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1.
JAMA ; 326(5): 420-432, 2021 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-34342614

RESUMO

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Regulamentação Governamental/história , História do Século XX , História do Século XXI , Legislação Médica/história , Legislação Médica/tendências , Patentes como Assunto/história , Patentes como Assunto/legislação & jurisprudência , Vigilância de Produtos Comercializados , Software/história , Software/legislação & jurisprudência , Estados Unidos , United States Food and Drug Administration/história
3.
Neurosurgery ; 88(6): 1051-1055, 2021 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-33826730

RESUMO

American tort law (a.k.a. negligence) is designed to be flexible and elastic to adapt to changes in time and public policy. It provides a structure of elements and factors to be applied to each case's specific facts on a case-by-case basis. The purpose of this structure is to achieve as much uniformity as possible in the application of tort law. One side effect is that this structure makes predicting the outcome difficult because of so many variables. In addition, there is no national tort law. Instead, each state has developed its own law in the area of torts, which has resulted in differing exceptions and requirements based on where the medical care was given. The purpose of this article is to explain the first element of a negligence case-"duty to use care"-and its accompanying factors/variables. The first element that must be established in a medical negligence case is a duty to use care. In short, this means the physician must use a certain level of care in providing medical services. The physician typically owes her or his patient the duty to exercise care. However, there are special situations in which a physician may not owe a duty of care and thus cannot be held liable for medical negligence. This article is designed to provide an overview of the most common situations and summarizes the processes to determine whether a duty is owed.


Assuntos
Imperícia/legislação & jurisprudência , Erros Médicos/prevenção & controle , Segurança do Paciente/legislação & jurisprudência , Padrão de Cuidado/legislação & jurisprudência , Humanos , Legislação Médica/organização & administração
4.
Ann Biol Clin (Paris) ; 79(2): 123-142, 2021 Apr 01.
Artigo em Francês | MEDLINE | ID: mdl-33881398

RESUMO

The SARS-CoV-2 has emerged in China at the end of 2019. In order to meet the growing demand in laboratories for RT-PCR testing for viral genome detection, rapid tests detecting a SARS-CoV-2 protein (antigenic rapid test) have been developed. In this review, we present for different SARS-CoV-2 antigenic rapid tests authorized in France: legislation, technological principle, and analytical and clinical performances. Data bellow are those provided by the manufacturer/distributor. From the list of tests authorized by the French Ministry of Health, we have selected 25 for which the distributors/manufacturers have provided the technical data essential to their comparative analysis. The kits use immunochromatography technology, with detection of the nucleocapsid protein (n = 24) or the spike protein (n = 1). The matrix used is a nasopharyngeal (n = 23), oropharyngeal (n = 9) or nasal (n = 3) swab. According to the test, the reading of the result is done from 15 to 30 minutes after it is performed. The clinical sensitivity, for the more performant tests is conversely linked to the Ct of RT-PCR, ranging from 80.2% to 98.4%, according to the quantity of virus present in the sample. This percentage is inversely proportional to the Ct obtained using RT-PCR. The limit of detection ranges from 31.55 to 7200 TCID50/mL. The clinical specificity, compared to a negative result of RT-PCR, is between 99.2% and 100%. Analytical specificity evaluated on other microorganisms is 100%, except for 3 kits that show cross-reactivities with SARS-CoV-1 (n = 3) and MERS-CoV (n = 1). Positive and negative predictive values range from 96.3% to 100% and 95% to 99.4%, respectively.


