Introdução: A existência de uma relação importante entre o uso de produtos para a assistência à saúde e a ocorrência de infecções, torna prioritário estabelecer medidas eficazes de processamento daqueles passíveis de reuso.O Centro de Material e Esterilização (CME) tem como missão fornecer produtos para saúde (PPS) seguramente processados, ou seja, limpos, desinfetados ou esterilizados, livres de biofilmes, de endotoxinas, de proteínas priônicas e de substâncias tóxicas, e ainda funcionalmente efetivos.No Brasil, o CME tem as suas Boas Práticas regulamentadas por legislação federal da Agência Nacional de Vigilância Sanitária desde 15/03/2012 por meio da Resolução da Diretoria Colegiada (RDC) nº 15. Expirado o prazo de 24 (vinte e quatro) meses contados a partir da data de sua publicação para que os CME fizessem as adequações necessárias, pode-se inferir que muitos dos serviços de saúde e das empresas processadoras abrangidos por esta Resolução não conseguiram atender integralmente as exigências legais. Analisando a RDC ANVISA nº 15, nem todos os itens se encaixam no mesmo nível desegurança para os PPS processados,ou seja, numa situação de inspeção sanitária as inconformidades não devem ser consideradas com a mesma gravidade. Apresente análise das inconformidades do Centro de Material e Esterilização com base na RDC ANVISA nº15/2012 para julgamento da gravidade validada por especialistaspoderá subsidiaro gestor do CME na priorização de planos de ação junto à administração do Estabelecimento de Saúde para tornar o serviço conforme com a legislação vigente. Objetivo: Analisar asinconformidades apresentadas pelo CME, com base na RDC ANVISA nº15/2012 para julgamento da gravidade esubmeter a validação por especialistas. Materiais e métodos: Tratou-se deuma pesquisa metodológica, que consistiu na atribuiçãode gravidade para 132 inconformidades em relação ao não cumprimento de 89 itens da RDC ANVISA nº 15/2012. Atribuiu-se gravidadealtapara itens da lei cujo não cumprimento comprometia a segurança do processamento seguro do PPS, ou baixa para itens que permitiam um tempo maior para adequação às exigências legais, sem comprometimento do processamento seguro do PPS.Posteriormente, a atribuição da gravidade foi validada por um grupo de 14 especialistas por meio da técnica Delphi, em duas rodadas.Resultados: Das 132 inconformidades referentes ao não cumprimento dos artigos da RDC ANVISA nº15/2012, julgou-se 108 inconformidades como gravidade alta referentes à infra-estrutura, aos equipamentos, aos processos de limpeza, de inspeção, de preparo, de acondicionamento, de desinfecção, de esterilização, de monitoramento da esterilização e do transporte, que poderiam comprometer a segurança do PPS, 105 validadas pela concordância acima de 70% dos juízes especialistas. Julgou-se como gravidade baixa 24 inconformidades; destas, 13 foram validadas, com consenso de mais de 70%, que se referiram à saúde ocupacional, à climatização, à estrutura física e aos equipamentos e 11 não obtiveram a concordância no percentual necessário para validação. Estes itens não validados referiram-se à climatização, à separação de áreas limpas e sujas, à desinfecção química, à qualidade da água de enxágue de PPS, à atribuição do CPPS e ao CME classe I processando materiais complexos. Conclusão: Para as 132 inconformidades referentes ao não cumprimento de 89 artigos da RDC ANVISA nº15/2012, validou-se 118 inconformidades quanto ao grau de gravidade atribuído 105 como gravidade alta e 13 como gravidade baixa. Das inconformidades elencadas como sendo de gravidade baixa, 11 não obtiveram a concordância no percentual necessário para validação. Evidenciou-se lacunas de conhecimento científico na área de processamento de produtos para saúde, como a influência do diferencial de pressão na área de limpeza de PPS como fator de segurança para os profissionais, e o efeito do desgaste/abrasão do PPS limpo com material abrasivo na facilitação da adesão de biofilmes. / Introduction: The existence of an important relationship between the use of products for health care and the occurrence of infections makes it a priority to establish effective measures for the processing of those that can be reused. The purpose of the Material and Sterilization Center (CME) is to provide safely processed, cleaned, disinfected or sterilized health products (PPS) free from biofilms, endotoxins, prion proteins and toxic substances, and still functionally effective . In Brazil, the CME has its Good Practices regulated by federal legislation of the National Sanitary Surveillance Agency since 03/15/2012 through the Resolution of the Collegiate Board of Directors (RDC) No. 15. The term of twenty-four (24) month, counted from the date of its publication for the CME to make the necessary adjustments, it can be inferred that many of the health services and processing companies covered by this Resolution have not been able to fully meet the legal requirements. Analyzing RDC ANVISA No. 15, not all items fit the same level of safety for the processed PPS, that is, in a sanitary inspection situation, nonconformities should not be considered with the same seriousness. The present analysis of the nonconformities of the Center of Material and Sterilization based on the ANVISA RDC nº15 / 2012 for severity validated by specialists can subsidize the CME manager in the prioritization of action plans with the Administration of the Health Establishment to make the service conform With current legislation. Objective: To analyze the nonconformities presented by CME, based on ANVISA RDC nº15 / 2012, to assess severity and to submit validation by specialists. Materials and methods: This was a methodological research, which consisted in the attribution of seriousness to 132 nonconformities in relation to the non-compliance of 89 items of DRC ANVISA nº 15/2012. High severity was assigned to items of law whose non-compliance compromised the security of PPS\'s secure processing, or lowering to items that allowed longer time to conform to legal requirements without compromising PPS\'s secure processing. Subsequently, the assignment of gravity was validated by a group of 14 specialists using the Delphi technique, in two rounds. Results: Of the 132 nonconformities related to the non-compliance of the articles of DRC ANVISA nº15 / 2012, 108 non-conformities were judged as \"high severity\" regarding infrastructure, equipment, cleaning, inspection, preparation, packaging , Disinfection, sterilization, sterilization and transport monitoring, which could compromise the safety of the PPS, validated by the agreement of more than 70% of the expert judges. It was judged as \"low gravity\" 24 nonconformities; Of these, 13 were validated, with a consensus of more than 70%, referring to occupational health, air conditioning, physical structure and equipment and 11 did not obtain agreement on the percentage required for validation. These items were not validated, they referred to the air conditioning, the separation of clean and dirty areas, the chemical disinfection, the quality of the rinsing water of PPS, the assignment of CPPS and the CME class I processing complex materials. Conclusion: For the 132 nonconformities regarding non-compliance with 89 articles of the ANVISA RDC nº15 / 2012, 118 nonconformities were validated regarding the degree of severity attributed - 105 as high severity and 13 as low severity. Of the nonconformities listed as being of low severity, 11 did not obtain the agreement in the percentage necessary for validation. There was evidence of gaps in scientific knowledge in the area of health products processing, such as the influence of the pressure differential in the PPS cleaning area as a safety factor for professionals, and the wear / abrasion effect of clean PPS with abrasive material In facilitating biofilm adhesion.

