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Radiation Dose Management for Fluoroscopically- Guided Interventional Medical Procedures

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Radiation Dose Management for Fluoroscopically- Guided Interventional Medical Procedures 99107NCRP_Cover-R1 10/18/07 12:44 PM Page 1 156 NCRP REPORT No. 168 AND PROCEDURES FOR THEIR ASSESSMENT, DOSIMETRY AND TREATMENT AND DOSIMETRY ASSESSMENT, THEIR AND PROCEDURES FOR WOUNDS A BIOKINETIC MODEL FOR RADIONUCLIDE-CONTAMINATED DEVELOPMENT OF RADIATION DOSE MANAGEMENT FOR FLUOROSCOPICALLY- GUIDED INTERVENTIONAL MEDICAL PROCEDURES ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. NCRP REPORT No. 168 Radiation Dose Management for Fluoroscopically-Guided Interventional Medical Procedures Recommendations of the NATIONAL COUNCIL ON RADIATION PROTECTION AND MEASUREMENTS July 21, 2010 National Council on Radiation Protection and Measurements 7910 Woodmont Avenue, Suite 400 / Bethesda, MD 20814-3095 ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. LEGAL NOTICE This Report was prepared by the National Council on Radiation Protection and Measurements (NCRP). The Council strives to provide accurate, complete and use- ful information in its publications. However, neither NCRP, the members of NCRP, other persons contributing to or assisting in the preparation of this Report, nor any person acting on the behalf of any of these parties: (a) makes any warranty or rep- resentation, express or implied, with respect to the accuracy, completeness or use- fulness of the information contained in this Report, or that the use of any information, method or process disclosed in this Report may not infringe on pri- vately owned rights; or (b) assumes any liability with respect to the use of, or for damages resulting from the use of any information, method or process disclosed in this Report, under the Civil Rights Act of 1964, Section 701 et seq. as amended 42 U.S.C. Section 2000e et seq. (Title VII) or any other statutory or common law theory governing liability. Disclaimer Any mention of commercial products within NCRP publications is for informa- tion only; it does not imply recommendation or endorsement by NCRP. Library of Congress Cataloging-in-Publication Data Radiation dose management for fluoroscopically guided interventional medical procedures. p. ; cm. -- (NCRP report ; no. 168) Includes bibliographical references and index. ISBN 978-0-9823843-6-7 (alk. paper) 1. Fluoroscopy--Equipment and supplies. 2. Radiation--Dosage. 3. Radiation-- Safety measures. I. National Council on Radiation Protection and Measurements. II. Series: NCRP report ; no. 168. [DNLM: 1. Fluoroscopy--instrumentation. 2. Equipment Safety. 3. Radiation Dosage. 4. Radiation Protection. 5. Radiography, Interventional--adverse effects. WN 220] RC78.5.R33 2011 616.07'572--dc22 2011002846 Copyright © National Council on Radiation Protection and Measurements 2011 All rights reserved. This publication is protected by copyright. No part of this publica- tion may be reproduced in any form or by any means, including photocopying, or utilized by any information storage and retrieval system without written permission from the copyright owner, except for brief quotation in critical articles or reviews. [For detailed information on the availability of NCRP publications see page 314.] ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. Preface This Report was developed under the auspices of Program Area Committee 2 of the National Council on Radiation Protection and Measurements, the committee that provides oversight for opera- tional radiation safety. Fluoroscopically-guided interventional medical procedures (e.g., diagnostic angiography, angioplasty, stent placement) are now commonly performed in the United States, are often less invasive and less costly, and result in shorter hospital stays than surgical procedures. They are performed by radiologists and other medical specialists (e.g., cardiologists, orthopedic surgeons) with the assis- tance of medical support staff. This Report will be of benefit to these physicians and the medi- cal support staff, particularly those who currently participate in fluoroscopically-guided interventional procedures but do not have sufficient training in the practical radiation protection aspects of the use of the equipment for the procedures (e.g., knowledge of equipment operation, optimal imaging techniques, radiation dose management for patients and medical staff, benefit-risk tradeoffs, and the potential for early or late detrimental radiation effects). An extensive bibliography is provided to facilitate access to the pri- mary literature. This Report is also intended for policymakers who can place radiation-dose management requirements on those who conduct fluoroscopically-guided interventional procedures with regard to: • optimizing imaging protocols; • managing procedure