The latest report Mapping the Global Future on US national security by the National Intelligence Council suggests that a major threat to the country right through to 2020 will be a terrorist biological weapons attack.1 Given the recent intelligence failures concerning biological weapons in Iraq, it might be considered that there are reasonable grounds for suspicion about that conclusion. This paper attempts to answer the question of what the real threat of bioterror is by reference to the open scientific literature. Section 2 of the paper discusses the nature of the agents of concern and in section 3 various potential attack scenarios are reviewed. The overall conclusion is that there are real threats from terrorists with the capability to carry out a range of attacks with biological agents today, but that these threats do not include the one most commentators probably have in mind when they discuss the issue ¿ a weapons of mass destruction scale of attack on people. In the final section of this paper the implications of the analysis for the risk questions we have been posed are addressed.

Yes

Thesis (PhD (Process Engineering))--University of Stellenbosch, 2010. / ENGLISH ABSTRACT: Biological agents offer several opportunities to address the many challenges faced in intensive reticulated aquaculture. We therefore isolated and selected Bacillus spp. as potential biological agents, because this group has demonstrated an array of biological activities of possible benefit to aquaculture. They also display advantages in terms of robustness during bioprocessing and end product application. Natural isolates obtained from Cyprinus carpio, selected as a model high-value ornamental fish species, and associated culture environments, were purified and assessed for in vitro efficacy based on the inhibition of growth of pathogenic Aeromonas hydrophila and the decrease in concentrations of ammonium, nitrite, nitrate and phosphate ions, typically found as waste products in aquaculture systems. Based on suitability for aquaculture application, isolates B001, B002 and B003 were selected and further evaluated in vitro and in an in vivo trial with C. carpio. Inhibition of Aer. hydrophila growth and a decrease in concentrations of waste ions were demonstrated in these studies. Based on 16S RNA sequence homology, the isolates were identified as Bacillus subtilis, B. cereus and B. licheniformis, respectively. High sequence homology between B. subtilis and B. anthracis necessitated further safety studies on the best isolate, B. cereus NRRL100132 (B002). The isolate was shown not to contain the anthrax virulence genes pOX1, pOX2 or the B. cereus enterotoxin. Elucidation of the potential modes of action of a biological agent facilitates an understanding of functionality and encourages technology uptake by end users. Competitive exclusion through growth rate and competitive uptake of glucose and iron, the latter facilitated by siderophore production, were shown to be key mechanisms at play in inhibition of Aer. hydrophila by the B. cereus isolate. As production cost is an important consideration in development of commercially relevant biological products, we examined the optimization of nutrient supplementation, which has an impact on high-density production of spores by fermentation. Corn steep liquor (CSL) was identified as a lower cost and more effective nutrient source in comparison to conventional nutrient substrates, in particular yeast extract and nutrient broth. The improved sporulation performance of B. cereus could be related to the increased availability of free amino acids, carbohydrates, and minerals in CSL, which had a positive effect on organism growth and sporulation efficiency. The impact of nutrient concentration on spore yield and productivity was modelled to develop a tool for selection of optimal conditions. Excellent correlation with actual laboratory fermentation data was demonstrated. A cost analysis revealed that production using liquid phytase treated and ultra-filtered CSL was less expensive than spray dried CSL and supported cultivation of B. cereus spores at densities higher than 1×1010 CFU ml 1. Adoption of biological agents in commercial applications is lacking, due to limitations in process and product development that address key end user product requirements such as cost, efficacy, shelf life and convenience. The development of suitable spore recovery, drying, formulation and tablet production process steps was thus performed. Key criteria used for downstream process unit evaluation included spore viability, recovery, spore balance closure, spore re-germination, product intermediate stability, end product stability and efficacy. A process flow sheet comprising vertical tube centrifugation, fluidised bed agglomeration and tablet pressing yielded an attractive product. The formulation included corn steep liquor and glucose to enhance subsequent spore re-germination. Viable spore recovery and spore balance closure across each of the process units was high (>70% and >99% respectively), with improvement in recovery possible by adoption of continuous processing at large scale. Spore re-germination was 97%, whilst a product half-life in excess of 5 years was estimated based on thermal resistance curves. The process resulted in a commercially attractive product and affordable variable cost of production. Functionality of the product, incorporating the B. cereus isolate, was investigated across a range of physiological conditions, including salinity, pH and temperature, based on rearing of C. carpio. Temperature had a significant influence on germination, specific growth rate and increase in cell number of B. cereus, whilst salinity and pH did not have any measurable effect on growth. Controlled studies in bioreactors and modelling of the data to the Arrhenius function indicated the existence of high and low growth temperature domains. The rates