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Objectives:

The aims of this study were to develop reportable event codes that are applicable to the national hemovigilance systems for hospital blood banks, and to present expansion strategies for the blood banks.

Materials and Methods:

The data were obtained from a literature review and expert consultation, followed by adding to and revising the established hemovigilance code system and guidelines to develop reportable event codes for hospital blood banks. The Medical Error Reporting System-Transfusion Medicine developed in the US and other codes of reportable events were added to the Korean version of the Biologic Products Deviation Report (BPDR) developed by the Korean Red Cross Blood Safety Administration, then using these codes, mapping work was conducted. We deduced outcomes suitable for practice, referred to the results of the advisory councils, and conducted a survey with experts and blood banks practitioners.

Results:

We developed reportable event codes that were applicable to hospital blood banks and could cover blood safety - from blood product safety to blood transfusion safety - and also presented expansion strategies for hospital blood banks.

Conclusion:

It was necessary to add 10 major categories to the blood transfusion safety stage and 97 reportable event codes to the blood safety stage. Contextualized solutions were presented on 9 categories of expansion strategies of hemovigilance system for the hospital blood banks.

Summary

The Agence Française de Securite Sanitaire des Produits de Santé (Afssaps; French Health Products Safety Agency) is responsible, through its hemovigilance unit, for the organization and the functioning of the national hemovigilance network. In accordance with the French law, it receives all data on adverse transfusion reactions regardless of their severity. With the aim of evaluating the tolerance of two kinds of labile blood products (LBP), pooled platelet concentrates (PP) and apheresis platelet concentrates (APC), we screened the French national database from January 1, 2000 to December 31, 2006. We observed that the number of transfusion incident reports is more than twice as high with APC (8.61:1,000 LBP) than with PP (4.21:1,000 LBP). The difference between these two ratios is statistically significant as shown by chi-square test (e = 21.00 with α = 5%). The risk to suffer adverse reactions of any type, except for alloimmunization, is higher with APC, and the major type of diagnosis related to APC is allergic reaction (1:200 APC issued) even if those allergic reactions are rarely serious. The new French National Hemovigilance Commission should impel a working group evaluating this topic and above all the impact of additive solutions which have been used since 2005 to put forward preventives measures.

Summary

Background

The transmission of pathogens via blood transfusion is still a major threat. Expert conferences established the need for a pro-active approach and concluded that the introduction of a pathogen inactivation/reduction technology requires a thorough safety profile, a comprehensive pre-clinical and clinical development and an ongoing hemovigilance program.

Material and Methods

The INTERCEPT Blood System utilizes amotosalen and UVA light and enables for the treatment of platelets and plasma in the same device. Preclinical studies of pathogen inactivation and toxicology and a thorough program of clinical studies have been conducted and an active he-movigilance-program established.

Results

INTERCEPT shows robust efficacy of inactivation for viruses, bacteria (including spirochetes), protozoa and leukocytes as well as large safety margins. Furthermore, it integrates well into routine blood center operations. The clinical study program demonstrates the successful use for very diverse patient groups. The hemovigilance program shows safety and tolerability in routine use. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide. The system is in clinical use since class III CE-mark registration in 2002. The safety and efficacy has been shown in routine use and during an epidemic.

Conclusion

The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections.

Summary

Background

In recent years, pulmonary transfusion reactions have gained increasing importance as serious adverse transfusion events.

Methods

Review of the literature.

Results

Pulmonary transfusion reactions are not extremely rare and, according to hemovigilance data, important causes of transfusion-induced major morbidity and death. They can be classified as primary with predominant pulmonary injury and secondary as part of another transfusion reaction. Primary reactions include transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and transfusion-associated dyspnea (TAD). Secondary pulmonary reactions are often observed in the wake of hemolytic transfusion reactions, hypotensive/anaphylactic reactions, and transfusion-transmitted bacterial infections.

Conclusion

Knowledge and careful management of cases of pulmonary transfusion reactions are essential for correct reporting to blood services and hemovigilance systems. Careful differentiation between TRALI and TACO is important for taking adequate preventive measures.

