Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

Blood Advances

Volumn 1, Issue 15, 2017, Pages 1142-1147

  Sachais, Bruce S ^a   Paradiso, Sarai ^a   Strauss, Donna ^a   Shaz, Beth H ^a  

^a NEW YORK BLOOD CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85048103395     PISSN: 24739529     EISSN: 24739537     Source Type: Journal    
DOI: 10.1182/bloodadvances.2017008334     Document Type: Letter

References (27)

1. Food and Drug Administration. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. https://www.fda.gov/downloads/Guidances/Blood/UCM425952.pdf. Accessed 12 June 2017.
2. Shaz BH, Hillyer CD, Mikhail R, Abrams CS, eds. Transfusion Medicine and Hemostasis: Clinical and Laboratory Aspects. 2nd ed. Oxford, UK: Elsevier; 2013.
3. Bravo M, Shaz BH, Kamel H, et al. Detection of bacterial contamination in apheresis platelets: is apheresis technology a factor? Transfusion. 2015;55(9):2113-2122.
4. Hong H, Xiao W, Lazarus HM, Good CE, Maitta RW, Jacobs MR. Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance. Blood. 2016;127(4):496-502.
5. Advisory Committee on the Safety of Blood, Tissues and Organs. Pathogen inactivation of platelets: report of the SABTO working group. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/324354/SaBTO_platelets_report.pdf. Accessed 12 June 2017.
6. Jacobs MR, Smith D, Heaton WA, Zantek ND, Good CE; PGD Study Group. Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test. Transfusion. 2011;51(12):2573-2582.
7. Food and Drug Administration. Fatalities reported to FDA following blood collection and transfusion: annual summary for fiscal year 2015. https://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/UCM518148.pdf. Accessed 12 June 2017.
8. Whitaker BI, Rajbhandary S, Harris A. The 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey Report. http://www.aabb.org/research/hemovigilance/bloodsurvey/Docs/2013-AABB-Blood-Survey-Report.pdf. Accessed 12 June 2017.
9. McDonald C, Allen J, Brailsford S, et al. Bacterial screening of platelet components by National Health Service Blood and Transplant, an effective risk reduction measure. Transfusion. 2017;57(5):1122-1131.
10. Whitaker B, Rajbhandary S, Kleinman S, Harris A, Kamani N. Trends in United States blood collection and transfusion: results from the 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey. Transfusion. 2016;56(9):2173-2183.
11. Triulzi DJ, Assmann SF, Strauss RG, et al. The impact of platelet transfusion characteristics on posttransfusion platelet increments and clinical bleeding in patients with hypoproliferative thrombocytopenia. Blood. 2012;119(23):5553-5562.
12. Knutson F, Osselaer J, Pierelli L, et al. A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment. Vox Sang. 2015;109(4):343-352.
13. Nussbaumer W, Amato M, Schennach H, et al. Patient outcomes and amotosalen/UVA-treated platelet utilization in massively transfused patients. Vox Sang. 2017;112(3):249-256.
14. Lozano M, Knutson F, Tardivel R, et al. A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion. Br J Haematol. 2011;153(3):393-401.
15. Vamvakas EC. Meta-analysis of the randomized controlled trials of the hemostatic efficacy and capacity of pathogen-reduced platelets. Transfusion. 2011;51(5):1058-1071.
16. Rebulla P, Vaglio S, Beccaria F, et al. Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies. Transfusion. 2017;57(5):1171-1183.
17. Butler C, Doree C, Estcourt LJ, et al. Pathogen-reduced platelets for the prevention of bleeding. Cochrane Database Syst Rev. 2013; (3): CD009072.
18. Dunbar NM, Dumont LJ, Szczepiorkowski ZM. How do we implement day 6 and day 7 platelets at a hospital-based transfusion service? Transfusion. 2016;56(6):1262-1266.
19. Ypma PF, van der Meer PF, Heddle NM, et al; PREPAReS Study Group. A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial. BMJ Open. 2016;6(1):e010156.
20. Yazer MH, Triulzi DJ. Anti-D alloimmunization propensity cannot be determined without information on D antigen exposure. Transfusion. 2012;52(9):2069-2070, author reply 2070.
21. Gerber B, Alberio L, Rochat S, et al. Safety and efficacy of cryopreserved autologous platelet concentrates in HLA-alloimmunized patients with hematologic malignancies. Transfusion. 2016;56(10):2426-2437.
22. Cap AP, Perkins JG. Lyophilized platelets: challenges and opportunities. J Trauma. 2011;70(5 Suppl):S59-S60.
23. Pidcoke HF, Cap AP. Refrigerated platelets for the treatment of acute bleeding: a review of the literature and reexamination of current standards [reply]. Shock. 2015;43(3):298-299.
24. Getz TM, Montgomery RK, Bynum JA, Aden JK, Pidcoke HF, Cap AP. Storage of platelets at 4°C in platelet additive solutions prevents aggregate formation and preserves platelet functional responses. Transfusion. 2016;56(6):1320-1328.
25. Vollmer T, Knabbe C, Geilenkeuser WJ, Schmidt M, Dreier J. Bench test for the detection of bacterial contamination in platelet concentrates using rapid and cultural detection methods with a standardized proficiency panel. Transfus Med Hemother. 2015;42(4):220-225.
26. Dreier J, Vollmer T, Kleesiek K. Novel flow cytometry-based screening for bacterial contamination of donor platelet preparations compared with other rapid screening methods. Clin Chem. 2009;55(8): 1492-1502.
27. Müller B, Walther-Wenke G, Kalus M, et al. Routine bacterial screening of platelet concentrates by flow cytometry and its impact on product safety and supply. Vox Sang. 2015;108(3):209-218.