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Geni Neumann Lima de Camara - Brazil - Monday 28 - Traceability and Biovigilance

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    Geni Neumann Lima de Camara -  Brazil - Monday 28 - Traceability and Biovigilance Geni Neumann Lima de Camara - Brazil - Monday 28 - Traceability and Biovigilance Presentation Transcript

    • 2011 Organ Donation Congress 11th Congress of the Society of Organ Donation and Procurement 2nd Iberoamerican Congress of the Society of Transplant Coordinators November 27 – 30, 2011 - Buenos Aires , Argentina Tracebility and Biovigilance:Achievements and Chalenges in Brazil Geni Neumman, MHSc Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Presentation Outline Tracebility and Biovigilance: Achievements and Chalenges in Brazil 1. Introduction: What...? Why ...? Where? 2. Achievements: How...? 3. Biovigilance .... Chalenges.Agência Nacionalde Vigilância Sanitária www.anvisa.gov.br
    • What .... ?Tracebility ... “the ability to trace the pathof a transplantation product from thedonor to the recipient, and vice versa.”ASHFORD (2010) Product: human cells, tissues and organs, substances and materials coming into contact with them. Unique identification  Coding systems. Proper registration and labeling. Relevant data on the procedures for procurement and receipt, processing, storage and distribution. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • What ... ? Biovigilance ... Vigilance and surveillance of therapeutic use of human cells, tissues and organs. Quality of care (donor and recipient). Safety and effectiveness of procedures. Evaluation of results (benefits and risks). Quality Management Systems. Systems for reporting adverse reactions/events. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • What ...? Procurement Patient outcome  Processing  Donor Testing, Storage and evaluation Distribution or Disposition  Screening  Transplantation TRACEBILITY BIOVIGILANCEMartiniere,K. - Eustite project, Madrid, 2007 (modified) Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Why ...? ~ 100 tissue products Multiple Donor recipients ~ 8 organs Risks are complex. Amplified risk to transmit pathogens and malignant cells. Broad distribution Thousands of tissue and cell grafts distributed Diversity of establishments. Fragmented responsibility. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Where ...? Brazil Area (Km2): ~ 8,514 million Population : ~192 million people Geographical regions: 5 States: 27 Federal District: 1 Capital: Brasília Continental dimensions Widespread regional and social inequalities Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • How ...?1988: Unified Health System (SUS)1997: National System for Transplants (SNT)1999:National Health Vigilance System (SNVS) Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • SNT : www.saude.gov.br/transplantesBrasil, Ministério da Saúde, DATASUS ( 2011) Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • SNVS: www. anvisa.gov.br System for Reporting AR/AE Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Reporting on:Drugs, medical supplies, clinical research, cosmetics, blood - Web based online reports Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Agência Nacionalde Vigilância Sanitária www.anvisa.gov.br
    • How ...Notification FormAgência Nacionalde Vigilância Sanitária www.anvisa.gov.br
    • How ...? Tissue and Cell Banks – Brazil, 2010 Tissue and Cell Banks TotalEye Banks 42 Autorization byMuscle-skeletical Banks 8 local/federalSkin Banks 1 authoritiesHeart Valves Banks 2Alogeneic Cord Blood Banks 5 (+7)(public Brasilcord)Autologous Cord Blood Banks Inspection by 16(private) local/federalCells and Germinatives TissuesBanks 107 authorities Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Estimated Tissue Transplants per year - locally donated Brazil, 2004-2010 Tissue 2004 2005 2006 2007 2008 2009 2010 Bone 700 752 1,997 2,340 5,521 16,979 23,647 Valves NA 151 102 62 67 91 27 Skin NA NA NA 1 0 17 26 Brazilian Registration of Transplants - RBT/ABTO 2004 – 2010. Hematopoietic Stem Cell Transplants, Brazil, 2004 – 2010 Cell 2004 2005 2006 2007 2008 2009 2010Allogeneic 582 543 570 513 610 /79* 590/57* 665 HSCAutologous 585 661 786 846 821 803 916 HSCBrazilian Registration of Transplants RBT/ABTO, 2004 – 2010.* Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
    • Tracebility of HSCell Transplants - BRASILCORD RENACORD ISBT 128Agência Nacionalde Vigilância Sanitária www.anvisa.gov.br
    • Chalenges in Brazil Effective Quality management Standardization of nomenclature Setting priorities - sentinel events Information on the “denominator” Developing standardized tools for data collection Systems integration and database Awareness and trainingAgência Nacionalde Vigilância Sanitária www.anvisa.gov.br
    • ChallengesAgência Nacionalde Vigilância Sanitária www.anvisa.gov.br
    • Thank you for your attention !!! ggsto@anvisa.gov.brAgência NacionalAgência Nacionalde Vigilância Sanitáriade Vigilância Sanitária www.anvisa.gov.br www.anvisa.gov.br