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Does the low prevalence of bacterial contamination in random platelet concentrates justify the use of preventive measures?

Despite the growing advancement of transfusion medicine, bacterial contamination of blood components still represents a serious risk to recipients and is currently the leading cause of adverse effects( 11. Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev. 2005;18(1):195-204. ) and the second leading cause of death related to blood transfusions( 22. Campos TC, Pedroso CD, Dantas SC, Pinheiro FC, Costa LF, Pereira AF, et al. Monitorização da contaminação bacteriana em concentrados de plaquetas randômicas - Experiência de um banco de sangue [Abstract 696]. Rev Bras Hematol Hemoter. 2009; 31(5): 276. ).

It is estimated that the risk of sepsis related to platelet transfusions is 1:12.000, with a mortality rate of 26%. The rates are further increased when transfusions of platelet concentrates are obtained from multiple donors( 33. Razouk FH, Reiche EM. Caracterização, produção e indicação clínica dos principais hemocomponentes. Rev Bras Hematol Hemoter. 2004;26(2):126-34. ). Currently the Ordinance nº 1353 of June 13, 2011 is in force in Brazil; this regulation determines that 75% or more of blood products must comply with the established quality and sterility standards( 44. Agência Nacional de Vigilância Sanitária. Portaria nº 1.353, de 13 de Junho de 2011. Aprova o Regulamento Técnico de Procedimentos Hemoterápicos [Internet]. Brasília: ANVISA; 2011. [cited 2012 Jun 21]. Available from: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt1353_13_06_2011.html
http://bvsms.saude.gov.br/bvs/saudelegis...
).

Given the importance of microbiological control in blood banks, the present study aimed to analyze the prevalence of positive bacterial cultures in random platelet concentrates (RPC) obtained in the period from November 2010 to April 2011 in the Instituto Pasquini de Hemoterapia e Hematologia in Curitiba, Brazil. A retrospective observational study was conducted of 409 reports of bacterial cultures on RPC, which represented a total of 3183 donations.

It is recommended that a patient requiring a platelet transfusion receives one unit for every 10 kg body weight. The Instituto Pasquini has standardized eight units of RPC for all patients except for surgical and pediatric patients. The material is prepared in a laminar flow hood with prior irradiation of germicidal light for 15 minutes. After, the eight units of RPC are transferred to a 600 mL pouch, from which 10 mL are removed for blood cultures (BacT / Alert (r) 3D, bioMérieux, USA) using a previously validated method( 55. Magalhães GL, Pelisson M, Colluço AG, Koti AN, Gelinski JR, Saito M, et al. Validação do sistema BactAlert utilizado para controle microbiológico de hemocomponentes no Hemocentro Regional de Londrina [Abstract 750]. Rev Bras Hematol Hemoter. 2009;31(5):291. ).

A culture in January 2011 was positive (Table 1), showing a growth of coagulasenegative Staphylococcus. This represented 1.25% of the cultures performed in January 2011 and 0.24% in the period from November 2010 to April 2011. As at least one unit of this pool was contaminated, this represents 0.15% of random platelet donors of January, and is thus well within the parameters established by Ordinance nº 1353 for the sterility of blood components( 44. Agência Nacional de Vigilância Sanitária. Portaria nº 1.353, de 13 de Junho de 2011. Aprova o Regulamento Técnico de Procedimentos Hemoterápicos [Internet]. Brasília: ANVISA; 2011. [cited 2012 Jun 21]. Available from: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt1353_13_06_2011.html
http://bvsms.saude.gov.br/bvs/saudelegis...
) which determines a level of sterility higher than 75%.


Table 1 - Donors and results of blood cultures

The rate of minimal bacterial contamination was 1:3183 donations which corresponds to 0.03%. In the United States it is estimated that bacterial contamination of random platelets is 1 in every 3000 units( 66. Fiebig EW, Busch MP. Infectious disease screening. In: Roback JD. Combs MR. Grossman BJ, Hillyer CD, editors. Technical Manual. 16th ed. Bethesda: AABB; 2008. p. 241-82. ), with transfusion-related septicemia occurring in 1 of every 20,000 transfusions( 77. Mendrone AJ. Terapia transfusional no transplante de células-tronco hematopoeticas. In: Voltarelli JC, Pasquini R, Ortega ET. Transplante de células-tronco. São Paulo: Atheneu; 2009. p 653-75. ).

