Criteria and suspension levels in diagnostic radiology.

The EC (European Council) Directive on radiation protection of patients requires that criteria for acceptability of equipment in diagnostic radiology, nuclear medicine and radiotherapy be established throughout the member states. This study reviews the background to this requirement and to its implementation in practice. It notes and considers parallel requirements in the EC medical devices directive and International Electrotechnical Commission standards that it is also important to consider and that both sets of requirements should ideally be harmonised due to the global nature of the equipment industry. The study further reviews the types of criteria that can be well applied for the above purposes, and defines qualitative criteria and suspension levels suitable for application. Both are defined and relationships with other acceptance processes are considered (including acceptance testing at the time of purchase, commissioning and the issue of second-hand equipment). Suspension levels are divided into four types, A, B, C and D, depending on the quality of evidence and consensus they are based on. Exceptional situations involving, for example, new or rapidly evolving technology are also considered. The publication and paper focuses on the role of the holder of the equipment and related staff, particularly the medical physics expert and the practitioner. Advice on how the criteria should be created and implemented is provided for these groups and how this might be coordinated with the supplier. Additional advice on the role of the regulator is provided.

Safety and efficacy for new techniques and imaging using new equipment to support European legislation: an EU coordination action.

The past two decades have witnessed a technologically driven revolution in radiology. At the centre of these developments has been the use of computing. These developments have also been driven by the introduction of new detector and imaging devices in radiology and nuclear medicine, as well as the widespread application of computing techniques to enhance and extract information within the images acquired. Further advances have been introduced into digital practice. These technological developments, however, have not been matched by justification and optimisation studies to ensure that these new imaging devices and techniques are as effective as they might be, or performed at the lowest possible dose. The work programme of the SENTINEL Coordination Action was subdivided into eight work packages: functional performance and standards; efficacy and safety in digital radiology, dentistry and nuclear medicine, cardiology, interventional radiology, population screening/sensitive groups; justification, ethics and efficacy; good practice guidance and training; and project management. The intention of the work programme was to underwrite the safety, efficacy and ethical aspects of digital practice as well as to protect and add value to the equipment used in radiology.

Dosemeter readings and effective dose to the cardiologist with protective clothing in a simulated interventional procedure.

A personal dosemeter issued for individual monitoring is calibrated in terms of personal dose equivalent, usually H(P)(10). In general it yields a reasonable estimate of effective dose (E) when the exposed person does not wear protective clothing. In interventional cardiology, however, a lead equivalent apron is worn and often a thyroid collar. A correction factor will then be necessary to convert a dosemeter reading to E. To explore this factor an interventional cardiology procedure is simulated based on exposure conditions typical for a modern hospital in the BENELUX area. The dose to the cardiologist is investigated using Monte Carlo simulation of radiation transport. It is concluded that a personal dosemeter may best be worn outside the apron at a central position high on the chest for least dependence on the beam direction. It will overestimate E by roughly a factor of 20 (apron and thyroid collar of 0.25 mm Pb).

Results of a European dose survey for mammography.

For the dose study, a semi-automated method of data collection is used in this study. The participating centres were asked to fill out a spreadsheet with all necessary data and return it. For direct digital (DR) systems, the relevant data available in the DICOM header were used. All data is automatically added to a database and processed. The data were used to calculate the mean glandular dose for every image and for different thicknesses of polymethyl methacrylate phantoms using available conversion factors. Second-degree polynomials were fitted to the patient dose data and a reference dose curve was constructed for a range of thicknesses instead of a dose reference level at a single point. The dose reference curve rises from 1.57 mGy for a thickness of 30 mm to 2.50 mGy for 55 mm and 3.83 mGy for 75 mm. The results show centres that exceed this curve lie only in the lower or higher range of thicknesses and would remain undetected using a dose reference value in a single point. This gives better information to radiographers on where there is room for improvement of the dose levels in their system.

Quality control measurements for fluoroscopy systems in eight countries participating in the SENTINEL EU coordination action.