The aim of this study was to conduct a systematic review on the photoinactivators used in hemotherapy, with action on viral genomes. The SciELO, Science Direct, PubMed and Lilacs databases were searched for articles. The inclusion criterion was that these should be articles on inactivators with action on genetic material that had been published between 2000 and 2010. The key words used in identifying such articles were "hemovigilance", "viral inactivation", "photodynamics", "chemoprevention" and "transfusion safety". Twenty-four articles on viral photoinactivation were found with the main photoinactivators covered being: methylene blue, amotosalen HCl, S-303 frangible anchor linker effector (FRALE), riboflavin and inactin. The results showed that methylene blue has currently been studied least, because it diminishes coagulation factors and fibrinogen. Riboflavin has been studied most because it is a photoinactivator of endogenous origin and has few collateral effects. Amotosalen HCl is effective for platelets and is also used on plasma, but may cause changes both to plasma and to platelets, although these are not significant for hemostasis. S-303 FRALE may lead to neoantigens in erythrocytes and is less indicated for red-cell treatment; in such cases, PEN 110 is recommended. Thus, none of the methods for pathogen reduction is effective for all classes of agents and for all blood components, but despite the high cost, these photoinactivators may diminish the risk of blood-transmitted diseases.

Summary

Epidemiological data are essential for monitoring trends and outbreaks of infectious diseases in the general population. The reporting system pursuant to the Infection Protection Act in Germany results in a very good quality of timely nationwide data on all reportable diseases including those relevant for the blood supply: HIV, hepatitis C, hepatitis B and syphilis. Notifications of acute hepatitis B and first-time diagnosed hepatitis C infections in the general population showed a declining trend in the past years, but the number of reports of HIV and syphilis infections increased until 2007 especially among men who have sex with men. New preventive strategies should also address changes in sexual behavior. The specific surveillance of blood donors is an important part of the hemovigilance system. The highly effective donor selection process results in a small number of confirmed infections among donors in Germany. The surveillance data enable us to identify specific trends that might challenge blood safety like the increase in HIV infections among repeat donors. Specific evaluations are performed when needed. These additional studies can be used to modify guidelines or recommendations and to (re)evaluate the need for or the effect of further testing.

Summary

The French Hemovigilance Network has been established in 1994 and records all adverse events associated with the transfusion of a labile blood products (LBP) regardless of their severity. From 1994 to 2006 35,423,172 LBP were issued, 85,812 adverse transfusion reactions notified, and 139 cases of transfusion related acute lung injury (TRALI) observed. The LBP most at risk is fresh frozen plasma (FFP), followed by platelets concentrates (PC) and packed red cells (PRC). However, because the use of FFP is not frequent in France, it only accounts for about 10% of TRALI, whereas PRC and PC are involved in the remaining cases. In no case, pooled FFP treated with solvent-detergent were involved. Patients’ profiles are peculiar with a high disease burden. Therefore, targeting a prevention policy only on FFP would result in a marginal reduction of TRALI in France.

Neither screening method completely detects all clinically relevant bacterial contaminations. The effect of sampling time and volume as well as standardization of the assay applied has also to be taken into account. Therefore, minimizing the risk of contamination during manufacture by measures such as donor selection, skin disinfection, division, and processing within closed systems remains crucial. In this context new concepts in sterility testing, especially with instable advanced therapy medicinal products (ATMPs), are needed as well as reassessment of pathogen inactivation techniques. At present hemovigilance data indicate that shortening the shelf life of platelet concentrates as introduced in Germany 2008 reduced the risk of transfusion-transmitted bacterial infections to the same extent as bacterial screening as done in Canada or the Netherlands. The evolving methodological progress, e.g. by standardizing culture methods or enhancing detection systems, requires careful follow-up in parallel to hemovigilance data in order to ensure optimal bacterial safety in hemotherapy.