of pathogenic Aer. hydrophila suppression and decrease in waste ion concentrations (ammonium, nitrite, nitrate and phosphate) were translated into a linear predictive indicator of efficacy of the B. cereus isolate at different temperatures. This study has resulted in development of an upstream and downstream process for production of a new B. cereus isolate (NRRL 100132) which was shown to be safe, stable, functional, robust and cost effective for application in aquaculture. / AFRIKAANSE OPSOMMING: Biologiese middels bied verskeie maniere om die veelvoudige uitdagings van intensiewe netsgewyse akwakultuur aan te spreek. Gevolglik het ons uitgesoekte Bacillus spesies as potensiële biologiese middels geïsoleer, omdat hierdie groep verskeie biologiese aktiwiteite demonstreer wat van potensiële waarde kan wees in akwakultuur. Die groep toon ook voordele in terme van robuustheid gedurende bioprosessering en eind-toepassings. Natuurlike bakteriële isolate vanuit Cyprinus carpio geassosieerde kultuur omgewings, geselekteer as 'n hoë-waarde model ornamentele spesie, is gesuiwer. Die in vitro doeltreffendheid van die isolate is bepaal gebasseerd op die groei inhibisie van patogeniese Aeromons hydrophila asook die afname in konsentrasies van ammonium, nitriete, nitrate en fosfaat ione wat as tipiese afval produkte gevind word in akwakultuur sisteme. Isolate B001, B002 en B003 is geselekteer op grond van geskiktheid en verder evalueer in in vitro en in vivo proewe met C. carpio. Groei inhibisie van Aer. hydrophila asook 'n afname in konsentrasies van afval ione was tydens die studies gedemonstreer is. Die isolate is identifiseer as Bacillus subtilis, B. cereus en B. licheniformis, respektiewelik, op grond van 16S RNS volgorde homologie. Die hoë volgorde homologie tussen B. subtilis en B. anthracis het verdere veiligheidstudies op die beste isolaat, B. cereus NRRL100132 (B002) genoodsaak. Die isolaat het nie die antraks virulensie plasmied pOX1, pOX2 of die B. cereus enterotoksien getoon nie. Uitklaring van die potensiële meganismes van aksie van biologiese middels fasiliteer 'n begrip van funksionaliteit en moedig tegnologie aanvaarding deur eind-gebruikers aan. Mededingende uitsluiting deur groeitempo en mededingende opname van glukose asook die produksie van siderofore is bewys as sleutel meganismes betrokke in die inhibisie van Aer. hydrophila deur die B. cereus isolaat. Aangesien koste 'n belangrike oorweging is in die ontwikkeling van kommersiële toepaslike biologiese produkte, is die optimisering van voedingstof aanvullings wat 'n impak het op hoëdigtheid produksie van spore deur fermentasie ondersoek. Week-vloeistof van mielie prosessering (CSL) is identifiseer as 'n lae koste en effektiewe voedingsbron in vergelyking met konvensionele voeding substrate, veral gisekstrak en voedingsboeljon. Die verbeterde sporulering prestasie van B. cereus kon toegeskryf word aan die verhoogde beskikbaarheid van vrye aminosure, koolhidrate en minerale in CSL, wat 'n postitewe effek op organisme groei en sporulerings effektiwiteit getoon het. Die impak van voedingstof konsentrasie op spoor opbrengs en produktiwiteit is gemodelleer om 'n werktuig vir die selektering van optimale kondisies te ontwikkel. Uitstekende korrelasie met werklike laboratorium data is gedemonstreer. Koste analises het getoon dat produksie deur middel van vloeibare fitase-behandelde en ultra-filtreerde CSL goedkoper is as sproei-gedroogde CSL en ondersteun verder die kultivering van B. cereus spore teen digthede hoër as 1 x 1010 kolonie vormende eenhede.ml-1. Die opname van biologiese middels in kommersiële toepassings skiet tekort as gevolg van beperkinge in proses en produk ontwikkeling wat belangrike eind-gebruiker vereistes soos koste, doeltreffendheid, rak leeftyd en gerieflikheid aanspreek. Die ontwikkeling van toepaslike prosesse vir spoor herwinning, droging, formulering en tablet produksie is gevolglik uitgevoer. Belangrike maatstawwe wat gebruik is vir stroomaf proseseenheid-ontwikkeling het lewensvatbaarheid, herwinning, spoor balans sluiting, spoor her-ontkieming, intermediêre produk stabiliteit, eindproduk stabiliteit en doeltreffendheid ingesluit. 'n Proses vloeidiagram bestaande uit vertikale buis sentrifugasie, vloeibare bed agglomerasie en tablet persing het 'n aantreklike produk voortgebring. Die formulering het ook CSL en glukose ingesluit om gevolglike spoor herontkieming te verbeter. Lewensvatbare spoor herwinning en spoor balans sluiting oor elke proses eenheid was hoog (>70% en 99% respektiewelik) met verbetering in herwinning wat moontlik gemaak is deur die gebruik van aaneenlopende prosessering op groot skaal. Spoor her-ontkieming was 97%, terwyl produk halfleeftyd langer as 5 jaar beraam is, gebasseer op termiese weerstand grafieke. Die proses het gelei tot 'n kommersiële aantreklike produk asook bekostigbare veranderbare produksie koste. Die funksionaliteit van die tablet-produk met die ingeslote B. cereus isolaat is ondersoek oor 'n reeks fisiologiese kondisies insluitend soutgehalte, pH en temperatuur, gebasseer op die kultivering van C. carpio. Temperatuur het 'n betreklike invloed op ontkieming, spesifieke groeitempo en toename in sel hoeveelheid van B. cereus gehad, terwyl soutgehalte en pH nie enige meetbare effek op groei gehad het nie. Gekontrolleerde studies in bioreaktors en modellering van die data op die Arrhenius funksie het hoë en lae groei temperatuur domeins gewys. Die tempo van patogeniese Aer. hydrophila onderdrukking en afname in konsentrasies van afval-ione (ammonium, nitriete, nitrate en fosfaat) is herlei na 'n liniêre voorspellende aanwysing van effektiwiteit van B. cereus isolate by verskillende temperature. Die studie het gelei tot die ontwikkeling van stroomop- en stroomaf-prosesse vir die produksie van 'n nuwe B. cereus isolaat (NRRL 100132) wat bewys is as veilig, stabiel, funksioneel, robuust en koste effektiewe vir toepassing in akwakultuur.

