Bacterial contamination of platelet concentrates prepared by different methods: results of standardized sterility testing in Germany

Walther-Wenke, G.; Doerner, Rita; Montag, Thomas W.; Greiss, O.; Hornei, B.; Knels, Ralf; Strobel, Jürgen; Volkers, Peter; Däubener, Walter

doi:10.1111/j.1423-0410.2006.00753.x

Cited by 32 publications

(19 citation statements)

References 17 publications

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“…Transfusion associated sepsis cases are encountered occasionally and bacterial transmission remains the major cause of acute morbidity and mortality following post transfusion infection [1][2][3][4]. Bacterial contamination of platelet products is generally the most frequent infectious risk associated with transfusion [5][6][7][8]. Possible mechanisms of bacterial contamination of blood components include donor bacteremia, contamination during the whole blood collection procedure, contamination of the collection pack or contamination during the blood processing procedure [3,4,9].…”

Section: Introductionmentioning

confidence: 99%

Impact of Donor Arm Cleaning with Different Aseptic Solutions for Prevention of Contamination in Blood Bags

Patel

Shukla

Gupte

2012

Indian J Hematol Blood Transfus

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Transfusion associated sepsis cases are encountered occasionally and bacterial transmission remains the major cause. The goal of our study was to compare the efficacy of disinfectants in phlebotomy site preparation. After selection of donor the antecubital fossa area of the arm was disinfected with different types of disinfectants namely sprit (70% isopropyl alcohol), povidone iodine (0.5% w/v available iodine in distilled water), savlon (1.5% v/v chlorhexidine gluconate solution and 3.0% cetrimide solution) and combination of sprit and povidone iodine. Swabs were collected from 20 donors using a sterile forceps, after cleaning with different antiseptic solutions. Swab was streaked on blood agar plate aseptically and the plate was incubated at 37°C for 24 h. Colonies were counted and a single colony was recultured by growing on nutrient and Mac-Conkey agar. The biochemical characteristics were determined by performing Gram staining, Motility, Catalase and Oxidase tests. The mean values of colonies were significantly higher with savlon compared to other three solutions. The difference was statistically significant by ''t'' test (t values 1.7-3.0; P \ 0.05). Staphylococcus epidermidis, Staphylococcus sp., Streptococcus sp., Micrococcus sp., Bacillus megaterium and Bacillus cereus were the organisms identified. After completion of bleeding, samples from the bag were aseptically inoculated in aerobic and anaerobic culture bottles to be tested on BacT/Alert system. The bag containing donor's blood did not show any contamination when three cleanings were carried out using sprit, povidone iodine and spirit respectively.

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Section: Introductionmentioning

confidence: 99%

Impact of Donor Arm Cleaning with Different Aseptic Solutions for Prevention of Contamination in Blood Bags

Patel

Shukla

Gupte

2012

Indian J Hematol Blood Transfus

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“…This was true in the recent past as demonstrated by a report that presented results from a 1998 through 2001 survey in Germany with bacterial contamination rates of 0.60% for pooled platelet concentrates (P-PCs) prepared from 4 whole blood-derived buffy coats (BC) versus 0.18% for apheresis-derived SD PCs (A-PCs) [1]. However, a number of technical developments as well as recent scientific findings are currently undermining the preference of SD A-PC components.…”

Section: Introductionmentioning

confidence: 77%

A General Change of the Platelet Transfusion Policy from Apheresis Platelet Concentrates to Pooled Platelet Concentrates is Associated with a Sharp Increase in Donor Exposure and Infection Rates

