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. Presentation Outline
Tracebility and Biovigilance:
Achievements and Chalenges in Brazil
1. Introduction: What...? Why ...? Where?
2. Achievements: How...?
3. Biovigilance .... Chalenges.
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

3. What .... ?
Tracebility ... “the ability to trace the path
of a transplantation product from the
donor 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. 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. What ...?
Procurement
Patient
outcome
 Processing
 Donor Testing, Storage and
evaluation Distribution or Disposition
 Screening  Transplantation
TRACEBILITY
BIOVIGILANCE
Martiniere,K. - Eustite project, Madrid, 2007 (modified)
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

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. 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. 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. SNT : www.saude.gov.br/transplantes
Brasil, Ministério da Saúde, DATASUS ( 2011)
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

10. SNVS: www. anvisa.gov.br
System for Reporting AR/AE
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

11. Reporting on:
Drugs, medical supplies, clinical
research, cosmetics, blood - Web based online
reports
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

12. Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

13. How ...Notification Form
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

14. How ...?
Tissue and Cell Banks – Brazil, 2010
Tissue and Cell Banks Total
Eye Banks 42 Autorization by
Muscle-skeletical Banks 8 local/federal
Skin Banks 1
authorities
Heart Valves Banks 2
Alogeneic Cord Blood Banks
5 (+7)
(public Brasilcord)
Autologous Cord Blood Banks
Inspection by
16
(private)
local/federal
Cells and Germinatives Tissues
Banks
107 authorities
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

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 2010
Allogeneic 582 543 570 513 610 /79* 590/57* 665
HSC
Autologous 585 661 786 846 821 803 916
HSC
Brazilian Registration of Transplants RBT/ABTO, 2004 – 2010.
* Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

16. Tracebility of HSCell Transplants - BRASILCORD
RENACORD
ISBT 128
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

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 training
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

18. Challenges
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

19. Thank you for your attention !!!
ggsto@anvisa.gov.br
Agência Nacional
Agência Nacional
de Vigilância Sanitária
de Vigilância Sanitária www.anvisa.gov.br
www.anvisa.gov.br