CHDS State/Local / Approved for public release; distribution is unlimited / The concept of biosecurity as it pertains to Biological Select Agents and Toxins in American biomedical research institutions is explored in some depth. Posing the research question "How can specific public biomedical research universities securely use and store biological select agents?" the thesis outlines the dynamics of the select agent and toxin list, the relevant history of the control of biological agents both in the international and domestic settings, including federal regulations pertaining to biosecurity (42CFR73). Two specific case studies are presented in the thesis. The biosecurity strategies and tactics at these two distinct biomedical research are compared. An answer to the research question is proposed and additional areas for research are outlined. / Captain, the University of Texas at Houston Police Department

Os trabalhadores de enfermagem são expostos a riscos biológicos que podem causar-lhes adoecimento e/ou acidente de trabalho. Diante dessa realidade em vários países, e considerando que a adesão de muitos profissionais às condutas pós-exposição a material biológico, potencialmente contaminado, ainda não é satisfatória, buscou-se, na literatura nacional e internacional, instrumentos validados que quantificassem as variáveis psicossociais envolvidas no comportamento em saúde e, em especial, a adesão às condutas pós-exposição ocupacional a material biológico, internacionalmente recomendadas, necessárias à prevenção das infecções advindas dessa exposição ocupacional. Diante da inexistência de instrumentos brasileiros, validados, que abordassem as condutas pós- exposição a material biológico, selecionamos um instrumento chinês, estruturado no referencial da Teoria do Comportamento Planejado, para traduzi-lo e adaptá-lo para uso em nosso país. Assim, este estudo metodológico, quantitativo teve como objetivo traduzir, adaptar culturalmente e validar para Brasil o instrumento Comply with post-exposure management among health care workers, que avalia a intenção de cumprir as condutas pós- exposição ocupacional a material biológico. Trata-se de um instrumento autoaplicável, composto por questões de caracterização e dimensões relacionadas aos constructos da Teoria do Comportamento Planejado, distribuídas em 61 itens com opções de resposta em escala tipo Likert, específicas para cada uma das seis subescalas (Atitude, Normas Subjetivas, Conhecimento, Autoeficácia, Recursos e Intenção). O processo de adaptação seguiu as diretrizes recomendadas pela literatura. O estudo foi aprovado quanto aos aspectos da ética em pesquisa (Protocolo no 041/12). Os dados foram coletados em seis hospitais da cidade de Uberlândia, Minas Gerais, em amostra de 137 profissionais de enfermagem expostos a material biológico, sendo 119 técnicos de enfermagem (86,9%) e 18 enfermeiros (13,1%). Foi verificada a existência dos efeitos floor e ceiling e a fidedignidade foi avaliada pela consistência interna dos itens e pela estabilidade da medida (teste-reteste). A validade de construto foi avaliada por meio da análise multitraço-multimétodo. O valor do nível de significância adotado foi de 0,05. Foram verificados efeitos ceiling nas subescalas Autoeficácia e Intenção. Em relação às propriedades psicométricas, os resultados obtidos foram: consistência interna verificada pelo coeficiente alfa de Cronbach para as subescalas Atitude, Normas Subjetivas, Autoeficácia, Recursos e Intenção, com valores variando entre 0,81 e 0,91, resultados considerados satisfatórios e para a subescala Conhecimento, avaliada pelo coeficiente de Kuder-Richarson (0,37), considerado insatisfatório. A avaliação da estabilidade da medida obteve resultados positivos em relação à significância estatística, com valores do Coeficiente de Correlação Intraclasse, entre as duas medidas, variando de 0,301 a 0,727; a validade de construto convergente e divergente foi confirmada por meio da análise multitraço-multimétodo, com exceção da subescala Atitude, que apresentou valores insatisfatórios. Assim, podemos concluir que a versão adaptada do instrumento \"Adesão às Condutas Pós-Exposição entre Trabalhadores de Saúde\", para a realidade brasileira, apresenta resultados satisfatórios de validade e fidedignidade, excluindo-se a dimensão Atitude. Assim, após a redefinição da referida subescala com os autores do instrumento original, outros estudos devem ser realizados com amostras maiores. Este estudo resultou em novos conhecimentos científicos relevantes à prevenção do adoecimento de trabalhadores, relacionado às infecções veiculadas por material biológico potencialmente contaminado. / Nursing workers are exposed to biological risks that can cause occupational illness and/or accidents. In view of this reality in different countries, and considering that many professionals\' adherence to the conducts post-exposure to potentially contaminated biological material remains unsatisfactory, a search was undertaken in Brazilian and international literature for validated instruments to quantify the psychosocial variables involved in health behavior, and particularly in the adherence to internationally