Eventos adversos e incidentes notificados em um centro de materiais e esterilização / Adverse events and incidents reported in a materials and sterilization center

Objetivo: Caracterizar as notificações dos incidentes e eventos adversos do Centro de Material e Esterilização (CME) de um hospital de ensino. Método: Estudo retrospectivo, documental, descritivo e quantitativo em um CME classe II, em que foram analisadas as notificações contidas no banco de dados do Núcleo do Sistema de Gestão da Qualidade e Segurança do paciente, entre 2016 e 2020. Como técnica de análise dos dados coletados, utilizou-se o diagrama de causa e efeito, e a descrição das notificações foram agrupadas conforme o diagrama de 6M: método; material; mão de obra; máquina; medida; e meio ambiente. Resultados: Entre as notificações realizadas, as variáveis matéria-prima e método foram as que mais geraram incidentes durante todo o período, representando 28,54 e 26,44%, respectivamente. Além disso, o Centro Cirúrgico foi o que mais notificou e foi notificado pelo CME. Conclusão: Foi possível conhecer os incidentes que mais predominam no CME da instuição, e as variáveis materiais e método, com o centro cirúrgico, foram as variáveis e setor que mais geraram notificações no período pesquisado (AU)

Percentual de utilização de instrumentais em procedimentos cirúrgicos / Percentage of use of instruments in surgical procedures / Porcentaje de uso de instrumentos en procedimientos quirúrgicos

Objetivo: analisar o percentual de instrumentais cirúrgicos que compõem a caixa de laparotomia exploradora e não são utilizados durante as cirurgias. Método: estudo descritivo, transversal com abordagem quantitativa, que contabilizou instrumentais constituintes da caixa de laparotomia exploradora utilizados e não utilizados durante 13 cirurgias realizadas em um período de 17 dias, em um hospital do interior paulista. Resultados: nas 13 cirurgias analisadas, obteve-se um total de 1300 (100%) pinças presentes nas caixas, onde 832 (64%) não foram utilizadas e 468 (36%) foram utilizadas. Nos tempos cirúrgicos, o maior número de uso foi de 166 (35,5%) artigos, para preensão e afastadores. Conclusão: houve 64% de instrumentais não utilizados nas cirurgias analisadas. Há necessidade de implementar estratégias gerenciais que reduzam os números encontrados e, consequentemente, reduzam gastos, para gerar menor desperdício e reduzir falhas no gerenciamento de recursos materiais.

Objective: to analyze the percentage of surgical instruments that make up the operating laparotomy box and are not used during surgeries. Method: descriptive, cross-sectional study with quantitative approach, which counted instrumental constituents of the exploratory laparotomy box used and not used during 13 surgeries performed in a period of 17 days, in a hospital in the interior of São Paulo. Results: in the 13 surgeries analyzed, a total of 1300 (100%) tweezers were obtained in the boxes, where 832 (64%) were not used and 468 (36%) were used. In surgical times, the highest number of use was 166 (35.5%) articles, for seizures and reparators. Conclusion: there were 64% of instruments not used in the analyzed surgeries. There is a need to implement management strategies that reduce the numbers found and, consequently, reduce expenses, to generate less waste and reduce failures in the management of material resources.

Objetivo: analizar el porcentaje de instrumentos quirúrgicos que componen la caja de laparotomía quirúrgica y no se utilizan durante las cirugías. Método: estudio descriptivo, transversal con enfoque cuantitativo, que contó constituyentes instrumentales de la caja de laparotomía exploratoria utilizada y no utilizada durante 13 cirugías realizadas en un período de 17 días, en un hospital del interior de São Paulo. Resultados: en las 13 cirugías analizadas, se obtuvieron un total de 1300 (100%) pinzas en las cajas, donde no se utilizaron 832 (64%) y 468 (36%). En tiempos quirúrgicos, el mayor número de uso fue de 166 (35,5%) artículos, para convulsiones y reparadores. Conclusión: hubieran 64% de instrumentos no utilizados en las quirurgias analizadas. Es necesario implementar estrategias de gestión que reduzcan los números encontrados y, en consecuencia, reduzcan los gastos, para generar menos residuos y reducir las fallas en la gestión de los recursos materiales.

Medical injection and access to sterile injection equipment in low- and middle-income countries: a meta-analysis of Demographic and Health Surveys (2010-2017).