Assuntos
Teste para COVID-19 , COVID-19/diagnóstico , SARS-CoV-2 , Antígenos Virais/análise , Cromatografia de Afinidade , Proteínas do Nucleocapsídeo de Coronavírus/isolamento & purificação , França , Humanos , Legislação Médica , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Glicoproteína da Espícula de Coronavírus/isolamento & purificação
5.
Hum Gene Ther ; 32(19-20): 997-1003, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33843251

RESUMO

Advanced therapy medicinal products (ATMPs), such as gene therapies that consist of or contain genetically modified organisms (GMOs) need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State, before a clinical trial can commence. Complying with GMO requirements is complex, varies significantly across EU Member States and is leading to delays to clinical trials with ATMPs. Such delays and varying implementation of the GMO legislation makes the EU less attractive as a region to conduct clinical trials with investigational gene therapies. This is detrimental to EU patients, since their timely access to these transformative potentially curative medicines is delayed. Despite recent initiatives coordinated by the European Commission (EC) to facilitate and reduce discrepancies across the EU regarding the application of the GMO requirements, it remains particularly difficult to conduct multicenter clinical trials with ATMPs containing or consisting of GMOs involving several EU Member States. The recent decision for the EC to temporarily derogate potential coronavirus disease 2019 treatments and vaccines from some provisions of the GMO requirements was made on the basis of a clear recognition of such complexities and resulting delays to clinical development. The Alliance for Regenerative Medicine, the European Federation of Pharmaceutical Industries and Associations, and the European Association for Bioindustries call upon the EC, together with national competent authorities, to exempt ATMPs containing or consisting of GMOs from the GMO legislation. Such a simplification will eliminate the delays currently reported to occur when submitting environmental risk assessments and GMO applications to the national competent authorities. An exemption from GMO requirements will make the EU a more attractive region for clinical development of gene therapies and could accelerate European patients' access to these potentially life-saving medicines. Maintaining a system for GMO assessment that is different across countries may also prevent ATMPs from realizing the full benefits of a harmonized clinical trial approval process under the Clinical Trials Regulation. The undersigned organizations to this publication urge the EC to use its right of initiative to put forward a legislative proposal to exempt ATMPs in clinical development from the EU GMO legislation, within the timeframe proposed in the 2020 EU Pharmaceutical Strategy (by 2022). Implementation of a GMO exemption scheme before the end of the transition period for the Clinical Trial Regulation (the end of 2023) is important to avoid new Clinical Trial Application submissions for ATMPs under the Clinical Trial Regulation having to conduct the whole GMO assessment process in parallel. It is considered that ATMPs pose negligible risk to the environment. Such ATMPs include the following: human somatic cells modified ex vivo; recombinant virus-based vectors, including those containing genome editing nucleic acid sequences (which may also be delivered nonvirally); and bacterial vectors. Outside of controlled storage conditions, gene therapies cannot survive for any appreciable length of time. Upon clinical administration, any recombinant gene therapy viral vector particles that do not enter host cells are diluted within the body and if excreted are in such low multiplicity to no longer be viable or considered infectious to persons, animals, or living organisms within the environment. Any nucleic acids released into the environment are rapidly degraded.


Assuntos
COVID-19 , Alimentos Geneticamente Modificados , Legislação Médica , Estudos Multicêntricos como Assunto/legislação & jurisprudência , Organismos Geneticamente Modificados , SARS-CoV-2 , União Europeia , Humanos
6.
Tex Med ; 117(1): 20-27, 2021 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-33641112

RESUMO

The way the Texas Legislature conducts business during the 2021 session may look different due to the COVID-19 pandemic. But the Texas Medical Association's commitment to improving health care remains the same. Some of those goals are up against deep cuts to state agency budgets. At the same time, however, the pandemic has created opportunities for medicine to bend lawmakers' ear on some of its longstanding goals, including advancing access to care, vaccines, health coverage, and telemedicine.