recommended conducts post-occupational exposure to biological material, necessary to prevent the infections originating in this occupational exposure. In view of the lack of Brazilian validated instruments focused on conducts post-exposure to biological material, we selected a Chinese instrument, structured in the framework of the Theory of Planned Behavior, for translation and adaptation to be used in Brazil. Hence, the objective in this methodological, quantitative study was to translate, culturally adapt and validate the instrument Comply with post-exposure management among health care workers for Brazil, which assesses the intention to comply with conducts post-occupational exposure to biological material. This self-applied instrument consists of characterization questions and dimensions related to the constructs of the Theory of Planned Behavior, distributed into 61 items with specific Likert-scale response alternatives for each of the six subscales (Attitude, Subjective Standards, Knowledge, Self-Efficacy, Resources and Intention). The adaptation process followed the guidelines recommended in the literature. The study received ethical clearance (Protocol 041/12). The data were collected at six hospitals in Uberlândia, Minas Gerais, in a sample of 137 nursing professionals exposed to biological material, including 119 nursing technicians (86.9%) and 18 nurses (13.1%). The existence of floor and ceiling effects was verified and the reliability was assessed through the internal consistency of the items and the stability of the measure (test-retest). The construct validity was assessed using the multitrait-multimethod analysis. Significance was set at 0.05. Ceiling effects were verified in the Self-efficacy and Intention subscales. As regards the psychometric properties, the obtained results were: internal consistency verified using Cronbach\'s alpha for the subscales Attitude, Subjective standards, Self-efficacy, Resources and Intention, ranging between 0.81 and 0.91, which are considered satisfactory, and for the Knowledge subscale, assessed using Kuder-Richarson\'s coefficient (0.37), considered unsatisfactory. The stability assessment of the measure found positive results for the statistical significance, with Intraclass Correlation Coefficients between the two measures ranging between 0.301 and 0.727; the convergent and divergent content validity was confirmed through the multitrait-multimethod analysis, except for the Attitude subscale, with unsatisfactory coefficient. Hence, it can be concluded that the adapted version of the instrument \"Adesão às Condutas Pós-Exposição entre Trabalhadores de Saúde\", for application in the Brazilian reality, presents satisfactory validity and reliability results, excluding the Attitude dimension. Hence, after redefining the subscale with the authors of the original instrument, further research is needed using larger samples. This study resulted in new scientific knowledge that is relevant to prevent occupational illness related to infections caused by potentially contaminated biological material.

Teve como objetivo estudar os riscos ocupacionais em profissionais da equipe do Atendimento Pré-Hospitalar móvel (APH) com ênfase nos acidentes com material potencialmente contaminado, desenvolvido em duas etapas. A primeira teve como objetivo identificar a exposição acidental a fatores de riscos ocupacionais em profissionais da equipe de saúde no APH móvel, no período de 2000 a 2005 e a segunda teve como objetivo analisar a exposição acidental a material biológico potencialmente contaminado (mbpc), em profissionais da equipe de saúde de APH móvel de uma empresa privada de APH móvel, do interior paulista, que realiza atendimento tanto na área urbana quanto nas rodovias. Na primeira etapa realizou-se pesquisa descritiva documental com dados obtidos de 4992 Fichas de Atendimento Rodoviário e das notificações dos Serviços Especializados em Engenharia de Segurança e Medicina do Trabalho - SEESMT, e na segunda realizou-se um estudo descritivo, exploratório, através de entrevista semi estruturada em 50 profissionais da equipe de APH móvel envolvendo bombeiros, enfermeiros, médicos, técnicos de enfermagem e motoristas de ambulância. O projeto obteve aprovação do Comitê de Ética em Pesquisa. Os dados foram analisados em Epi Info versão 3.4.3. Na primeira etapa foram detectadas 54 exposições aos riscos ocupacionais, dos quais apenas seis foram notificadas ao SEESMT. Entre os os riscos ocupacionais destacou-se o risco de acidente (64,8%), seguidos de situação não ergonômicas (16,7%) e riscos biológicos (9,2%). Na segunda etapa da pesquisa, de uma amostra de 50 profissionais da equipe de Atendimento Pré Hospitalar, a maioria (94,4%) apresentava faixa etária entre 20 e 50 anos; sexo masculino (84%); atuação na área de seis 06 a 60 meses (56%); apresentava esquema de vacinação contra HBV (92%). Dos profissionais entrevistados (56%) referiu exposição acidental ao material biológico potencialmente contaminado, perfazendo um total de 41 acidentes. Das exposições acidentais ao mbpc (70,7%) acometeu pele íntegra; (17,1%) o percutâneo; (7,3%) a mucosa; e (4,9%) a pele lesada. As áreas