Towards cost saving in surgery without compromising safety: stapleless laparoscopic splenectomy in a developing country-a prospective cohort study.

BACKGROUND: Minimally invasive surgery has been steadily growing in popularity. Control of splenic hilar vessels is the most delicate step during laparoscopic splenectomy (LS). In the earlier eras of LS, hilar vessels were controlled using clips and/or ligation. Laparoscopic staples were later introduced and have arguably led to an increase in popularity of LS. They do not abolish potential complications of splenectomy and theoretically represent an added operative cost.In this study, we aimed to assess the safety and efficacy of stapleless LS (using knots, haemostatic devices and clips) compared with the now more conventional stapled LS. METHODS: A pilot randomised prospective study was conducted in a university hospital between September 2018 and April 2020. It included 40 patients randomly assigned to two equal groups: (1) 20 patients: stapleless LS and (2) 20 patients: LS using laparoscopic staples.We compared operative time, intra and postoperative complications and postoperative recovery. RESULTS: There was no statistically significant difference between both groups across all comparative outcomes. CONCLUSION: Both techniques are comparable in terms of safety and operative time. In terms of cost efficiency, we recommend more comprehensive analyses of hospital costs.

Novel solutions to old problems: improving the reliability of emergency equipment provision in critical care using accessible digital solutions.

Reliable provision of emergency equipment in Critical Care is key to ensure patient safety during medical emergencies and transfers. A problem was identified in incident reports and external inspections of processes that ensured the provision of such equipment for use by critical care teams in non-critical care areas in the form of grab bags. A comprehensive project was undertaken to tackle this including the provision of a bespoke digital system.Existing systems were reliant on staff remembering to check equipment and document checks on paper and there was no formal ability to hand over ongoing problems. A local project management approach, '7 Steps to Quality Improvement', which integrated many of the philosophies and tools from Healthcare Improvement was used. A bespoke digital system was designed and implemented with integrated improvements in equipment stocking ergonomics.The reliability of documented equipment checks improved significantly, there was a significant reduction in the number of incident reports regarding emergency equipment and the time spent by staff doing equipment checks was reduced substantially with significant cost and resource improvements. This was so successful the format has been rapidly translated and spread to other areas such as operating theatres' difficult airway trolleys.Undertaking a structured quality improvement approach, using appropriate stakeholder engagement, digitalisation of systems and improvements in basic system ergonomics can have a substantial impact on the reliability and safety of emergency equipment provided for use by members of the critical care team.

Assessment of pre-anesthesia machine check and airway equipment preparedness: A cross-sectional study.

Background: Anesthesia Equipment malfunction is one of the most common factors contributing to intraoperative surgical patient morbidity and mortality. It is impossible to give anesthesia without proper anesthesia machine checks and airway equipment preparation. Therefore, all anesthesia professionals should make sure that the anesthetic machine and equipment are working correctly. Method: An institutional-based prospective observational study was conducted at the University Comprehensive Specialized Hospital, Operation rooms, from April 10, 2020 to May 10, 2020. About 90 anesthetists were working regularly in the operation theater both emergency and elective patients. Those include; 26 Msc holders, 17 MSc students, 7 BSc anesthetists, and 40 graduating BSc students. These descriptive data were presented with frequency, percentage, and table. Result: The overall compliance rate was 87%. Whereas; 12.46% of clinicians have not met the standard. Out of standards that were not performed, 25.81% were not available from the setup. Conclusion: The result shows that there was poor compliance with anesthesia machine check and equipment preparation before anesthesia in the operation theater according.

Remote Programming in Patients With Parkinson's Disease After Deep Brain Stimulation: Safe, Effective, and Economical.