Blood transfusion is a life-saving component of health care systems. Nevertheless, it can also be a quick and easy method of exposing patients to risks, particularly the transmission of infectious agents to recipients. Despite substantial improvements in the safety of transfusion services worldwide, the presence of paid and replacement blood donors are still of cause concern for ensuring sustainable safe blood donations. Although the Eastern Mediterranean region consists of a heterogeneous group of countries that vary in their levels of development, they all share common concerns regarding blood safety. In the region, concerns regarding the spread of Hepatitis B and C through blood transfusion continue to exist. Therefore, there is an urgent need for further improvements in both organization and safety measures of blood transfusion activities in the region. Although establishing a centralized blood transfusion system might not be achievable in the short term in some of the countries in the region, the implementation of centralized test kit procurement, data collection, and donation testing could be considered feasible approaches.

Background

Blood transfusion has always been an important route for Chagas Disease (CD) transmission. The high prevalence of CD in Latin America and its lifelong asymptomatic clinical picture pose a threat for the safety of the blood supply. The outcome of measures designed to improve transfusion safety can be assessed by evaluating the prevalence of CD among multitransfused patients

Methods

In order to assess the impact of CD control measures on the safety of the blood supply, an observational cross-sectional study was designed to determine the prevalence of CD in 351 highly transfused patients, in which vectorial transmission was excluded. This study compared patients that received transfusion products before (n = 230) and after (n = 121) 1997, when measures to control transfusion-transmitted CD were fully implemented in Brazil.

Results

The study group consisted of 351 patients exposed to high numbers of blood products during their lifetime (median number of units transfused = 51, range 10–2086). A higher prevalence of transfusion-transmitted CD (1.30%) was observed among multitransfused patients that received their first transfusion before 1997, compared with no cases of transfusion-transmitted CD among multitransfused patients transfused after that year. The magnitude of the exposure to blood products was similar among both groups (mean number of units transfused per year of exposure = 25.00 ± 26.46 and 23.99 ± 30.58 respectively; P = 0.75, Mann-Whitney test).

Conclusion

Multiple initiatives aimed to control vector and parental transmission of CD can significantly decrease transfusion-transmitted CD in Brazil. Our data suggest that mandatory donor screening for CD represents the most important measure to interrupt transmission of CD by blood transfusions.

Blood is life. Transfusion of blood and blood components, as a specialized modality of patient management saves millions of lives worldwide each year and reduce morbidity. It is well known that blood transfusion is associated with a large number of complications, some are only trivial and others are potentially life threatening, demanding for meticulous pretransfusion testing and screening particularly for transfusion transmissible infections (TTI). These TTI are a threat to blood safety. The priority objective of BTS is thus to ensure safety, adequacy, accessibility and efficiency of blood supply at all levels. The objective of the present study was to assess the prevalence and trend of transfusion transmitted infections (TTI) among voluntary and replacement donors in the Department of Blood bank and transfusion Medicine of JSS College Hospital, a teaching hospital of Mysore during the period from 2004 to 2008. A retrospective review of donors record covering the period between 2004 and 2008 at the blood bank, JSS Hospital, Mysore was carried out. All samples were screened for HIV, HBsAg, HCV, syphilis and malaria. Of the 39,060, 25,303 (64.78%) were voluntary donors and the remaining 13,757 (35.22%) were replacement donors. The overall prevalence of HIV, HbsAg, HCV and syphilis were 0.44, 1.27, 0.23 and 0.28%, respectively. No blood donor tested showed positivity for malarial parasite. Majority were voluntary donors with male preponderance. In all the markers tested there was increased prevalence of TTI among the replacement donors as compared to voluntary donors. With the implementation of strict donor criteria and use of sensitive screening tests, it may be possible to reduce the incidence of TTI in the Indian scenario.

Background

Unsafe reuse of injection equipment in hospitals is an on-going threat to patient safety in many parts of Africa. The extent of this problem is difficult to measure. Standard WHO injection safety assessment protocols used in the 2003 national injection safety assessment in Cameroon are problematic because health workers often behave differently under the observation of visitors. The main objective of this study is to assess the extent of unsafe injection equipment reuse and potential for blood-borne virus transmission in Cameroon. This can be done by probing for misconceptions about injection safety that explain reuse without sterilization. These misconceptions concern useless precautions against cross-contamination, i.e. "indirect reuse" of injection equipment. To investigate whether a shortage of supply explains unsafe reuse, we compared our survey data against records of purchases.