do corpo mais expostas ao mbpc foram antebraço (41,5%); braço (21,9%), e mão (21,9%). As exposições Andrea Alves Soerensen 9 acidentais com mbpc ocorreram em sua maioria ao realizar procedimentos de imobilização (39%), extricação (21,9%), exame físico (19,9%). O sangue foi o material biológico mais freqüente nas exposições (85%). Quanto a utilização do Equipamento de Proteção Individual no momento do acidente, a maioria fazia uso de macacão de brim (95%), botas de cano alto (90,2%) e luvas de procedimentos (63,4%). A conduta mais freqüente pós-exposição acidental foi a procura da consulta média (29,3%); realização de sorologias (17,1%). A maioria não registrou o acidente de Trabalho (78,1%). As situações favorecedoras que mais contribuíram para as exposições acidentais ao mbpc foram: emergência (46,4%); agitação do paciente (28,6%); operações de resgate (25%); distração (21,4%); estresse (17,9%) e presença de grande volume de material biológico potencialmente contaminado (14,3%). A maioria do entrevistados sugeriu medidas para prevenção de acidentes com mbpc. Os resultados do estudo, sugestões dos entrevistados e revisão de literatura subsidiaram propostas gerais aplicadas aos profissionais da saúde, e as específicas ao APH móvel, para prevençao e controle de acidentes com mbpc / This research aimed to study occupational risks in Mobile Prehospital Care (MPC) team professionals, emphasizing accidents with potentially contaminated material, and was developed in two phases. In the first, the goal was to identify accidental exposure to occupational risk factors in health team professionals working in MPC between 2000 and 2005. The second aimed to analyze accidental exposure to potentially contaminated biological material (pcbm) among health team professionals in MPC working for a private MPC company in the interior of São Paulo state, Brazil, which is active in the urban area and on highways. In the first phase, a descriptive documentary research was performed, using data obtained from 4992 Highway Care Records and notifications presented to Specialized Safety Engineering and Occupational Medicine Services SEESMT. In the second phase, a descriptive-exploratory study was carried out, using semi-structured interviews with 50 professionals from the MPC team, involving firefighters, nurses, physicians, nursing technicians and ambulance drivers. The project was approved by the Research Ethics Committee. Data were analyzed using Epi Info software, version 3.4.3. In the first phase, 54 cases of exposure to occupational risks were detected, only six of which were notified to the SEESMT. Among occupational risks, accident risks stood out (64.8%), followed by nonergonomic situations (16.7%) and biological risks (9.2%). In the second phase, in a sample of 50 MPC team professionals, a majority (94.4%) was between 20 and 50 years old; male (84%); active in the area between 06 and 60 months (56%); vaccinated against HBV (92%). Among the interviewees, (56%) indicated accidental exposure to pcbm, totaling 41 accidents. Of all cases of accidental exposure to pcbm, (70.7%) affected integral skin; (17.1%) percutaneous tissue; (7.3%) mucous tissue; and 4.9% injured skin. The body areas most exposed to the pbcm were forearm (41.5%); arm (21.9%) and hand (21.9%). Most cases of accidental exposure to pbcm occurred while performing immobilization (39%), extraction Andrea Alves Soerensen 11 (21.9%) and physical examination (19.9%) procedures. Blood was the most frequent biological material involved in exposures (85%). As to the use of Individual Protection Equipment at the moment of the accident, most professionals were wearing denim overalls (95%), long boots (90.2%) and procedure gloves (63.4%). The most frequent conduct after the accidental exposure was the search for a medical appointment (29.3%) and blood tests (17.1%). Most professionals did not file an Occupational Accident register (78.1%). The situations that most contributed to accidental exposure to pcbm were: emergency (46.4%); patients agitation (28.6%); rescue operations (25%); distraction (21.4%); stress (17.9%) and the presence of a large volume of potentially contaminated biological material (14.3%). Most interviewees suggested pcbm accident prevention measures. The study results, the interviewees suggestions and a literature review served as the base for general proposals applied to health professionals, as well as specific proposals for MPC, with a view to the prevention and control of pcbm accidents