Objective: The purpose of this study was to evaluate the safety, efficiency, and cost expenditure of remote programming in patients with Parkinson's disease (PD) after deep brain stimulation (DBS). Methods: A total of 74 patients who underwent DBS at the Department of Neurosurgery, Zhongnan Hospital of Wuhan University between June 2018 and June 2020 were enrolled in this study. There were 27 patients in the remote programming group and 47 patients in the outpatient programming group. Clinical data, programming efficiency, adverse events, expenditure, and satisfaction were compared between the two groups. Results: A total of 36 times of remote programming were performed on the 27 patients in the remote programming group, and four had mild adverse events during programming, and the adverse events disappeared within 1 week. The satisfaction questionnaire showed that 97.3% of the patients were satisfied with the surgical effect. The patients in the remote programming group (88.9%) were more likely to receive long-term programming after DBS than the patients in the outpatient programming group (74.5%). The Parkinsonism symptoms improved in both programming groups. The majority (18/27) of patients in the remote programming group lived away from the programming center, while the majority (27/47) of patients in the outpatient programming group lived in Wuhan, where the programming center was located (P = 0.046). The cost per patient per programming was US$ 43.5 in the remote programming group and $59.5 (56-82.7) in the outpatient programming group (P < 0.001). The median time cost for each visit was 30 min (25-30) in the remote programming group and 150 min (135-270.0) in the outpatient programming group (P < 0.001). Conclusion: Remote programming is safe and effective after DBS in patients with Parkinson's disease. Moreover, it reduces expenditure and time costs for patients and achieves high satisfaction, particularly for patients living far from programming centers.

The evolving landscape of policies, rules, and law in sport-related concussion.

Beginning in 2009 with the passage of the Zackery Lystedt law in the state of Washington, all 50 states have passed concussion laws that implement a mandatory framework of care for high school and youth athletes. The structure of these laws generally shares the three primary components of the Lystedt law: (1) preseason concussion education; (2) mandatory removal from play with suspected concussion; and (3) clearance from a healthcare professional prior to return to play. These same three policy components are also found at the collegiate and professional levels of sport, either through established policy or labor contracts. This chapter explores concussion-specific legal and policy developments that currently inform concussion management practices across multiple levels of the US athletic system.

EXPLORING MEDICAL DEVICES: THE USE OF RISK ASSESSMENT TOOLS AND THEIR LINK WITH TRAINING IN HOSPITALS.

OBJECTIVES: The aim of this study was to explore the risk assessment tools and criteria used to assess the risk of medical devices in hospitals, and to explore the link between the risk of a medical device and how those risks impact or alter the training of staff. METHODS: Within a broader questionnaire on implementation of a national guideline, we collected quantitative data regarding the types of risk assessment tools used in hospitals and the training of healthcare staff. RESULTS: The response rate for the questionnaire was 81 percent; a total of sixty-five of eighty Dutch hospitals. All hospitals use a risk assessment tool and the biggest cluster (40 percent) use a tool developed internally. The criteria used to assess risk most often are: the function of the device (92 percent), the severity of adverse events (88 percent) and the frequency of use (77 percent). Forty-seven of fifty-six hospitals (84 percent) base their training on the risk associated with a medical device. For medium- and high-risk devices, the main method is practical training. As risk increases, the amount and type of training and examination increases. CONCLUSIONS: Dutch hospitals use a wide range of tools to assess the risk of medical devices. These tools are often based on the same criteria: the function of the device, the potential severity of adverse events, and the frequency of use. Furthermore, these tools are used to determine the amount and type of training required for staff. If the risk of a device is higher, then the training and examination is more extensive.

[Legal framework for E­health products on the European market]. / Medizinprodukterechtliche Rahmenbedingungen für E­Health-Produkte im europäischen Wirtschaftsraum.

Legitimately categorizing software in the healthcare sector is complex. According to European medical devices law, software can be considered a medical device. The decisive factor is whether the software is used for directly controlling a therapeutic or diagnostic medical device or as stand-alone software that achieves specific medical purposes, as they are described in the legal definition of a medical device. A contribution of the software to diagnosis or therapy can be sufficient for the categorization; it does not have to provide the complete diagnosis or the complete therapy itself.This principle will continue to be the same with the new Regulation on Medical Devices (EU) 2017/745, even though the classification rules have been more closely and more specifically tailored to software and more stringent requirements for essential safety and performance requirements have to be met.

Semi-Automatic Electronic Stent Register: a novel approach to preventing ureteric stents lost to follow up.

