Federal Medical Council Research Articles

Advance Care Planning in Brazil

Brazil is a country of continental size marked by extreme social inequalities. Its regulation of Advance Directives (AD) was not enacted by law but within the scope of the norms that govern the relationships between patients and physicians, as a resolution of the Federal Medical Council without any specific requirement for notarization. Despite this innovative starting point, most of the debate regarding Advance Care Planning (ACP) in Brazil has been dominated by a legal transactional approach focused on making decisions in advance and the creation of AD. Yet, other novel ACP models have recently emerged in the country with a focus on the creation of a specific quality of relationship between patients, families, and physicians aiming at the facilitating future decision-making. Most of the education on ACP in Brazil happens in the context of palliative care courses. As such, most ACP conversations are performed within palliative care services or by healthcare professionals with training in that area. Hence, the scarce access to palliative care services in the country means that ACP is still rare and that those conversations usually happen late in the course of disease. The authors posit that the existing paternalistic healthcare culture is one of the most important barriers to ACP in Brazil and envision with great concern the risk that its combination with extreme health inequalities and the lack of healthcare professionals’ education on shared decision-making could lead to the misuse of ACP as a form of coercive practice to reduce healthcare use by vulnerable populations.

Evaluation of the regional distribution of the pediatric surgery workforce and surgical load in Brazil

ObjectiveThe purpose of this study is to examine the regional distribution of the pediatric surgery workforce and the expected local demand for pediatric surgical procedures in Brazil.MethodsWe collected data on...

There is no shortage, but inequality: demographic evolution of neurologists in Brazil (2010–2020)

Neurology is a medical specialty that deals with prevalent diseases such as stroke, headache, epilepsy, and neurodegenerative diseases. Many countries, such as Brazil, struggle to provide neurological care for their populations, but the inadequacy and unequal distribution of the neurologist workforce are real challenges. To analyze the demographic evolution of neurologists and the first-year Neurology residency positions in Brazil during the last decade (2010-2020) and the distribution imbalance between regions. The demographic and geographic distribution of neurologists was calculated based on data extracted from the Brazilian Federal Medical Council reports, and the number of Neurology residency positions was based on the Brazilian National Commission of Medical Residency reports. Indicators of wealth were associated with demographic data. The number of neurologists per 100,000 population has increased since 2011, with a similar increase in the geographic distribution of neurologists. However, there was a marked inequality of distribution of neurologists through regions, with a gap between the Northern (lowest) and Southeastern (highest) regions. Furthermore, the imbalance of distribution of neurologists strongly correlated with social inequality. The number of Neurology residency positions increased, but with an imbalance between North and Southeast regions. Brazil has advanced in providing neurologists. However, instead of a shortage, inequality between regions is the greatest challenge regarding the neurological workforce. The training of new neurologists is unequal between regions and occurs at a slower rate than needed. Neurologists, public health authorities, and patients should discuss solutions for these issues.

Procurement of abdominal organs

Solid organ transplantation is frequently carried out in this society. Under these circumstances the basic principles are altruistic organ donation and abidance by the law, which are regulated by the German Transplantation Act and by directives of the Federal Medical Council from which process instructions of the German Organ Transplantation Foundation are derived. The organ allocation is carried out by the Eurotransplant International Foundation (ET) located in Leiden, the Netherlands. Organ procurement is an essential component of the process of organ donation. This article highlights the procedure for harvesting of abdominal organs and also nonsurgical issues in the process of organ donation.

Transexualidade, ordem médica e política de saúde: controle normativo do processo transexualizador no Brasil

Este estudo teve por objetivo examinar a trajetória histórica do posicionamento oficial do Conselho Federal de Medicina (CFM) acerca dos procedimentos médicos associados às demandas do Processo Transexualizador (PrTr). Como objetivo específico, discutir as implicações das normatizações existentes, que regulam as intervenções médicas no campo da transgenitalização, para que se possa repensar a formação médica e de outros profissionais de saúde. O método utilizado consiste na análise documental, realizada a partir do banco de dados de pareceres, resoluções, notas técnicas, despachos e recomendações do CFM, com foco nos documentos oficiais de domínio público, que abordam o posicionamento dessa entidade representativa da classe médica em relação à realização de cirurgias de transgenitalização e prescrição da hormonioterapia para pessoas trans. Por meio dessa análise foi possível traçar, retrospectivamente, a evolução desse posicionamento e identificar quais foram os prováveis fatores que desencadearam progressivas mudanças da posição oficial assumida pelo CFM em relação à legalidade e aos aspectos éticos envolvidos nessas intervenções.