Benzodiazepines (Benzos) and ketamine (K) are compounds that have been encountered in Drug-Facilitated Sexual Assault (DFSA) cases. Due to the intimate nature of these crimes, evidence collection is often postponed due to delays and/or reluctance in reporting these crimes. Further delays in analysis may be encountered in laboratories with large caseloads and/or backlogs. Drug identification in biological samples is important to determine whether victims knowingly or unknowingly took an impairing substance, however, the results could be negative due to chemical degradation over a long storage period. The purpose of this project was to study if degradation could be prevented with a new preservation method at the time of collection. Urine samples were prepared by the addition of K and metabolites and selected benzos and metabolites that were subjected to different sample pre-treatment techniques, and were analyzed after storage at room temperature (25°C), refrigerator (4°C) and freezer (-20°). The samples were either pre-treated with preservative (0.5% toluene) or filtration sterilization (sterile filter kit) within two hours after sample collection, and a control group with no pre-treatment was incorporated into the study for comparison. The changes in concentrations over 50 days (Benzos group) and 210 days (K group) were evaluated between different pre-treated methods and different temperature conditions. Sample that were treated with 0.5% toluene showed the most degradation: 44% of oxazepam and 96% of diazepam degraded over 10 days, and 80% of dehydronorketamine degraded after storage of 150 days regardless the temperature conditions. Clonazepam and flunitrazepam concentrations were reduced by 80% of the original concentration when stored at room temperature for 10 days. The major benzodiazepines evaluated in this study were stable when stored in the freezer. In K group, ketamine and norketamine that were stored at room temperature and refrigerated over 210 days were stable, however, degradation was observed after 150 days when the samples were stored in the freezer. There was no statistically different change observed among the samples pre-treated with or without filtration sterilization. Each sample pH was measured and it was determined that those stored at room temperature had an average pH of 8.5, while samples stored in the refrigerator and freezer had an average pH of 6.7 and 6.5, respectively. This finding revealed that pH could be the major factor affecting compound degradation rather than the bacterial contamination with high pH contributing to degradation, and low pH potentially preventing sample lost.

