Bacterial contamination of platelets for transfusion: strategies for prevention

Critical Care

Volumn 22, Issue 1, 2018, Pages

  Levy, Jerrold H ^a   Neal, Matthew D ^b   Herman, Jay H ^c  

^a DUKE UNIVERSITY HOSPITAL   (United States)

^b UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^c THOMAS JEFFERSON UNIVERSITY HOSPITAL   (United States)

Author keywords

Bacterial contamination; Bacterial detection; Hemovigilance; Pathogen reduction inactivation; Platelets; Prevention strategies; Septic transfusion reaction (STR); Transfusion; Transfusion transmitted bacterial infection (TTBI)

Indexed keywords

AMOTOSALEN; ANTIBIOTIC AGENT; NUCLEIC ACID; FUROCOUMARIN DERIVATIVE; PHOTOSENSITIZING AGENT;

BACTERIAL GROWTH; BACTERIAL INFECTION; BACTERIUM CONTAMINATION; BACTERIUM CULTURE; BACTERIUM DETECTION; BIOFILM; BLOOD SAFETY; BLOOD TRANSFUSION REACTION; CLINICAL EFFECTIVENESS; CONTROL STRATEGY; DONOR SELECTION; EUROPE; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HUMAN; MORBIDITY; MORTALITY; NONHUMAN; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; SEPTIC TRANSFUSION REACTION; SKIN FLORA; THROMBOCYTE PRESERVATION; THROMBOCYTE TRANSFUSION; THROMBOCYTOPHERESIS; TRANSFUSION TRANSMITTED BACTERIAL INFECTION; ULTRAVIOLET A RADIATION; UNITED STATES; BACTERIAL LOAD; DRUG CONTAMINATION; PREVENTION AND CONTROL; PROCEDURES; STANDARDS; ULTRAVIOLET RADIATION;

BACTERIAL LOAD; DRUG CONTAMINATION; FUROCOUMARINS; HUMANS; PHOTOSENSITIZING AGENTS; PLATELET TRANSFUSION; TRANSFUSION REACTION; ULTRAVIOLET RAYS;

EID: 85055613454     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/s13054-018-2212-9     Document Type: Review

References (70)

