Platelet bacterial contamination: assessing progress and identifying quandaries in a rapidly evolving field
2007; Wiley; Volume: 47; Issue: 8 Linguagem: Inglês
10.1111/j.1537-2995.2007.01402.x
ISSN1537-2995
AutoresRoslyn Yomtovían, Peter Tomasulo, Michael R. Jacobs,
Tópico(s)Blood groups and transfusion
ResumoTransfusionVolume 47, Issue 8 p. 1340-1346 Free Access Platelet bacterial contamination: assessing progress and identifying quandaries in a rapidly evolving field Roslyn Yomtovian MD, Roslyn Yomtovian MD Department of PathologyCase Western Reserve UniversitySchool of MedicineCleveland, OhioSearch for more papers by this authorPeter Tomasulo MD, Peter Tomasulo MD Blood Systems, Inc.Scottsdale, ArizonaSearch for more papers by this authorMichael R. Jacobs MD, PhD, Michael R. Jacobs MD, PhD Department of PathologyCase Western Reserve UniversitySchool of Medicine andUniversity Hospitals Case Medical CenterCleveland, Ohioe-mail: mrj6@cwru.eduSearch for more papers by this author Roslyn Yomtovian MD, Roslyn Yomtovian MD Department of PathologyCase Western Reserve UniversitySchool of MedicineCleveland, OhioSearch for more papers by this authorPeter Tomasulo MD, Peter Tomasulo MD Blood Systems, Inc.Scottsdale, ArizonaSearch for more papers by this authorMichael R. Jacobs MD, PhD, Michael R. Jacobs MD, PhD Department of PathologyCase Western Reserve UniversitySchool of Medicine andUniversity Hospitals Case Medical CenterCleveland, Ohioe-mail: mrj6@cwru.eduSearch for more papers by this author First published: 25 July 2007 https://doi.org/10.1111/j.1537-2995.2007.01402.xCitations: 12AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Bacterial contamination of blood is the oldest transfusion-transmitted infectious complication, but it still remains a problem, especially with platelets (PLTs).1 With the recommendation in 2002 by the College of American Pathologists that a method be introduced to detect bacterial contamination of PLTs,2 and later with the AABB requirement, beginning March 1, 2004, that methods be introduced to both reduce and detect the presence of bacterial PLT contamination,3 it was hoped that this complication would finally be greatly reduced if not eliminated. It is appropriate now, with several recent publications in TRANSFUSION,4-7 to assess our progress, determine the current incidence of septic complications with modern techniques in place, identify remaining quandaries (Table 1), and evaluate interim strategies to further understand and reduce the risk of PLT bacterial contamination. Two of these articles in the current issue of TRANSFUSION attempt to influence our opinions on the limitations of current PLT bacterial contamination testing.4, 5 Regarding culture detection, the article by Brecher and Hay4 advocates the routine use of an anaerobic culture bottle in addition to an aerobic bottle to both increase the sensitivity of detection and capture potentially clinically significant anaerobic organisms. Regarding increasing the room temperature shelf life of culture-tested apheresis PLTs from 5 to 7 days, the article by Benjamin and Wagner5 cautions about the possibility of an increased rate of PLT bacterial contamination and sepsis from these older PLTs and advocates an additional strategy to reduce the risk of contamination, such as an at-issue test when using 7-day-stored PLTs or utilization of pathogen inactivation technology. In keeping with these themes, a third article in the current issue of TRANSFUSION,6 with an accompanying editorial,8 describes and discusses the potential application of pathogen inactivation technology to eradicate PLT bacterial contamination. Finally, an article in the previous issue of TRANSFUSION presents important information from the American Red Cross providing data on the incidence of bacterial contamination of apheresis PLT collections after implementation throughout their system of methods to both reduce, by appropriate use of skin cleansing and diversion technology, and detect, by application of an early aerobic culture, bacterial contamination of PLTs.7 Table 1. Quandaries and challenges of platelet bacterial contamination management in 2007 Closing the gap in safety between apheresis PLTs and RDPs Defining the residual incidence of PLT bacterial contamination in PLTs with a modern skin preparation, diversion pouch on the draw line, and culture sampling by the collection facility and by quantitative culture at the time of issue Assessing whether the utilization of a point-of-issue assay performed by the hospital transfusion service while preparing the PLTs for transfusion is clinically efficacious and cost-effective either as a stand-alone test or in addition to early culturing