Radiation in medicine : a need for regulatory reform

Radiation in medicine a need for regulatory reform

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Detalles Bibliográficos
Autores Corporativos: U.S. Nuclear Regulatory Commission. Medical Use Program (-), Institute of Medicine (U.S.). Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission
Otros Autores: Gottfried, Kate-Louise D. (-), Penn, Gary
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1996.
Edición:1st ed
Materias:
Nuclear medicine > Safety regulations > United States.
Radiology, Medical > Safety regulations > United States.
Ionizing radiation > Safety measures.
Radioactivity > Safety measures.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820305706719
Tabla de Contenidos:
  • RADIATION IN MEDICINE
  • Copyright
  • Preface
  • Acknowledgments
  • Contents
  • Summary
  • BENEFITS OF IONIZING RADIATION
  • THE REGULATORY FRAMEWORK
  • The Current Situation
  • The NRC Medical Use Program
  • The Quality Management Rule
  • The NRC Agreement State Program
  • ALTERNATIVE REGULATORY SYSTEMS
  • Seven Alternative Structures
  • Assessment of the Alternatives
  • The Preferred Choice: Alternative D, Federal Guidance
  • FINDINGS AND CONCLUSIONS
  • RECOMMENDATIONS
  • A: Recommendations to Congress
  • B: Recommendations to the Nuclear Regulatory Commission
  • C: Recommendations to the Conference of Radiation Control Program Directors and to the States
  • CONCLUDING OBSERVATIONS
  • 1 Introduction
  • ERRORS AND SUCCESSES, BENEFITS AND PROBLEMS OF RADIATION MEDICINE
  • THE CURRENT REGULATORY SYSTEM
  • The NRC Medical Use Program
  • Regulation of Other Sources
  • Evolution of Federal and State Regulatory Programs
  • THE INSTITUTE OF MEDICINE STUDY
  • The NRC Request to the IOM and the Committee Charge
  • Elements of the Study
  • Meetings
  • Public Hearing
  • Technical Panel
  • Commissioned Papers
  • Site Visits
  • Professional Meetings
  • Organization of the Report
  • Scope and Limitations of the Report
  • CHAPTER SUMMARY
  • REFERENCES
  • 2 Clinical Applications of Ionizing Radiation
  • MEASURES OF PATIENT EXPOSURE TO IONIZING RADIATION
  • DIAGNOSTIC APPLICATIONS OF IONIZING RADIATION
  • External Sources: Radiology
  • Types of Procedures
  • Utilization Rates
  • Radiation Doses
  • Radiation Regulation and Control
  • Internal Sources: Diagnostic Nuclear Medicine
  • Types of Procedures
  • Utilization Rates
  • Radiation Doses
  • Radiation Regulation and Control
  • THERAPEUTIC APPLICATIONS OF IONIZING RADIATION
  • External Sources: Radiation Oncology and Teletherapy
  • General Approaches
  • Clinical Uses in Illustrative Medical Conditions.