BACKGROUND: Unsafe injection practices contribute to increased risks of blood-borne infections, including human immunodeficiency virus, hepatitis B and hepatitis C viruses. The aim of this study was to estimate the prevalence of medical injections as well as assess the level of access to sterile injection equipment by demographic factors in low- and middle-income countries (LMICs). METHODS: We carried out a meta-analysis of nationally representative Demographic and Health Surveys (DHSs) conducted between 2010 and 2017 in 39 LMICs. Random effects meta-analysis was used in estimating pooled and disaggregated prevalence. All analyses were conducted using Stata version 14 and Microsoft Excel 2016. RESULTS: The pooled 12-month prevalence estimate of medical injection was 32.4% (95% confidence interval 29.3-35.6). Pakistan, Rwanda and Myanmar had the highest prevalence of medical injection: 59.1%, 56.4% and 53.0%, respectively. Regionally, the prevalence of medical injection ranged from 13.5% in west Asia to 42.7% in south and southeast Asia. The pooled prevalence of access to sterile injection equipment was 96.5%, with Pakistan, Comoros and Afghanistan having comparatively less prevalence: 86.0%, 90.3% and 90.9%, respectively. CONCLUSIONS: Overuse of medical injection and potentially unsafe injection practices remain a considerable challenge in LMICs. To stem the tides of these challenges, national governments of LMICs need to initiate appropriate interventions, including education of stakeholders, and equity in access to quality healthcare services.

A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation.

For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the well-known DT , z, and Fo values that are used in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these values to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters, and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion.LAY ABSTRACT: For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the critical process parameters that are evaluated in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these parameters to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters, and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion.

Declining rates of sterilization procedures in Western Australian women from 1990 to 2008: the relationship with age, hospital type, and government policy changes.

OBJECTIVE: To describe trends in age-specific incidence rates of female sterilization (FS) procedures in Western Australia and to evaluate the effects of the introduction of government-subsidized contraceptive methods and the implementation of the Australian government's baby bonus policy on FS rates. DESIGN: Population-based retrospective descriptive study. SETTING: Not applicable. PATIENT(S): All women ages 15-49 undergoing an FS procedure during the period January 1, 1990, to December 31, 2008 (n = 47,360 procedures). INTERVENTION(S): Records from statutory statewide data collections of hospitals separations and births were extracted and linked. MAIN OUTCOME MEASURE(S): Trends in FS procedures and the influence on these trends of the introduction of government policies: subsidization of long-acting reversible contraceptives (Implanon and Mirena) and the Australian baby bonus initiative. RESULT(S): The annual incidence rate of FS procedures declined from 756.9 per 100,000 women in 1990 to 155.2 per 100,000 women in 2008. Compared with the period 1990-1994, women ages 30-39 years were 47% less likely (rate ratio [RR] = 0.53; 95% confidence interval [CI], 0.39-0.72) to undergo sterilization during the period 2005-2008. Adjusting for overall trend, there were significant decreases in FS rates after government subsidization of Implanon (RR = 0.89; 95% CI, 0.82-0.97) and Mirena (RR = 0.81; 95% CI, 0.73-0.91) and the introduction of the baby bonus (RR = 0.70; 95% CI, 0.61-0.81). CONCLUSION(S): Rates of female sterilization procedures in Western Australia have declined substantially across all age groups in the last two decades. Women's decisions to undergo sterilization procedures may be influenced by government interventions that increase access to long-term reversible contraceptives or encourage childbirth.

Instrumentais nas caixas cirúrgicas: avaliação de custo / Instrumental in surgical boxes: cost evaluation

Avaliar o número de instrumentais das caixas cirúrgicas que não são utilizados durante as cirurgias, em um hospital do interior do Estado de São Paulo. Método: A coleta de dados resultou da observação direta dos instrumentais utilizados nas cirurgias, registrando o número real de instrumentais na caixa, número de instrumentais utilizados na cirurgia e número de não utilizados. Resultados: Em média, cerca de 52% dos materiais existentes nas caixas cirúrgicas não são utilizados, gerando custos elevados para a instituição. Calculando o desperdício, foi obtida uma média no valor de R$ 8,00 (oito reais) por caixa cirúrgica utilizada, podendo chegar ao valor de R$ 1.584,17 por mês. Conclusões: Conclui-se que há um desperdício de materiais que são esterilizados e não são utilizados nos procedimentos cirúrgicos, refletindo diretamente na qualidade e nos custos do gerenciamento do centro de material e esterilização...