O sigilo do prontuário médico como um direito essencial do paciente: uma análise a partir das normativas do Conselho Federal de Medicina

Objetivo: avaliar a condição de sigilo do prontuário médico a partir da perspectiva do direito do paciente, considerando as normativas vigentes no país emanadas do Conselho Federal de Medicina. Metodologia: a pesquisa tem natureza bibliográfica e documental, consubstanciando-se em livros e artigos da área jurídica, em legislação ordinária e resoluções do Conselho Federal de Medicina. Resultados: o prontuário médico é documento complexo, que apresenta caráter informativo e científico. Confidencialidade, sigilo e segurança das informações são princípios observados quando da divulgação das informações contidas no documento. Conclusão: o prontuário médico, seja físico, seja digital, mais do que uma ferramenta de trabalho dos médicos e instituições de saúde, é um direito do paciente e que se encontra acobertado pelo sigilo em respeito à intimidade do paciente.

Labordiagnostik bei Diabetes mellitus

AbstractLaboratory parameters are essential for diagnosis, prognosis and therapy control of diabetes mellitus. Diabetes-specific parameters including glucose, glycated hemoglobin (HbA1c), C-peptide and autoantibodies against beta cell epitopes as well as parameters of lipid metabolism and renal function should be taken into account. The precise and reliable determination of these parameters in accordance with the guidelines of the German Federal Medical Council for the determination of laboratory diagnostics is fundamental for the correct classification and evaluation of the measurement results. For this, important pre-analytical and analytical limitations must be considered.

Critical analysis on the evolution of ethical norms for the use of assisted reproduction techniques in Brazil

The Federal Medical Council (FMC) published FMC Resolution No. 1,358/1992 with the aim of adopting ethical standards for the use of Assisted Reproduction Techniques (ART). This resolution was updated in 2010 (CFM No. 1957/2010), in 2013 (CFM No. 2,013/13) and the last update was in 2015 (CFM No. 2.121/2015). The scope of this article is to conduct a critical analysis of the evolution of the ethical norms proposed by FMC for the use of ART in Brazil. A documentary analysis of the text of the four published Resolutions was carried out, in which the ethical standards for the use of ART were described. It was observed that the resolution evolved in relation to the rights of homosexuals, adopted more permissive measures regarding cryopreservation, donation of gametes and embryos and uteruses on loan and lastly authorized some procedures in ART such as postmortem reproduction, donation and shared gestation. From 2013 onwards the resolution gained a liberal character being updated in terms of clinical practice. For the next updates it would be interesting to include procedures in ART not previously addressed such as nuclear and cytoplasmic transfer. The update frequency (every two years) should be kept to the ethical standards enabling the ART to continue evolving together with the advancement of science.

O direito à fertilização “in vitro” no Brasil: análise jurídico-literária à luz da obra “Admirável mundo novo”

Consiste em análise jurídico-literária do contexto atual brasileiro para o exercício dos direitos reprodutivos e, em especial, do direito à fertilização in vitro, reconhecido pela Corte Interamericana no emblemático caso Artavia Murillo, para evidenciar a indissociabilidade da teoria e da prática, principalmente no que concerne à esfera dos direitos e das garantias nos âmbitos interno e internacional global de proteção sob o enfoque da obra Admirável mundo novo, do teor da última resolução do CFM - Conselho Federal de Medicina sobre o tema e das normas que compõem o sistema protetivo de modo geral que afetam diretamente à autonomia reprodutiva por meio de pesquisa teórica, bibliográfica e exploratória.