RESUMO A exposição ocupacional aos fluidos biológicos é inerente ao trabalho desempenhado pela equipe de enfermagem durante a realização da assistência, tornando o trabalhador susceptível a ocorrência de acidentes e exposto aos fluidos corporais que podem conter diferentes patógenos causadores de doenças como HIV, Hepatite B e C. Trata-se de um estudo de natureza qualitativa que objetivou compreender a experiência do acidente com fluido biológico e da assistência prestada aos trabalhadores de enfermagem, considerando suas necessidades de cuidado. Foram realizadas entrevistas individuais a partir da seguinte questão norteadora: Conte-me como foi para você ter se acidentado com fluido biológico?. Os discursos foram analisados à luz do Referencial de Martin Heidegger onde surgiram as seguintes Unificações Ontológicas: Ser no mundo vivenciando a acidente com fluido biológico; A angústia por ter se acidentado com fluido biológico; As necessidades manifestas pelas trabalhadoras de enfermagem após o acidente com material biológico: vivenciando o cuidado autêntico; Vivenciando o cuidado inautêntico e a impessoalidade após o acidente de trabalho com material biológico; Superação e reorganização do trabalho por meio da transcendência. Os resultados demonstram que após o acidente com fluido biológico as trabalhadoras vivenciam a angústia e a assistência à trabalhadora acidentada é efetiva quanto ao acompanhamento clínico e ambulatorial por meio do protocolo de atendimento, porém ele não aborda questões consideradas fundamentais no ponto de vista do sujeito que sofre o acidente. / Occupational exposure to biological fluids is inherent in the work performed by the nursing staff during the implementation of assistance, making the worker liable to accidents and exposed to body fluids that may contain various pathogens causing diseases like HIV, Hepatitis B and C. This is a qualitative study that aimed to understand the experience of the accident with biological fluid and assistance to the nursing staff, considering their care needs. Individual interviews were conducted with the following question: \"Tell me how it was for you to have crashed with biological fluid?. The reports were analyzed in the light of Martin Heidegger Referential where Ontological Unifications following emerged: Being in the world experiencing the accident with biological fluid ; The anguish because you are injured in biological fluid ; The manifest need for nursing workers after the accident with biological material : experiencing authentic care ; Experiencing care inauthentic and impersonality after work accident with biological material ; Resilience and reorganization of work through transcendence . The results show that after the accident with biological fluid workers experience distress and assisting rugged working is effective for clinical and outpatient follow- through care protocol, but it does not address fundamental issues considered in view of the individual who suffers the accident.

A prática odontológica expõe pacientes e profissionais a numerosos microorganismos e infecções. A transmissão pode ocorrer via sangue, saliva ou partículas dispersas no ar e por meio de contato direto ou indireto via instrumentos ou superfícies contaminadas. Assim, é necessário se utilizar precauções universais e procedimentos de controle de infecção para proteger tanto profissionais quanto pacientes. Na radiologia odontológica, como não há produção de aerosóis, muitos profissionais menosprezam os cuidados com a biossegurança. Nosso objetivo neste trabalho foi de alertar os profissionais com relação ao risco de contaminação cruzada por meio de todos os equipamentos envolvidos nos procedimentos radiológicos e apresentar medidas efetivas para controle de infecção cruzada por meio de um protocolo de biossegurança para uso em radiologia odontológica. / Patients and dentists are exposed to many different microorganisms and infections in dental practice. Infection may occur through the blood, saliva or airborne particles, as well as direct or indirect contact with contaminated instruments or surfaces. Thus, it is necessary to follow universal precautions and infection control procedures to protect both the dentist and the patient. Because there is no production of aerosol particles in oral radiology, many specialists ignore biosafety procedures. The purpose of this study was to warn specialists of the risk of cross contamination through the equipment used in radiology, as well as to propose effective measures for the control of cross infection, developing a biosafety protocol to be adopted in oral radiology.

Trata-se de pesquisa descritiva, quantitativa com objetivo de analisar os riscos ocupacionais e acidentes em profissionais de enfermagem da saúde coletiva, com ênfase no material biológico - MB. Teve como local de estudo os municípios de um Colegiado de Gestão Regional do Estado de São Paulo, Brasil e foi desenvolvida em duas fases. Na primeira, os dados foram extraídos das fichas de notificação de acidentes do período de agosto de 2006 a agosto de 2011. Na segunda, foram coletados por meio de entrevista realizada com 158 profissionais. Os dados digitados foram transportados para análise no programa SPSS versão 16.0. Nas fichas de notificação, verificou-se registro de 30 acidentes, notificados por 30 profissionais; 90% ocorreram por exposição a MB, 6,7% por quedas e 3,3% por mordedura de animal doméstico. Na entrevista, 56 profissionais mencionaram ocorrência de um ou mais tipos de acidentes de trabalho no período de 2006 a 2011, sendo que 45 relataram acidentes com MB, oito com cortes e perfurações com material limpo, cinco quedas, quatro acidentes de trajeto e dois, outros tipos. No total, foram 74 acidentes com MB relatados por 45 profissionais: 50 percutâneos, 19 em pele íntegra, quatro em mucosas e um em pele lesada. A