1. Bolton-Maggs PH, Cohen H. Serious Hazards of Transfusion (SHOT) haemovigilance and progress is improving transfusion safety. Br J Haematol. 2013;163:303-14.
2. Kleinman S, Reed W, Stassinopoulos A. A patient-oriented risk-benefit analysis of pathogen-inactivated blood components: application to apheresis platelets in the United States. Transfusion. 2013;53:1603-18.
3. Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev. 2005;18:195-204.
4. FDA. In: CBER, editor. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry. Silver Spring: US Food and Drug Administration; 2016.
5. Engele LJ, Straat M, van Rooijen IHM, de Vooght KMK, et al. Transfusion of platelets, but not of red blood cells, is independently associated with nosocomial infections in the critically ill. Ann Intensive Care. 2016;6:67.
6. Lieberman L, Bercovitz RS, Sholapur NS, Heddle NM, Stanworth SJ, Arnold DM. Platelet transfusions for critically ill patients with thrombocytopenia. Blood. 2014;123:1146-51 quiz 1280.
7. Lopez D, Vlamakis H, Kolter R. Biofilms. Cold Spring Harb Perspect Biol. 2010;2:a000398.
8. Eder AF, Dy BA, DeMerse B, Wagner SJ, Stramer SL, O'Neill EM, et al. Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions. Transfusion. 2017;57:2969-76.
9. Aubron C, Flint AW, Bailey M, Pilcher D, Cheng AC, Hegarty C, et al. Is platelet transfusion associated with hospital-acquired infections in critically ill patients? Crit Care. 2017;21:2.
10. AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda: AABB; 2013.
11. 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;127:496-502.
12. Murphy WG, Foley M, Doherty C, Tierney G, Kinsella A, Salami A, et al. Screening platelet concentrates for bacterial contamination: low numbers of bacteria and slow growth in contaminated units mandate an alternative approach to product safety. Vox Sang. 2008;95:13-9.
13. Pearce S, Rowe GP, Field SP. Screening of platelets for bacterial contamination at the Welsh Blood Service. Transfus Med. 2011;21:25-32.
14. Ning S, Barty R, Liu Y, Heddle NM, Rochwerg B, Arnold DM. Platelet Transfusion Practices in the ICU: Data From a Large Transfusion Registry. Chest. 2016;150:516-23.
15. Greinacher A, Selleng S. How I evaluate and treat thrombocytopenia in the intensive care unit patient. Blood. 2016;128:3032-42.
16. Gershman MD, Kennedy DJ, Noble-Wang J, Kim C, Gullion J, Kacica M, et al. Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy. Clin Infect Dis. 2008;47:1372-9.
17. Taleghani BM, Heuft H-G. Hemovigilance. Transfus Med Hemother. 2014;41(3):170-71.
18. Hendrickson JE, Roubinian NH, Chowdhury D, Brambilla D, Murphy EL, Wu Y, et al. Incidence of transfusion reactions: a multicenter study utilizing systematic active surveillance and expert adjudication. Transfusion. 2016;56:2587-96.
19. Rollins MD, Molofsky AB, Nambiar A, Pandey S, Weiskopf RB, Toy P. Two septic transfusion reactions presenting as transfusion-related acute lung injury from a split plateletpheresis unit. Crit Care Med. 2012;40:2488-91.
20. Horth RZ, Jones JM, Kim JJ, Lopansri BK, Ilstrup SJ, Fridey J, et al. Fatal Sepsis Associated with Bacterial Contamination of Platelets - Utah and California, August 2017. MMWR Morb Mortal Wkly Rep. 2018;67:718-22.
21. FDA. Vaccines, Blood & Biologics. 2018 [cited 2018 Sept 8]. Available from: https://www.fda.gov/BiologicsBloodVaccines/default.htm. Accessed 10 Oct 2018.
22. AABB. Standards for Blood Banks and Transfusion Services 31th Edition. Bethesda: AABB; 2018.
23. Grossman BJ, Kollins P, Lau PM, Perreten JL, Bowman RJ, Malcolm S, et al. Screening blood donors for gastrointestinal illness: a strategy to eliminate carriers of Yersinia enterocolitica. Transfusion. 1991;31:500-1.
24. de Korte D, Marcelis JH. Platelet concentrates: reducing the risk of transfusion-transmitted bacterial infections. Int J Clin Transfus Med. 2014;2:29-37.
25. FDA. US Food and Drug Administration. Blood Products Advisory Committee. 104th Meeting. Topic III: Considerations for options to further reduce the risk of bacterial contamination in platelets. US Food and Drug Administration. 2012.
26. Störmer M, Vollmer T. Diagnostic Methods for Platelet Bacteria Screening: Current Status and Developments. Transfus Med Hemother. 2014;41:19-27.