Defining the utility and the cost-effectiveness of mandating use of an anaerobic as well as an aerobic BacT/ALERT culture bottle Defining the optimal volume to provide most cost-effective detection of PLT bacterial contamination by early culture Determining whether a pathogen inactivation strategy is safe, efficacious, and cost-effective in the eradication of PLT bacterial contamination To understand our progress in reducing the risk of PLT bacterial contamination and to comment on the need for additional strategies, as advocated by Brecher and Hay and Benjamin and Wagner,4, 5 it is important to first define, as best as possible, the magnitude and significance of the problem of PLT bacterial contamination before the promulgation of the new accreditation requirements. Although the exact incidence has always been difficult to define because of variability in detection methods, reliance on passive surveillance, and differences in interpreting a positive result, a range of estimates is possible.9 Based on 2004 data, the latest available on PLT utilization, nearly 3 million PLT units were transfused in the United States in the form of 1.4 million single-donor apheresis PLT (SDP) units and 1.5 million random-donor PLT (RDP) units, the latter administered in an estimated 0.26 to 0.38 million pools of 4 to 6 units.10 If it is assumed, before the implementation of the new accreditation requirements, that an estimated 1:1000 to 1:3000 units were bacterially contaminated,9, 11, 12 then 967 to 2900 PLT units and 553 to 1780 PLT transfusions per year in the United States were bacterially contaminated during the period when no testing or uniform measures to reduce contamination were performed. Projected fatalities per year from these contaminated PLTs vary from 8 (based on BaCon study)13 to up to 40 (based on a fatality rate of 1% of contaminated units).9 There were 60 deaths reported to the FDA from 1995 to 2004 (6 per year),1 reflecting the low end of the spectrum and similar to the BaCon estimates. The specific organisms involved in fatalities reported to the FDA were as follows: 33 Enterobacteriacea (including 9 Escherichia coli and 11 Klebsiella sp.); 15 staphylococci (11 coagulase-negative staphylococci and 4 Staphylococcus aureus); 5 streptococci and/or enterococci; 2 Pseudomonas aeruginosa; 1 Clostridium perfringens (the only strict anaerobe in the series); and 4 other aerobic and/or facultative organisms. It is noteworthy that two-thirds of the fatalities in the FDA series are related to bacteria not typical of skin flora, a point to which we will return in our discussion of the application and utility of diversion as a strategy to reduce PLT bacterial contamination. It is particularly important to emphasize that the BaCon Study,13 the FDA report,1 and the most recent American Red Cross analysis7 are based on identification of clinical contamination through passive surveillance—the concurrent linkage of clinical signs and symptoms of sepsis to a bacterially contaminated PLT. Because clinical signs and symptoms suggestive of PLT bacterial contamination are often missed,11 it is likely that these reports all underestimate the morbidity and mortality associated with transfusion of bacterially contaminated PLTs. Thus, to understand the clinical impact of PLT bacterial contamination, it would be necessary to perform surveillance cultures at the time of PLT issue. In one such analysis at the institution of two of the authors of this editorial over a period of 15 years, 13 transfusion reactions were associated with the transfusion of 32 bacterially contaminated PLT units identified by at issue culture surveillance.14 Only 3 of these reactions, however, were clinically identified before receipt of the information by the clinical team that the transfused units were bacterially contaminated, emphasizing the important role of surveillance cultures at time of issue in providing the most accurate information regarding the incidence of PLT bacterial contamination. What then has been the impact of the new accreditation requirements2, 15 that require methods to both reduce and detect PLT bacterial contamination and what issues and concerns remain? The most important information detailing the impact of the these new requirements is that provided in the report of Eder and coworkers,7 which examines the systemwide American Red Cross experience from March 1, 2004, to May 31, 2006, based on BacT/ALERT (bioMérieux, St Louis, MO) aerobic cultures procured on more than 1 million apheresis PLTs 24 hours after collection and incubated for 12 hours before release. Using the definitions promulgated by the AABB16 and summarized in Table 2, the authors report 186 