Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

Study on Testing Methods of Pen-injector's Dosing Accuracy / 中国医疗器械杂志

OBJECTIVE@#An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests.@*METHODS@#According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed.@*RESULTS@#After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested.@*CONCLUSIONS@#Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

Reprocessamento e reutilização de cânulas de perfusão / Perfusion cannulas reprocessing and reuse

Os procedimentos utilizados para reprocessamento e reuso de artigos médicos de uso único não estão normalizados nem avaliados quanto a segurança. Os objetivos deste estudo foram: (i) determinar o tempo de esterilização e aeração de canulas de perfusão em ambiente industrial; (ii) avaliar os níveis de resíduos de óxido de etileno, concentração de endotoxinas e resistência a tração de cânulas de perfusão após reprocessamento e reuso em ambiente hospitalar. No ambiente industrial as cânulas foram submetidas à esterilização com 450mg/Lde 10 por cento de óxido de etileno e 90 por cento de CO² por um período de 2 horas a uma temperatura de 45 a 55 graus C, umidade entre 30 e 90 por cento e aeração com 26 trocas de ar por hora com temperatura de 35 graus C...

Acceptability and use of clean home delivery kits in Nepal: a qualitative study.

This research was carried out in rural Nepal to explore how different categories of birth attendants at home deliveries accepted and used clean home delivery kit (CHDK) and its contents, including hand-washing practices, during delivery and preparations for birth. In-depth interviews were conducted to collect information from 51 women-both users and non-users of the kit. The respondents were interviewed within one month of their most recent delivery. Results of the interviews showed that the attendants who used the kit perceived it as hygienic and convenient, affordable, and culturally acceptable. The razor blade and thread were the most useful items, and the purpose of the plastic coin was understood. Despite its perceived usefulness, awareness and use of the kit were low, and common reasons for non-use included not knowing about the kit or difficulty in procuring a kit locally. In addition, the kit had limited influence on general hygiene practices. The authors explore the importance of evaluating promotional efforts re-targeted to individuals who hold decision-making power regarding the use of the kit. They recommend that kit promoters emphasize hand-washing and single use of the kit.

Monitoring of presterile disposable syringes and needles marketed in Pune.

Out of hundred syringes and hundred needles (both presterile, disposable) tested, 41 syringes (41%) and 6 needles (6%) showed aerobic growth. Forty of the above syringes were tested simultaneously for fungi and anaerobes. Fungi isolated were 5.7% and no anaerobe was grown. Fifty glass syringes and fifty needles autoclaved in the departmental laboratory served as controls and did not show any growth. As a preventive measure, proper disposal of used disposable material should be made mandatory so that it does not find its way into the market. Or has the time come to switch back to the former conventional practice of using in house autoclaved articles?

Hipertensäo arterial na infância: avaliaçäo crítica / Hypertension blood in children: evaluation critics

Avaliaçäo crítica do conhecimento dos pediatras sobre hipertensäo arterial, por meio de questionário encaminhado a todas as Faculdades de Medicina, do país, aos pediatras nefrologistas, cardiologistas, intensivistas e pediatras gerais das principais cidades do Estado de Säo Paulo. Dos 230 questionários enviados, obtivemos 148 repostas (64,3%), o que proporcionou verdadeiro instantâneo de como os pediatras estäo se conduzindo, neste capítulo da maior importância médica e social. Concluímos que o estudo da hipertensäo arterial precisa ser mais difundido na Pediatria, em todos os níveis, isto é, na Graduaçäo, na Residência, na Especializaçäo, na Pós-graduaçäo, nas Jornadas e Congressos Pediátricos, para afastar definitivamente a idéia de que hipertensäo arterial é doença de adulto e deixar de negligenciá-la na criança

Bacterial contamination of re-usable and disposable syringes and needles.

Re-usable glass and disposable plastic syringes and needles were tested for their sterility. Ninety-one re-usable glass, 111 disposable plastic syringes, 105 re-usable and 91 disposable needles were determined for microbial contamination by direct method using soy-bean-casein digest and fluid thioglycolate media. The positive results were 2.2 per cent (2/91), 0.9 per cent (1/111), 2.9 per cent (3/105) and 3.3 per cent (3/91) for re-usable and disposable syringes and needles, respectively. It is concluded that there is no difference in the rates of contamination of re-usable and disposable items.