The new hemotherapy guideline

The 2017 update of the German guidelines on hemotherapy is highly associated with the drug legislation and guidelines and thus necessitated anew structure of the contents. These guidelines reflect the state of the art for collection and application of blood and blood components corresponding to the Transfusion Act and is therefore the main document in hemotherapy. Topics of high interest in this 2017 update related to application of blood products are clarification and consent of patients, obligation for documentation, information, reporting and notification reports in the case of transfusion reactions and detailed description of quality management and quality assurance, as well as task description of persons responsible for the organization or implementation of transfusion-associated workflows. Surveillance, collating and management of errors are important prerequisites for the continuous optimization of patient safety. Patient blood management (PBM) as a requirement for the efficient use of blood products and the controlled and economical usage of autologous hemotherapy procedures (e. g. mechanical autotransfusion, MAT) are measures to reduce the need for blood products. All medical specialist societies, which carry out hemotherapy and participate in the standing committee of the Federal Medical Council (BÄK) to revise the hemotherapy guidelines have to take care that the guidelines are understandable for medical doctors and the transfusion team. Additionally, the core principles of hemotherapy have to be described in aclear and distinct manner.

Testamento vital à luz do ordenamento jurídico brasileiro e o princípio pro homine

Objetivo: O artigo teve por escopo analisar se o Testamento Vital, previsto na Resolução nº 1.995 do Conselho Federal de Medicina, publicada em 31 de dezembro de 2012, atende ao princípio pro homine. Metodologia: Tratou-se de pesquisa qualitativa, descritiva e analítica, com utilização de material bibliográfico, legislativo e jurídico. Resultados: Apesar da existência do Testamento Vital não há, até o momento, legislação específica sobre o tema; a discussão sobre as diretivas antecipadas de vontade no cenário nacional tem-se mostrado tímidas; o princípio pro homine representa uma maneira de salvaguardar a aplicabilidade da Resolução nº 1.995/2012 do Conselho Federal de Medicina. Conclusão: O Testamento Vital previsto na Resolução nº 1.995/2012 do Conselho Federal de Medicina atende ao melhor interesse do paciente, mesmo não havendo legislação específica sobre o tema, o que, por seu turno, precisa ser sanado com brevidade, uma vez que o direito à vida está diretamente implicado nesta discussão, e o desenvolvimento técnico científico tem proporcionado formas artificiais de prolongar a vida ou como alguns preferem, adiar a morte.

Medical Ethics Code: an Analysis from Ethical-Disciplinary Cases Against Medical Professionals within the Specialty of Psychiatry

Objective: To identify the nature of infractions committed by doctors working within the field of psychiatry, between 2010 and 2016, from the scope of appeals within ethical-disciplinary cases judged at the Plenary Tribunal of the Federal Medical Council, based on the medical ethics code, and to list some elements that make it possible to outline the professional profile of those involved.
 Method: This was a document-based investigation in the form of a retrospective and descriptive study. Data were gathered using the Federal Medical Council (CFM) database and from consultation of judgments issued by the Plenary Body of the Medical Ethics Tribunal (TSEM), of the CFM. The investigation used a sample consisting of 206 appeals and 19 referrals, totaling 224 appeals by doctors who underwent trials. We took into account cases judged between April 13, 2010 and August 3, 2016. Three databases were used in the investigation: cases (224); doctors facing charges (191) and cases/penalties (146). Based on the records of the 191 doctors charged, the ethical-disciplinary cases of seven doctors working in psychiatry were analyzed specifically for the present study, whether or not they had a specialist title. Characterization of infractions committed encompassed references to the articles of the medical ethics code most frequently infringed in the field of psychiatry, along with a survey of the motives for these infractions and some characteristics relating to these professionals’ profile.
 Results: Among the findings from this investigation, infractions of the articles of the medical ethics code can be highlighted, such as article 30 “[...] Use of the profession to corrupt customs and to commit or favor crime [...]” and article 40 “[...] Taking advantage of situations arising from the doctor-patient relationship to obtain physical, emotional, financial or any other advantage [...]”. The professional profile of those involved in these cases was also shown: the average age was 49.8 years, and all of these professionals were male. The mean length of time since graduation among the psychiatrists with appeals to the plenary body of the TSEM was 31.28 years at the time of judgment. The punishment handed down most frequently was to strike these professionals off the register, reaching the percentage of 42.9%. Among the five professionals with specialist titles, four complemented their studies with specializations, after the episode that originated the ethics charges. 
 Conclusion: The data gathered showed that the professionals were punished for irregularities in the sphere of ethics, including issues going beyond technical and/or scientific competence. This makes it possible to highlight that punishments proportional to the seriousness of the infraction act were applied, along with the importance of bioethics in medical training and the need for specialization, from the results of the judgments on ethical-professional cases before the plenary body of the TSEM.