confirmed-positive cultures for a rate of 1:5399 collections. They note that with the use of a 12-hour hold before release, they interdicted all but one of these PLTs and associated components before transfusion. They also note a significant difference in the rate of bacterial contamination of apheresis PLTs collected with dual-needle systems that lacked diversion pouches on the inlet line (1:4411) compared to the single-needle collections with an appropriately placed diversion pouch (1:8405). These data highlight the important role of diversion technology in reducing the rate of contamination, as has previously been documented.17-20 The effect of diversion, however, is limited to organisms resident on the skin, most notably coagulase negative staphylococci.18 There was no statistically significant difference in the rate of contamination of nonskin contaminants related to diversion in this report, and thus most of the fatalities reported to the FDA, noted above, likely would not have been impacted by diversion technology, although they may have been detected by bacterial culture. Table 2. AABB test result criteria for bacterially contaminated PLTs with use of BacT/ALERT culture system3 Definition BacT/ALERT test result Culture on product Transfusion reaction Initial positive True positive Positive Positive OR Posttransfusion sepsis False positive Positive Negative AND No sepsis Indeterminate Positive Not done Transfused product False negative Negative Positive IF Sepsis, same organism Indeterminate Negative Not available Posttransfusion sepsis True negative Negative Negative Posttransfusion sepsis In addition to assessing rates of bacterial contamination in apheresis PLT collections and the interdiction of contaminated PLTs with a combination of early culture and diversion technology, Eder and colleagues7 also report on their experience with the occurrence of septic PLT transfusion reactions in PLTs undergoing culture screening for bacterial contamination. They note a significantly higher rate of definite and probable septic reactions (1:41,173) with products collected using double-needle collection kits, which lacked diversion pouches on the inlet line, compared to using single-needle collection kits (1:193,305), which had diversion pouches on the draw line; all three deaths were associated with the double-needle kits without a diversion pouch on the inlet line. These data may provide the first documentation of the benefits of a diversion pouch in reducing septic reactions in the postbacterial detection era. The data discussed above reinforce the importance of a properly placed diversion pouch in combination with culture to significantly reduce the clinical impact of PLT bacterial contamination, but are these strategies sufficient to lay the problem of PLT bacterial contamination to rest? And what issues and concerns do these data continue to highlight? What increment in safety can we expect, and at what cost, from using an anaerobic bottle? What increment in safety can we expect from adding a bacterial detection test at the time of PLT transfusion? It is difficult to answer these questions definitively because all our data concerning PLT units collected with a kit utilizing a proper diversion pouch and taking advantage of modern bacterial detection techniques are based on passive surveillance and are likely to underestimate the true remaining risk. Nevertheless, some estimate of the residual risk when modern procedures are in place is necessary to evaluate future interventions. We can achieve this by comparing the rates of septic transfusion reactions and fatalities based on passive surveillance before and after culture techniques were introduced. The report by Eder and coworkers7 of the ARC experience describes 386,611 collections with a kit with a diversion pouch on the draw line. There were three septic reactions from two of these collections resulting in a reaction rate of 1 in 193,305 collections. Blood Systems, Inc., has had 1 probable septic reaction from 209,654 collections tested with aerobic BacT/ALERT culture since 2003 (anaerobic cultures were added in late 2006 with most centers converting in January 2007; S. Vanderpool, Blood Systems, Inc., 2007, personal communication). Ninety-five percent (100% since June of 2006) of these collections utilized kits with diversion pouches on the draw line, and the rate of septic reactions was similar to that of the ARC with proper diversion pouch placement. In addition, the New York Blood Center has tested 150,241 apheresis PLT collections with aerobic BacT/ALERT cultures (anaerobic cultures were added in mid-2006) utilizing a kit with a draw line diversion pouch on about 100,000 of these collections (diversion pouch was used on all collections from October 2005), with no reports of septic transfusion reactions (D. Strauss, New York Blood Center, 2007, personal communication). If we sum the experience from these three organizations collecting apheresis PLTs, the rate of passively reported septic PLT transfusion reactions is approximately 1 in 230,000 collections, compared to approximately 1:40,000 reported by the ARC in a 10-month period in 2003.21 Although this calculation is pertinent and objective, it is limited by reliance on passive surveillance. Active surveillance has demonstrated significantly higher rates of septic reactions than seen with passive surveillance, but the active surveillance data sets are small and most were performed before utilization of bacterial screening and proper diversion pouches.12, 14 In addition, data on duration of storage before transfusion are not always included in published series. A limitation of the data from Eder and colleagues7 because it is based on passive surveillance is that it certainly represents an underestimate of the problem of clinically significant PLT bacterial contamination because it misses an unknown number of PLTs with false-negative culture results in which clinical sequelae occur but are not recognized as associated with the PLT transfusion. Because PLTs at greatest risk for transfusion-associated sepsis have the longest storage age, it is possible, and indeed likely, as Benjamin and Wagner5 note, that the increase in allowable storage of PLTs from 5 to 7 days will result in an increase in transfusion-associated sepsis. Several investigators have shown a strong correlation between PLT storage age and the occurrence and severity of transfusion-associated sepsis.1, 5, 12, 22, 23 In fact, the very first initiative in the United States in dealing with the problem of PLT bacterial contamination occurred because of the recognition by the FDA BPAC that the prolongation of room temperature storage of PLTs to 7 days was associated with increased incidence of PLT transfusion-associated bacterial sepsis.24 Although this risk was not quantified, the FDA BPAC nonetheless recommended in 1986 that PLTs, whose storage time had increased to 7 days only 3 years earlier, now be rolled back to 5 days.25 Although it was noted during its deliberations that significant risk was likely present with 5-day PLTs as well, a compromise decision balancing improved safety with adequate availability was made. Soon thereafter, the blood bank at Johns Hopkins voluntarily rolled back their PLT storage time to 4 days because of data from their institution showing a five times higher risk of PLT transfusion–associated sepsis with PLTs of 5 days of age compared to those 4 days old and less.26 Data from the facility of two of the authors of this editorial (RY and MJ) similarly demonstrated a disproportionate risk of demonstrable PLT bacterial contamination in PLTs stored for 5 days at room temperature (11.9/10,000) compared to those stored for 4 days or less (1.8/10,000; p < 0.05).14 This relation of storage time to reports of septic transfusion reactions in the era before apheresis units were tested at 24 hours for bacterial contamination continues in new data provided by the American Red Cross in which 13 of 20 septic reactions and all three deaths occurred in 5-day-old PLTs.7 These latter findings, however, are confounded by the diversion pouch placement issue as septic reactions were 4.7-fold higher in the two-needle collection system group, which lacked diversion pouches on the inlet line versus the single-needle group having the diversion pouches on the draw line. In an effort to further estimate the upper limit of the increased risk of bacterial contamination in 7-day-old PLT units, Benjamin and Wagner5 apply an experimental probability distribution model which they use to demonstrate the hypothetical limitations of the BacT/ALERT culture platform (and presumably any similar culture system) in identifying PLT bacterial contamination of apheresis PLTs when small numbers of organisms are initially present.5 This model treats all bacteria equally without consideration that some organisms are more pathogenic than others or that different organisms have different growth characteristics in different media, as discussed by Brecher and Hay.4 It also assumes that the transfusion of even one organism is a clinically significant event. Although the Benjamin and Wagner5 model provides "food for thought" concerning the limitations of the culture system to reduce the risk, it is a theoretical model and should not serve as a replacement for clinical data when it comes to setting policy. Nonetheless, based on this