Methods

All health workers at public hospitals in two health districts in the Northwest Province of Cameroon were interviewed about their own injection practices. Injection equipment supply purchase records documented for January to December 2009 were compared with self-reported rates of syringe reuse. The number of HIV, HBV and HCV infections that result from unsafe medical injections in these health districts is estimated from the frequency of unsafe reuse, the number of injections performed, the probability that reused injection equipment had just been used on an infected patient, the size of the susceptible population, and the transmission efficiency of each virus in an injection.

Results

Injection equipment reuse occurs commonly in the Northwest Province of Cameroon, practiced by 44% of health workers at public hospitals. Self-reported rates of syringe reuse only partly explained by records on injection equipment supplied to these hospitals, showing a shortage of syringes where syringes are reused. Injection safety interventions could prevent an estimated 14-336 HIV infections, 248-661 HBV infections and 7-114 HCV infections each year in these health districts.

Conclusions

Injection safety assessments that probe for indirect reuse may be more effective than observational assessments. The autodisable syringe may be an appropriate solution to injection safety problems in some hospitals in Cameroon. Advocacy for injection safety interventions should be a public health priority.

Objectives

Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism.

Design

We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically.

Participants

Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated.

Results

Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making.

Conclusions

Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose significant public health risks.

Several studies have demonstrated a link between blood viscosity and various forms of liver dysfunction. Therefore, we investigated the effect of liver protective herbal materials, Sesamin combined with extract of Schisandra chinensis berry (Schisandra) for its potential to improve blood fluidity in humans. Ten human subjects were recruited to study the effect of sesamin combined with schisandra extract (SCH) for two weeks on blood viscosity. Blood fluidity was measured as the transit time for 100μl of heparinized whole blood to pass through a micro-channel array setup at baseline, 1 week and 2 weeks. For safety assessment, blood biochemistry, hematology and urine analysis were taken at baseline, 1 week and 2 weeks after SCH administration. No safety concern and adverse effects were observed during the 2-week continuous intake period. Intake of SCH reduced blood passage time by 9.0% and 9.7% at 1 and 2 weeks, respectively. In conclusion, this pilot clinical study indicates that the combined administration of sesamin with schisandra extract could improve blood fluidity after 1 week of oral intake and this effect was sustained up to 2 weeks.

Overall contamination (on- plus off-streak) of the Isolator (Du Pont Co.) blood culture tube (23%) was greater than that of a conventional broth blood culture bottle (0.6%) or that of a biphasic blood culture bottle (1.3%). To determine the source of this contamination, Isolator cultures of blood from 59 healthy volunteers and of sterile broth from 60 vials were made. A total of 37% of the blood cultures and 22% of the broth cultures were contaminated (P = 0.06). Staphylococcus epidermidis-contaminated cultures represented 31 and 10% of the blood and broth cultures, respectively (P = 0.06). Contamination of plates processed on a bench top, in front of horizontal laminar flow, and in a biological safety cabinet with vertical laminar flow were compared. Processing plates in a biological safety cabinet resulted in a significant reduction in the number of contaminated plates (P less than 0.05). The contamination rate for 7,874 Isolator blood cultures processed in the biological safety cabinet was significantly decreased to 6.7% on-streak (9.3% on- plus off-streak). Contamination of Isolator-processed blood cultures originated from the laboratory and the patient. The former can be reduced by inoculating plates in a vertical laminar flow biological safety cabinet and by maintaining adequate quality control of media. The latter may be unavoidable.

A prospective study of the use of a laminar flow cabinet, an exhaust-ventilated safety hood, and the open bench for the microbiological examination of blood is described. Blood samples from 1600 patients were subcultured on the open bench, 2700 in a safety hood, and 2607 in a laminar flow cabinet. Use of the laminar flow cabinet produced a significantly greater level of contamination than the other methods, and it is concluded that the exhaust-ventilated safety hood should be used for this procedure.

