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Just over a year ago, the Occupational Safety and Health Administration (OSHA) issued the final bloodborne pathogens standard, "Occupational Exposure to Bloodborne Pathogens; Final Rule," which requires healthcare institutions to protect their employees from all occupational exposure to bloodborne pathogens." According to OSHA, the only criterion for applying the standard is the likelihood of exposure to blood and other potentially infectious materials (OPIMs). Thus, the standard is designed to protect all vulnerable personnel, from the clinical engineers who service contaminated equipment to the staff in clinical laboratories, patient care or treatment areas, and housekeeping and laundry services--any location where the nature of the work poses the risk of exposure to bloodborne pathogens. All department heads and employees must have access to the standard and should carefully review our analysis of the regulations and recommendations for implementing them, as presented in this special issue of Health Devices. The standard is aimed at protecting employees from occupational exposure to all bloodborne pathogens and, especially, to the human immunodeficiency virus (HIV) and the hepatitis B virus (HBV)--the most infamous pathogens transmitted through occupational exposure to blood and body fluids. Other bloodborne diseases referenced by OSHA in the preamble to the standard include arboviral infections, babesiosis, brucellosis, Creutzfeldt-Jakob disease, hepatitis C, human T-lymphotropic virus type I, leptospirosis, malaria, relapsing fever, syphilis, and viral hemorrhagic fever. In this issue, we provide a clinical overview of HIV and HBV and the diseases they cause, as well as a brief discussion of other bloodborne pathogens; an analysis of the most significant regulations affecting hospitals; and our recommendations for compliance. The recommendations presented in this article do not exhaust the possibilities for reducing exposure and complying with the standard. We invite you to communicate your ideas and practices regarding compliance issues to the ECRI-sponsored Center for Healthcare Environmental Management (CHEM) for possible inclusion in a future update to its loose-leaf reference publication, the Healthcare Environmental Management System. We wish to acknowledge CHEM's contribution in developing this special report, which was reviewed by the Centers for Disease Control and Prevention (CDC), the National Institute for Occupational Safety and Health (NIOSH), and OSHA. Also see "CDC's Recommendations for Hepatitis B Vaccination and Postexposure Follow-up" and "A Minimal Training Syllabus" in this issue.
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PMID:OSHA's bloodborne pathogens standard: analysis and recommendations. 844 29

Viral and other exotic diseases may be transmitted by blood transfusion. These infections include human immunodeficiency virus (HIV), hepatitis viruses (A, B, C, D and E), syphilis, malaria, retrovirus HTLV-1, and cytomegalovirus. Other more exotic diseases which may be transmitted by transfusion of blood or blood components include Chagas' disease (Trypanosomiasis cruzi), Lyme disease (Borrelia burgdorferi), and Jakob-Creutzfeldt disease. Screening procedures currently used in Australian blood banks minimise transfusion-transmitted infection. The risk of acquiring any infection in this manner may be less than 0.1%.
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PMID:Transfusion transmitted infection: viral and exotic diseases. 844 2

Emerging and reemerging infections are attracting greater attention from the public health and medical communities. Pathologists and other physicians are increasingly aware of the importance of the subspecialty of infectious disease pathology as a tool for diagnosis, surveillance, and research of emerging infections. In this communication, we describe the role that infectious disease pathologists have played during the last 2 years in broadening our understanding of selected emerging infections, including such examples as new variant Creutzfeldt-Jakob disease and bovine spongiform encephalopathy, leptospirosis, microsporidiosis, Ebola hemorrhagic fever, and cyclosporiasis. The significance of providing pathology services, especially the autopsy, to patients with potentially hazardous communicable diseases is discussed with the supposition that it is unethical to exclude or withhold health care from a patient based on his or her underlying disease or on risk factors for acquiring a disease. The increasing occurrence of infectious diseases imported into the United States and other nations, including human immunodeficiency virus-1 group O, dengue fever, tuberculosis, malaria, diphtheria and cholera in immigrants and travelers, and Ebola virus in nonhuman primates, emphasizes the necessity for pathologists of having competence with infectious disease pathology. It is critical that new generations of pathologists not only be trained in the subspecialty of infectious disease pathology, but that they also be willing participants in the diagnosis and investigation of infectious diseases. The lack of training programs for infectious disease pathologists, as well as the deficiency in infectious disease pathology support for ongoing and future epidemiologic investigations and research, has led to the broadening of pathology services and initiation of a dedicated section of Infectious Disease Pathology at one of the nation's premier public health institutions, the Centers for Disease Control and Prevention in Atlanta, Ga. Together with preexisting groups of medical and veterinary infectious disease pathologists at universities, the Armed Forces Institute of Pathology, the US Army Medical Research Institute of Infectious Diseases, and the National Institutes of Health, this new program will significantly strengthen the capability of the United States to respond to future challenges of emerging and reemerging infections, both in this country and abroad.
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PMID:Emerging and reemerging infections. Progress and challenges in the subspecialty of infectious disease pathology. 927 4

