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2011 Organ Donation Congress                  11th Congress of the Society of Organ Donation and Procurement              ...
Presentation Outline         Tracebility and Biovigilance:     Achievements and Chalenges in Brazil  1. Introduction: What...
What .... ?Tracebility ... “the ability to trace the pathof a transplantation product from thedonor to the recipient, and ...
What ... ?    Biovigilance    ... Vigilance and    surveillance of therapeutic use of    human cells, tissues and organs....
What ...?       Procurement                                                              Patient                        ...
Why ...?                              ~ 100 tissue                               products       Multiple    Donor         ...
Where ...?                                        Brazil                      Area (Km2):                       ~ 8,514 mi...
How ...?1988: Unified Health System (SUS)1997: National System for Transplants (SNT)1999:National Health Vigilance System ...
SNT : www.saude.gov.br/transplantesBrasil, Ministério da Saúde, DATASUS ( 2011)      Agência Nacional      de Vigilância S...
SNVS: www. anvisa.gov.br         System for Reporting AR/AE   Agência Nacional   de Vigilância Sanitária                  ...
Reporting on:Drugs,       medical       supplies,    clinical  research, cosmetics, blood - Web based online  reports    A...
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                ...
Estimated Tissue Transplants per year - locally donated                   Brazil, 2004-2010  Tissue         2004          ...
Tracebility of HSCell Transplants - BRASILCORD                          RENACORD                           ISBT 128Agência...
Chalenges in Brazil                Effective     Quality management                Standardization       of nomenclature...
ChallengesAgência Nacionalde Vigilância Sanitária                                       www.anvisa.gov.br
Thank you for your attention !!!                     ggsto@anvisa.gov.brAgência NacionalAgência Nacionalde Vigilância San...
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Geni Neumann Lima de Camara - Brazil - Monday 28 - Traceability and Biovigilance

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

  1. 1. 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
  2. 2. 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
  3. 3. 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
  4. 4. 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
  5. 5. 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
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. SNT : www.saude.gov.br/transplantesBrasil, Ministério da Saúde, DATASUS ( 2011) Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
  10. 10. SNVS: www. anvisa.gov.br System for Reporting AR/AE Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
  11. 11. Reporting on:Drugs, medical supplies, clinical research, cosmetics, blood - Web based online reports Agência Nacional de Vigilância Sanitária www.anvisa.gov.br
  12. 12. Agência Nacionalde Vigilância Sanitária www.anvisa.gov.br
  13. 13. How ...Notification FormAgência Nacionalde Vigilância Sanitária www.anvisa.gov.br
  14. 14. 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
  15. 15. 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
  16. 16. Tracebility of HSCell Transplants - BRASILCORD RENACORD ISBT 128Agência Nacionalde Vigilância Sanitária www.anvisa.gov.br
  17. 17. 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
  18. 18. ChallengesAgência Nacionalde Vigilância Sanitária www.anvisa.gov.br
  19. 19. 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

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