HIV and the blood supply : an analysis of crisis decisionmaking

HIV and the blood supply an analysis of crisis decisionmaking

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Detalles Bibliográficos
Autor Corporativo: Institute of Medicine (U.S.) Committee to Study HIV Transmission Through Blood and Blood Products (-)
Otros Autores: Leveton, Lauren B. (-), Sox, Harold C., Stoto, Michael A.
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1995.
Edición:1st ed
Materias:
AIDS (Disease) > United States.
Blood banks > Risk management > United States.
Blood banks > Law and legislation > United States.
Medical policy > United States.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820333606719
Tabla de Contenidos:
  • HIV AND THE BLOOD SUPPLY
  • Copyright
  • Preface
  • REFERENCE
  • Contents
  • Executive Summary
  • HISTORY
  • The Risk of AIDS
  • Immediate Responses to Evidence of Blood-Borne AIDS Transmission
  • Opportunities to Reformulate Policy
  • Research Activities
  • FINDINGS
  • Product Treatment
  • Donor Screening and Deferral Policies
  • Regulations and Recall
  • Communication to Physicians and Patients
  • CONCLUSIONS
  • Decisionmaking Under Uncertainty
  • Bureaucratic Management of Potential Crises
  • RECOMMENDATIONS
  • The Public Health Service
  • The Centers for Disease Control and Prevention
  • The Food and Drug Administration
  • Communication to Physicians and Patients
  • REFERENCES
  • 1 Introduction
  • HIV INFECTION VIA BLOOD TRANSFUSION
  • THE COMMITTEE'S CHARGE
  • ORGANIZATION OF THE REPORT
  • REFERENCES
  • 2 The U.S. Blood Supply System
  • INTRODUCTION
  • BLOOD AND BLOOD PRODUCTS
  • Whole Blood and Components
  • Plasma and Derivatives
  • Plasma Collection
  • Plasma Processing
  • Blood and Blood Components Distribution
  • BLOOD COLLECTION ORGANIZATIONS
  • Community Blood Banks
  • The American Red Cross Service
  • Hospital Blood Banks
  • PROFESSIONAL ASSOCIATIONS
  • American Association of Blood Banks
  • AABB Inspection and Accreditation Program
  • Council of Community Blood Centers
  • American Blood Resources Association
  • HEMOPHILIA ORGANIZATIONS
  • The Nature of Hemophilia
  • Hemophilia Treatment Centers
  • National Hemophilia Foundation
  • Medical and Scientific Advisory Council
  • ROLE OF THE U.S. PUBLIC HEALTH SERVICE
  • National Blood Policy of 1973
  • Public Health Service
  • Centers for Disease Control and Prevention
  • National Institutes of Health
  • National Institute of Allergy and Infectious Diseases
  • National Heart, Lung, and Blood Institute
  • Food and Drug Administration
  • Blood Products Advisory Committee.
  • BLOOD AND BLOOD PRODUCT REGULATION
  • Statutory Background
  • Biologics Act
  • Public Health Service Act
  • Blood Shield Laws
  • Federal Licensure of Blood Collection Organizations
  • Establishment Licensure and Registration
  • Product Licensure
  • Other Required Licensure
  • REGULATORY AUTHORITY OF THE FDA
  • Compliance with Regulations
  • Recall Policy
  • SUMMARY
  • REFERENCES
  • 3 History of the Controversy
  • INTRODUCTION
  • THE RISK OF AIDS
  • Kaposi's Sarcoma and PCP in Homosexual Men
  • Opportunistic Infections Among Heterosexual Intravenous (IV) Drug Users and Haitian Immigrants
  • Increased Risk Among Individuals with Hemophilia and a Similarity to Hepatitis B
  • Further Evidence of Sexual and Blood-Borne Transmission of AIDS
  • Summary
  • IMMEDIATE RESPONSES TO EVIDENCE OF BLOOD-BORNE AIDS TRANSMISSION
  • The CDC's Public Meeting
  • The Blood Bank Community's Statement
  • Position of the National Hemophilia Foundation
  • Position of the Plasma Fractionation Industry
  • Federal Recommendations on the Prevention of AIDS
  • Summary and Comment
  • RECONSIDERING THE EVIDENCE: FURTHER ATTEMPTS TO FORMULATE POLICIES
  • Summary and Comment
  • RESEARCH ACTIVITIES
  • The Public Health Service Effort
  • Isolation of the Virus and Development of a Screening Test
  • Summary and Comment
  • REFERENCES
  • 4 Product Treatment
  • INTRODUCTION
  • CRITICAL TIME PERIOD: 1970-1983
  • Hepatitis
  • Viral Inactivation of AHF Concentrate
  • Early Methods
  • Studies by U.S. Plasma Fractionation Companies
  • Problems of Viral Inactivation Development
  • Impact of the First Reported Cases of AIDS in Individuals with Hemophilia
  • Federal Research Support for Viral Inactivation
  • Specific Viral Inactivation Methods
  • Testing for the Effectiveness of the Inactivation Process
  • FDA Approval and Licensing of Treated Factor VIII
  • ANALYSIS AND CONCLUSIONS
  • SUMMARY.
  • AFTERWARD
  • Subsequent Events
  • Current Procedures and Challenges