In common with other developed countries, the United States has placed a great deal of emphasis on blood safety. As a result of careful donor selection and the use of advanced tests, including nucleic acid testing (NAT), the risk of transmission of human immunodeficiency virus and hepatitis C virus has been reduced to about 1 in 1.5 million donations. NAT for hepatitis B virus has not been introduced, but nevertheless the risk is low. Attention recently has been focused on emerging infections. NAT for West Nile virus was implemented within 6 to 8 months of recognition of the need to prevent transfusion transmission of this newly introduced virus. Approximately 1000 potentially infectious donations were identified and removed from the blood supply during the 2003 season. Other emerging infections attracting attention include Chagas' disease, babesiosis, malaria, and variant Creutzfeldt-Jakob disease.
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PMID:Current safety of the blood supply in the United States. 1561 52

Significant progress has been made in reducing the risk of pathogen transmission to transfusion recipients. Nonetheless, there remains a continuing risk of transmission of viruses, bacteria, protozoa, and prions to recipients. These include many of the viruses for which specific screening tests exist as well as pathogens for which testing is currently not being done, including various species of bacteria, babesiosis, variant Creutzfeld-Jacob disease, hepatitis A virus, human herpes virus 8, chikungunya virus, Chagas disease, and malaria. Pathogen inactivation (PI) technologies potentially provide an additional way to protect the blood supply from emerging agents and also provide additional protection against both known and as-yet-unidentified agents. However, the impact of PI on product quality and recipient safety remains to be determined. The purpose of this consensus conference was to bring together international experts in an effort to consider the following issues with respect to PI: implementation criteria; licensing requirements; blood service and clinical issues; risk management issues; cost-benefit impact; and research requirements. These proceedings are provided to make available to the transfusion medicine community the considerable amount of important information presented at this consensus conference.
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PMID:Proceedings of a Consensus Conference: pathogen inactivation-making decisions about new technologies. 1806 90

A spectrum of blood-borne infectious agents is transmitted through transfusion of infected blood donated by apparently healthy and asymptomatic blood donors. The diversity of infectious agents includes hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency viruses (HIV-1/2), human T-cell lymphotropic viruses (HTLV-I/II), Cytomegalovirus (CMV), Parvovirus B19, West Nile Virus (WNV), Dengue virus, trypanosomiasis, malaria, and variant CJD. Several strategies are implemented to reduce the risk of transmitting these infectious agents by donor exclusion for clinical history of risk factors, screening for the serological markers of infections, and nucleic acid testing (NAT) by viral gene amplification for direct and sensitive detection of the known infectious agents. Consequently, transfusions are safer now than ever before and we have learnt how to mitigate risks of emerging infectious diseases such as West Nile, Chikungunya, and Dengue viruses.
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PMID:Transfusion-transmitted infectious diseases. 1923 Dec 36

Corneal transplantation safety is widely dependent on clinical donor selection. Donor-to-host transmission of rabies and Creutzfeldt-Jakob disease is well established, and it is lethal for the recipient. Taking into consideration this latter figure, contraindications to ocular tissue transplantation include not only rabies, contact with rabies virus, spongiform encephalitis, family history of spongiform encephalitis, recipients of human pituitary-derived hormones before 1987, surgery using dura mater and brain/spinal surgery before 1992, but also CNS diseases of unknown etiology or those with unknown risk of transmission. It has been established that hepatitis B virus and herpes simplex virus can be transmitted by corneal transplantation, and both diseases are contraindications to transplantation. HIV infection, syphilis, hepatitis C, hepatitis A, tuberculosis, HTLV-1 and -2 infection, active leprosy, active typhoid, smallpox and active malaria are also contraindications to ocular tissue transplantation even if no evidence of donor-to-recipient transmission has been demonstrated. A history of corneal refractive surgery in the donor eye, ocular inflammation, retinoblastoma, and malignant tumors of the anterior segment are contraindications to keratoplasty.
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PMID:Donor selection, retrieval and preparation of donor tissue. Donor selection. 1949 34

