Medical malpractice in aortic valve and mitral valve replacement surgery in North America.

BACKGROUND: Aortic and mitral valve replacement are commonly performed by cardiovascular surgeons, but little data quantitatively analyzes the etiology and prevalence of medical malpractice litigations involving these operations. This study aims to analyze incidence, cause, and resolution of medical malpractice lawsuits involving aortic and mitral valve replacements, alone and in combination with coronary artery bypass and/or aortic procedures. METHODS: The Westlaw legal database was utilized to compile relevant litigations across the United States from 1994-2019. Clinical data, verdict data, demographic data, and litigation attributes were compiled. Fisher's Exact Tests and Mann-Whitney tests were performed for statistical analyses. One hundred four malpractice litigations involving aortic valve replacement and 55 litigations involving mitral valve replacement were included in this analysis. The mean age of patients was 55.2 years and proportion of female patients was 32.7% in aortic valve replacements litigations, compared to a mean age of 54.1 years and female patients in 61.8% of mitral valve replacements litigations. RESULTS: Significant relationships exist between an alleged failure to monitor the patient and defendant verdicts (P=0.01), delayed treatment and defendant verdicts (P=0.04), and incidence of infective endocarditis and plaintiff verdicts (P=0.04) in aortic valve replacement litigations. Similarly, significant relationships exist between an alleged failure to diagnose and settlement verdicts (P=0.047), and stroke incidence and defendant verdicts (P=0.03) in mitral valve replacement litigations. CONCLUSIONS: In addition to excellent surgeon patient/family communication, administering surgical treatment in a timely manner, diagnosing acting on concomitant medical conditions, and close patient monitoring may diminish medical malpractice litigation involving aortic and mitral valve replacement operations.

Eventos adversos cirúrgicos divulgados na mídia audiovisual: um estudo documental / Eventos quirúrgicos adversos en medios audiovisuales: estudio documental / Surgical adverse events in audiovisual media: a documentary study

RESUMO Objetivo analisar os eventos adversos cirúrgicos divulgados por uma mídia brasileira. Método pesquisa documental, qualitativa. A fonte de informação consistiu em reportagens audiovisuais sobre danos decorrentes de intervenções cirúrgicas, noticiadas em uma mídia brasileira. Para as buscas no portal eletrônico, consideraram-se as publicadas até junho de 2019. O referencial de Bardin foi empregado na análise temática. Os incidentes mencionados foram classificados segundo as barreiras de segurança contidas na Lista de Verificação de Segurança Cirúrgica (LVSC) da Organização Mundial da Saúde. Resultados foram analisados 16 casos apresentados através de 17 reportagens. Do total de falhas cometidas (n=16), a maioria (n=13) poderia ser prevenida através da checagem de itens contidos na LVSC. Na análise temática, três categorias emergiram: i. incidente relacionado à intervenção cirúrgica; ii. danos físicos, psicológicos e socioeconômicos decorrentes; iii. consequências ético-profissionais e/ou jurídicas. Conclusão e implicações para a prática os eventos adversos cirúrgicos divulgados pelas reportagens impactaram sobremaneira a vida dos pacientes, nos aspectos físicos, emocionais e socioeconômicos. Ainda trouxeram implicações para os profissionais envolvidos e instituições de saúde. Acredita-se que, as barreiras de segurança contidas em instrumento de verificação mundialmente reconhecido, são importantes ferramentas a serem empregadas para promover a segurança do paciente cirúrgico e salvar vidas.

RESUMEN Objetivo analizar los eventos quirúrgicos adversos reportados por un medio brasileño. Método investigación documental, cualitativa. La fuente de información consistió en reportajes audiovisuales sobre daños resultantes de intervenciones quirúrgicas, reportados en un medio brasileño. Para las búsquedas en el portal electrónico, se consideraron las publicaciones realizadas hasta junio de 2019. En el análisis temático se utilizó el marco de Bardin. Los incidentes mencionados fueron clasificados de acuerdo a las barreras de seguridad contenidas en la Lista de Verificación de Seguridad Quirúrgica (LVSC) de la Organización Mundial de la Salud. Resultados se analizaron 16 casos presentados a través de 17 informes. Del total de fallas cometidos (n = 16), la mayoría (n = 13) podría evitarse mediante la verificación de los elementos contenidos en el LVSC. En el análisis temático surgieron tres categorías: i. Incidente relacionado con la intervención quirúrgica; ii. daño físico, psicológico y socioeconómico resultante; iii. Consecuencias ético-profesionales y / o legales. Conclusión e implicaciones para la práctica los eventos quirúrgicos adversos reportados por los informes impactaron enormemente en la vida de los pacientes, en los aspectos físicos, emocionales y socioeconómicos. También trajeron implicaciones para los profesionales involucrados y las instituciones de salud. Se cree que las barreras de seguridad contenidas en un instrumento de verificación reconocido mundialmente son herramientas importantes que se utilizarán para promover la seguridad de los pacientes quirúrgicos y salvar vidas.