27. Dunne WM Jr, Dunne WM Jr, Case LK, Isgriggs L, Lublin DM. In-house validation of the BACTEC 9240 blood culture system for detection of bacterial contamination in platelet concentrates. Transfusion. 2005;45:1138-42.
28. Mastronardi C, Perkins H, Derksen P, denAdmirant M, Ramírez-Arcos S. Evaluation of the BacT/ALERT 3D system for the implementation of in-house quality control sterility testing at Canadian Blood Services. Clin Chem Lab Med. 2010;48:1179-87.
29. Ramirez-Arcos S, DiFranco C, McIntyre T, Goldman M. Residual risk of bacterial contamination of platelets: six years of experience with sterility testing. Transfusion. 2017;57:2174-81.
30. Thyer J, Perkowska-Guse Z, Ismay SL, Keller AJ, Chan HT, Dennington PM, et al. Bacterial testing of platelets - has it prevented transfusion-transmitted bacterial infections in Australia? Vox Sang. 2018;113:13-20.
31. Kamel H, Townsend M, Bravo M, Vassallo RR. Improved yield of minimal proportional sample volume platelet bacterial culture. Transfusion. 2017;57:2413-9.
32. Greco-Stewart VS, Brown EE, Parr C, Kalab M, Jacobs MR, Yomtovian RA, et al. Serratia marcescens strains implicated in adverse transfusion reactions form biofilms in platelet concentrates and demonstrate reduced detection by automated culture. Vox Sang. 2012;102:212-20.
33. Heaton WA, Good CE, Galloway-Haskins R, Yomtovian RA, Jacobs MR. Evaluation of a rapid colorimetric assay for detection of bacterial contamination in apheresis and pooled random-donor platelet units. Transfusion. 2014;54:1634-41.
34. 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;51:2573-82.
35. Vollmer T, Hinse D, Kleesiek K, Dreier J. The Pan Genera Detection immunoassay: a novel point-of-issue method for detection of bacterial contamination in platelet concentrates. J Clin Microbiol. 2010;48:3475-81.
36. ® Test [Package Insert]. Marlborough: Verax Biomedical; 2017. http://veraxbiomedical.com/wp-content/uploads/2018/01/US-Platelet-PGD-Test.pdf (Accessed 10/10/18).
37. Janssen MP, van der Poel CL, Buskens E, Bonneux L, Bonsel GJ, van Hout BA. Costs and benefits of bacterial culturing and pathogen reduction in the Netherlands. Transfusion. 2006;46:956-65.
38. Li JW, Brecher ME, Jacobson JL, Harm SK, Chen D, El-Gamil A, et al. Addressing the risk of bacterial contamination in platelets: a hospital economic perspective. Transfusion. 2017;57:2321-8.
39. Bell CE, Botteman MF, Gao X, Weissfeld JL, Postma MJ, Pashos CL, et al. Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States. Clin Ther. 2003;25:2464-86.
40. Moeremans K, Warie H, Annemans L. Assessment of the economic value of the INTERCEPT blood system in Belgium. Transfus Med. 2006;16:17-30.
41. Benjamin RJ, Braschler T, Weingand T, Corash LM. Hemovigilance monitoring of platelet septic reactions with effective bacterial protection systems. Transfusion. 2017;57:2946-57.
42. Mundt JM, Rouse L, Van den Bossche J, Goodrich RP. Chemical and biological mechanisms of pathogen reduction technologies. Photochem Photobiol. 2014;90:957-64.
43. Prowse CV. Component pathogen inactivation: a critical review. Vox Sang. 2013;104:183-99.
44. Schlenke P. Pathogen inactivation technologies for cellular blood components: an update. Transfus Med Hemother. 2014;41:309-25.
45. Irsch J, Lin L. Pathogen Inactivation of Platelet and Plasma Blood Components for Transfusion Using the INTERCEPT Blood System. Transfus Med Hemother. 2011;38:19-31.
46. Lin L, Dikeman R, Molini B, Lukehart SA, Lane R, Dupuis K, et al. Photochemical treatment of platelet concentrates with amotosalen and long-wavelength ultraviolet light inactivates a broad spectrum of pathogenic bacteria. Transfusion. 2004;44:1496-504.
47. Lin L, Hanson CV, Alter HJ, Jauvin V, Bernard KA, Murthy KK, et al. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion. 2005;45:580-90.
48. Corash L, Benjamin RJ. The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen-ultraviolet A pathogen reduction treatment model. Transfusion. 2016;56(Suppl 1):S29-38.
49. Lozano M, Knutson F, Tardivel R, Cid J, Maymó RM, Löf H, 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;153:393-401.
50. McCullough J, Vesole DH, Benjamin RJ, Slichter SJ, Pineda A, Snyder E, et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood. 2004;104:1534-41.