We investigated epidemiologic data from 61 cases of autopsy-confirmed sporadic Creutzfeldt-Jakob disease (CJD). Dura mater-associated CJD cases and familial CJD cases were excluded. There were 34 male and 27 female cases, with an average age at onset of 66.0 +/- 10.5 years (range 27 to 89). At onset of CJD, 1 case was aged in the 20's and 1 in 30's, but there were no cases aged in the 40's. In 6 cases, age at onset was in the 80's. There was no significant difference in relation to the age at onset between males and females, averaging 66.2 +/- 12.4 years (range 27 to 89), and 65.9 7.5 years (range 53 to 82), respectively. Two cases had been employed as medical workers (a medical technologist and a nurses' aide) but neither had an apparent history of contact with CJD patients. No cases in the study had either family history of CJD or apparent contact with CJD patients. Ten cases had a history of hypertension, 5 cases had a history of diabetes mellitus, 2 cases had a history of malaria and 1 case had suffered from atomic bomb exposure. Twenty-one cases had operation history, including 2 cases of an operation involving the central nervous system. One case had a skull-base fracture operation 19 years before the onset of CJD and the other case had an atlantoaxial subluxation operation 11 years before the onset of CJD; there was no transplantation of dura mater graft in either operation. There was one case with a history of conservative treatment for cerebral hemorrhage; this case had symptomatic secondary epilepsy as a coexisting disease at the onset of CJD. Two cases had Parkinson's disease as a coexisting disease at the onset of CJD. The source hospitals enforcing medical treatment were located in the Aichi (n = 42), Gifu (n = 12) and Mie (n = 7) prefectures of the Tokai region of Japan. Regarding patients' place of residence, 22 cases resided in Nagoya-city. Nagoya University Hospital performed the autopsy in 12 cases, but 10 cases of those were transported after death from the source hospital. Departments of neurology provided clinical treatment in 54 cases. Other departments that provided treatment were Internal Medicine (n = 3), Psychiatry (n = 2), Geriatrics (n = 1), and Neurosurgery (n = 1). In 39 cases, prion protein gene analyses using peripheral blood leukocyte or cryopreserved brain tissue were performed. As for polymorphic codon 129, 36 cases (92%) showed Met/Met, 3 cases showed Met/Val (8%) and no case showed Val/Val polymorphism. Polymorphic codon 219 showed Glu/Glu homozygosity in all of the examined cases. Active autopsy performance of CJD in the Tokai region was suggested from the present study. We estimated that the CJD autopsy rate of the district was more than 50% over the past 7 years.
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PMID:[Epidemiologic study of Creutzfeldt-Jakob disease from autopsy-confirmed cases]. 1982 94

The use of blood donor history and state-of-the-art FDA-licensed serological and nucleic acid testing (NAT) assays have greatly reduced the "infectious window" for several transfusion-transmitted pathogens. Currently transmission of human immunodeficiency virus (HIV), Human T-cell Lymphotropic Virus (HTLV), hepatitis viruses and West Nile Virus are rare events. The seroprevalence of cytomegalovirus in the donor population is high and cytomegalovirus infection can cause significant complications for immunocompromised recipients of blood transfusion. Careful use of CMV seronegative blood resources and leukoreduction of blood products are able to prevent most CMV infections in these patients. Currently, bacterial contamination of platelet concentrates is the greatest remaining infectious disease risk in blood transfusion. Specialized donor collection procedures reduce the risk of bacterial contamination of blood products; blood culture and surrogate testing procedures are used to detect potential bacterially contaminated platelet products prior to transfusion. A rapid quantitative immunoassay is now available to test for the presence of lipotechoic acid and lipopolysaccharide bacterial products prior to platelet transfusion. Attention has now turned to emerging infectious diseases including variant Creutzfeldt-Jakob disease, dengue, babesiosis, Chagas' disease and malaria. Challenges are presented to identify and prevent transmission of these agents. Several methods are being used or in development to reduce infectivity of blood products, including solvent-detergent processing of plasma and nucleic acid cross-linking via photochemical reactions with methylene blue, riboflavin, psoralen and alkylating agents. Several opportunities exist to further improve blood safety through advances in infectious disease screening and pathogen inactivation methods.
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PMID:Approaches to minimize infection risk in blood banking and transfusion practice. 2130 41

The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989 to 2001, and the REDS-II, conducted from 2004 to 2012, were National Heart, Lung, and Blood Institute-funded, multicenter programs focused on improving blood safety and availability in the United States. The REDS-II also included international study sites in Brazil and China. The 3 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 xenotropic murine leukemia virus-related virus. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of human immunodeficiency virus, human T-lymphotropic virus 1/2, hepatitis C virus, hepatitis B virus, West Nile virus, cytomegalovirus, human herpesvirus 8, parvovirus B19, malaria, Creutzfeldt-Jakob disease, influenza, and Trypanosoma 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, 2 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 2 REDS programs. In 2011, a new 7-year program, the Recipient Epidemiology and Donor Evaluation Study-III, was launched. The Recipient Epidemiology and Donor Evaluation Study-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.
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PMID:The National Heart, Lung, and Blood Institute retrovirus epidemiology donor studies (Retrovirus Epidemiology Donor Study and Retrovirus Epidemiology Donor Study-II): twenty years of research to advance blood product safety and availability. 2263 82


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