ABSTRACT Objective to analyze surgical adverse events reported by a Brazilian media. Method documentary and qualitative research. The source of information consisted of audiovisual reports on damages resulting from surgical interventions, reported in a Brazilian media. For searches on the electronic portal, those published until June 2019 were considered. Bardin's framework was used in the thematic analysis. The aforementioned incidents were classified according to the safety barriers contained in the Surgical Safety Checklist (SSC) of the World Health Organization. Results a total of 16 cases presented through 17 reports were analyzed. Of the total number of failures committed (n = 16), the majority (n = 13) could be prevented by checking items contained in the SSC. In the thematic analysis, three categories emerged: i. incident related to surgical intervention; ii. physical, psychological and socioeconomic resulting damage; iii. ethical-professional and/or legal consequences. Conclusion and implications for the practice the adverse surgical events disclosed by the reports greatly impacted on the lives of patients, in physical, emotional and socioeconomic aspects. They also brought implications for the professionals and health institutions involved. It is believed that the safety barriers contained in a globally recognized verification instrument are important tools to be used to promote the safety of surgical patients and save lives.

La seguridad en el paciente odontológico de acuerdo con la CONAMED / Safety in the dental patient according to CONAMED

La seguridad de los pacientes ha sido declarada por la Organización Mundial de la Salud (OMS) como un «principio fundamental para la atención sanitaria¼. Se menciona y define con la finalidad de caracterizar el problema de los incidentes relacionados con la atención de la salud, y especialmente sobre los eventos adversos. Existen definiciones básicas y operativas que sirven para elaborar reportes y proporcionar un marco referencial inicial, tal y como lo ha venido realizado en México la Comisión Nacional de Arbitraje Médico (CONAMED). La calidad en la atención es uno de los puntos más importantes, y se ha convertido poco a poco en un punto relevante en las agendas de los servicios de salud. Por esta razón debe afrontarse con un modelo de seguridad de los pacientes, con una visión que nos permita conocer los elementos básicos y conceptuales, así como la importancia de las medidas que el profesional en odontología da por hecho conocer por su entrenamiento dentro de las aulas universitarias (AU)

Patient safety has been declared by the World Health Organization (WHO) as a «fundamental principle for health care¼. It is mentioned and defined in order to characterize the problem of incidents related to health care, and especially about adverse events. There are basic and operational definitions that are used to prepare reports and provide an initial reference framework¸ as has been done in Mexico by the National Commission of Medical Arbitration (CONAMED). Quality of care is one of the most important points, gradually becoming a relevant point in the agendas of health services. It is the reason why it must be faced with a patient safety model, with a vision that allows us to know the basic and conceptual elements, as well as the importance of the measures that the professional in dentistry take for a fact to know for their Training within university classrooms (AU)

The process of litigation for medical errors in Saudi Arabia and the United Kingdom.

Efficient process of litigation of medical errors is a key to ensure fair, speedy, and accessible justice system. The conditions of establishing medical negligence are similar in both legal systems. These conditions include the duty of care, breach of that duty of care, the damages, and establishing causation. A culture of litigation and compensation is growing in the United Kingdom and Kingdom of Saudi Arabia; however the cost of medical claims and awarded compensations are much more in the United Kingdom compared to Kingdom of Saudi Arabia. In Kingdom of Saudi Arabia, there is a need for more transparency in the documentation and publication of litigated medical errors. In addition, there is a need to introduce interventions to shorten the duration of litigation in both legal systems. Financial caps on awarded compensation and caps on expert and legal fees are potential strategies to control the cost of medical errors which seems to work well in the Saudi model.

