Worldwide Implementation of Digital Mammography Imaging
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Worldwide Implementation of Digital Mammography Imaging - IAEA
WORLDWIDE IMPLEMENTATION
OF DIGITAL MAMMOGRAPHY
IMAGING
IAEA HUMAN HEALTH SERIES No. 46
WORLDWIDE IMPLEMENTATION
OF DIGITAL MAMMOGRAPHY
IMAGING
INTERNATIONAL ATOMIC ENERGY AGENCY
VIENNA, 2023
COPYRIGHT NOTICE
All IAEA scientific and technical publications are protected by the terms of the Universal Copyright Convention as adopted in 1952 (Berne) and as revised in 1972 (Paris). The copyright has since been extended by the World Intellectual Property Organization (Geneva) to include electronic and virtual intellectual property. Permission to use whole or parts of texts contained in IAEA publications in printed or electronic form must be obtained and is usually subject to royalty agreements. Proposals for non-commercial reproductions and translations are welcomed and considered on a case-by-case basis. Enquiries should be addressed to the IAEA Publishing Section at:
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© IAEA, 2023
Printed by the IAEA in Austria
October 2023
STI/PUB/2011
IAEA Library Cataloguing in Publication Data
Names: International Atomic Energy Agency.
Title: Worldwide Implementation of Digital Mammography Imaging / International Atomic Energy Agency.
Description: Vienna : International Atomic Energy Agency, 2023. | Series: IAEA Human Health Series No. 46, ISSN 2075–3772 ; no. 46 | Includes bibliographical references.
Identifiers: IAEAL 23-01599 | ISBN 978–92–0–126723–8 (paperback : alk. paper) | ISBN 978–92–0–126823–5 (pdf) | ISBN 978–92–0–126923–2 (epub)
Subjects: Diagnostic imaging. | Diagnostic imaging — Methods. | Radiology. | Breast — Radiography. | Radiography, Medical.
Classification: UDC 615.849 | STI/PUB/2011
FOREWORD
In medical imaging, digital technologies can have many fundamental advantages over screen-film technology, such as (i) improved efficiency of the use of radiation in forming the image, which allows for dose reduction, (ii) transmission of images electronically and from archival storage in a computer system, (iii) increased robustness to exposure techniques with the disappearance of obvious under- and overexposure failures and (iv) the many image processing and other digital applications, such as artificial intelligence, that can be applied to digital images. Other practical advantages include cost reduction and replacement of chemical developers by a more environmentally friendly detector. Finally, the digital framework allows expert diagnostic judgements to be made available regardless of the distance between the imaging facility and the expert. These advantages also apply to mammography. However, in mammography, image quality is critical, and a sufficient level of quality is achieved only if system operation is optimized. A switch from screen-film to digital technology ought to be performed, therefore, only if high quality images can be guaranteed. Optimal system operation and quality control are needed at all levels including for the newest digital systems.
It has been recognized that achieving optimized imaging in mammography is a complex multifactorial process that starts with the design and implementation of a proper infrastructure and the best technology. It requires well trained staff and a rigorous quality assurance programme. While many digital imaging devices exist, there is no unique answer to the best solution in practice, given set resources. It is also recognized that there is no practical guidance on how to transition to digital technology systems. The World Health Organization (WHO) also recognized that a noteworthy number of clinical radiologists had experienced great challenges in implementing digital radiology and that radiology departments could benefit from an unbiased and independent resource to guide them in this.
In 2016, the IAEA and WHO published IAEA Human Health Series No. 28, entitled Worldwide Implementation of Digital Imaging in Radiology, a publication intended to address issues associated with the introduction of digital radiology. In response to the need to advise Member States on topics specifically related to mammography, in 2016 the Scientific Committee of the IAEA/WHO Network of Secondary Standards Dosimetry Laboratories recommended that guidance be developed for the implementation of digital mammography technologies. The present publication is a companion to Human Health Series No. 28 and provides information on the resources needed for different mammography systems.
The IAEA acknowledges the contributions of the drafting committee responsible for the development of this publication in particular, H. Bosmans (Belgium), M.E. Brandan (Mexico), R.A. Jong (Canada), M. Yaffe (Canada) and C.H. Yeong (Malaysia). The IAEA officers responsible for this publication were H. Delis and V. Tsapaki of the Division of Human Health.
Editorial Note
Although great care has been taken to maintain the accuracy of information contained in this publication, neither the IAEA nor its Member States assume any responsibility for consequences which may arise from its use.
This publication does not address questions of responsibility, legal or otherwise, for acts or omissions on the part of any person.
Guidance and recommendations provided here in relation to identified good practices represent expert opinion but are not made on the basis of a consensus of all Member States.
The use of particular designations of countries or territories does not imply any judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities and institutions or of the delimitation of their boundaries.
The mention of names of specific companies or products (whether or not indicated as registered) does not imply any intention to infringe proprietary rights, nor should it be construed as an endorsement or recommendation on the part of the IAEA.