The most frequently agents related to platelet concentrates are gram-positive coccus, Staphylococcus spp and Streptococcus spp ( 88. Rodrigues MC, Almeida DR. Avaliação de análises microbiológicas de hemocomponentes [Abstract 984]. Rev Bras Hematol Hemoter. 2011;33(2):408. ). Ordinance nº 1353 is not specific about the sterility of RPC, unlike the Board Resolution (RDC) nº 153 of July 2004, repealed in December 2010, which stipulated a sterility of platelet concentrates greater than 99.5%( 99. Brasil. Ministério da Saúde. Agência Nacional de VigilânciaSanitária. Resolução RDC n.153, de 14 de junho de 2004. Determina o Regulamento Técnico para os procedimentos hemoterápicos,incluindo a coleta, o processamento, a testagem, o armazenamento, o transporte, o controle de qualidade e o uso humano de sangue, eseus componentes, obtidos do sangue venoso, do cordão umbilical, daplacenta e da medula óssea [Internet]. Brasilia, MS: 2004. [cited 2011 Sept 15]. Available from: http://portal.saude.gov.br/portal/arquivos/pdf/resolucao_153_2004.pdf
http://portal.saude.gov.br/portal/arquiv...
).

Despite the low prevalence of bacterial contamination in RPC demonstrated in this study, it is of paramount importance to adopt preventive measures that can ensure safety in blood transfusions, because RPC are used in large quantities and their administration is intravenous which facilitates the development of pathogens, especially in debilitated patients. Thus, astrict quality control, coupled with highly sensitive techniques would allow the correct identification of bacteria in blood products, and may contribute to reduce transfusion accidents.

References

  • 1
    Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev. 2005;18(1):195-204.
  • 2
    Campos TC, Pedroso CD, Dantas SC, Pinheiro FC, Costa LF, Pereira AF, et al. Monitorização da contaminação bacteriana em concentrados de plaquetas randômicas - Experiência de um banco de sangue [Abstract 696]. Rev Bras Hematol Hemoter. 2009; 31(5): 276.
  • 3
    Razouk FH, Reiche EM. Caracterização, produção e indicação clínica dos principais hemocomponentes. Rev Bras Hematol Hemoter. 2004;26(2):126-34.
  • 4
    Agência Nacional de Vigilância Sanitária. Portaria nº 1.353, de 13 de Junho de 2011. Aprova o Regulamento Técnico de Procedimentos Hemoterápicos [Internet]. Brasília: ANVISA; 2011. [cited 2012 Jun 21]. Available from: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt1353_13_06_2011.html
    » http://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt1353_13_06_2011.html
  • 5
    Magalhães GL, Pelisson M, Colluço AG, Koti AN, Gelinski JR, Saito M, et al. Validação do sistema BactAlert utilizado para controle microbiológico de hemocomponentes no Hemocentro Regional de Londrina [Abstract 750]. Rev Bras Hematol Hemoter. 2009;31(5):291.
  • 6
    Fiebig EW, Busch MP. Infectious disease screening. In: Roback JD. Combs MR. Grossman BJ, Hillyer CD, editors. Technical Manual. 16th ed. Bethesda: AABB; 2008. p. 241-82.
  • 7
    Mendrone AJ. Terapia transfusional no transplante de células-tronco hematopoeticas. In: Voltarelli JC, Pasquini R, Ortega ET. Transplante de células-tronco. São Paulo: Atheneu; 2009. p 653-75.
  • 8
    Rodrigues MC, Almeida DR. Avaliação de análises microbiológicas de hemocomponentes [Abstract 984]. Rev Bras Hematol Hemoter. 2011;33(2):408.
  • 9
    Brasil. Ministério da Saúde. Agência Nacional de VigilânciaSanitária. Resolução RDC n.153, de 14 de junho de 2004. Determina o Regulamento Técnico para os procedimentos hemoterápicos,incluindo a coleta, o processamento, a testagem, o armazenamento, o transporte, o controle de qualidade e o uso humano de sangue, eseus componentes, obtidos do sangue venoso, do cordão umbilical, daplacenta e da medula óssea [Internet]. Brasilia, MS: 2004. [cited 2011 Sept 15]. Available from: http://portal.saude.gov.br/portal/arquivos/pdf/resolucao_153_2004.pdf
    » http://portal.saude.gov.br/portal/arquivos/pdf/resolucao_153_2004.pdf

Publication Dates

  • Publication in this collection
    June 2013

History

  • Received
    28 Jan 2013
  • Accepted
    03 Mar 2013
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