probability distribution model and the association of the increased risk of transfusion-associated sepsis related to increased PLT age, combined with recent literature reports of false-negative culture results on PLT units,27-32 Benjamin and Wagner5 suggest that if 7-day PLTs are to be routinely used, even in a study context, they should be used only with the implementation of further measures to reduce or detect bacterial contamination. Possible methods noted in this regard include increasing the sample volume for the culture (the American Red Cross has recently increased the volume of sample in the aerobic bottle from 4 to 8 mL), storing the PLT unit for 36 hours rather than 24 hours before culture sample collection, reculturing the PLTs closer to the time of transfusion, point of issue testing of PLTs by a rapid assay, or pathogen inactivation. Regarding the latter two strategies, point-of-issue test methods are being developed by several manufacturers,9 one of which has been submitted to the FDA for 510(k) approval,33 and, while pathogen inactivation remains in a research-only mode in the United States, Casenave34 and Nussbaumer and colleagues6 note that in Europe the INTERCEPT Blood System for Platelets (Cerus Europe BV, Leusden, the Netherlands) received the CE Mark for pathogen inactivation of PLTs in 2002, Agence française de sécurité sanitaire des produits de santé approval in France in 2005, and Paul-Ehrlich-Institut approval in Germany in 2007 and is currently in clinical use in several European countries.34 The INTERCEPT Blood System for Platelets is projected for introduction into use throughout France by 2009 for apheresis and buffy-coat PLTs, with the benefit of there being no need for a bacterial detection system if an inactivation system is used.34 How application of one or more of these new strategies suggested by Benjamin and Wagner5 will impact the bacterial safety of PLTs in general remains to be determined. The article by Brecher and Hay,4 through a detailed examination of a single case report of a PLT transfusion fatality associated with Staphylococcus lugdunensis, argues for the routine implementation of an anaerobic bottle together with an aerobic bottle for detection of PLT bacterial contamination. Their argument rests on the finding that this bacterial isolate, under experimental conditions, grew to detection faster, particularly at low inoculum levels, in the anaerobic bottle compared to the aerobic bottle—a mean, for 20 replicate samples, of 19.5 hours in the anaerobic bottle compared to 22.3 hours in the aerobic bottle. Although this modest growth differential is significant in mathematical terms, it is uncertain, based on a single case report, if this is significant in clinical terms. Furthermore, this differential effect was eliminated when the volume of the inoculum was increased to 10 mL in the aerobic culture bottle. Thus, by increasing the volume in the aerobic bottle, as suggested by Benjamin and Wagner5 (and recently implemented by the American Red Cross), improved detection of a small bacterial inoculum is likely to occur. Nonetheless, Brecher and Hay4 argue that, given the great diversity of bacteria, different bacteria will have a preference for growth in either the aerobic or anaerobic bottle. In addition, anaerobic bacteria, such as Propionibacterium acnes, will display growth largely limited to the anaerobic media.12 This raises yet other important questions, namely, what is the rate of contamination, magnitude of contamination, and clinical importance of anaerobic organisms that may contaminate PLT products? To our knowledge, only three fatal cases due to anaerobes have been described, two associated with Clostridium perfringens and one with Eubacterium limosum.1, 28, 35 Two of these cases were reported before bacterial detection techniques were generally in use. Propionibacterium acnes is detected fairly frequently when anaerobic BacT/ALERT bottles are used (20 of 37 initial positive samples, with 3 confirmed-positive on reculture in one series;31 45 of 98 initial positive samples, with 20 confirmed positive on reculture in another series32), and a few instances of transfusion reactions to this organism have been described, including one severe reaction.36 It is hoped that a study in progress, the PASSPORT Study, will help to clarify the current level of risk when modern prevention techniques are in place and adjudicate the recommendations proposed by Benjamin and Wagner5 and Brecher and Hay.4 The PASSPORT Study (Post-Approval Surveillance Study of Platelet Outcomes, Release Tested) is a postmarket surveillance study for 7-day PLT storage in the United States jointly supported by Gambro BCT and