maior parte se deu por exposição ao sangue (91,9%); durante remoção de punção venosa (16,2%). Em 67,6% dos casos, os profissionais não utilizavam equipamentos de proteção individual, embora 77% afirmassem que os tinham à disposição. Em 50% dos acidentes com MB o profissional não procurou atendimento ou este não foi prestado; em 9,5% a conduta foi consulta médica, realização de exames no profissional e teste rápido no paciente-fonte e em 70,3% não houve interesse ou não foi indicado seguimento. Em 73% das exposições os profissionais realizaram práticas adequadas em relação ao local atingido; 63,5% dos acidentes não foram notificados de forma oficial, falha evidenciada também pela diferença entre o número de acidentes notificados nas fichas e obtidos na entrevista. Todos os profissionais mencionaram a existência de riscos para saúde no trabalho, o mais citado foi o biológico (sangue, microrganismos e fluidos corpóreos). A maioria (98,7%) dos profissionais apresentava esquema de vacinação completo contra hepatite B; 19,6% possuíam conhecimento sobre normas de prevenção de acidentes no trabalho, 20,9% sobre a existência de um protocolo de condutas pós-exposição a MB, 58,2% sobre os procedimentos com o local do corpo afetado e 62,6% sobre a notificação. A maioria (77,9%) informou não ter recebido treinamento sobre acidentes com MB e medidas de precaução, durante o tempo de experiência na enfermagem, o que pode ter influenciado a baixa adesão referida a algumas medidas. Este estudo detectou vários motivos que propiciaram os profissionais sofrerem acidentes de trabalho, destacando-se os relacionados a fatores materiais, individuais/comportamentais e institucionais. O problema deve ser investigado nas diferentes realidades vivenciadas por trabalhadores de enfermagem para que se possa garantir redução de riscos e acidentes a estes profissionais. Esses dados e a revisão de literatura subsidiaram propostas de prevenção e controle de acidentes com MB, bem como elaboração de um protocolo pós-exposição. / The objective of this descriptive and quantitative study was to analyze occupational risks and accidents among nursing workers in the collective health field with a focus on biological material - BM. The study\'s setting included the cities participating in a Committee of Regional Management in the state of São Paulo, Brazil and was developed in two phases. In the first phase, data were collected from the accident report forms from August 2006 to August 2011. Interviews were held with 158 workers in the second phase. Data were then analyzed in the SPSS, version 16.0. The accident report forms revealed that 30 workers reported 30 accidents; 90% involved exposure to BM, 6.7% involved falls, and 3.3% domestic animal bite. In the interview, 56 workers reported the occurrence of one or more types of occupational accidents from 2006 to 2011: 45 reported accidents with BM, eight with cuts and perforations with clean material, five reported falls, four reported commuting accidents and two reported other types of accidents. A total of 74 accidents with BM were reported by 45 workers; 50 of which with cutting-piercing material, 19 in intact skin, four in mucosal and one in injured skin. Most was exposed to blood (91.9%) during venipuncture removal (16.2%). In 67.6% of the cases the professionals were not wearing individual protection equipment, though 77% stated that there was available. In 50% of the accidents with BM, the professional did not seek or did not receive any type of care; in 9.5% of the cases the worker attended a medical consultation, took exams or performed a rapid testing on the source patient; 70.3% reported not being referred to follow-up or had no interest in follow-up. In 73% of the exposures, the workers took appropriate actions in relation to the affected site; 63.5% of the accidents were not officially reported. Such failure in reporting accidents is verified in the difference between the number of accidents reported in the forms and those reported in the interviews. All the professionals reported the occupational risks to health and the most frequently mentioned was the biological risk (exposure to blood, microorganisms, and body fluids). Most (98.7%) professionals were fully immunized against Hepatitis B; 19.6% had knowledge concerning occupational accidents prevention; 20.9% were aware of a protocol for BM post-exposure prophylaxis; 58.2% knew the procedures to be follow concerning the affected site; and 62.6% were aware of accident report forms. Most (77.9%) reported no training concerning BM accidents and precaution measures was provided during their nursing experience, which may have led to the workers\' low adherence to some measures. This study revealed the various reasons that led workers to suffer occupational accidents, among which material, individual/behavioral and institutional factors. Such reasons should be investigated in the different contexts experienced by nursing workers so to minimize occupational risks and accidents. These data and literature review supported propositions of prevention actions and control of accidents with BM as well as the development of a post-exposure protocol.