Images

In the drive to develop drugs with well-characterized and clinically monitorable safety profiles, there is incentive to expand the repertoire of safety biomarkers for toxicities without routine markers or premonitory detection. Biomarkers in blood are pursued because of specimen accessibility, opportunity for serial monitoring, quantitative measurement, and the availability of assay platforms. Cytokines, chemokines, and growth factors (here referred to collectively as cytokines) show robust modulation in proximal events of inflammation, immune response, and repair. These are key general processes in many toxicities; therefore, cytokines are commonly identified during biomarker discovery studies. In addition, multiplexed cytokine immunoassays are easily applied to biomarker discovery and routine toxicity studies to measure blood cytokines. However, cytokines pose several challenges as safety biomarkers because of a short serum half-life; low to undetectable baseline levels; lack of tissue-specific or toxicity-specific expression; complexities related to cytokine expression with multiorgan involvement; and species, strain, and interindividual differences. Additional challenges to their application are caused by analytical, methodological, and study design–related variables. A final consideration is the strength of the relationship between changes in cytokine levels and the development of phenotypic or functional manifestations of toxicity. These factors should inform the integrated judgment-based qualification of novel biomarkers in preclinical, and potentially clinical, risk assessment. The dearth of robust, predictive cytokine biomarkers for specific toxicities is an indication of the significant complexity of these challenges. This review will consider the current state of the science and recommendations for appropriate application of cytokines in preclinical safety assessment.

The majority of people diagnosed with diabetes mellitus are in the working age group in developing countries. The interrelationship of diabetes and work, that is, diabetes affecting work and work affecting diabetes, becomes an important issue for these people. Therapeutic options for the diabetic worker have been developed, and currently include various insulins, insulin sensitizers and secretagogues, incretin mimetics and enhancers, and alpha glucosidase inhibitors. Hypoglycemia and hypoglycaemic unawareness are important and unwanted treatment side effects. The risk they pose with respect to cognitive impairment can have safety implications. The understanding of the therapeutic options in the management of diabetic workers, blood glucose awareness training, and self-monitoring blood glucose will help to mitigate this risk. Employment decisions must also take into account the extent to which the jobs performed by the worker are safety sensitive. A risk assessment matrix, based on the extent to which a job is considered safety sensitive and based on the severity of the hypoglycaemia, may assist in determining one's fitness to work. Support at the workplace, such as a provision of healthy food options and arrangements for affected workers will be helpful for such workers. Arrangements include permission to carry and consume emergency sugar, flexible meal times, self-monitoring blood glucose when required, storage/disposal facilities for medicine such as insulin and needles, time off for medical appointments, and structured self-help programs.

Background

Generally, the safety of transfusion terapies for patients depends in part on the distribution of the blood products. The prevention of adverse events can be aided by technological means, which, besides improving the traceability of the process, make errors less likely. In this context, the latest frontier in automation and computerisation is the remote-controlled, automated refrigerator for blood storage.

Materials and methods

Computer cross-matching is an efficient and safe method for assigning blood components, based on Information Technology applied to typing and screening. This method can be extended to the management of an automated blood refrigerator, the programme of which is interfaced with the Transfusion Service’s information system. The connection we made in our Service between EmoNet® and Hemosafe® enables real-time, remote-controlled management of the following aspects of blood component distribution: a) release of autologous and allogeneic units already allocated to a patient, b) release of available units, which can be allocated by remote-control to known patients, in the presence of a valid computer cross-match, c) release of O-negative units of blood for emergencies.

Results

Our system combines an information database, which enables computer cross-matching, with an automated refrigerator for blood storage with controlled access managed remotely by the Transfusion Service. The effectiveness and safety of the system were validated during the 4 months of its routine use in the Transfusion Service’s outpatient department.

Conclusions

The safety and efficiency of the distribution of blood products can and must be increased by the use of technological innovations. With the EmoNet®/Hemosafe® system, the responsibility for the remote-controlled distribution of red blood cell concentrates remains with the chief of the Transfusion Services, through the use of automated computer procedures and supported by continuous training of technicians and nursing staff.