Quality control (QC) is becoming increasingly important in relation to the introduction of digital medical imaging systems using X rays. It was, therefore, decided to organise and perform a trial on image quality and physical measurements. The SENTINEL toolkit for QC measurements of fluoroscopy systems containing equipment and instructions for their use in the assessment of dose and image quality circulated among participants in the trial. The participants reported on their results. In the present contribution, the impact of the trial on the selected protocols is presented. The Medical Physics and Bioengineering protocol appeared to be useful for QC, and also for digital systems. The protocol needs an additional section, or an addition to each section, to state compliance with the requirements. The circular cross-sections of the Leeds test objects need adaptation for rectangular flat panel detector (FPD) systems. Only one participant was able to perform the monitor test using MoniQA. This is due to the fact that assistance is required from the suppliers of the X-ray systems. This problem needs to be solved to apply MoniQA in practice.

The SENTINEL project.

Health-care expenditure on radiological equipment in Europe is a growing fraction of the gross domestic product for all member states. This increase in expenditure has been driven by technical developments in equipment design, matched by the introduction of novel clinical practices, examinations and procedures. The radiation protection implications of these developments have to be assessed. The SENTINEL co-ordination action covered radiation protection, safety and related issues that arise from these technical and clinical developments. SENTINEL covered 90% of patient examinations in European Radiology, 60% of the collective dose from medical sources and approximately 50% of the collective dose to European citizens from man-made sources. The SENTINEL co-ordination actions 'main' objective was to address the safety and efficacy issues which are common to all digital diagnostic imaging systems, including nuclear medicine. High-dose procedures and sensitive groups (such as children) were covered by the project. Specifically, the co-ordination action aimed: (1) to establish both physical and clinical image quality criteria and link the two, (2) to undertake a series of dosimetry studies to establish the reference levels for new procedures and (3) to develop good practice guidelines for radiation protection in digital imaging and produce training material.

Results of a European survey on patient doses in paediatric radiology.

Paediatric patients represent a very specific group within the radiology department. Compared to adult patients, they are more sensitive to radiation. As they are sometimes submitted to several radiology procedures, dose and image quality should be well balanced. Nowadays, only a few centres specialize in paediatric imaging, and knowledge of paediatric patient doses is, therefore, very scattered. The effect of the introduction of digital technology on paediatric patient doses remains largely undocumented. Data collected in the present survey illustrate that there is a clear need for standardisation in this domain. The proposal of a European diagnostic reference level (DRL) is quite difficult. Preliminary DRLs, based on typically 5-7 radiology centres per examination are proposed. The 'effective dose' may or may not be a very rigorous parameter, but it still remains useful nowadays to calculate a parameter that summarises the possible radiation-induced detriment to these young patients. However, conversion factors for calculation of the effective dose should be harmonised. Future studies should include an image quality evaluation study, using criteria that account for digital equipment. Data collection would be straightforward and could be performed in a systematic and automatic way if DICOM headers of digital images would include appropriate as well as relevant information for the particular case of paediatric examinations.

Response to 'Patient dose measurements in radiological practices'.

A lack of suitable dosimetric quantities for application in diagnostic radiology is noted by Dr Moores. It is concluded by Dr Moores that it is not possible to adhere to the basic principles of the International Commission on Radiation Units and Measurements (ICRU) regarding patient dosimetry in diagnostic radiology due to the extremely wide variety of quantities and units employed. The conclusion of the ICRU on similar observations, however, was that there is a need for harmonization of quantities and terminology for dosimetry in diagnostic and interventional radiology and they established a Report Committee with the aim of formulating an ICRU report on 'dosimetric procedures in diagnostic radiology'. The report produced by this committee entitled 'Patient dosimetry for x rays used in medical imaging' was accepted for publication in December 2005 and is currently at press, and may serve to improve the current situation with regard to patient dose measurement in diagnostic and interventional radiology.

Glandularity and mean glandular dose determined for individual women at four regional breast cancer screening units in the Netherlands.