Submitted by Priscila Nascimento (pnascimento@icict.fiocruz.br) on 2012-11-12T16:41:28Z No. of bitstreams: 1 marli-melo-da-silva.pdf: 1647102 bytes, checksum: c7302fa37032bf7ffbdd181c59e1eba8 (MD5) / Made available in DSpace on 2012-11-12T16:41:28Z (GMT). No. of bitstreams: 1 marli-melo-da-silva.pdf: 1647102 bytes, checksum: c7302fa37032bf7ffbdd181c59e1eba8 (MD5) Previous issue date: 2005 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil. / As vacinas estão entre os produtos biológicos mais seguros, eficazes e com maior relação custo-benefício, pois têm permitido a erradicação de várias doenças imunopreveníveis. Porém, não são absolutamente inócuas e freqüentemente estão associadas a eventos adversos, nem sempre detectados nos estudospré-clínicos e clínicos. Vacinação é uma intervenção médica, da qual se espera um elevado padrão de segurança e efetividade: por serem as vacinas aplicadas em pessoas saudáveis e de forma compulsória, em contraste com outros medicamentos, a aceitação a eventos adversosse torna consideravelmente mais baixa. Com a finalidade de assegurar a qualidade e a segurança de vacinas e soros, em resposta a algumas crises e tragédias ocorridas na saúde pública, tem início no século XX, nos Estados Unidos a regulação de produtos biológicos, sendo, oincidente com o Laboratório Cutter (Cutter Incident), na década de 50, considerado como marco no surgimento da farmacovigilância, exigindo o estabelecimento de sistemas de vigilância de eventos adversos, tanto por parte das agências regulatórias quanto dosetor industrial. Nesse cenário, este trabalho tem por objetivo contribuir com proposta para aperfeiçoar e consolidar o sistema de monitoramento de eventos adversos pós-comercialização de vacinas em Bio-Manguinhos. Para atender os objetivos propostos, foram realizadas consultas a materiais impressos, como livros e relatórios não publicados, e meios eletrônicos para consulta, como por exemplo, aos portais eletrônicos de sistemas regulatórios nacional e internacional; entrevistas com gestores e ex-gestores de Bio-Manguinhos e do Programa Nacional de Imunizações (PNI); e visita a uma empresa farmacêutica privada, visando a obtenção de informações que levassem ao conhecimento e à análise crítica da vigilância pós-comercialização de vacinas. Dentre os resultados, observou-se que, apesar da vigilância pós-comercialização ser, há vários anos, uma exigência regulatória, países desenvolvidos como Estados Unidos, já possuem sistemas operando, enquanto que, países em desenvolvimento, como Brasil, ainda estão implantando seus sistemas. A ANVISA, Autoridade Regulatória Nacional, criada em 1999, ainda, não monitora eventos adversos pós-vacinação, sendo esta atividade realizada, apenas, pelo PNI. No ano de 2000, Bio-Manguinhos, unidade da Fiocruz produtora de vacinas e um dos principais fornecedores de vacinas ao Ministério da Saúde, criou setor para responder aos questionamentos e investigar, em conjunto com o PNI, eventos adversos associados aos seus produtos. Esta atividade, entretanto, vem sendo realizada de forma não sistematizada, sem orientação adequada aos participantes do processo. Estes fatos constituíram-se fundamentais para a elaboração da proposta para a Instituição, apresentada neste trabalho, que poderácontribuir para reduzir a descentralização das informações relacionadas a eventos adversos, aumentar o nível de conhecimento e participação de todos os envolvidos no processo, sobretudo na geração de informações relevantes tanto para a segurança dos produtos comercializados quanto para formulação de respostas para o público, clientes, profissionais de saúde e Autoridade Regulatória Nacional, contribuindo assim para o reconhecimento da importância desta atividade na área de vacinas. / Vaccines are among the safest, effective and largercost-benefit biological products, because they have been allowing eradication of several vaccine preventable diseases. However, vaccines are not quite innocuous and they are frequently associated to adverse events. Pre-clinical and clinical trials do not always detect all possible adverse events and reactions. Vaccination is a medical intervention of high safety and effectiveness patterns expectation, as they are compulsorily applied in healthy people, incontrast with drugs, it makes acceptance considerably lower to the adverse events. Although much has been concerned about adverse reactions since the antiquity, regulation of biological products only had began in the 20 th century in the United States, with the purpose of assuring purity and safety of vaccines and serums, in response to the crises and tragedies occurred in public health. But the incident that happened in the 50s with the Cutter Laboratory – Cutter Incident – can be considered a starting point in Pharmacovigilance. This study aims to analyze the post-marketing surveillance system activities for adverse events and also to contribute for consolidation of these activities in Bio-Manguinhos. In order to assure the quality and safety of vaccines and sera in response to some public health crises and tragedies, in the beginning of 20 th century, the regulation of biological products has been started in the United States being Cutter Incident, in the 50s, the starting point of pharmacovigilance. This has demanded the establishment of adverse events surveillance systems, not only for regulatory agencies but also for industrial sector. In this scenario, this study aims to contribute with proposal to improve and consolidate, in Bio-Manguinhos, the monitoring system of post-marketing vaccines adverse events. In order to meet proposed aims, printed materials like books, unpublished reports, and electronic media like homepages of national and international regulatory systems have been referred to; current and former managers of Bio-Manguinhos and the National Program of Immunization (PNI) havebeen interviewed; and a private pharmaceutical company has been visited in order tocollect information that would lead to knowledge and critical analysis of the post-marketing surveillance. Among the results, it was observed that, although post-marketing surveillancehas been a regulatory requirement for many years, in developed countries like the United States, developing countries like Brazil, their systems are still being implemented. ANVISA, National Regulatory Authority, created in 1999, has not monitored post-vaccination adverseevents yet. This activity has been performed by PNI only. In 2000, Bio-Manguinhos, vaccine manufacturer unit of Fiocruz and one of the main suppliers of the Ministry of Health, created a sector to respond to questions and investigate, with PNI, adverse events related to its products. These facts have been fundamental for elaborating a proposal for the institution, presented in this work, which may contribute to reduce the decentralization of information related to adverse events and increase the level of knowledge and participation of everyone involved in the process, especially in the generation of information that are relevant not only for the safety of products but also for the answers to the public, clients, health workers and the National Regulatory Authority. It may contribute to the recognition of the importance of this activity in the area of vaccines.