Heuft¹,

Mende²,

Blasczyk³

2008

Transfus Med Hemother

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Background: We compare the actual with the potential donor exposure and possible infection rates in the Hanover Medical School (MHH) platelet (PLT) transfusion recipients if the current MHH standard of apheresis PLT concentrate (A-PC) supply would be replaced by a pooled PLT concentrate (P-PC) transfusion regimen. Donors, Patients, and Methods: The electronic records of the MHH Institute of Transfusion Medicine and the MHH Department of Medical Controlling were evaluated to assess the development of PLT needs and supply at MHH from 2003–2006. For 2006, we evaluated all PLT transfusion recipients with respect to their overall transfusion needs, classified them for low and high PLT transfusion needs, and related them to the diagnostic groups that underlie their PLT demands. We assumed a P-PC preparation procedure using 4 whole blood-derived buffy coats for all calculations for potential donor exposure. To predict the possible infection rates of an unrecognized viral infection with low prevalence in the general population to A-PC or to P-PC recipients and the influence of neutralizing agent specific antibodies (NAB), we established a mathematical contamination/ infection model based on the current PLT transfusion mode and data about GBV-C virus infection among Hanover blood donors. Results: From 2003 to 2006, the 1,300–1,400 persons comprising MHH apheresis donor pool covered a 36% increase in PC transfusions. The exclusive use of P-PCs instead of A-PC would require a total of 36,240–49,276 whole blood donations to meet MHH demands, corresponding to a more than 1 log step increase in donor exposure. For individual hematological patients, the change to P-PCs would imply an 80–125%, for individual surgical patients a 40–50% higher donor exposure. Our infection model revealed an approximately 4 times higher infection. Conclusions: A change to P-PC would imply a more than one log step higher donor exposure, and an unrecognized infection with a prevalence around 1% leads to an up to 4 times higher infection rate. A general change in the PC transfusion policy that favors P-PCs is dangerous and must be avoided.

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“…A further element of safety is sterility testing of a certain share of the produced blood components. In Germany, as a result of these efforts, comparably low contamination rates could be shown [33]. One concept currently followed is complete sterility release testing of platelet concentrates and releasing them as 'sterile-to-date' [34].…”

Section: Challenges and Solutionsmentioning

confidence: 99%

Quality and Safety in Blood Supply in 2010

Seitz

Heiden²

2010

Transfus Med Hemother

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The past two decades saw tremendous achievements in blood safety, which are due to the commitment of blood establishments and industry, progress in technology such as the improvement of serological and NAT screening tests, and stringent regulatory control. Milestones in the legislation were the inclusion of plasma derivatives in the pharmaceutical legislation of the European Community (EC) in the year 1989 and special laws for the blood sector in EC and in member states, such as the Transfusionsgesetz (Transfusion Law) in Germany. The legal frame has to be supplemented by scientific and technical guidance, which is provided on the European level by the European Directorate for the Quality of Medicines and Health Care and by the European Medicines Agency. In the member states, guidelines taking into account the national peculiarities can be elaborated, such as the German hemotherapy guidelines issued by the German Medical Association (BundesÄrztekammer) in agreement with the Paul-Ehrlich-Institut. The regulatory control of screening tests, and the introduction of NAT testing lead to a remarkably high degree of safety concerning the most relevant viruses HIV, HBV and HCV. Issues needing further attention are bacterial contamination and transfusion-associated acute lung injury (TRALI). Measures aiming at minimizing risks have to be balanced against their impact on supply. In order to ensure the assured supply with safe blood products, sustained efforts and research are needed as well as a continuous dialogue among blood services, industry, physicians, patients and regulatory authorities.

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Bacterial contamination of platelet concentrates prepared by different methods: results of standardized sterility testing in Germany

Cited by 32 publications

References 17 publications

Impact of Donor Arm Cleaning with Different Aseptic Solutions for Prevention of Contamination in Blood Bags

Impact of Donor Arm Cleaning with Different Aseptic Solutions for Prevention of Contamination in Blood Bags

A General Change of the Platelet Transfusion Policy from Apheresis Platelet Concentrates to Pooled Platelet Concentrates is Associated with a Sharp Increase in Donor Exposure and Infection Rates

Quality and Safety in Blood Supply in 2010

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