time; • utilizing available radiation protective equipment and dose- management features; • tracking and trending radiation doses to patients and medi- cal staff; and • credentialing and privileging physicians to use the fluoro- scopic equipment for these specialized procedures. This Report was prepared by Scientific Committee 2-3 on Radi- ation Safety Issues for Image-Guided Interventional Medical Pro- cedures. Serving on Scientific Committee 2-3 were: iii ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. iv / PREFACE Stephen Balter, Chairman Columbia University Medical Center New York, New York Vice Chairmen Beth A. Schueler Donald L. Miller Mayo Clinic Uniformed Services University Rochester, Minnesota of the Health Sciences Bethesda, Maryland Members Jeffrey A. Brinker Cynthia H. McCollough Johns Hopkins Hospital Mayo Clinic Baltimore, Maryland Rochester, Minnesota Charles E. Chambers Keith J. Strauss Pennsylvania State College Harvard Medical School of Medicine Boston, Massachusetts Hershey, Pennsylvania Kenneth F. Layton Louis K. Wagner Baylor University Medical University of Texas Medical Center School Dallas, Texas Houston, Texas M. Victoria Marx University of Southern California Medical Center Los Angeles, California Consultants John F. Angle Norman J. Kleiman University of Virginia Columbia University Charlottesville, Virginia New York, New York Lionel Desponds John W. Hopewell GE Healthcare Green Templeton College Buc, France University of Oxford Oxford, United Kingdom Andrew Einstein Matthew Williams Columbia University Medical Columbia University Center New York, New York New York, New York NCRP Secretariat Marvin Rosenstein, Staff Consultant Cindy L. O’Brien, Managing Editor David A. Schauer, Executive Director ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. PREFACE / v The Council expresses its appreciation to the Committee mem- bers for the time and effort devoted to the preparation of this Report. NCRP gratefully acknowledges the financial support pro- vided by the National Cancer Institute (NCI) under Grant Number R24 CA074296-10. The contents of this Report are the sole respon- sibility of NCRP, and do not necessarily represent the official views of NCI, National Institutes of Health. Thomas S. Tenforde President ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. Contents Preface . iii 1. Executive Summary . .1 1.1 General . .1 1.2 Recommendations . .3 2. General Information . .10 2.1 Scope and Applicability of this Report . .10 2.2 Procedures . .11 2.2.1 Definition of a Fluoroscopically-Guided Interventional Procedure . .11 2.2.2 Types of Procedures . .11 2.2.3 Temporal Trends . .14 2.2.4 Individuals Performing Interventional Procedures (interventionalists) . .16 2.3 Efficacy, Effectiveness, Benefit-Cost Analyses . .17 2.3.1 Diagnostic Procedures . .17 2.3.2 Therapeutic Procedures . .18 2.4 Justification, Appropriateness, and Benefit-Risk Analyses . .18 2.4.1 Patient Benefit-Risk Analysis Models . .19 2.4.1.1 Diagnostic Studies . .19 2.4.1.1.1 Benefit . .19 2.4.1.1.2 Procedure Risk . .20 2.4.1.1.3 Radiation Risk . .20 2.4.1.2 Therapeutic Procedures . .20 2.4.1.2.1 Benefit . .20 2.4.1.2.2 Procedure Risk . .21 2.4.1.2.3 Radiation Risk . .21 2.4.2 Applying Benefit-Risk Analyses . .23 2.4.3 Risks to Interventionalists and Staff . .25 2.4.3.1 Radiation Risk . .25 2.4.3.2 Medical Risks . .26 2.4.3.2.1 Ergonomic Risks to Interventionalists. .26 2.4.3.2.2 Economic Benefit to Operator and Staff . .27 2.4.4 Benefit to Society . .27 2.4.5 Discussion . .28 2.5 Physics and Dosimetry . .29 vii ©NCRP 2011 - All rights reserved. Licensed to Beth Schueler/Mayo Clinic Downloaded 04/05/11 Single user license only, copying and networking prohibited. viii / CONTENTS 2.6 Radiation Health Effects . 33 2.6.1 Demographic Factors . 33 2.6.2 Medical History Factors . 34 2.6.3 Cancer Risks . 35 2.6.3.1 Worker Cancer Risk . 37 2.6.3.2 Patient Cancer Risk . 37 2.6.3.3 Stochastic Risk-Related Aspects of Dosimetry . 38 2.6.4 Deterministic Effects . 41 2.6.4.1 Tissue Reactions: Skin and Hair . 43 2.6.4.2 Tissue Reactions: Lens of the Eye . 44 2.6.5 In Utero Irradiation . 49 2.6.6 Heritable Effects . 50 3. Fluoroscopy Equipment and Facilities . 51 3.1 Equipment Configurations . 53 3.1.1 General Considerations . 53 3.1.2 Specific Equipment Components . 58 3.1.3 Specific Equipment Components for Pediatric Procedures . 60 3.2 Room Design and Structural Radiation Protection . 61 4. Protection of the Patient . 67 4.1 Patient Dose Review . 67 4.1.1 Cardiac Procedures . 69 4.1.2 Other Interventional Procedures . 70 4.1.3 Pediatric Interventional Procedures . 74 4.2 Patient Radiation Dose-Management Program . 86 4.2.1 Radiation History . 86 4.2.2 Pregnancy . 86 4.2.3 Type of Procedure . 87 4.2.4 General Principles of Radiation Dose Management . 88 4.2.4.1 Patient Dose Monitoring. 89 4.2.4.2 Optimizing Patient Dose.
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