BACKGROUND: Ureteric stents are indispensable tools in modern urology; however, the risk of them not being followed-up once inserted poses medical and medico-legal risks. Stent registers are a common solution to mitigate this risk; however, manual registers are logistically challenging, especially for busy units. METHODS: Western Sydney Local Health District developed a novel Semi-Automatic Electronic Stent Register (SAESR) utilizing billing information to track stent insertions. To determine the utility of this system, an audit was conducted comparing the 6 months before the introduction of the register to the first 6 months of the register. RESULTS: In the first 6 months of the register, 457 stents were inserted. At the time of writing, two of these are severely delayed for removal, representing a rate of 0.4%. In the 6 months immediately preceding the introduction of the register, 497 stents were inserted, and six were either missed completely or severely delayed in their removal, representing a rate of 1.2%. A non-inferiority analysis found this to be no worse than the results achieved before the introduction of the register. CONCLUSION: The SAESR allowed us to improve upon our better than expected rate of stents lost to follow up or severely delayed. We demonstrated non-inferiority in the rate of lost or severely delayed stents, and a number of other advantages including savings in personnel costs. The semi-automatic register represents an effective way of reducing the risk associated with a common urological procedure. We believe that this methodology could be implemented elsewhere.

Movimento pela segurança na terapia nutricional enteral: o que há de novo com os dispositivos? / Movement for safety in enteral nutrition therapy: what's new with devices?

Introdução: O uso da terapia nutricional enteral (TNE) é considerado de alta complexidade e a grande profusão de produtos disponibilizados pela indústria farmacêutica exige do enfermeiro conhecimentos e destreza para administração segura ao paciente. Neste contexto, buscamos apresentar a evolução das iniciativas para a prevenção de erros e as principais mudanças ocorridas. Método: Foi realizado um levantamento em publicações científicas sobre as iniciativas internacionais para prevenção dos erros na TNE, seguidos das evoluções dos principais dispositivos: dietas enterais, equipos de administração, acessos enterais e bombas de infusão, considerando a forma de prevenção do evento adverso, descrição do produto, a funcionalidade, a segurança e o manuseio. Resultados: Ao longo de 40 anos, várias estratégias foram introduzidas para minimizar o risco de erros entre o acesso enteral e intravenoso. As modificações foram gradativas e heterogêneas para cada dispositivo, iniciando-se pela adoção de cor lilás e alaranjada, seguidas de alteração nas conexões de forma exclusiva ao sistema de administração da TNE, como as bombas de infusão, as pontas em cruz para equipos e saídas dos frascos das dietas enterais, os alertas nas bolsas de dietas enterais. Recentemente, padronizou-se o sistema ENFit® nos Estados Unidos, um conector que deverá ser utilizado para todos dispositivos envolvidos na TNE. Especialistas têm, também, destacado o aspecto educativo e a participação do setor de suprimentos dos hospitais, a fim de garantir uniformidade nos processos. Conclusão: Apesar da evolução histórica com as estratégias voltadas para minimizar os erros de conexão, as mudanças estão sendo gradativas e heterogêneas. É necessário um esforço mundial envolvendo fabricantes, órgãos regulatórios, profissionais da área da saúde e até mesmo do próprio consumidor para que estas mudanças se tornem realidade o mais breve possível, visando à segurança ao paciente e ao profissional da saúde.(AU)

Introduction: The enteral nutrition therapy (ENT) is considered of high complexity and the great profusion of products offered by the pharmaceutical industry, requires the nurse knowledge and ability to secure patient's administration. In this context, we present the initiatives and evolution for the prevention of errors. Methods: We did a survey of scientific publications about the international initiatives to prevention of errors in ENT, and the main devices developments: enteral diets, sets administration, feeding tube and infusion pumps, considering the product description, functionality, form of prevention of the adverse event, safety, and handling. Results: Over 40 years, several strategies were introduced to minimize the risk of errors to enteral and parenteral access.The changes were gradual and heterogeneous to each device, starting by the adoption of lilac and orange color, followed the connections exclusive to the system of administration of the ENT, such as infusion pumps, cross spike in infusion devices and output of enteral bags and alerts on the enteral bags. Recently, the United States of America, standardized the ENFit® system which a connector used for all devices involved in ENT.Specialists have also highlighted the educational aspect and participation of the hospital supply sector in order to ensure uniformity in the processes. Conclusion: Despite the historical evolution with the strategies to minimize the connection errors, changes are being graded and heterogeneous. There is a need for a global effort involving manufacturers, regulatory agencies, health professionals and even consumers themselves to these changes become reality as soon as possible, in order to patient and health professional security.(AU)