El aseguramiento del daño en la Ley 14/2007, de Investigación Biomédica / The insurance of the damage in the Law 14/2007, of Biomedical Research

La realización de procedimientos invasivos en seres humanos que impliquen un riesgo físico o psíquico con fines de investigación, debe contar con un seguro de responsabilidad que compense los posibles daños. La elección del tipo de aseguramiento tiene repercusiones directas tanto en los derechos de las personas que participan como en la calidad ética de la propia investigación. Existen buenas razones basadas en la justicia compensatoria para optar por un sistema de aseguramiento que no sólo obligue a la contratación de un seguro, sino que también establezca un sistema de responsabilidad objetiva en el que se presuponga la relación de causalidad entre la investigación biomédica y los daños que puedan producirse. La obligación de contratar un seguro específico se puede excepcionar cuando sea una investigación que implique un nivel bajo de intervención o un riesgo mínimo siempre que los posibles daños estén cubiertos por un seguro colectivo o individua

The performance of invasive procedures in humans that involve a physical or psychological risk for research purposes, must have a liability insurance that compensates for possible damages. The choice of type of insurance has direct repercussions both on the people rights involved and on the ethical quality of the research itself. There are good reasons based on compensatory justice to opt for an insurance system that not only requires the purchase of insurance but also establishes a system of strict liability in which assumes the causal relationship between biomedical research and damages that may occur. The obligation to contract a specific insurance can be excepted when it is an investigation that implies a low level of intervention or a minimum risk provided that the possible damages are covered by a collective or individual insurance

¿Comunicar el error médico o esconderlo? A propósito de las memorias de Henry Marsh / Communicate medical error sor hide them? In relation to the henry marsh's memoirs

"Do no harm" es la obra de Henry Marsh, neurocirujano inglés que en el epílogo de su carrera profesional en el National Health Service, hace memoria no tanto de sus éxitos profesionales como de sus fracasos, lo que nos sirve de punto de partida para plantear un sistema de notificación de errores médicos en España que permita cumplir con la máxima hipocrática que da título al libro: "primum non nocere". Con ese objetivo propuesto nos planteamos primero analizar hasta qué punto existe un conflicto de lealtades en la actuación profesional del médico (institución vs. paciente) que condicione la posibilidad de comunicar los errores que se produzcan, concluyendo que existen contrapesos normativos para cumplir con la máxima de informar al paciente respetando otros derechos en conflicto. El equilibrio entre el derecho a estar informado y el derecho a defenderse frente a ulteriores acciones de responsabilidad tiene el fiel de esa imaginaria balanza en la idea canónica de que para aprender del error lo primero es reconocerlo y lo segundo analizar porqué se produjo. Sólo desde el aprendizaje puede evitarse que el error se repita y con ello mejorar la calidad de la asistencia. En el análisis que hacemos del sistema español de comunicación de efectos adversos (SiNASP) llegamos a la conclusión de que no cumple los estándares que nos planteamos, y no sólo desde un análisis ético y jurídico, sino tomando como referencia los sistemas que con el mismo objetivo existen en nuestro entorno europeo, con las referencias de los tratados y acuerdos internacionales en esta materia. La conclusión final a la que llegamos como colofón de toda la reflexión previa es que para que un sistema de comunicación de errores funciones realmente, tiene que ser obligatorio y anónimo para el informante, transparente y concluyente para el informado y, sobre todo, reflexivo y didáctico para la institución, de modo que se cumpla no sólo con el deber de informar sino también con el de evitar que el error se repita

"Do no harm" is the work of Henry Marsh, an English neurosurgeon who, in the epilogue of his professional career at the National Health Service, remembers not only his professional successes but also his failures. This is the starting point to propose a system of notification of medical errors in Spain that allows to comply with the hippocratic key principle that gives title to the book: "primum non nocere". With this objective, our proposal is, in first place, to analyze the extent to which there is a conflict of loyalties in the professional performance of any doctor (institution vs. patient) that conditions the possibility of communicating the errors that may occur, concluding that there are normative counterweights to comply with this principle: to inform the patient respecting other rights in conflict. The balance between the right to be informed and the right to defend oneself against further actions of responsibility has the faithful of that imaginary balance in the canonical idea that to learn from error the starting point is to recognize it, and the second to analyze why it occurred. Only from learning can the error be avoided and, thus, improved the quality of care assistance. In our analysis of the Spanish system of adverse effects communication (SiNASP), we conclude that it does not meet the standards we set ourselves, and not only from an ethical and legal analysis, but also taking as reference the systems with the same Objective in our European environment - including the references of treaties and international agreements in this area. The final conclusion to which we arrive as the culmination of all the previous reflection is that for a system of communication of errors to actually function, it has to be obligatory and anonymous for the informant, transparent and conclusive for the informed and, above all, reflexive and didactic for the institution, so that it fulfils with the duty to inform and it also avoids that the error is repeated