manner as part of the supplementary training programme when arranging professional supplementary training of persons participating in the medical use of radiation. The Radiation and Nuclear Safety Authority shall confirm the requirements for the content of supplementary training with respect to radiation protection.

Special care shall be taken when introducing a new kind of method of examination or treatment or commissioning new radiological equipment to ensure that the persons involved in the operation thereof receive adequate familiarization training.

Section 28 Reference provision

Authentication of the qualifications required of health care professionals, the right to serve as a health care professional and the registration of health care professionals shall be governed by the provisions of the Professional Health Care Staff Act (559/1994). The said Act shall also govern the conditions to be met so that a citizen of another State may serve as a health care professional in Finland.

The right of a person undergoing vocational training to perform the duties of a health care professional shall be governed by the provisions of the Professional Health Care Staff Act and by regulations issued pursuant thereto.

Section 29 Transitional provision

The provisions of this chapter governing requirements for training and qualifications shall be met by no later than the end of the year 2004. A physician or other health care professional shall be deemed to have met the qualification requirements if the previously acquired training of the said person corresponds to the training required for the qualification requirements prescribed in this chapter.

Chapter 6 Equipment and its use

Section 30 General requirements and restrictions

Procedures involving exposure to radiation shall be performed using equipment suited for the said purpose. The requirements and criteria of acceptability for specific equipment functions to be considered from the point of view of radiation safety shall be confirmed by the Radiation and Nuclear Safety Authority.

The following restrictions shall be considered in the use of X-ray equipment:

equipment without image intensifier shall not be used for fluoroscopy; and

fluoroscopic equipment with no automatic means of regulating dose rate may be used only for fluoroscopy of limbs.

Section 31 Display device of exposure to radiation

New X-ray equipment to be commissioned shall, where necessary, include a monitor or corresponding device indicating the radiation exposure of the patient. This requirement may also be applied to X-ray equipment commissioned before the entry into force of this Decree if the radiation doses arising from procedures performed using the equipment are of considerable magnitude.

The Radiation and Nuclear Safety Authority shall issue detailed instructions as necessary on the application of the requirement prescribed in paragraph 1, having regard to the properties of the X-ray equipment and to the reliability and availability of suitable monitors.

Section 32 Supervision of equipment

A quality assurance programme shall set out the principal tasks involved in supervising the operating condition and performance characteristics of radiological equipment. The responsibilities and instructions for measures pertaining to the supervision of individual items of equipment shall be specified separately for each item of equipment.

The functions of radiological equipment shall be tested in particular:

before the equipment is commissioned (acceptance testing);

at specified intervals according to device-specific instructions;

following significant repairs or servicing; and

when there is cause to suspect a malfunction or a change in operation of an item of equipment.

Section 33 Avoiding unnecessary proliferation of equipment

A health care district municipal federation shall direct the development of X-ray services within its area and shall oversee their quality in the manner prescribed in section 10 of the Special Health Care Act (1062/1989). The health care district municipal federation shall pay particular attention to ensuring that the services that it provides for medical use are adequately and effectively organized.

When planning procurement of radiological equipment a health centre shall request the opinion of the health care district municipal federation with a view to ascertaining the expediency of the procurement, having particular regard to the prospects for developing services through co-operation with the health care district.

It shall be the duty of the Radiation and Nuclear Safety Authority to oversee compliance of radiological equipment with the requirements prescribed in the Radiation Act and in this Decree and to ensure that staff engaged in the medical use of radiation are qualified for their duties.

Chapter 7 Protection during pregnancy and breastfeeding

Section 34 Assesing the possibility of pregnancy

A physician issuing a referral shall, through appropriate questioning, ascertain the possible pregnancy of a woman of childbearing age if a procedure might subject a foetus to radiation. A woman shall be treated as though pregnant when the possibility of pregnancy is unclear.

Should a referral fail to state that a woman is pregnant the person responsible for performing the procedure shall enquire as to her possible pregnancy before performing the procedure.

Section 35 Protection of the foetus

When planning the performance of a procedure involving exposure to radiation on a pregnant woman special attention shall be paid to the risk of the foetus sustaining radiation damage. If such a risk exists, then the possibility of deferring the procedure until after the birth or of using some other method that does not subject the foetus to ionizing radiation shall be considered.

If the procedure is performed, then the exposure of the foetus to radiation shall be kept as low as possible. The estimated radiation dose of the foetus and all data that are significant from the point of view of radiation exposure shall be entered in the patient records.

Section 36 Protection during breastfeeding

When considering nuclear medicine examination or treatment attention shall be paid to protection in cases of breastfeeding. Appropriate questions shall be asked to ascertain whether a woman is breastfeeding before prescribing examination or treatment.