Dispositivos de segurança em instrumentos perfurocortantes versus acidentes com exposição a material biológico / Safety-engineered sharp devices versus accidents with exposure to biological material / Dispositivos de seguridad en instrumentos cortopunzantes versus accidentes con exposición a material biológico

Objetivou-se analisar, a partir da literatura, a relação entre a incorporação de dispositivos de segurança em instrumentos perfurocortantes e a ocorrência de acidentes de trabalho com o uso desses instrumentos, envolvendo profissionais da área da saúde. Trata-se de uma revisão integrativa, realizada nos bancos de dados Scientific Eletronic Library Online e Biblioteca Virtual em Saúde, cujos descritores foram segurança de equipamentos, gestão de risco, prevenção de acidentes, exposição a agentes biológicos e pessoal de saúde. Como resultado, foram encontrados 14 artigos, publicados no período de 2006 a 2014, os quais foram discutidos em duas categorias: dispositivo de segurança em instrumentos perfurocortantes e acidentes utilizando instrumentos perfurocortantes com e sem dispositivo de segurança. Conclui-se que a incorporação de dispositivos de segurança em instrumentos perfurocortantes proporciona redução de acidentes relacionados à exposição a material biológico; favorece economicamente a instituição; promove a segurança e a saúde dos trabalhadores e, consequentemente, melhora a qualidade da assistência prestada aos clientes.

This integrative literature review, to examine the relationship between safety engineering of sharp devices and the occurrence of accidents among health care professionals using these devices, was conducted on the Scientific Electronic Library Online and Virtual Health Library databases, with the descriptors [in Portuguese] equipment safety, risk management, accident prevention, exposure to biological agents, and health personnel. The 14 articles found as a result were discussed in two categories: safety engineering on sharp devices, and accidents using sharp devices with and without safety engineering. It was concluded that safety engineering on sharp devices has yielded a reduction in accidents involving exposure to biological material; favors the institution economically; promotes workers' health and safety and, consequently, improves the quality of client care.

Este estudio tuvo como objetivo analizar la relación entre la incorporación de dispositivos de seguridad en instrumentos cortopunzantes y la ocurrencia de accidentes laborales al usar estos instrumentos, con la participación de profesionales de la salud, a partir de la literatura. Se trata de una revisión integradora de literatura realizada en los bancos de datos Scientific Eletronic Library Online y Biblioteca Virtual em Saúde, cuyos descriptores fueron seguridad de equipos, gestión de riesgos, prevención de accidentes, exposición a agentes biológicos y personal de salud. Como resultado, se encontraron 14 artículos, publicados en el periodo de 2006 a 2014, que fueron discutidos en dos categorías: dispositivos de seguridad en instrumentos cortopunzantes, y accidentes utilizando instrumentos cortopunzantes con y sin dispositivos de seguridad. Se concluye que la incorporación de dispositivos de seguridad en instrumentos cortopunzantes proporciona una reducción de accidentes relacionados con la exposición a material biológico; favorece económicamente la institución; promueve la seguridad y la salud de los trabajadores y, consecuentemente, mejora la calidad de la asistencia proporcionada a los clientes.

Integrating Cost-effective Rollover Protective Structure Installation in High School Agricultural Mechanics: A Feasibility Study.

This study with three Appalachian county agricultural education programs examined the feasibility, effectiveness, and impact of integrating a cost-effective rollover protective structure (CROPS) project into high school agricultural mechanics classes. The project aimed to (1) reduce the exposure to tractor overturn hazards in three rural counties through the installation of CROPS on seven tractors within the Cumberland Plateau in the east region; (2) increase awareness in the targeted rural communities of cost-effective ROPS designs developed by the National Institution for Occupational Safety and Health (NIOSH) to encourage ROPS installations that decrease the costs of a retrofit; (3) test the feasibility of integration of CROPS construction and installations procedures into the required agricultural mechanics classes in these agricultural education programs; and (4) explore barriers to the implementation of this project in high school agricultural education programs. Eighty-two rural students and three agricultural educators participated in assembly and installation instruction. Data included hazard exposure demographic data, knowledge and awareness of CROPS plans, and pre-post knowledge of construction and assessment of final CROPS installation. Findings demonstrated the feasibility and utility of a CROPS education program in a professionally supervised secondary educational setting. The project promoted farm safety and awareness of availability and interest in the NIOSH Cost-effective ROPS plans. Seven CROPS were constructed and installed. New curriculum and knowledge measures also resulted from the work. Lessons learned and recommendations for a phase 2 implementation and further research are included.