Despite importance of blood transfusion services as life saving procedures, some countries are unable to meet their national requirements for blood and blood components in a timely manner. Since establishment of Iran Blood Transfusion Organization (IBTO) in 1974 as an integral part of national health system, Iran has experienced a drastic improvement both in availability and safety of blood and blood products. Iran now has not only reached to a 100% non remunerated voluntary blood donation but also secured a national self sufficiency of blood and blood components. Efforts of IBTO as the sole player of transfusion medicines in Iran enabled the country for timely providing of life saving blood transfusion services for all Iranian patients in need of such services. In order to meet the country’s demand in 2011 about 2 million units of whole blood for a population of about 75 million collected by IBTO. This indicates 26.2 donations per 1000 population. Currently about 94% of blood donors in Iran are 25–35 years old males and contribution of female donors in blood donation is less than 6%. IBTO screen all donated blood for important transfusion transmissible infections such as HBV, HIV, HCV and syphilis. Prevalence of HBsAg, HCV and HIV in donated blood in IBTO in 2011 was 0.20%, 0.06% and 0.004% respectively.

The safety of the blood supply, an issue in the 1970s and 1980s, created an increased need to screen the blood supply for HIV-1 and hepatitis C virus infections. The possibility exists that other contamination could again affect the blood supply. This has resulted in the increased use of strategies to minimize the transfusion of allogeneic blood, such as autologous blood predeposit for elective surgical procedures. Many studies indicate, however, that autologous blood donation is overutilized so that half of the blood withdrawn for autologous use is discarded. Cost-effectiveness studies have indicated that autologous blood donation has little benefit compared with many medical procedures, from which one might conclude that the procedure could be eliminated. Alternatively, the benefit could be improved by reducing the wastage of autologous donated blood. This wastage must occur only because of a premise that autologous blood is obtained to ensure avoidance of a homologous transfusion. This results in an amount of blood withdrawn that is more than is used in an uncomplicated procedure. We examined the transfusion requirements in surgical procedures for which there is autologous blood donation to establish the optimum amount of blood to be taken based on expected blood use. The transfusion records of 493 patients who donated blood preoperatively (340 orthopedic, 69 urological and 83 gynecological, in the years 1992 and 1993) were audited to determine the characteristics of the transfusion practices associated with the surgical procedures. The study sample underwent 182 total knee and 123 total hip arthroplasties, 33 laminectomies with fusion and three without, 83 hysterectomies and myomectomies, 59 radical retropubic prostatectomies and 10 nephrectomies and lymph node resections. Data used for evaluation were age, sex, units donated and transfused, predonation hemoglobin concentration, initial and final hemoglobin concentration, surgical procedure and surgical blood loss. The study suggests that autologous predeposit is not indicated for hysterectomies because of the low likelihood of transfusion. Even when a transfusion is likely according to the surgical blood order schedule, predonation is greater than actual use. Use of predonation hemoglobin could facilitate better efficiency of use for procedures where use is anticipated, thereby significantly reducing a wastage near 50 percent.

Background

Climate change is expected to promote more intense and prolonged outbreaks of vector-borne disease, and alter the geographic boundaries of transmission. This has implications for the safety and supply of fresh blood products around the world. In Australia, a recent outbreak of dengue fever caused a prolonged regional shortage in the supply of fresh blood products.

Objective

To highlight the potential for climate change to affect the safety and supply of blood globally through its impact on vector-borne disease, using the example of dengue in Australia as a case-study.

Design

We modelled geographic regions in Australia suitable for dengue transmission over the coming century under four climate change scenarios, estimated changes to the population at risk and effect on blood supply.

Results

Geographic regions with climates that are favourable to dengue transmission could expand to include large population centres in a number of currently dengue-free regions in Australia and reduce blood supply across several states.

Conclusion

Unless there is strong intergovernmental action on greenhouse gas reduction, there could be an eight-fold increase in the number of people living in dengue prone regions in Australia by the end of the century. Similar impacts will be experienced elsewhere and for other vector-borne diseases, with regions currently on the margins of transmission zones most affected. Globally, climate change is likely to compound existing problems of blood safety and supply in already endemic areas and cause future shortages in fresh blood products through its impact on transmission of vector-borne disease.

Background

The safety of blood with regards to transmission of infectious diseases is guaranteed by European laws that regulate both the selection of donors through pre-donation questionnaires and serological screening. However, variability in the epidemiology of human immunodeficiency virus (HIV) infection in different countries and some differences in the selection of donors can influence the efficacy (with regards to the safety of blood) of these processes. In this study we compared the prevalence of HIV in blood donations in the three macro-areas of Europe and in various western European countries, analysed the criteria of selection and rewarding of donors in western European countries, and studied the trend in the prevalence of HIV in Italy from to 1995 and 2006.