  • REFERENCES
  • 5 Donor Screening and Deferral
  • INTRODUCTION
  • Critical Events
  • Critical Event 1
  • Critical Event 2
  • Explanatory Hypotheses
  • DONOR SCREENING PRACTICES
  • Hepatitis
  • Donor Pools
  • Early Donor Screening Practices
  • ANALYSIS AND FINDINGS
  • January 4, 1983, CDC Meeting
  • Outcomes of the Meeting
  • Donor Questioning and Opposition to It
  • Surrogate Testing and Opposition to It
  • Criticism of the CDC's Data and Motives
  • Risk Assessment
  • Lack of Leadership
  • Conclusions
  • December 1983 Blood Products Advisory Committee Meeting
  • Interim Local Efforts to Screen Aggressively
  • Reliability of Surrogate Tests
  • Task Force Report on Surrogate Testing
  • Comment on the Blood Products Advisory Committee
  • Informing the Public
  • AIDS Politics
  • CONCLUSIONS
  • Hypothesis One
  • Hypothesis Two
  • Political Factors
  • Ideological Factors
  • Organizational Factors
  • Historical Factors
  • AFTERWORD
  • Donor Screening 1985-1995
  • HIV
  • Hepatitis
  • HTLV-I and HTLV-II
  • Current Donor Screening Procedures
  • Current Infectious Risk Through Blood Transfusion
  • REFERENCES
  • 6 Regulations and Recall
  • INTRODUCTION
  • FRAMEWORK OF ANALYSIS
  • Critical Events
  • Critical Event 1
  • Critical Event 2
  • Critical Event 3
  • Critical Event 4
  • FDA Regulatory Authority and Practice
  • Explanatory Hypotheses
  • FINDINGS AND CONCLUSIONS
  • FDA Letters of March 1983
  • Analysis
  • Summary and Conclusions
  • Nonautomatic Recalls
  • Analysis
  • Summary and Conclusions
  • Heat-Treated AHF Concentrate and the FDA's Recall Policy
  • Analysis
  • Summary and Conclusions
  • Lookback and Notification of Individuals Transfused with Contaminated Blood Products
  • Analysis
  • Summary and Conclusions
  • INFLUENCE AND RESPONSIBILITIES OF OTHER ORGANIZATIONS.
  • Governmental Organizations
  • Nongovernmental Organizations
  • Implications
  • THE ADVANTAGES OF MARGINAL THINKING
  • Lookback and Notification
  • Removal of Untreated AHF Concentrate
  • Use of Screened Whole Blood
  • Destruction of Potentially Contaminated Cryoprecipitate
  • Innovative Techniques for Pooling Plasma
  • Testing Previously Untested Blood and Plasma for HIV
  • SUMMARY
  • REFERENCES
  • 7 Risk Communication to Physicians and Patients
  • INTRODUCTION
  • FRAMEWORK FOR ANALYSIS
  • Critical Questions
  • Critical Factors
  • The Role of the National Hemophilia Foundation
  • RISK REDUCTION OPTIONS
  • Specific Options
  • The Process for Developing NHF Guidelines
  • CASE STUDIES
  • Case Study One: Conviction and Change
  • Case Study Two: Reduction in Use of AHF Concentrate
  • Case Study Three: Continue AHF Concentrate Treatment
  • Case Study Four: Prescribing Cryoprecipitate for a Newborn and Continuing AHF Concentrate Treatment For a Four-Year-Old
  • Case Study Five: A Transfusion Case
  • Summary of the Case Studies
  • OBSTACLES TO COMMUNICATION
  • Institutional Obstacles
  • Resources and Expertise of the NHF
  • The NHF and the Plasma Fractionation Industry
  • Communication Style of the NHF
  • Social and Cultural Obstacles
  • CONCLUSIONS
  • REFERENCES
  • 8 Conclusions and Recommendations
  • GENERAL CONCLUSIONS
  • Decisionmaking Under Uncertainty
  • Risk Perception
  • Risk Assessment Versus Risk Management
  • Consider the Full Range of Possibilities
  • Risk Reduction Versus Zero Risk
  • Risk Communication
  • Bureaucratic Management of Potential Crises
  • Coordination and Leadership
  • Advisory Mechanisms
  • Analytic Capability and Long-Range Vision
  • Presumptive Regulatory and Public Health Triggers
  • Product Treatment
  • Donor Screening
  • Recall
  • Communication to Patients and Providers
  • RECOMMENDATIONS
  • The Public Health Service.
  • Leadership
  • Blood Safety Council
  • Compensation Policy
  • The Centers for Disease Control and Prevention
  • Early Warning Systems
  • Surveillance
  • The Food and Drug Administration
  • Risk Reduction
  • Decision Processes
  • Regulatory Efforts
  • Advisory Committees
  • Communication to Physicians and Patients
  • Clinical Practice
  • Credibility
  • REFERENCES
  • Appendixes
  • A Individuals Interviewed by the Committee
  • B Individuals Providing Oral and Written Testimony (for a public meeting held September 12, 1994)
  • C Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Asse...
  • D Key Documents Provided to the Committee
  • E Glossary of Acronyms and Terms
  • Acronyms
  • Terms
  • SOURCES
  • F Committee and Staff Biographies
  • COMMITTEE
  • STAFF BIOGRAPHIES
  • Index.

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