Reuse of single-use devices: looking back, looking forward.

The reuse of medical devices marked as 'single use' by manufacturers has been going on for several decades. The process has been rationalized and legislated in the West as well as in Japan. However, the practice continues in an unregulated manner in India due to a paucity of guidance from the Food and Drug Administration in India. We trace the evolution of reuse policies, look at the prevalent practices in the Indian and international contexts, analyse the available Indian literature and address the ethical and economic implications of reuse. We also suggest some guidelines which may be adopted to formulate policies.

A life cycle assessment of reusable and single-use central venous catheter insertion kits.

BACKGROUND: For most items used in operating rooms, it is unclear whether reusable items are environmentally and financially advantageous in comparison with single-use variants. We examined the life cycles of reusable and single-use central venous catheter kits used to aid the insertion of single-use, central venous catheters in operating rooms. We did not examine the actual disposable catheter sets themselves. We assessed the entire financial and environmental costs for the kits, including the influence of the energy source used for sterilization. METHODS: For the reusable central venous catheter kit, we performed a "time-in-motion" study to determine the labor costs and measured the energy and water consumption for cleaning and sterilization at Western Health, Melbourne, Australia. For the majority of the inputs for the single-use kit, we relied upon industry and inventory-sourced databases. We modeled the life cycles of the reusable and single-use central venous catheter kits with Monte Carlo analysis. RESULTS: Inclusive of labor, the reusable central venous catheter insertion kits cost $6.35 Australian ($A) (95% confidence interval [CI], $A5.89 to $A6.86), and the single-use kits cost $A8.65. For the reusable kit, CO(2) emissions were 1211 g (95% CI, 1099 to 1323 g) and for the single-use kit 407 g (95% CI, 379 to 442 g). Water use was 27.7 L (95% CI, 27.0 to 28.6 l) for the reusable kit and 2.5 L (95% CI, 2.1 to 2.9 l) for the single-use kit. For the reusable kit, sterilization had the greatest environmental cost, and for the single-use kit, the manufacture of plastic and metal components had the largest environmental costs. Different sources of electricity to make the reusable kits patient-ready again affected the CO(2) emissions: electricity from hospital gas cogeneration resulted in 436 g CO(2) (95% CI, 410 to 473 g CO(2)), from the United States electricity grid 764 g CO(2) (95% CI, 509 to 1174 g CO(2)), and from the European electricity grid 572 g (95% CI, 470 to 713 g CO(2)). CONCLUSIONS: Inclusive of labor, the reusable central venous catheter insertion kits were less expensive than were the single-use kits. For our hospital, which uses brown coal-sourced electricity, the environmental costs of the reusable kit were considerably greater than those of the single-use kit. Efforts to reduce the environmental footprint of reusable items should be directed towards decreasing the water and energy consumed in cleaning and sterilization. The source of hospital electricity significantly alters the relative environmental effects of reusable items.

Family planning use among urban poor women from six cities of Uttar Pradesh, India.

Family planning has widespread positive impacts for population health and well-being; contraceptive use not only decreases unintended pregnancies and reduces infant and maternal mortality and morbidity, but it is critical to the achievement of Millennium Development Goals. This study uses baseline, representative data from six cities in Uttar Pradesh, India to examine family planning use among the urban poor. Data were collected from about 3,000 currently married women in each city (Allahabad, Agra, Varanasi, Aligarh, Gorakhpur, and Moradabad) for a total sample size of 17,643 women. Participating women were asked about their fertility desires, family planning use, and reproductive health. The survey over-sampled slum residents; this permits in-depth analyses of the urban poor and their family planning use behaviors. Bivariate and multivariate analyses are used to examine the role of wealth and education on family planning use and unmet need for family planning. Across all of the cities, about 50% of women report modern method use. Women in slum areas generally report less family planning use and among those women who use, slum women are more likely to be sterilized than to use other methods, including condoms and hormonal methods. Across all cities, there is a higher unmet need for family planning to limit childbearing than for spacing births. Poorer women are more likely to have an unmet need than richer women in both the slum and non-slum samples; this effect is attenuated when education is included in the analysis. Programs seeking to target the urban poor in Uttar Pradesh and elsewhere in India may be better served to identify the less educated women and target these women with appropriate family planning messages and methods that meet their current and future fertility desire needs.