O óxido de etileno é um agente esterilizante dos mais importantes para materiais termo-sensíveis, dentre eles os artigos médico-hospitalares. Fios para sutura cirúrgica foram submetidos à exposição, em autoclave, a misturas gasosas com capacidade anti-microbiana, monitorando-se o processo através de Bacillus subtilis como indicador biológico. O objetivo deste estudo foi determinar a relação da letalidade do ciclo em função dos parâmetros de processo temperatura, tempo e pressão, expressando-a através de equações polinomiais decorrentes de modelo de ajuste pelo método da regressão linear múltipla. Os resultados analíticos e suas representações gráficas permitiram delimitar a região de letalidade, com simultânea confirmação da manutenção das características físicas farmacopeicas dos fios para sutura cirúrgica. Concluiu-se que o método estatístico empregado é adequado para a obtenção de equações de previsibilidade da atividade anti-microbiana em função dos parâmetros de processo. Além disto, a integridade física dos artigos médico-hospitalares foi preservada, assegurando-se sua utilização eficaz e segura. / Ethylene oxide is one of the most important sterilizing agents for thermo-sensitive materials, including the medical-hospital products. Strings for surgical sutures were exposed by autoclave to gaseous mixtures with anti-microbial properties, being the process monitored by Bacillus subtilis as a biological indicator. The purpose of this study was to determine the relation of cycle lethality in terms of process parameters (temperature, time and pressure) expressing them through polynomial equations decurrent of an adjustment model, by the multiple linear regression method. The analytical results and its graphic representations enabled us to delimit the lethal region having simultaneously the confirmation that the physical pharmacopeia requirements of the strings for surgical suture are maintained. It was concluded that the statistical method used is adequate to obtain equations of foreseeable anti-microbial activity in terms of process parameters. Besides, the physical integrity of the medical/hospital articles was preserved, so asserting its safe and effective use.

<p>The purpose of this project has been to cut production costs for the fascia panels of</p><p>Getinge’s largest autoclaves. The cost for the stainless steel plates currently used is very</p><p>high. An alternative material solution could cut costs significantly.</p><p>In addition, improvements have been made to the instrument tower which is a central part</p><p>of the fascia panel. As a result of the new modular design in a new material the</p><p>instrument tower has been improved in several aspects.</p>

No description available.

The purpose of this project has been to cut production costs for the fascia panels of Getinge’s largest autoclaves. The cost for the stainless steel plates currently used is very high. An alternative material solution could cut costs significantly. In addition, improvements have been made to the instrument tower which is a central part of the fascia panel. As a result of the new modular design in a new material the instrument tower has been improved in several aspects.