Baxter Healthcare Corp.37 This study is investigating the residual risk of bacterial contamination in leukoreduced, apheresis PLTs sampled at 24 to 36 hours after collection for aerobic and anaerobic culture (4-5 mL per bottle) compared to PLTs similarly cultured after 7 days of storage, using AABB interpretations (see Table 2). The primary endpoint of the PASSPORT study is to assess the hypothesis that "release" tested 7-day PLTs, previously tested by BacT/ALERT 24 to 36 hours after collection, do not present a greater risk of detectable bacterial contamination than untested 5-day PLTs, thus addressing the concerns by Benjamin and Wagner.5 This study, however, is being performed by reculturing only the small proportion of units that are not used and outdate after 7 days, with a target of obtaining 50,000 such determinations, a target that will be difficult to attain and that may not be representative of contaminated units that were transfused before becoming outdated. A secondary endpoint is to evaluate the utility of the anaerobic culture bottle, thus addressing the concerns of Brecher and Hays4 by determining the number and range of organisms detected with each bottle as well as noting the time required for the positive results to appear. Although the PASSPORT Study may demonstrate that the anaerobic bottle is useful in the differential detection of P. acnes and possibly other anaerobes, however, it likely will not demonstrate if this contamination is of potential clinical significance since qualitative rather than quantitative cultures are being utilized. Because it is known that there is an important correlation between the quantity of organisms and the manifestations of a clinical reaction,14 this represents a limitation of the PASSPORT Study as currently designed. A second limitation of the PASSPORT Study is that, although all expired and tranfused PLT units will be cultured in both aerobic and anaerobic bottles, there will be no opportunity for clinical correlation in transfusion recipients to assess if units negative in the aerobic bottle alone are as safe as units negative in both the anaerobic and the aerobic bottle. Finally it should be noted that the PASSPORT Study will not answer the question that Benjamin and Wagner5 ask, "Is putting 8 mL in the aerobic bottle just as good as putting 4 mL in each bottle?" Nonetheless, this study will provide much useful information to help clarify some important questions and concerns raised by Benjamin and Wagner and Brecher and Hay. An important ongoing concern, not discussed in either the article by Brecher and Hay or the article by Benjamin and Wagner, relates to the gap in safety between apheresis and RDPs. Although the use of RDPs has diminished over time, one-quarter to one-third of PLTs are transfused in the form of RDPs.38 Closing the safety gap between RDPs and apheresis PLTs should be of the highest priority. In particular, diversion technology, given its demonstrable utility in reducing bacterial contamination associated with skin flora should become a required standard for apheresis PLT as well as whole blood donations. In addition, application of insensitive and nonspecific detection methods, such as pH and glucose testing, should be phased out and replaced by more specific and sensitive testing methods. In this regard, bacterial testing of RDPs from a sample obtained from a PLT pool prepared shortly following collection, such as with the Acrodose system (Pall Corp., East Hills, NY)39 should provide an enhanced level of bacterial detection. Although other methods, as noted above, such as rapid at issue tests and pathogen inactivation strategies, are in the FDA pipeline it is uncertain when these will be available in the market place. Although Brecher and Hay4 and Benjamin and Wagner5 have warned us about the remaining risk of septic reactions from PLT transfusions and both have recommended some steps that might be taken to further reduce that remaining risk, neither has quantified the incremental safety that will be achieved by their selected interventions over the level of safety we have achieved with the current testing system, arm preparation, and use of a properly placed diversion pouch. Nor has either attempted to provide a cost–benefit analysis of their selected interventions. Although the value of the observations both have made is great, decisions on further improvements to our current system require more clinical data. PRIMUM NON NOCERE One strategy that does not require more data, and perhaps the most important strategy of all with any PLT transfusion, is to carefully assess and fully document the clinical need for transfusion. The optimal use of blood components