Neonatal and adult ICU ventilators to provide ventilation in neonates, infants, and children: a bench model study.

BACKGROUND: Using a bench test model, we investigated the hypothesis that neonatal and/or adult ventilators equipped with neonatal/pediatric modes currently do not reliably administer pressure support (PS) in neonatal or pediatric patient groups in either the absence or presence of air leaks. METHODS: PS was evaluated in 4 neonatal and 6 adult ventilators using a bench model to evaluate triggering, pressurization, and cycling in both the absence and presence of leaks. Delivered tidal volumes were also assessed. Three patients were simulated: a preterm infant (resistance 100 cm H2O/L/s, compliance 2 mL/cm H2O, inspiratory time of the patient [TI] 400 ms, inspiratory effort 1 and 2 cm H2O), a full-term infant (resistance 50 cm H2O/L/s, compliance 5 mL/cm H2O, TI 500 ms, inspiratory effort 2 and 4 cm H2O), and a child (resistance 30 cm H2O/L/s, compliance 10 mL/cm H2O, TI 600 ms, inspiratory effort 5 and 10 cm H2O). Two PS levels were tested (10 and 15 cm H2O) with and without leaks and with and without the leak compensation algorithm activated. RESULTS: Without leaks, only 2 neonatal ventilators and one adult ventilator had trigger delays under a given predefined acceptable limit (1/8 TI). Pressurization showed high variability between ventilators. Most ventilators showed TI in excess high enough to seriously impair patient-ventilator synchronization (> 50% of the TI of the subject). In some ventilators, leaks led to autotriggering and impairment of ventilation performance, but the influence of leaks was generally lower in neonatal ventilators. When a noninvasive ventilation algorithm was available, this was partially corrected. In general, tidal volume was calculated too low by the ventilators in the presence of leaks; the noninvasive ventilation algorithm was able to correct this difference in only 2 adult ventilators. CONCLUSIONS: No ventilator performed equally well under all tested conditions for all explored parameters. However, neonatal ventilators tended to perform better in the presence of leaks. These findings emphasize the need to improve algorithms for assisted ventilation modes to better deal with situations of high airway resistance, low pulmonary compliance, and the presence of leaks.

Risco e segurança sanitária: análise do reprocessamento de produtos médicos em hospitais de Salvador, BA / Risk and sanitary safety: analysis on medical product reprocessing in hospitals in Salvador, Northeastern Brazil / Riesgo y seguridad sanitaria: análisis del reprocesamiento de productos médicos en hospitales de Salvador, Nordeste de Brasil

OBJETIVO: Analisar condições técnicas do reprocessamento de produtos médicos em hospitais. MÉTODOS: Estudo descritivo de casos múltiplos em centros de material e esterilização de quatro hospitais da cidade de Salvador, BA, em 2010. Foram realizadas entrevista semiestruturada e observação direta, com base em modelo regulatório de reprocessamento de produtos médicos elaborado com a técnica de Conferência de Consenso como padrão de referência. As categorias analíticas utilizadas neste estudo foram: gerenciamento da prática de reprocessamento de produtos médicos, protocolos de reprocessamento, monitoramento do processo de esterilização e rastreabilidade de produtos. Essas categorias foram pontuadas segundo sua conformidade com o modelo regulatório de reprocessamento utilizado. RESULTADOS: Observou-se inadequação generalizada das condições técnicas de reprocessamento de produtos médicos, das condições estruturais dos centros de material e esterilização estudados e das condições dos processos de trabalho, além de dificuldades organizacionais e gerenciais que interferiram nas práticas analisadas. CONCLUSÕES: As práticas de reprocessamento dos produtos médicos nos hospitais analisados configuram risco para os pacientes usuários. É necessária a adoção de um sistema de gerenciamento de risco nesses hospitais e de maior controle sanitário pelo Estado, a fim de proteger a saúde dos pacientes.