A breast-feeding woman shall be advised and furnished with written protection instructions according to the nature of the examination or treatment.

Section 37 Protection instructions

Information advising pregnant and breastfeeding women to notify the staff of pregnancy and breastfeeding in order to protect the foetus and the child being breastfed shall be posted in waiting and dressing rooms pertaining to the medical use of radiation.

Chapter 8 Screening and mass examinations

Section 38 Screening involving exposure to radiation

The expression "screening involving exposure to radiation" (hereinafter referred to as "screening") shall denote screening and other mass examination in which radiological equipment is used in early diagnosis of cases of disease for the examination of persons showing no symptoms and belonging to high risk population groups.

Section 39 Authorization for screening

Pursuant to point 9 of section 14 of the Public Health Act (66/1972) and section 4 of the Public Health Decree (802/1992) a municipality shall arrange breast cancer screening based on mammography for women aged between 50 and 59 years. The Ministry of Social Affairs and Health shall issue recommendations on other screenings as necessary.

Screening other than that referred to in paragraph 1 shall be separately justified and submitted for evaluation to the National Research and Development Centre for Welfare and Health. Screening may be approved if it is assessed as justified and the benefit to public health thereby achieved outweighs the overall drawbacks thereby caused.

Section 40 Screening programme

For the execution of each screening involving exposure to radiation a screening programme shall be prepared setting out the following:

the purpose of the screening and the population groups to be screened;

the party executing the screening and the regional extent of the screening;

the suitability of the screening method;

the radiological equipment used in the screening and the suitability thereof;

the parties performing the procedures causing exposure to radiation and their training;

the physicians who will interpret the results of the screening examinations, issue a statement upon them and be responsible for verification examinations;

the quality assurance programme;

the supervision of the operating condition and performance characteristics of equipment;

the plan for performing clinical audit; and

the recording and reporting of information on the screening and the results thereof.

The screening programme shall be submitted to the Radiation and Nuclear Safety Authority for inspection before the screening begins. If the programme concerns the screening referred to in paragraph 2 of section 39 hereof, then the evaluation of the National Research and Development Centre for Welfare and Health concerning the justification for the screening shall be appended to the said screening programme.

Section 41 Interpretation of results

An assessment asserting or excluding an occurrence of a screenable disease or disorder shall be based on two mutually independent statements of mutually supporting content. If the statements are contradictory with one another then the parties issuing the statements shall consult together before issuing a final assessment. Any further examination that is considered justifiable shall be performed if necessary.

The parties issuing the statements shall be physicians of considerable radiological experience who are familiar with the screenings in question.

Where a justification exists for interpreting screening results in a manner at variance with the provisions of paragraph 1 a proposal to this effect shall be submitted in the plan pertaining to the screening programme. If the proposed method is appropriate, having regard to the content of the procedures involving exposure to radiation, then it may be approved when the screening programme is approved.

Section 42 Monitoring of results

The party executing a screening programme shall take care to ensure that summaries are prepared of the screening examinations and of the results thereof, on the basis of which the quality and results of the screening may be assessed. Requirements pertaining to the presentation of summary information shall be imposed when approving the screening programme.

The summary information shall be submitted to the mass inspection register of the Finnish Cancer Register in accordance with the Act on National Personal Data Files in Health Care (5561989) and the provisions and regulations issued pursuant thereto.

Separate provisions shall govern the information to be submitted from the Cancer Register to the party executing a screening programme for the purpose of monitoring screening results.

Chapter 9 Special provisions

Section 43 Recording of information on procedures

Information on procedures involving exposure to radiation shall be recorded, on the basis of which the radiation dose from the procedure to a person examined or treated may be determined if necessary. Further instructions on the recording of information shall be issued by the Radiation and Nuclear Safety Authority.

A summary of the number of examinations and of radiation doses shall be prepared according to instructions to be separately issued, on the basis of which national appraisals of the radiation exposure caused by the medical use of radiation and its development shall be prepared.

The national appraisals shall be collated and published by the Radiation and Nuclear Safety Authority.

Section 44 Medical section of the Advisory Board for Radiation Safety

The medical section of the Advisory Board for Radiation Safety prescribed in section 30 of the Radiation Decree (1512/1991) shall take a position when necessary on issues of ethics and principle pertaining to the medical use of radiation and on matters requiring broad radiological expertise.

Section 45 Entry into force

This Decree shall enter into force on 12 May 2000. However, Chapter 8 of this Decree shall be applicable only from 1 July 2001.

Council Directive 97/43/Euratom; Official Journal No. L 180, 9 July 1997, p. 22

Helsinki 10 May 2000

Minister for Basic Services Osmo Soininvaara

Special Adviser Raimo Salonen