Heightened infection-control practices are associated with significantly lower infection rates in office-based Mohs surgery.

BACKGROUND: Reported infection rates for Mohs micrographic surgery (MMS) range from less than 1% to 3.5%. OBJECTIVE: To determine whether lower infection rates are possible for MMS with a consistently applied infection-control regimen. METHODS: A series of 832 consecutive patients with 950 tumors undergoing MMS formed the cohort for a retrospective study of infections before and after a program of heightened infection-control practices at a single-surgeon academic Mohs practice. The sterility upgrade included jewelry restrictions, alcohol hand scrub before stages and reconstruction, sterile gloves and (during reconstruction) sterile gowns for staff, and sterile towels and dressings for patients during Mohs stages. RESULTS: Infection rate was 2.5% (9 infections/365 tumors) before the sterility upgrade and 0.9% (5 infections/585 tumors) after, a statistically significant difference (p=.04). CONCLUSION: MMS already has low rates of infection, but this study shows that rigorous infection-control practices can significantly affect infection rates. The authors have indicated no significant interest with commercial supporters.

A multi-criteria assessment of scenarios on thermal processing of infectious hospital wastes: a case study for Central Macedonia.

In Greece more than 14,000 tonnes of infectious hospital waste are produced yearly; a significant part of it is still mismanaged. Only one off-site licensed incineration facility for hospital wastes is in operation, with the remaining of the market covered by various hydroclave and autoclave units, whereas numerous problems are still generally encountered regarding waste segregation, collection, transportation and management, as well as often excessive entailed costs. Everyday practices still include dumping the majority of solid hospital waste into household disposal sites and landfills after sterilization, still largely without any preceding recycling and separation steps. Discussed in the present paper are the implemented and future treatment practices of infectious hospital wastes in Central Macedonia; produced quantities are reviewed, actual treatment costs are addressed critically, whereas the overall situation in Greece is discussed. Moreover, thermal treatment processes that could be applied for the treatment of infectious hospital wastes in the region are assessed via the multi-criteria decision method Analytic Hierarchy Process. Furthermore, a sensitivity analysis was performed and the analysis demonstrated that a centralized autoclave or hydroclave plant near Thessaloniki is the best performing option, depending however on the selection and weighing of criteria of the multi-criteria process. Moreover the study found that a common treatment option for the treatment of all infectious hospital wastes produced in the Region of Central Macedonia, could offer cost and environmental benefits. In general the multi-criteria decision method, as well as the conclusions and remarks of this study can be used as a basis for future planning and anticipation of the needs for investments in the area of medical waste management.

[Assessment of disinfection and sterilization processes in dental practice as an important factors in prevention of infections]. / Ocena prawidlowonci procesów dezynfekcji i sterylizacji w wybranych gabinetach stomatologicznych jako istotnych elementów zapobiegania zakazeniom.

The dental health-care settings is an environment where disease transmission occurs easily. Prevention of cross infection is therefore a crucial aspect of dental practice and dental clinic stuffmust adopt certain basic routines while practicing. Infections may be transmitted in the dental operatory through direct contact with blood, oral fluids or other secretions; via indirect contact with contaminated instruments, equipment or environmental surfaces; or by contact with airborne contaminants present in either droplet splatter or aerosols of oral and respiratory fluids. Strategies to prevent dental patient infections have focused on disinfection and sterilization. This study evaluates basic routines in prevention of cross-infection in the dentistry. The sample comprised 100 dentists, who completed questionnaires. Based on inquires the conditions for disinfection and sterilization of medical devices were assessed. The following issues were taken into consideration: the way of disinfection and preparation of the disinfectants, the localization of disinfection, preparing to disinfection, washing and packing of dental devices, the frequency of disinfection, methods of sterilization and the monitoring system, type of sterilizers and the available cycles. The dental practices are well equiped to proceed the steam sterilization, but 33% of dentists don't know the available cycles in their autoclaves. Only 35% of them made sterilization process protocols. Very common are three failures of instruments disinfections: multiple use of disinfectant, adding of disinfectant, adding new instruments. There is still need for improvement in disinfection and sterilization in dental practice, especially including: monitoring and documentation of sterilization process, proper use of disinfectants according to manufactures instructions, frequent disinfection of surfaces which contact with patients. Dental stuff should take part in advanced training courses about disinfection and sterilization.

Quantitative risk modeling in aseptic manufacture.