  • Utilization Rates
  • Collective Dose
  • Radiation Regulation and Control
  • Internal Sources: Brachytherapy
  • Overview
  • Types of Procedures
  • Radiation Regulation and Control
  • Internal Unsealed Sources: Therapeutic Nuclear Medicine
  • Overview
  • Types of Procedures and Number of Treatments
  • Radiation Regulation and Control
  • CHAPTER SUMMARY
  • REFERENCES
  • 3 Regulation and Radiation Medicine
  • REGULATORY GOALS
  • THE CURRENT REGULATORY FRAMEWORK
  • How Society Regulates Health Care Delivery
  • The Regulatory Framework
  • Nuclear Regulatory Commission
  • Food and Drug Administration
  • Environmental Protection Agency
  • States
  • THE COSTS OF NRC REGULATION
  • Cost Recovery by the NRC Through Fee Collection
  • Cost of a Full-Time Equivalent at NRC
  • Fee Schedules for Selected NRC License Categories
  • Fees Collected from Selected NRC License Categories in 1993
  • Fines Collected from Selected NRC License Categories in 1993
  • Non-Fee Costs of NRC Regulation
  • Recordkeeping Requirements
  • Security Requirements
  • Radioactive Waste Management
  • Cost Savings Estimates for Some NRC Licensees
  • Summary of Fee and Non-Fee Costs of NRC Regulation
  • QUALITATIVE ASSESSMENTS OF NRC REGULATIONS
  • Criticism of the Regulatory System
  • Fragmentation and Disproportionality
  • Administrative Requirements
  • Fees and Fines
  • CHAPTER SUMMARY
  • REFERENCES
  • 4 Risks of Ionizing Radiation in Medicine
  • RISK ASSESSMENT
  • Kinds of Radiation Injury
  • Human Study Limitations
  • Models of Radiation Injury
  • The Tolerance Dose, Threshold Model
  • Introduction of the Linear, No-Threshold Model
  • Summary Observations
  • RISKS OF IONIZING RADIATION IN MEDICAL TREATMENT
  • Risk of Unintended Exposures in Radiation Medicine
  • Human Error and Unintended Events
  • Rates of Misadministration.
  • Misadministrations in Byproduct-Related Ionizing Radiation in Medicine
  • Gaps in Data Collection
  • Comment
  • Conclusion
  • Misadministrations and Adverse Events in Other Medical Modalities
  • Medications
  • Anesthesia
  • Blood Transfusions
  • Comparison of Risks in the Use of Ionizing Radiation in Medicine with Those in Other Medical Modalities
  • Inappropriate and Unnecessary Care
  • Efforts That Reduce Adverse Events and Inappropriate Care
  • Section Summary
  • PUBLIC PERCEPTION OF RADIATION RISK
  • Nature of Risk Perception
  • Perception of Radiation Risk
  • Impact of Perceptions
  • Risk Communication and Trust
  • Implications for Radiation Medicine
  • CHAPTER SUMMARY
  • REFERENCES
  • 5 Alternative Regulatory Systems
  • SEVEN ALTERNATIVE STRUCTURES
  • Alternative A1: Status Quo
  • Pro
  • Con
  • Alternative A2: Status Quo Modified
  • Pro
  • Con
  • Alternative B: Laissez Faire
  • Pro
  • Con
  • Alternative C: State Control
  • Pro
  • Con
  • Alternative D: Federal Guidance
  • Functions of the Federal Agency
  • Pro
  • Con
  • Alternative E: Reserve Federal Authority
  • Pro
  • Con
  • Alternative F:Centralization of Regulation Within One Federal Agency
  • Pro
  • Con
  • Alternative G: Health Finance Agency
  • Pro
  • Con
  • ASSESSMENT OF THE ALTERNATIVES
  • Alternatives Eliminated from Consideration
  • Alternative D: The Preferred Alternative
  • CHAPTER SUMMARY
  • 6 Findings, Conclusions, and Recommendations
  • REPORT PREMISES
  • FINDINGS
  • Risks and Benefits
  • Regulations
  • The Regulated Community
  • Private and Voluntary Involvement in Radiation Safety
  • CONCLUSIONS
  • RECOMMENDATIONS
  • A: Recommendations to Congress
  • B: Recommendations to the Nuclear Regulatory Commission
  • C: Recommendations to the Conference of Radiation Control Program Directors and to the States
  • CONCLUDING STATEMENT
  • A Committee Biographies
  • COMMITTEE STAFF.