51. Knutson F, Osselaer J, Pierelli L, Lozano M, Cid J, Tardivel R, 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;109:343-52.
52. Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez-Plaza I, Liin JS, et al. Clinical safety of platelets photochemically treated with amotosalen-HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion. 2005;45:1864-875.
53. Amato M, Schennach H, Astl M, Chen CY, Lin J-S, Benjamin RJ, et al. Impact of platelet pathogen inactivation on blood component utilization and patient safety in a large Austrian Regional Medical Centre. Vox Sang. 2017;112:47-55.
54. Marschner S, Goodrich R. Pathogen reduction technology treatment of platelets, plasma and whole blood using riboflavin and UV light. Transfus Med Hemother. 2011;38:8-18.
55. Goodrich RP, Gilmour D, Hovenga N, Keil SD. A laboratory comparison of pathogen reduction technology treatment and culture of platelet products for addressing bacterial contamination concerns. Transfusion. 2009;49:1205-16.
56. Taha M, Culibrk B, Kalab M, Schubert P, Yi QL, Goodrich R, et al. Efficiency of riboflavin and ultraviolet light treatment against high levels of biofilm-derived Staphylococcus epidermidis in buffy coat platelet concentrates. Vox Sang. 2017;112:408-16.
57. Perez-Pujol S, Tonda R, Lozano M, Fuste B, Lopez-Vilchez I, Galan AM, et al. Effects of a new pathogen-reduction technology (Mirasol PRT) on functional aspects of platelet concentrates. Transfusion. 2005;45:911-9.
58. Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology. Transfusion. 2010;50:2362-75.
59. Ignatova AA, Karpova OV, Trakhtman PE, Rumiantsev SA, Panteleev MA. Functional characteristics and clinical effectiveness of platelet concentrates treated with riboflavin and ultraviolet light in plasma and in platelet additive solution. Vox Sang. 2016;110:244-52.
60. Johnson L, Marks D. Treatment of platelet concentrates with the Mirasol pathogen inactivation system modulates platelet oxidative stress and NF-kappaB activation. Transfus Med Hemother. 2015;42:167-73.
61. Seltsam A, Muller TH. UVC Irradiation for Pathogen Reduction of Platelet Concentrates and Plasma. Transfus Med Hemother. 2011;38:43-54.
62. Mohr H, Steil L, Gravemann U, Thiele T, Hammer E, Greinacher A, et al. A novel approach to pathogen reduction in platelet concentrates using short-wave ultraviolet light. Transfusion. 2009;49:2612-24.
63. Faddy HM, Faddy HM, Fryk JJ, Prow NA, Watterson D, Young PR, Hall RA, et al. Inactivation of dengue, chikungunya, and Ross River viruses in platelet concentrates after treatment with ultraviolet C light. Transfusion. 2016;56(6 Pt 2):1548-55.
64. Sandgren P, Tolksdorf F, Struff WG, Gulliksson H. In vitro effects on platelets irradiated with short-wave ultraviolet light without any additional photoactive reagent using the THERAFLEX UV-Platelets method. Vox Sang. 2011;101:35-43.
65. Thiele T, Pohler P, Kohlmann T, Sümnig A, Aurich K, Selleng K, et al. Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction - a phase I clinical trial. Vox Sang. 2015;109:44-51.
66. AABB. AABB. Response to docket No. FDA-2014-D-1814 "Bacterial detection testing by blood and blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion". 2015 [cited December 2017 20 April]. Available from: http://www.aabb.org/advocacy/comments/Documents/comments150309.pdf. Accessed 10 Oct 2018.
67. Snyder EL, Stramer SL, Benjamin RJ. The safety of the blood supply - time to raise the bar. N Engl J Med. 2015;372:1882-5.
68. Drew VJ, Barro L, Seghatchian J, Burnouf T. Towards pathogen inactivation of red blood cells and whole blood targeting viral DNA/RNA: design, technologies, and future prospects for developing countries. Blood Transfus. 2017;15:512-21.
69. Giordano K. Pathogen-reduced (PR) cryoprecipitate stored for five days post thaw: apheresis source plasma yields more fibrinogen. SCA 39th Annual Meeting & Workshops, April 22-26 2017 [cited December 2017]. Available from: http://sca.planion.com/Web.User/AbstractDet?ACCOUNT=SCA&ABSID=20927&CONF=AM17&ssoOverride=OFF&CKEY. Accessed 10 Oct 2018.
70. Spindler-Raffel E, Benjamin RJ, CP MD, Ramirez-Arcos S, Aplin K, Bekeredjian-Ding I, et al. Enlargement of the WHO international repository for platelet transfusion-relevant bacteria reference strains. Vox Sang. 2017;112:713-22.