A centralized hemovigilance program to assure patient safety and to promote public health has been launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. National Institute of Biologicals (NIB) will be the National Coordinating Centre for Hemovigilance. This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC). All medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform.
Hemovigilance; India; Medical colleges; Transfusion Reaction Reporting Form
The goal of hemovigilance is to increase the safety and quality of blood transfusion. Identification of the adverse reactions will help in taking appropriate steps to reduce their incidence and make blood transfusion process as safe as possible.
To determine the frequency and type of transfusion reactions (TRs) occurring in patients, reported to the blood bank at our institute.
Materials and Methods:
A retrospective review of all TRs reported to the blood bank at the All India Institute of Medical Sciences, between December 2007 and April 2012 was done. All the TRs were evaluated in the blood bank and classified using standard definitions.
During the study period a total of 380,658 bloods and blood components were issued by our blood bank. Out of the total 196 adverse reactions reported under the hemovigilance system, the most common type of reaction observed was allergic 55.1% (n = 108), followed by febrile non-hemolytic transfusion reaction (FNHTR) 35.7% (n = 70). Other less frequently observed reactions were Anaphylactoid reactions 5.1% (n = 10), Acute non-immune HTRs 2.6% (n = 5), Circulatory overload 0.5% (n = 1), Transfusion related acute lung injury 0.5% (n = 1), Delayed HTRs 0.5% (n = 1). Not a single case of bacterial contamination was observed.
The frequency of TRs in our patients was found to be 0.05% (196 out of 380,658). This can be an underestimation of the true incidence because of under reporting. It should be the responsibility of the blood transfusion consultant to create awareness amongst their clinical counterpart about safe transfusion practices so that proper hemovigilance system can be achieved to provide better patient care.
Adverse transfusion reactions; blood transfusion; hemovigilance
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.
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.
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.
Biologic products deviation report; hemovigilance; medical error reporting system-transfusion medicine; reportable event code
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.
French hemovigilance; Apheresis platelet concentratece; Pooled platelet concentrate; Adverse reaction
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.
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.
The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections.
Pathogen inactivation; Platelets; Plasma; Amotosalen
In recent years, pulmonary transfusion reactions have gained increasing importance as serious adverse transfusion events.
Review of the literature.
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.
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.
Acute lung injury; Transfusion reaction; Transfusion risks
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.
Blood safety; Virus inactivation; Chemoprevention; Nucleic acids
Hemovigilance is an organized system of surveillance throughout the transfusion chain
intended to evaluate information in order to prevent the appearance or recurrence of
adverse reactions related to the use of blood products.
The aims of this study were to assess the late reporting of incidents related to
possible seroconversion in respect to age, marital status and ethnical background,
annual variations in late reporting, the number of reports opened and closed,
seroconversion of donors and transfusions of blood products within the window period.
This retrospective, descriptive study used data on blood donations in the blood bank in
Uberaba during the period from 2004 to 2011. Some socio-epidemiological characteristics
of the donors and serology test results of donors and recipients were analyzed in
respect to the late reporting of incidents related to possible seroconversion. The
Chi-square test, odds ratio and a regression model were used for statistical analysis.
From 2004 to 2011, the blood bank in Uberaba collected 117,857 blood bags, 284 (0.24%)
of which were investigated for late reported incidents. The profile of the donors was
less than 29 years old, unmarried and non-Whites. Differences in age (p-value <
0.0001), marital status (p-value = 0.0002) and ethnical background (p-value <
0.0001) were found to be statistically significant. There was no statistical difference
between men and women (0.24% and 0.23% respectively; p-value = 0.951). The number of
late reported incidents increased until 2008 followed by a downward trend until 2011.
There were twelve cases of seroconversion in subsequent donations (seven human
immunodeficiency virus, four hepatitis B and one hepatitis C) with proven human
immunodeficiency virus infection after screening of only one recipient.
The twelve cases of seroconversion in donors with subsequent infection proven in one
recipient underscores the importance of this tool to increase transfusion safety.
Blood safety; Serology; Blood donors; Blood transfusion/adverse effects; Communicable diseases/transmission; Quality assurance, health care; Retrospective studies
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.
Blood donation; HBV; HCV; Hemovigilance; HIV; Epidemiology
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.
TRALI; Hemovigilance; Blood transfusion; Sickle cell disease; Public health
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.
Sterility testing; Bacterial contamination; Blood components; Advanced therapy medicinal products; Hemovigilance
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.
Blood transfusion; Blood donors; Mediterranean region
Blood safety remains an important public health concern in Africa where lack of availability or provision of unsafe blood adversely impacts morbidity and mortality in the region. In recognition of this shortfall, the World Health Organization (WHO) established a goal of regional blood safety by 2012 through improved “organization and management, blood donor recruitment and collection, testing of donor blood as well as appropriate clinical use of blood” (Tagny et al: Transfusion. 2008;48:1256–1261; Tapko et al: Status of Blood Safety in the WHO African Region: Report of the 2006 Survey http://www.afro.who.int/en/divisions-a-programmes/dsd/health-technologies-a-laboratories.html. Brazzaville, Republic of Congo: WHO Regional Office for Africa; 2006). Although there has been substantial progress toward meeting these objectives, there are continued obstacles to both development and sustainability. In a setting where transfusion oversight is still being improved, transfusion-transmitted infections are of real concern. The high prevalence of some transfusion-transmissible agents such as hepatitis B virus and HIV in the general population means that some infected blood units escape detection by even well-performed laboratory testing, resulting in potential downstream transmission to patients. The spectrum of transfusion-transmitted infection include conventional as well as exotic pathogens, many of which are endemic to the region, thereby imparting ongoing challenges to recruitment and testing strategies.
