Microbiological Screening of Platelet Concentrates in Europe

Prax, Marcel; Bekeredjian‐Ding, Isabelle; Krut, Oleg

doi:10.1159/000499349

Cited by 36 publications

(45 citation statements)

References 57 publications

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“…7 Bacterial load can be minimized or prevented from entering the blood collection bag by careful skin preparation with disinfectant and diversion of initial blood flow. 8,9 Contaminated units can be detected by screening PC samples by culture methods [10][11][12][13] and by visually inspecting components, or by rapid tests immediately before transfusion. 14,15 The bacterial load can be reduced using pathogen reduction techniques that have been developed and introduced in some countries as an ultimate solution to this issue.…”

Section: Discussionmentioning

confidence: 99%

Platelet safety strategies in Japan: impact of short shelf life on the incidence of septic reactions

et al. 2020

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BACKGROUND Transfusion‐transmitted bacterial infections (TTBIs) often have serious consequences for patients. The Japanese Red Cross (JRC) has not implemented culture screening for platelet concentrate (PC), but it has maintained a shelf life of 85 hours for PC. STUDY DESIGN AND METHODS The JRC collected reports of suspected TTBI and investigated causal relationships using PC samples and patient blood samples. PCs showing apparent abnormalities were retrieved and cultured and analyzed for bacterial growth. RESULTS The JRC analyzed 86 samples available from 135 transfused PCs with suspected TTBIs that were collected over the past 12 years; 17 (19.8%) were culture‐positive. One, 6, and 10 TTBIs developed in patients on Days 1, 2, and 3 after PC collection, respectively. Assuming that PC is transfused on the day of issue, the TTBI risk was fourfold higher on Day 3 than on Day 2, after adjusting the TTBI incidence for the number of PCs issued per day. Compared with the model of issuing all PCs on Day 3, issuing PCs with the current distribution of storage time could have decreased the TTBI incidence by 56%. During the past 8 years, the JRC retrieved 960 PC units because of apparent abnormalities, 2.8% of which were culture‐positive. CONCLUSION The short shelf life of PC is associated with a low incidence of reported TTBIs, more than half of which occurred on Day 3 relative to earlier time points. Visual inspection of PC before transfusion is crucial in detecting bacterially contaminated PC despite its low positive predictive value.

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Section: Discussionmentioning

confidence: 99%

Platelet safety strategies in Japan: impact of short shelf life on the incidence of septic reactions

et al. 2020

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“…Nevertheless, two septic transfusion reactions were observed over a period of 15 years, one with BC-PC and one with apheresis PC, 13 both after 4 days of storage. An overview of different approaches on precaution measures to mitigate the risk of bacterial transmission in Europe is given by Prax et al 14 regarding several aspects such as the shelf life of PLTs, time of sampling, and the applied control measures. The analysis revealed a broad heterogeneity of procedures.…”

Section: Discussionmentioning

confidence: 99%

Pathogen reduction of double‐dose platelet concentrates from pools of eight buffy coats: Product quality, safety, and economic aspects

2020

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Background Pathogen reduction (PR) of platelet concentrates (PCs) contributes to the safety of platelet (PLT) transfusion by reducing the risk of transfusion‐transmitted infections and transfusion‐associated graft‐versus‐host disease. In vitro quality of pathogen‐reduced double‐dose PC (PR‐PC) made of eight whole blood (WB)‐derived buffy coats (BCs) were evaluated. Methods Eight small‐volume WB BCs from donors with at least 200 × 109 PLT/L were pooled with an additive solution to produce double‐dose PCs (DD‐PCs), which were treated with amotosalen/ultraviolet A light in a dual storage processing set, yielding 2 units of PR‐PC. Quality controls were undertaken as per European Directive for the Quality of Medicines (EDQM) guidelines. PLT recovery rates were measured. Production costs and savings were compared over the 3 years before and after PR implementation. Results In the pre‐PR period, 19 666 PCs were produced, compared to 17 307 PCs in the PR period. Single BC in the PR period had 41 ± 2 mL, hematocrit 0.39 ± 0.04 and 1.06 ± 0.18 × 1011 PLTs, and showed a recovery of 91% ± 8%. After pooling, separation, PR treatment of DD‐PC, and splitting, each single PC had 189 ± 6 mL with 2.52 ± 0.34 × 1011 PLTs, compared to 2.48 ± 0.40 in the pre‐PR period. The PLT recovery rate after PR was 87% ± 14%. EDQM requirements were met. An increase of about €12 (+7.5%) per PC from the pre‐PR to the PR period was identified. Conclusion A new production method resulting in two PR‐PCs made from pools of 8 BCs with use of one PR set was successfully introduced, and our experience of nearly 3 years demonstrated the high efficacy and in vitro quality of the PR‐PCs obtained.

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“…Bacterial contamination rates in platelet concentrates from healthy donors reportedly range from 0.01 to 0.2% . The frequency of positive culture tests that failed in confirmation testing is usually higher, i.e., 0.11 to 0.72% .…”

Section: Discussionmentioning

confidence: 99%

Bacterial contamination rates in extracorporeal photopheresis

et al. 2020

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BACKGROUND Extracorporeal photopheresis (ECP) is an immunosuppressive treatment that involves leukocyte apheresis, psoralen and UV light treatment, and subsequent reinfusion. Patients treated with ECP are usually immunosuppressed. Bacterial contamination therefore poses a much unwanted risk, but incidence data are lacking. PATIENTS AND METHODS We screened all 1922 consecutive ECP procedures scheduled within a roughly 3‐year period for eligibility. Those with missing data on ECP method (inline or offline) or type of venous access (peripheral or central) were excluded. ECPs with complete aerobic and anaerobic microbial testing of baseline patient blood samples (n = 1637) and of ECP cell concentrates (n = 1814) were included in the analysis. RESULTS A test for microbial contamination was positive for 1.82% of the cell concentrates, with central venous access was the most significant risk factor for the contamination (odds ratio = 19). Patient blood samples were positive in 3.85% of cases, but no patients became septic. Staphylococcus spp. were most abundant, and products with bacterial contamination did not cause side effects after reinfusion. There were no significant differences in contamination rates between inline and offline ECP. CONCLUSION These findings stress the importance of sterile procedures and the benefits of using peripheral over central venous access for reducing the risk of bacterial contamination in ECP.

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Microbiological Screening of Platelet Concentrates in Europe

Cited by 36 publications

References 57 publications

Platelet safety strategies in Japan: impact of short shelf life on the incidence of septic reactions

Platelet safety strategies in Japan: impact of short shelf life on the incidence of septic reactions

Pathogen reduction of double‐dose platelet concentrates from pools of eight buffy coats: Product quality, safety, and economic aspects

Bacterial contamination rates in extracorporeal photopheresis

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