OBJECTIVE: To analyze the technical conditions for medical product reprocessing in hospitals. METHODS: This was a descriptive study on multiple cases in materials and sterilization centers at four hospitals in the city of Salvador, Southeastern Brazil, in 2010. Semi-structured interviews were conducted and direct observations were made, based on a regulatory model for medical product reprocessing that was drawn up with the technique of consensus verification as the reference standard. The analytical categories used in this study were: management of the practice of medical product reprocessing; reprocessing protocols; monitoring of the sterilization process; and capacity for product tracking. These categories were scored according to their degree of conformity with the regulatory model for reprocessing used. RESULTS: General inadequacy of the technical conditions for medical product reprocessing was observed, with regard to the structural conditions of the materials and sterilization centers studied and the work process conditions, along with organizational and managerial difficulties that interfered with the practices analyzed. CONCLUSIONS: The practices of medical product reprocessing in the hospitals analyzed constitute a risk for the patient users. Risk management systems need to be introduced in these hospitals, with greater sanitary control by the state, in order to protect patients' health.

OBJETIVO: Analizar condiciones técnicas de reprocesamiento de productos médicos en hospitales. MÉTODOS: Estudio descriptivo de casos múltiples en centros de material y esterilización de cuatro hospitales de la ciudad de Salvador, BA, en 2010. Se realizaron entrevista semi-estructurada y observación directa, con base en modelo regulatorio de reprocesamiento de productos médicos elaborado con la técnica de Conferencia de Consenso como patrón de referencia. Las categorías analíticas utilizadas en este estudio fueron: gerenciamiento de la práctica de reprocesamiento de productos médicos, protocolos de reprocesamiento, monitoreo del proceso de esterilización y rastreo de productos. Esas categorías fueron calificadas según su conformidad con el modelo regulatorio de reprocesamiento utilizado. RESULTADOS: Se observó inadecuación generalizada de las condiciones técnicas de reprocesamiento de productos médicos de las condiciones estructurales de los centros de material y esterilización estudiados y de las condiciones de los procesos de trabajo, así como, dificultades organizacionales y gerenciales que interfirieron en las prácticas analizadas. CONCLUSIONES: Las prácticas de reprocesamiento de los productos médicos en los hospitales analizados configuran riesgo para los pacientes usuarios. Es necesaria la adopción de un sistema de gerenciamiento de riesgo en tales hospitales y de mayor control sanitario por el Estado, a fin de proteger la salud de los pacientes.

Electro-Mechanical Safety Testing of Portable ECG Devices for Home Healthcare Usage.

OBJECTIVES: This paper suggests the experimental guidelines to evaluate the electro-mechanical safety of belt type equipment. The electro-mechanical safety was determined by using the International Electrotechnical Commission guidelines, which are widely used as important factors for assessing the electro-mechanical safety of belt type equipment. However, the local guidelines on wearable healthcare sensors are currently not well-established. Therefore, safety guidelines suited for the actual circumstances in Korea are required, and this paper attempts to try a new experimental safety test procedure of the wearable healthcare sensor. METHODS: This belt type device measures the electrocardiogram (ECG) and heart rates by attaching to the chest. Examination lists were selected by analyzing the common standards ofelectro-mechanical safety (IEC 60601-1) and environment tests (IEC 60068-1, IEC 60068-2) of home-healthcare equipment. RESULTS: The essential electrical safety, which was required for the RS300G3 as a medical device, was evaluated, and most of the examination lists were selected by considering the circumstances of the users. The device passed all the selected examinable lists that are applicable to the Korean environment. CONCLUSIONS: This study has limitations to estimate and to conduct electro-mechanical safety experiments because our study focused on the belt type of heart-rates equipment. We are not taking into account the overall electro-mechanical home-healthcare measurements. According to industrial and technological development, there are infinite possibilities for the advancement of home-healthcare equipment, so more examination lists for safety are being added in addition to what we have done.