The nationwide breast cancer screening programme using mammography has been in full operation in The Netherlands since 1997. There is concern that the mean glandular doses due to mammography might be differing between different regions of the country due to differences in glandularity and compressed breast thickness. To investigate regional differences, glandularity, compressed breast thickness and mean glandular dose were determined for individual breasts during screening at mammography units at four locations in The Netherlands. Differences in glandularity were observed, which could be related qualitatively to differences in age of the participants at the different locations. Mean glandular dose depends on compressed breast thickness, glandularity and technical conditions of screening. The lowest average value of the mean glandular dose was found for the unit in Amsterdam. This is most likely due to the use of the Mo/Rh anode/filter combination at this unit, in addition to the Mo/Mo combination. At the other three units, almost exclusively the Mo/Mo anode/filter combination was used. Differences in mean glandular dose averaged per unit could be related mainly to differences in tube-current exposure-time product values. Consequently, it is concluded that differences in mean glandular dose at different units are marginal.

Assessment of induction of secondary tumours due to various radiotherapy modalities.

One of the objectives of the European Sixth Framework integrated project MAESTRO is to perform an assessment of risk due to various radiotherapy modalities, regarding secondary tumour induction. Initially, the study will focus on cancer of the prostate and the present work represents the first step towards that goal. One of the intended tools, to be used in the assessment, is the Monte Carlo radiation transport code ORANGE. A validation of the ORANGE code's capability to tally dose on a grid superimposed on an existing MCNP geometry is given. Preliminary results on the dose distribution due to conventional radiotherapy treatment of prostate cancer are discussed. Two mathematical models of the patient are proposed and the clinical relevance of the ADAM phantom is investigated. A problem in comparing average doses provided by commercial treatment planning systems and those calculated with Monte Carlo is noticed. The two proposed models are shown to receive a lower dose and average energy deposition than a 'real' patient.

Estimating effective dose for a cardiac catheterisation procedure with single or double personal dosemeters.

In most countries of the European Union legislation requires individual determination and registration of the dose to radiological workers exposed to ionising radiation to check whether dose limits are exceeded. To assess stochastic risk, ideally effective dose (E) should be known. In practice, personal dose equivalent [H(P)(10)] is used as it can be measured with a personal dosemeter. The dosemeter reading may provide a reasonable assessment of H(P)(10), but it may deviate strongly from E, in particular in radiology procedures for medical diagnosis or intervention when protective clothing like lead-equivalent apron and thyroid collar is worn. In the literature various correction factors and algorithms to convert readings of single or dual dosemeters to an estimate of E can be found. An illustrative example of a cardiac catheterisation procedure, in which dose calculations are made by Monte Carlo simulation of radiation transport, shows that such corrections may still yield considerable overestimation.

Dose constraints and guidance for exposure of individuals knowingly and willingly helping in the support and comfort of individuals undergoing medical exposure.

The council of the European Union (EU) has adopted directive 97/43/EURATOM that states that Member States shall ensure that dose constraints are established for exposure of those individuals (voluntary helpers) knowingly and willingly helping patients undergoing medical diagnosis or treatment. This study investigates for which medical diagnoses and treatments voluntary helpers are active. It provides a rough estimation of the effective dose to the voluntary helper for various applications. It summarises the dose constraints established in various EU Member States. Voluntary helpers are especially active in paediatric radiology and in nuclear medicine for both diagnostic and for therapeutic purposes. No voluntary helpers are active during radiotherapy. Voluntary helpers are commonly one of the parents, relatives or friends of the patient. In The Netherlands, the highest effective dose to voluntary helpers of approximately 2.3 mSv is found for therapy of patients younger than 1 y with metaiodobenzylguanidine labelled with 131I. Effective doses to voluntary helpers in paediatric radiology are, generally, quite small, i.e. lower than several tens of microSv at maximum without wearing protective clothing.

Method for determination of the mean fraction of glandular tissue in individual female breasts using mammography.