  • B Abbreviations and Acronyms
  • ASSOCIATIONS AND SOCIETIES
  • FEDERAL GOVERNMENT PROGRAMS AND AGENCIES
  • INTERNATIONAL ORGANIZATIONS
  • LEGISLATION AND EXECUTIVE ORDERS
  • MISCELLANEOUS
  • C Glossary
  • D Selected Sections of the United States Code of Federal Regulations
  • PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION
  • Subpart A-General Provisions
  • Subpart B-Radiation Protection Programs
  • Subpart C-Occupational Dose Limits
  • Subpart D-Radiation Dose Limits for Individual Members of the Public
  • Subpart E-(Reserved)
  • Subpart F-Surveys and Moniforing
  • Subpart G-Control of Exposure From External Sources in Restricted Areas
  • Subpart H-Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas
  • Subpart I-Storage and Control of Licensed Material
  • Subpart J-Precautionary Procedures
  • Subpart K-Waste Disposal
  • Subpart L-Records
  • Subpart M-Reports
  • Subpart N-Exemptions and Additional Requirements
  • Subpart O-Enforcement
  • Subpart A-General Provisions
  • Subpart B-Radiation Protection Programs
  • Subpart C-Occupational Dose Limits
  • APPENDIX A TO PART 34
  • PART 35-MEDICAL USE OF BYPRODUCT MATERIAL
  • Subpart A-General Information
  • Subpart B-General Administrative Requirements
  • Subpart C-General Technical Requirements
  • Subpart D-Uptake, Dilution, and Excretion
  • Subpart E-Imaging and Localization
  • Subpart F-Radiopharmaceuticals for Therapy
  • Subpart G-Sources for Brachytherapy
  • Subpart H-Sealed Sources for Diagnosis
  • Subpart I-Teletherapy
  • Subpart J-Training and Experience Requirements
  • Subpart K-Enforcement
  • Subpart A-General Information
  • Subpart B-General Administrative Requirements
  • Subpart C-General Technical Requirements
  • Subpart D-Uptake, Dilution, and Excretion
  • Subpart E-Imaging and Localization
  • Subpart F-Radiopharmaceuticals for Therapy.
  • Subpart G-Sources for Brachytherapy
  • Subpart H-Sealed Sources for Diagnosis
  • Subpart I-Teletherapy
  • Subpart J-Training and Experience Requirements
  • Subpart K-Enforcement
  • PART 36-LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
  • Subpart A-General Provisions
  • Subpart B-Specific Licensing Requirements
  • Subpart C-Design and Performance Requirements for Irradiators
  • Subpart D-Operation of Irradiators
  • Subpart E-Records
  • Subpart F-Enforcement
  • E Nuclear Regulatory Commission Agreement and Non-agreement States
  • AGREEMENT STATES
  • NON-AGREEMENT STATES
  • F Regulatory Chronology
  • G History of Radiation Regulation in Medicine
  • PROFESSIONAL SELF-REGULATION
  • GOVERNMENT REGULATION
  • NUCLEAR REGULATORY COMMISSION
  • Atomic Energy Act
  • Other Federal Agencies
  • Federal Radiation Council
  • Other Executive Agencies
  • PHS Radiological Health Program
  • Environmental Protection Agency
  • STATE REGULATION
  • REFERENCES
  • H Public Meeting Documents
  • ORGANIZATIONS FORMALLY CONTACTED FOR PUBLIC MEETING PARTICIPATION
  • COMMITTEE FOR REVIEW AND EVALUATION OF THE MEDICAL USE PROGRAM OF THE NUCLEAR REGULATORY COMMISSION
  • PUBLIC MEETING ANNOUNCEMENT AND REQUEST FOR WRITTEN TESTIMONY
  • Background
  • Providing Testimony
  • Guide to Preparing Testimony
  • TOPICS
  • Regulation
  • Data/Risk
  • Quality Management/Quality Assurance
  • Education
  • Other
  • PUBLIC HEARING OCTOBER 12, 1994 ORGANIZATIONS AND INDIVIDUALS SUBMITTING TESTIMONY
  • QUESTION SUMMARIES
  • I Quality Management Technical Panel
  • LIST OF PARTICIPANTS, TUESDAY, OCTOBER 11, 1994
  • Speakers
  • Observers
  • Subcommitee Members
  • J Commissioned Papers
  • K The Linear, No-Threshold Model
  • ADOPTION OF THE LINEAR, NO-THRESHOLD MODEL
  • Divided Scientific Opinion, 1958-1966
  • Joint Committee on Atomic Energy Hearings, 1957-1960s.
  • The BEIR Report and the Code of Federal Regulations, 1972.

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