Heat transfer to canned particulate laden Newtonian fluids was studied during free axial agitation thermal processing in a pilot STOCK retort which was modified to simulate the can motion in continuous turbo cookers. Evaluation of heat transfer coefficients (overall, U and fluid to particle, hfp) associated with canned liquid/particle mixtures, while they are subjected to free axial motion is difficult because of the problems involved with attaching temperature measuring devices to liquid and particles without affecting their normal motion. A new methodology was developed to evaluate U and hfp in Newtonian liquids. The methodology involved first correlating U and hfp as a function of input variables for cans in fixed axial mode of rotation in which both particle and fluid temperatures were measured using thin wire thermocouples. Subsequently, only liquid temperatures were measured in cans using wireless sensors in the free axial mode, and hfp values were empirically computed from the developed correlations and the measured temperatures. An L-16 orthogonal experimental design of experiment was carried out to select system and product parameters that significantly influence hfp and U for particles in the Newtonian liquid. With significant parameters selected, a response surface methodology and two full factorial experimental designs were used to relate U and hfp to process variables in each mode of rotation (fixed and free axial modes). / Dimensionless correlations were then developed using the evaluated data for heat transfer coefficients (U and hfp), in canned high viscosity Newtonian liquids (with and without particles) using stepwise multiple non-linear-regressions of significant dimensionless groups. In free axial mode, combining the natural and forced convection, Nu = A 1(GrxPr)A2+ A3(Re) A4 (Pr)A5 FrA 6 (rhop/rhop1)A 7 (e/100-e)A8 (dp/Dc) A9 (Kp/K1)A10 yielded a higher R2 (0.93) than using a pure forced convection model when particles were present in the can. Even in the absence of particles, and with the end-over-end mode of agitation where forced convection dominates, introducing natural convection term (GrxPr), improvedR2 from 0.81 to 0.97. Artificial neural network (ANN) models were also developed for heat transfer coefficient predictions and the trained models gave better predictions than dimensionless correlations. All ANN models developed could be implemented easily in a spreadsheet as either matrices or a set of equations.

As a contraceptive technology, women’s sterilization is a medical event that is uniquely situated in relation to the dominant discursive link between women and reproduction. Intended as a contraceptive option that permanently ends a woman’s potential ability to sexually reproduce, women’s sterilization presents a significant point for exploring the discursive formation of femininity, and how the concepts thereof relate to broader questions of access, control, and regulation of sterilization and the female sterilization patient. This study uses a Foucauldian feminist theory of discourse to explore such questions in a qualitative discourse analysis of women’s sterilization, from both a historical perspective and from within contemporary medical texts. Sterilization has had a particularly tumultuous history in the provision of reproductive healthcare for women; situated within public health and welfare discourse that differentiates the “unfit” from the “fit” reproducers, women have been forcibly sterilized under classist and racist eugenic programs, while subtle yet coercive forms of sterilization abuse continue to occur as inequality of reproductive healthcare access is an ongoing issue for immigrant women, poor women, and women of colour. In light of this historical analysis, as well as the impact of feminist and bioethics discourse upon contemporary medical practice, an analysis of medical texts further explores the association of women with reproduction in the discursive form of the sterilization patient. This study argues that the sterilization patient is situated within a discourse of ideal femininity, associated with normalized forms of mothering, sexuality, and family structure. Given the historical link between the discursive “fit” reproducer, these concepts have continued implications for women’s experience of accessing sterilization as a contraceptive option. / Thesis (Master, Sociology) -- Queen's University, 2007-07-17 17:09:15.595

No description available.

After the forced sterilizations of low-income and minority women were exposed in the 1970’s, new Medicaid policies were put into place in order to protect vulnerable populations. The revised policy included a mandatory consent form and a waiting period of 30 days between consent and procedure, as well as a presentation of the form at time of procedure. Although these policies were enacted to protect vulnerable populations, research has shown they are ineffective and act as barrier to women receiving the post-partum tubal sterilization that they desire. The policy has been shown to have a disproportionate detrimental impact on minority populations, and it has created a two-tiered health care system in terms of sterilization. The unfulfilled requests lead to many inadvertent consequences, including higher rates of unintended pregnancies, abortions, loss of self-efficacy, and higher costs for the Medicaid system. In order to ensure equitable treatment of Medicaid patients in regards to tubal sterilization, the 30-day waiting period should be rescinded. Additionally, to confirm that patients are fully knowledgeable of the implications of the tubal sterilization, the form and any ensuing consent should be rewritten to meet literacy standards for the target demographic. This analysis will include a history of the issue, an examination of relevant research, a policy analysis and recommendations to enhance healthcare equity.