Expedient risk assessment of aseptic manufacturing processes offers unique opportunities for improved and sustained assurance of product quality. Contemporary risk assessments applied to aseptic manufacturing processes, however, are commonly handicapped by assumptions and subjectivity, leading to inexactitude. Quantitative risk modeling augmented with Monte Carlo simulations represents a novel, innovative, and more efficient means of risk assessment. This technique relies upon fewer assumptions and removes subjectivity to more swiftly generate an improved, more realistic, quantitative estimate of risk. The fundamental steps and requirements for an assessment of the risk of bioburden ingress into aseptically manufactured products are described. A case study exemplifies how quantitative risk modeling and Monte Carlo simulations achieve a more rapid and improved determination of the risk of bioburden ingress during the aseptic filling of a parenteral product. Although application of quantitative risk modeling is described here purely for the purpose of process improvement, the technique has far wider relevance in the assisted disposition of batches, cleanroom management, and the utilization of real-time data from rapid microbial monitoring technologies.

[Assessment of the sterilization of medical devices--an important challenge to health care in Poland]. / Ocena procesów sterylizacji wyrobów medycznych jako istotnego elementu higieny szpitalnej w wybranych szpitalach.

The aim of the study was the evaluation of sterilization of medical devices in Polish hospitals. The system that we use to establish which sterilization procedures should be employed to reduce the risk of hospital infections associated with medical devices. Based on inquiries, the conditions for the sterilization of medical devices in 21 Warsaw hospitals were assessed. The following issues were taken into consideration: preparation of medical supplies for sterilization, methods of sterilization and the monitoring system. In order to evaluate hygienic conditions due to sterilization points system was applied. 10% of the hospitals had Central Sterilization Service Department with 3 zones where automatic washing and disinfection, sorting, packaging, sterilization and storage of medical devices had been performed. The other 20% had CSSD without zones. In more than 65% there were common services for sterilization only. Instruments were delivered already prepared for sterilization. In remaining hospitals all steps, including sterilization were performed in words. According preparation of medical devices for sterilization it was established that mainly chemical disinfection just after use and than manual cleaning was used; the automatic cleaning in washer-disinfectors is used mainly in CSSD. Steam was the preferred method of sterilization, but also low temperature methods were used for heat sensitive devices. The monitoring of sterilization processes was satisfactory. There were first trials of the validation of the sterilization processes. There is still a need for improvement in the sterilization of medical devices, especially including: the organisation of CSSD in all Polish hospitals; replacement of manual cleaning processes by automatic cleaning; organisation of advanced training courses for the heads and staff of the CSSD.

Disinfection/sterilization in U.S. dental practices--practice behavior and attitudes.

In an era when we are experiencing an increased awareness of communicable infectious diseases such as tuberculosis and hepatitis B, and in which stories regarding the fear of the spread of the HIV virus receive almost nightly news coverage, all health care professionals are taking extra precautions when providing care to patients. The concern of occupational transmission of infectious diseases from the perspective of patient to health care worker is not new. However, the sensationalized singular instance of a dentist in Florida who reportedly transmitted the HIV virus to five of his patients raises questions about the possibility of health care worker to patient transmission and puts the spotlight on the dental community.

Multi-state investigation of the actual disinfection/sterilization of endoscopes in health care facilities.

PURPOSE: The purpose of this investigation was to observe and assess the actual disinfection or sterilization of endoscopes in health care facilities. MATERIALS AND METHODS: A total of 22 hospitals and four ambulatory care centers in three states were studied. Facility protocols were reviewed, interviews conducted with relevant personnel, actual disinfection or sterilization procedures observed, and biologic tests performed to determine and assess disinfection/sterilization procedures. RESULTS: Fundamental errors observed during the course of the investigation included respective failures to time the period of disinfection, to clean all channels, to flush all channels with disinfectant, to fully immerse the endoscope in the disinfectant solution, and to use a disinfectant. At 78% of the facilities, failure to sterilize all biopsy forceps was observed. A total of 23.9% of the bacterial cultures from the internal channels of 71 gastrointestinal endoscopes grew 100,000 colonies or more of bacteria. These cultures were obtained after the completion of all disinfection/sterilization procedures and the device was deemed ready for use in the next patient. CONCLUSIONS: These data indicate that actual disinfection/sterilization procedures for endoscopes are not always optimal, and high-level disinfection of gastrointestinal endoscopes is not always achieved.