The nationwide breast cancer screening programme using mammography has been in full operation in the Netherlands since 1997. Quality control of the screening programme has been assigned to the National Expert and Training Centre for Breast Cancer Screening. Limits are set to the mean glandular dose and the centre monitors these for all facilities engaged in the screening programme. This procedure is restricted to the determination of the entrance dose on a 5 cm thick polymethylmethacrylate (PMMA) phantom. The mean glandular dose for a compressed breast is estimated from these data. Individual breasts may deviate largely from this 5 cm PMMA breast model. Not only may the compressed breast size vary from 2 to 10 cm, but breast composition varies also. The mean glandular dose is dependent on the fraction of glandular tissue (glandularity) of the breast. To estimate the risk related to individual mammograms requires the development of a method for determination of the glandularity of individual breasts. A method has been developed to derive the glandularity using the attenuation of mammography x-rays in the breast. The method was applied to a series of mammograms at a screening unit. The results, i.e., a glandularity of 93% within the range of 0 to 1, were comparable with data in the literature. The glandularity as a function of compressed breast thickness is similar to results from other investigators using differing methods.

Calculation of absorbed dose around a facility for disposing of low activity natural radioactive waste (C3-dump).

A C3-dump is a facility for disposing of low activity natural radioactive waste containing the uranium series 238U, the thorium series 232Th and 40K. Only the external radiation owing to gamma rays, X-rays and annihilation photons is considered in this study. For two situations--the semi-infinite slab and the tourist geometry--the conversion coefficients from specific activity to air kerma rate at 1 m above the relevant level are calculated. In the first situation the waste material is in contact with the air but in the tourist geometry it is covered with a 1.35 m thick layer. For the calculations, the Monte Carlo radiation transport code MCNP is used. The yield and photon energy for each radionuclide are according to the database of Oak Ridge National Laboratory. For the tourist situation, the depth-dose distribution through the covering layer is calculated and extrapolated to determine the exit dose.

Dose conversion coefficients for interventional procedures.

Effective dose (E) is a convenient quantity to estimate the stochastic risk of radiation applied to patients in interventional procedures and can be used for optimisation. Relatively long exposure times may cause deterministic effects. Hence it is necessary to know the (maximum local) doses in organs owing to the interventional procedure. In practice, organ doses cannot be measured directly. They are derived by applying a conversion coefficient to a measurable quantity, e.g. dose-area product (DAP) or entrance skin dose. For a number of interventional procedures, dose conversion coefficients (DCCs) can be found in the literature. Various DCCs are stated for nominally equal procedures, e.g. for percutaneous transluminal coronary angioplasty both 0.18 and 0.27 mSv Gy(-1) cm(-2) were reported to convert DAP to effective dose. Dependence of DCC on protocol and equipment parameters, as demonstrated through Monte Carlo simulation in this paper, makes it hazardous to simply adopt a literature value.

Quality control of equipment used in digital and interventional radiology.

Digital and interventional radiology are increasingly important areas of radiology. Quality control (QC) of such equipment is of particular importance to avoid unnecessary high doses and to help to achieve good image quality. Within the DIMOND III project, equipment requirements and specifications for digital and interventional radiology have been formulated. A protocol for QC tests has been drafted based on various national and international recommendations. Tests are included for various parts of the imaging chain, i.e. X-ray tube and generator, X-ray tube control system, laser printer and display station, and image quality and patient dose. Preliminary tolerance levels have been set for the various tests, after initial measurements. To check the suitability of QC tests and stated tolerance levels, measurements were made at the University Hospital Gasthuisberg in Leuven for equipment used for paediatric radiology and a unit used for chest examinations. The results of the various tests are reported.

Investigation of possible methods for equipment self-tests in digital radiology.

Quality control in digital radiology can be time-consuming. Equipment self-tests may significantly decrease staff workload. The two most essential parameters for radiology systems are image quality and patient dose. Concerning patient dose, information on the dose-area product (DAP) values generally forms the basis for assessment of patient dose. DAP-values can be measured using a transmission ionisation chamber or calculated from equipment settings. In the present study, various image quality parameters were derived using a contrast-detail (C-D) phantom. The investigation included a computer-aided assessment of C-D images, which produced various parameters, and also parameters based upon scoring by human observers. In addition, another parameter was calculated from modulation transfer function (MTF) measurements. The automatically calculated parameters showed good correlation with human readings, although the number of X-ray systems studied is still limited. We propose a combined evaluation of DAP and automatically calculated C-D or MTF parameters for equipment self-tests.