O período de tempo para guarda dos processos clínicos e exames

No que refere o tempo de conservação dos documentos clínicos, a legislação em Portugal é esparsa, com referências sobre a conservação em diversos diplomas legais, o que contribuiu para o desconhecimento de grande parte dos profissionais da saúde e gestores de instituições de saúde o período em que encontram-se obrigados a conservar as informações dos seus pacientes. Já no Brasil apesar da ausência legislativa o Conselho Federal de Medicina, através de Resoluções vem consolidando a temática. Ambos os países encaminham-se a favor da guarda permanente, que só pode ser alcançada através da mudança do suporte de papel para o suporte eletrónico.

As Técnicas de Reprodução Humana Assistida e a Problemática da Responsabilidade Civil dos Pais

The present study aims to analyze the issues related to the civil responsibility of parents, when using the assisted human reproductions techniques. Drew up a discussion about the reflections of the principles of responsible parenting and of human dignity in the use of those techniques, delineating one by one of them that can cause damages to the embryo, unborn or child already born. Discussing about the assisted human reproduction techniques, it outlined those allowed by the Federal Medical Council through the Resolution no 2013/2013 and stood out the legal system omission related to the regulation of the use of those techniques, since the only legal instrument that deals with it, that is the Law no 11.105/2005, did not specify about it. Was presented therefore, all human assisted reproduction techniques that give rise to a possible potentiation of vulnerability of the embryo as well as to possibly answers regarding to the legal status of the embryo that the doctrine is trying to trace. Finally, we discussed about the civil responsibility forms, relating it to the responsible parenthood and the damages caused from not using those techniques.

Lebendnierenspende – ein aktueller Überblick

The living kidney donation has become increasingly important in recent years. Because of the decreasing number of postmortem donors, there has been a dramatic increase in morbidity and mortality due to the long waiting times for patients on dialysis. By timely living donation after dialysis entry or even preemptively, this can be avoided. In addition, the living donor has better graft function and better graft survival which is due to the predictability of the donation, the optimal conditioning of donor and recipient, and the short ischemia time. To protect the donor, to provide legal protection, and to avoid abuse, the German legislature reacted with the Transplantation Act and its amendment. The recent recommendations for donor evaluation from the Amsterdam Forum have been used by the Federal Medical Council to revise current guidelines and guidelines for living donation will be drawn up. The focus of these efforts is standardization of the procedure and protection of the kidney donor. This is also reflected in the recommendations for organ removal technique and the selection of the organ to be used for kidney donation.

Sociomedical outcome after outpatient withdrawal treatment: Results of a model project of integrated care

Dependence disorders represent a large socioeconomic problem due to insufficient and delayed diagnostics and treatment. This study investigated the effectiveness of the integrated care concept involving rapid clarification, diagnosis, initiation of withdrawal treatment, transfer to addiction rehabilitation and abstinence. In this prospective observational study 293 patients with dependency disorders were investigated in an outpatient withdrawal treatment concept with respect to the course of the integrated care concept, sociodemographic data and other important variables of addiction. In a 2-year follow-up period abstinence (after t1 = 3, t2 = 12 and t3 = 24 months), referral to and beginning addiction rehabilitation were recorded. All patients completed the outpatient detoxification treatment concept without complications of whom 95.3% were abstinent and 52.9% could be placed in long-term treatment (duration 1 year). The 24-month abstinence (DGSS 4) was high but decreased significantly over time (t1 = 59.4%, t2 = 50.5%, t3 = 39.7%, p<0.001). Placement in a long-term rehabilitation program showed the greatest effect on abstinence (p<0.001), followed by treatment duration (p<0.001). The disease severity (stress index) showed significantly lower negative effects (p<0.01). The integrated care concept is an effective outpatient withdrawal treatment, despite the methodological limitations. Break points in the addiction help system are stabilized and patients can be successfully treated. The results are equivalent to a qualified inpatient withdrawal treatment taking the recommendations of the Federal Medical Council into consideration.