provides the best approach to transfusion safety, and use of PLTs as soon as possible after collection minimizes both the probability of units being contaminated and the bacterial load in contaminated units. In addition, each transfusion facility in concert with its blood supplier(s) should seek methods to improve detection and reporting of adverse events in transfused patients. It is only through careful outcome analysis that accurate data will be developed. Once obtained, these data can be analyzed to provide support for better clinical and manufacturing decision making. REFERENCES 1 Niu MT, Knippen M, Simmons L, Holness LG. Transfusion-transmitted klebsiella pneumoniae fatalities, 1995-2004. Transfus Med Rev 2006; 20: 149- 57. CrossrefPubMedWeb of Science®Google Scholar 2 Statement to the U.S. Department of Health and Human Services Advisory Committee on Blood Safety and Availability [monograph on the Internet]. Northfield (IL): College of American Pathologists; 2004. Available from: http://www.cap.org/apps/docs/advocacy/testimony/blood_safety.htmGoogle Scholar 3 Guidance on implementation of new bacteria and reduction standard. Bulletin 04-07. Bethesda: American Association of Blood Banks; 2004. Google Scholar 4 Brecher ME, Hay SN. Investigation of an isolate of Staphylococcus lugdunensis implicated in a platelet fatality: a possible advantage of using an anaerobic bottle. Transfusion 2007; 47: 1390- 5. Wiley Online LibraryPubMedWeb of Science®Google Scholar 5 Benjamin RJ, Wagner SJ. The residual risk of sepsis: modeling the effect of concentration on bacterial detection in two-bottle culture systems and an estimation of false-negative culture rates. Transfusion 2007; 47: 1381- 9. Wiley Online LibraryPubMedWeb of Science®Google Scholar 6 Nussbaumer W, Allersdorfer D, Grabmer C, et al. Prevention of transfusion of platelet components contaminated with low levels of bacteria: a comparison bacteria culture pathogen inactivation methods. Transfusion 2007; 47: 1125- 33. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 7 Eder AF, Kennedy JM, Dy B, et al. Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross Experience (2004-2006). Transfusion 2007; 47: 1134- 42. Wiley Online LibraryPubMedWeb of Science®Google Scholar 8 Prowse C. Zero tolerance. Transfusion 2007; 47: 1106- 9. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 9 Palavecino EL, Yomtovian RA, Jacobs MR. Detecting bacterial contamination in platelet products. Clin Lab 2006; 52: 443- 56. CASPubMedWeb of Science®Google Scholar 10 Whitaker BI, Sullivan M. The 2005 nationwide blood collection and utilization survey report [monograph on the Internet]. Washington (DC): U.S. Department of Health and Human Services; 2007 [accessed 2007 May 1]. Available from: http://www.aabb.org/apps/docs/05nbcusrpt.pdfGoogle Scholar 11 Blajchman MA, Beckers EA, Dickmeiss E, et al. Bacterial detection of platelets: current problems and possible resolutions. Transfus Med Rev 2005; 19: 259- 72. CrossrefPubMedWeb of Science®Google Scholar 12 Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev 2005; 18: 195- 204. CrossrefPubMedWeb of Science®Google Scholar 13 Kuehnert MJ, Roth VR, Haley NR, et al. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion 2001; 41: 1493- 9. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 14 Yomtovian R, Palavecino E, Dykstra A, et al. Evolution of surveillance methods for detection of bacterial contamination of platelets in a University hospital, 1991-2004. Transfusion 2006; 46; 719- 30. Wiley Online LibraryPubMedWeb of Science®Google Scholar 15 Standards for blood banks and transfusion services. Bethesda: American Association of Blood Banks; 2004. Google Scholar 16 Guidance on management of blood and platelet donors with positive or abnormal results on bacterial contamination tests (supplements 04-07). Bulletin 05-02. Bethesda: American Association of Blood Banks; 2005. Google Scholar 17 McDonald CP, Roy A, Mahajan P, et al. Relative values of the interventions of diversion and improved donor-arm disinfection to reduce the bacterial risk from blood transfusion. Vox Sang 2004; 86: 178- 82. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 18 De Korte D, Marcelis JH, Verhoeven AJ, Soeterboek AM. Diversion of first blood volume results in a reduction of bacterial contamination for whole-blood collections. Vox Sang 2002; 83: 13- 6. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 19 De Korte D, Curvers J, Beckers E, Marcelis J. Bacterial contamination of platelet concentrates: status after implementation of diversion in the Netherlands [abstract S78-040E]. Transfusion 2005; 45(S3): 26A. Web of Science®Google Scholar 20 Robillard P, Nawej K, Delage G. Platelet bacterial contaminations and effectiveness of diverting the first 40 mls at whole blood donation [Abstract S77-040E]. Transfusion 2005; 45 (S3): 25A. Web of Science®Google Scholar 21 Fang CT, Chambers LA, Kennedy J, et al. Detection of bacterial contamination in apheresis platelet products: American Red Cross experience, 2004. Transfusion 2005; 45: 1845- 52. Wiley Online LibraryPubMedWeb of Science®Google Scholar 22 Morrow JF, Braine HG, Kickler TS, et al. Septic reactions to platelet transfusions. A persistent problem. JAMA 1991; 266: 555- 8. CrossrefCASPubMedWeb of Science®Google Scholar 23 Yomtovian R, Lazarus HM, Goodnough LT, et al. A prospective microbiologic surveillance program to detect and prevent the transfusion of bacterially contaminated platelets. Transfusion 1993; 33: 902- 9. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 24 Yomtovian R. Bacterial contamination of blood: lessons from the past and road map for the future. Transfusion 2004; 44: 450- 60. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 25 Reduction of the maximum platelet storage period to 5 days in an approved container [monograph on the Internet]. Rockville (MD): U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration; 1986. Available from: http://www.fda.gov/cber/bldmem/060286.pdfGoogle Scholar 26 Ness P, Braine H, King K, et al. Single-donor platelets reduce the risk of septic platelet transfusion reactions. Transfusion 2001; 41: 857- 61. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 27 Te Boekhorst PA, Beckers EA, Vos MC, et al. Clinical significance of bacteriologic screening in platelet concentrates. Transfusion 2005; 45: 514- 9. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 28 Vostal JG. Update on FDA review of bacterial detection devices for a platelet release test indication and extension of platelet dating [monograph on the Internet]. Washington (DC): U.S. Department of Health and Human Services; 2005. Available from: http://www.hhs.gov/bloodsafety/presentations/Vostal.pdfWeb of Science®Google Scholar 29 Fournier-Wirth C, Deschaseaux M, Defer C, et al. Evaluation of the enhanced bacterial detection system for screening of contaminated platelets. Transfusion 2006; 46: 220- 4. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 30 Ramirez-Arcos S, Jenkins C, Dion J, et al. Canadian experience with detection of bacterial contamination in apheresis platelets. Transfusion 2007; 47: 421- 9. Wiley Online LibraryPubMedWeb of Science®Google Scholar 31 Schmidt M, Karakassopoulos A, Burkhart J, et al. Comparison of three bacterial detection methods under routine conditions. Vox Sang 2007; 92: 15- 21. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 32 Schrezenmeier H, Walther-Wenke G, Muller TH, et al. Bacterial contamination of platelet concentrates: results of a prospective multicenter study comparing pooled whole blood-derived platelets and apheresis platelets. Transfusion 2007; 47: 644- 52. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 33 Verax Biomedical Submits 510(K) Application to FDA for Platelet PGD Test [monograph on the Internet]. Worcester (MA): Verax Biomedical; 2007. Available from: http://www.veraxbiomedical.com/news-events/releases/20070314.asp 2007 Google Scholar 34 Casenave JP. Clinical experience with pathogen inactivated platelets. In: Pathogen Inactivation: Making Decisions About New Technologies, Consensus Conference; 2007 Mar; Toronto, Canada. Google Scholar 35 McDonald CP, Hartley S, Orchard K, et al. Fatal Clostridium perfringens sepsis from a pooled platelet transfusion. Transfus Med 1998; 8: 19- 22. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 36 Perez P, Salmi LR, Follea G, et al. Determinants of transfusion-associated bacterial contamination: results of the French BACTHEM Case-Control Study. Transfusion 2001; 41: 862- 72. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 37 PASSPORTSTUDY.com [homepage on the Internet]. PASSPORT (Post Approval Surveillance Study of Platelet Outcomes, Release Tested) post-market surveillance study for 7-day platelet storage in the U.S. Available from: http://www.passportstudy.com/Google Scholar 38 Silva MA, Gregory KR, Carr-Greer MA, et al. Summary of the AABB Interorganizational Task Force on Bacterial Contamination of Platelets: Fall 2004 impact survey. Transfusion 2006; 46: 636- 41. Wiley Online LibraryPubMedWeb of Science®Google Scholar 39 Acrodose™ PL System [monograph on the Internet]. East Hills (NY): Pall Corp.; c2005. Available from: http://www.pall.com/pdf/AcrodosePL_Bro.pdf 2006 Google Scholar Citing Literature Volume47, Issue8August 2007Pages 1340-1346 ReferencesRelatedInformation
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