The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989–2001, and the Retrovirus Epidemiology Donor Study-II (REDS-II), conducted from 2004–2012, were National Heart Lung and Blood Institute (NHLBI) funded multicenter programs focused on improving blood safety and availability in the United States. REDS-II also included international study sites in Brazil and China. The three major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as XMRV. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of HIV, HTLV I/II, HCV, HBV, WNV, CMV, HHV-8, B19V, malaria, CJD, influenza, and T. cruzi infections. Other analyses have characterized: blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors’ perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, two large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these two REDS programs. In 2011, a new seven year program, the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III), was launched. REDS-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting, and adds a third country, South Africa, to the international program.
blood safety; transfusion-transmitted infections; blood availability; blood donors
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
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.
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).
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.
Transfusion transmitted infection; Human immunodeficiency virus; Hepatitis B virus; Hepatitis C virus; Syphilis; Malaria
Serological safety is an integral part of overall safety for blood banks. Emphasis is on the use of routinue Red Blood Cell (RBC) antibody screen test, at set time intervals, to reduce risks related to alloantibodies. Also emphasis is on importance of issuing antigen negative blood to alloantibody positive patients. Effect of using leucodepleted blood on the rate of alloimmunization is highlighted. The concept of provision of phenotypically matched blood is suggested.
Materials and Methods:
Antibody screen test is important to select appropriate blood for transfusion. Repeat antibody screen testing, except if time interval between the earlier and subsequent transfusion was less than 72 hours, followed by antibody identification, if required, was performed in patients being treated with repeat multiple blood transfusions. Between February 2008 and June 2009, repeat samples of 306 multi-transfused patients were analyzed. Search for irregular antibodies and reading of results was conducted using RBC panels (three-cell panel of Column Agglutination Technology (CAT) and two cell panel of the Solid Phase Red Cell Adherence Technology (SPRCAT). Specificities of antibodies were investigated using appropriate panels, 11 cell panel of CAT and 16 cell panel of SPRCA. These technologies, detecting agglutination in columns and reactions in solid phase, evaluate the attachment of irregular incomplete antibody to antigen in the first phase of immunological reaction more directly and hence improve the reading of agglutination. Three to four log leuco reduced red blood cells were transfused to patients in the study using blood collection bags with integral filters.
Alloimmunization rate of 4.24% was detected from 306 multiply transfused patients tested and followed up. The Transfusion therapy may become significantly complicated.
Red cell antibody screening and identification and subsequent issue of antigen negative blood have a significant role in improving blood safety. Centers that have incorporated antibody screen test and identification have ensured safe transfusion. Identified patients should be flagged in a database and information shared. Such patients can be given carry-on cards and educated about the names of the identified antibodies. Full red cell phenotyping of individuals, patients and donors, can be feasibility.
Antibody screen Test; antibody identification; cell panel
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.
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.
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.
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.
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.
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.
Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated.
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.
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.
Voluntary donation is a key issue in transfusion medicine. To ensure the safety of blood transfusions, careful donor selection is important. Although new approaches to blood safety have dramatically reduced the risks for infectious contamination of blood components, the quality and the availability of blood components depend on the willingness to donate and the reliability of the information given by the donors about their own health, including risk behavior. As donors who are deferred by the blood bank will be less motivated to return for donation, it is important to reduce the number of deferrals. The aims of the present study were to investigate the reasons for deferral of registered donors coming to the blood bank for donation, in order to identify areas of importance for donor education—as these deferrals potentially could be avoided by better donor comprehension. Deferral related to testing of donors is not included in this study as these deferrals are dependent on laboratory results and cannot be indentified by questionnaire or interview. Data were collected from all blood donors in a period for 18 months who came for blood donation at a large university hospital in Norway. 1 163 of the 29 787 regular donors, who showed up for donation, were deferred (3.9%). The main reasons were intercurrent illness (n = 182) (15.6%), skin ulcers (n = 170) (14.6%), and risk behaviour (n = 127) (10.9%). In a community, intercurrent illnesses, skin ulcers, and potential risk behavior are the most frequent reasons for deferral of regular donors. Strategized effort on donor education is needed, as “failure to donate” reduces donor motivation.
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.
Schisandra chinensis; sesamin; blood fluidity; blood passage time; micro-channel array
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.
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.
cytokines; toxicity; safety; risk assessment; biomarker; qualification; validation; multiplex immunoassay
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.
Blood glucose awareness training (BGAT); Fitness to work; Hypoglycemic unawareness; Safety sensitive; Self-monitoring blood glucose
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.