The IAEA has no responsibility for the persistence or accuracy of URLs for external or third party Internet web sites referred to in this book and does not guarantee that any content on such web sites is, or will remain, accurate or appropriate.
The authoritative versions of the publications are the hard copies issued and available as PDFs on www.iaea.org/publications.To create the versions for e-readers, certain changes have been made, including the movement of some figures and tables.
CONTENTS
1. INTRODUCTION
1.1. Background
1.2. Objective
1.3. Scope
1.4. Structure
2. A ROAD MAP FOR A MAMMOGRAPHY FACILITY
2.1. Implementation scenarios
3. RESOURCES AND NEEDS
3.1. Project management
3.2. Core considerations
3.3. Specific needs for DDM
3.4. Specific needs for CRM
3.5. Specific needs for an SFM
3.6. Costing and implementation
4. TRANSITION FROM SFM TO CRM AND DDM
4.1. General considerations
4.2. Radiation dose considerations
4.3. Impact of transition
4.4. Fixed installations versus mobile services
5. CONCLUSIONS
Appendix I: BREAST CANCER
Appendix II: MAMMOGRAPHY TECHNOLOGY
Appendix III: OTHER BREAST IMAGING MODALITIES
Appendix IV: MAMMOGRAPHY EQUIPMENT PERFORMANCE
Appendix V: QUALITY MANAGEMENT
APPENDIX VI: EDUCATION OF PROFESSIONALS IN MAMMOGRAPHY
Appendix VII: EVALUATION OF MAMMOGRAPHY SERVICE
REFERENCES
ABBREVIATIONS
GLOSSARY
CONTRIBUTORS TO DRAFTING AND REVIEW
1. INTRODUCTION
1.1. Background
The incidence of breast cancer is continuing to rise, particularly in low and middle-income countries (LMICs) [1]. Mammography is widely used to facilitate the detection of breast cancer at a point earlier in its natural history than is possible by clinical examination [2]. It is also the only imaging method for the early detection of breast cancer that has been demonstrated to contribute to reduced mortality through screening [3]. Its use is increasing in LMICs as the incidence of breast cancer increases. Digital mammography systems were introduced in 2000 and offer many advantages over screen-film mammography.
1.2. Objective
The purpose of this publication is to provide guidance on the establishment of digital mammography facilities or upgrade of existing facilities when selecting and implementing new technology for mammography imaging in different resource settings.
Guidance and recommendations provided here in relation to identified good practices represent expert opinion but are not made on the basis of a consensus of all Member States.
1.3. Scope
This IAEA publication is intended to assist health care policy decision makers, planners, programme administrators and professionals working in health care in establishing or upgrading capabilities for diagnostic and screening mammography. The IAEA and other organizations have published guidance around aspects related to breast cancer incidence [4], breast imaging [2], breast cancer prevention, quality assurance (QA) and quality control (QC) of screen-film [5] and digital systems [2], and QA in screening and diagnosis [6, 7]. The focus here is explicitly to inform and facilitate decisions and planning on how to select or transition mammography services to the best quality possible with available resources.
1.4. Structure
The present IAEA publication builds on existing guidance [2, 5, 8] and presents a ‘road map’ for how to move from any current situation to one that better addresses the needs of a community. Section 1 presents the background, objective, scope and structure of this publication. Section 2 shows a road map for a mammography facility and helps interested parties to identify the level of mammography service at which they are currently operating and the level that is feasible with upgraded services. Decision points in the road map are linked to relevant supporting information in subsequent sections and appendices. It also provides an overview of various implementation scenarios with more detailed information to facilitate making decisions. Section 3 discusses what is required to implement the different types of service, direct digital mammography (DDM), computed radiography mammography (CRM) or screen-film mammography (SFM). Aspects of equipment, infrastructure, quality needs, maintenance and staff training are included. In addition, the transition between screen-film and digital modalities is discussed in Section 4.
More detailed information is provided in the appendices as follows: Appendix I provides a review on breast cancer incidence, mortality and geographical factors as well as the principles of breast cancer screening and factors to consider before initiating a screening programme. Appendix II presents an overview of the different types of mammography technologies, including breast tomosynthesis and contrast-enhanced mammography. Appendix III reviews other breast imaging modalities such as ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET) and breast computed tomography (CT). Appendix IV reviews evaluations of physico-technical parameters that describe the performance of mammography systems and presents examples of relationships between tests and clinical performance. Appendix V reports briefly on QA and QC tests that assure the high quality performance of systems, describes metrics for digital detectors and discusses the importance of artefact evaluation as well as the use of contrast detail phantoms to evaluate system performance. Appendix VI outlines the needs for professional education and training of key personnel involved in the delivery of high quality mammography services. Finally, Appendix VII shows some examples of existing mammography evaluation programmes implemented in some countries or continents.
Ultimately, this publication potentially pertains to all people for whom the detection of breast cancer