Considerações da comissão de saúde suplementar do CBO sobre o tratamento com antiangiogenicos

Considerações da comissão de saúde suplementar do CBO sobre o tratamento com antiangiogenicos

Quality assurance in human genetic testing

Advances in technical developments of genetic diagnostics for more than 50 years, as well as the fact that human genetic testing is usually performed only once in a lifetime, with additional impact for blood relatives, are determining the extraordinary importance of quality assurance in human genetic testing. Abidance of laws, directives, and guidelines plays a major role. This article aims to present the major laws, directives, and guidelines with respect to quality assurance of human genetic testing, paying careful attention to internal and external quality assurance. The information on quality assurance of human genetic testing was obtained through a web-based search of the web pages that are referred to in this article. Further information was retrieved from publications in the German Society of Human Genetics and through a PubMed-search using term quality + assurance + genetic + diagnostics. The most important laws, directives, and guidelines for quality assurance of human genetic testing are the gene diagnostics law (GenDG), the directive of the Federal Medical Council for quality control of clinical laboratory analysis (RiliBÄK), and the S2K guideline for human genetic diagnostics and counselling. In addition, voluntary accreditation under DIN EN ISO 15189:2013 offers a most recommended contribution towards quality assurance of human genetic testing. Legal restraints on quality assurance of human genetic testing as mentioned in §5 GenDG are fulfilled once RiliBÄK requirements are followed.

Nurses' autonomy in end-of-life situations in intensive care units.

The intensive care unit environment focuses on interventions and support therapies that prolong life. The exercise by nurses of their autonomy impacts on perception of the role they assume in the multidisciplinary team and on their function in the intensive care unit context. There is much international research relating to nurses' involvement in end-of-life situations; however, there is a paucity of research in this area in Brazil. In the Brazilian medical scenario, life support limitation generated a certain reluctance of a legal nature, which has now become unjustifiable with the publication of a resolution by the Federal Medical Council. In Brazil, the lack of medical commitments to end-of-life care is evident. To understand the process by which nurses exercise autonomy in making end-of-life decisions in intensive care units. Symbolic Interactionism and Corbin and Strauss theory methodology were used for this study. Data were collected through single audio-recorded qualitative interviews with 14 critical care nurses. The comparative analysis of the data has permitted the understanding of the meaning of nurse's experience in exercising autonomy relating to end-of-life decision-making. Institutional ethics approval was obtained for data collection. Participants gave informed consent. All data were anonymized. The results revealed that nurses experience the need to exercise autonomy in intensive care units on a daily basis. Their experience expressed by the process of increase opportunities to exercise autonomy is conditioned by the pressure of the intensive care unit environment, in which nurses can grow, feel empowered, and exercise their autonomy or else can continuously depend on the decisions made by other professionals. Nurses exercise their autonomy through care. They work to create new spaces at the same time that they acquire new knowledge and make decisions. Because of the complexity of the end-of-life situation, nurses must adopt a proactive attitude that inserts them into the decision-making process.

Delegation yes, substitution no!

The aging of society leads on the one hand to increasing case numbers and on the other hand to a reduction in the number of physicians available for patient treatment. The delegation and substitution of medical duties as a tried and tested method is increasingly being recommended in order to compensate for the lack of physicians. The Berufsverband der Deutschen Urologen (BDU, Professional Association of German Urologists) supports the guiding principle of the Bundesärztekammer (Federal Medical Council) of "delegation yes, substitution no" and rejects a substitution of medical duties by non-medical academic health personnel. Against the background of the demographic changes, the increasing need for treatment and the current deficiency of junior physicians, a more extensive inclusion of well-qualified and experienced non-medical personnel by the delegation of medically responsible duties (medical scope of practice) can be an appropriate measure to maintain a good medical service in practices, hospitals and nursing homes.