Methods

European data were derived from the European Centre for the Surveillance of HIV; Italian data were obtained from the Transfusion-Transmitted Infections Surveillance System and National and Regional Register of blood and plasma. The information on eligibility criteria and rewarding offered to donors was derived from international sources.

Results

The prevalence of HIV in blood donations was highest in eastern Europe, followed by central Europe and western Europe. Among the western European countries, Spain, Italy and Israel had the highest prevalences; the prevalence was noted to be higher in countries which did not offer any rewarding to the donor. In Italy the prevalence of HIV was 3.8 cases per 100,000 donations in 2006 and increased between 1995 and 2006, both among donations from repeat donors and first time donors.

Conclusions

The data highlight the need to continue improving the selection of donors and the coverage of the surveillance systems for HIV infection in transfusion services.

Background

Malaria rapid diagnostic tests (RDTs) are increasingly used by remote health personnel with minimal training in laboratory techniques. RDTs must, therefore, be as simple, safe and reliable as possible. Transfer of blood from the patient to the RDT is critical to safety and accuracy, and poses a significant challenge to many users. Blood transfer devices were evaluated for accuracy and precision of volume transferred, safety and ease of use, to identify the most appropriate devices for use with RDTs in routine clinical care.

Methods

Five devices, a loop, straw-pipette, calibrated pipette, glass capillary tube, and a new inverted cup device, were evaluated in Nigeria, the Philippines and Uganda. The 227 participating health workers used each device to transfer blood from a simulated finger-prick site to filter paper. For each transfer, the number of attempts required to collect and deposit blood and any spilling of blood during transfer were recorded. Perceptions of ease of use and safety of each device were recorded for each participant. Blood volume transferred was calculated from the area of blood spots deposited on filter paper.

Results

The overall mean volumes transferred by devices differed significantly from the target volume of 5 microliters (p < 0.001). The inverted cup (4.6 microliters) most closely approximated the target volume. The glass capillary was excluded from volume analysis as the estimation method used is not compatible with this device. The calibrated pipette accounted for the largest proportion of blood exposures (23/225, 10%); exposures ranged from 2% to 6% for the other four devices. The inverted cup was considered easiest to use in blood collection (206/226, 91%); the straw-pipette and calibrated pipette were rated lowest (143/225 [64%] and 135/225 [60%] respectively). Overall, the inverted cup was the most preferred device (72%, 163/227), followed by the loop (61%, 138/227).

Conclusions

The performance of blood transfer devices varied in this evaluation of accuracy, blood safety, ease of use, and user preference. The inverted cup design achieved the highest overall performance, while the loop also performed well. These findings have relevance for any point-of-care diagnostics that require blood sampling.

Summary

Background

Through the implementation of modern technology, such as nucleic acid testing, over the last two decades, blood safety has improved considerably in that the risk of viral infection is less than 1 in a million blood transfusions. By contrast, the residual risk of transfusion-associated bacterial infection is stable at approximately 1 in 2,000 to 1 in 3,000 in platelets. To improve blood safety with regard to bacterial infections, many countries have implemented bacterial screening methods as part of their blood donor screening programmes.

Methods

Bacterial detection methods are clustered into three groups: i) culture methods in combination with the ‘negative-to-date’ concept, ii) rapid detection systems with a late sample collection, and iii) bedside screening tests.

Results

The culture methods are convincing because of their very high analytical sensitivity. Nevertheless, false-negative culture results and subsequent fatalities were reported in several countries. Rapid bacterial systems are characterised as having short testing time but reduced sensitivity. Sample errors are prevented by late sample collection. Finally, bedside tests reduce the risk for sample errors to a minimum, but testing outside of blood donation services may have risks for general testing failures.

Conclusion

Bacterial screening of blood products, especially platelets, can be performed using a broad range of technologies. Each system exhibits advantages and disadvantages and offers only a temporary solution until a general pathogen inactivation technology is available for all blood components.