Radiation in medicine : a need for regulatory reform / Committee for Review and Evaluation of the Medical Use Program of Nuclear Regulatory Commission ; Kate-Louise D. Gottfried and Gary Penn, editors.

Format:

Book

Contributor:

Gottfried, Kate-Louise D.

Penn, Gary.

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.

Language:

English

Subjects (All):

Nuclear medicine--Safety regulations--United States.

Nuclear medicine.

Medical radiology--Safety regulations--United States.

Medical radiology.

Ionizing radiation--Safety measures.

Ionizing radiation.

Radioactivity--Safety measures.

Radioactivity.

Physical Description:

xiii, 308 p. : ill.

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1996.

Language Note:

English

Summary:

Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.

Contents:

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

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

THERAPEUTIC APPLICATIONS OF IONIZING RADIATION

External Sources: Radiation Oncology and Teletherapy

General Approaches

Clinical Uses in Illustrative Medical Conditions.

Utilization Rates

Collective Dose

Internal Sources: Brachytherapy

Overview

Internal Unsealed Sources: Therapeutic Nuclear Medicine

Types of Procedures and Number of Treatments

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

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

5 Alternative Regulatory Systems

SEVEN ALTERNATIVE STRUCTURES

Alternative A1: Status Quo

Pro

Con

Alternative A2: Status Quo Modified

Alternative B: Laissez Faire

Alternative C: State Control

Alternative D: Federal Guidance

Functions of the Federal Agency

Alternative E: Reserve Federal Authority

Alternative F:Centralization of Regulation Within One Federal Agency

Alternative G: Health Finance Agency

ASSESSMENT OF THE ALTERNATIVES

Alternatives Eliminated from Consideration

Alternative D: The Preferred Alternative

6 Findings, Conclusions, and Recommendations

REPORT PREMISES

FINDINGS

Risks and Benefits

Regulations

The Regulated Community

Private and Voluntary Involvement in Radiation Safety

CONCLUSIONS

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

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 F-Radiopharmaceuticals for Therapy.

Subpart G-Sources for Brachytherapy

PART 36-LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

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

STATE REGULATION

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.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references and index.

ISBN:

9786610192847

9780309175678

0309175674

9781280192845

1280192844

9780309588751

0309588758

9780585023687

0585023689

OCLC:

923263161