Assuntos
COVID-19/epidemiologia , Legislação Médica , Governo Estadual , COVID-19/prevenção & controle , Humanos , Texas
8.
Ann Anat ; 233: 151608, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33022405

RESUMO

COVID-19 is an infection caused by the SARS-CoV-2 virus, initially identified in the city of Wuhan, China, in December 2019. Since then, the virus has spread to the continents, causing a major pandemic. The impacts of this pandemic on the education of human anatomy interfere in at least two aspects: (1) receiving and managing anatomical specimens in anatomy laboratories and (2) adaptations for classes on remote virtual teaching. Therefore, this study reviewed and discussed the legal and bioethical aspects, considering the scenario of a South American Country, aiming to stimulate the debate on these two relevant themes in the international community. Because of the COVID-19 pandemic and the impossibility of mass testing, anatomists and other workers in the field must deal with the risk of receiving bodies infected with SARS-CoV-2. In this situation, additional care measures in biosafety practices are essential to protect the staff. Such measures are: the bodies must be preserved by the perfusion of formaldehyde or other fixative solutions; embalming must be performed in ventilated rooms with a good air exhaust system; to avoid excessive manipulation of bodies and procedures such as pulmonary insufflation or craniotomy; and proper use of personal protective equipment, including lab coat, gloves and masks. As for exposure of body images in online classes, this review showed that there are no legal impediments to this end. However, anatomists must adopt measures aimed at protecting the memory of the deceased, such as using secure digital platforms with restricted access; family authorization/consent and student awareness.


Assuntos
Anatomia/educação , COVID-19 , Pandemias , Manejo de Espécimes/ética , Brasil , Teste para COVID-19 , Contenção de Riscos Biológicos , Embalsamamento , Pessoal de Saúde , Humanos , Legislação Médica , Segurança , Ventilação
10.
Rev. ANACEM (Impresa) ; 15(1): 8-12, 2021. tab, graf
Artigo em Espanhol | LILACS | ID: biblio-1248004

RESUMO

Actualmente el cáncer es la segunda causa de muerte en la población chilena; sin embargo, en algunas regiones del país como Arica y Parinacota, Antofagasta, La Serena, Los Lagos y Aysén, en Atacama y La Araucanía ya es la primera (1), inmediatamente apenas por debajo de las afecciones al sistema circulatorio y cardiovascular, y se espera que, al final de la próxima década, llegue a ser la primera causa de muerte en el país (2). Por otra parte, con respecto a los años de vida perdidos en Chile, el cáncer es la primera causa de años de vida perdidos por muerte prematura (175.741 años equivalentes al 22,5% del total de años). Si a lo anterior sumamos los años de vida perdidos por discapacidad, el cáncer es responsable de 221.529 AVISA (Años de vida ajustados por discapacidad), ubicándolo en el séptimo lugar de grupos de causas de carga de enfermedad.(3) Por su incidencia, el cáncer se ha constituido en un problema de salud pública indiscutible e insoslayable, por cuya gravedad demanda al sistema de salud chileno la máxima atención y el mejor de los esfuerzos en las tareas de las pesquisas temprana en toda la población, con el fin de minimizarsusefectos combinados enlasociedad demanera transversal y en cualquier contexto en el que ocurra, debido a la dificultad que significa para el sistema de salud chileno su pesquisa temprana en todos los ciudadanos, sumado a la escasez de recursos tanto humanos como materiales, por lo costos involucrados en su abordaje, es un importante problema social y económico, con repercusión y costos que afectan a laspersonas, sus familiasy comunidades, así como al sistema de salud y al país en su conjunto. (2) A la fecha, en Chile, grandes esfuerzos se han hecho para reducir estas brechas. El mayor de ellos es el programa GES (Garantías explícitas enSalud), mediante el cual los pacientes de acuerdo a su diagnóstico e independientemente de su capacidad de pago o seguro de salud asociado, región geográfica o nivel educacional, son asegurados con una canasta de prestaciones estandarizada, con tiempos de atención antes definidos, asegurando así acceso, oportunidad, protección financiera y calidad delprestador. (4) No obstante luego de 15 años de iniciado elprograma de prestaciones GES, persisten estas diferencias tanto por nivel socioeconómico, y/o educacional, queinfluyen negativamente sobre los estándares de atención de los diferentes prestadores de salud, en razón que diversos estudios se han observado diferencias estadisticamente significativas en las tasas de mortalidad entre el sistema público y privado de 3,12 a 5,8 veces más mortalidad en los pacientes atendidos por FONASA (Fondo nacional de Salud) , respecto a los prestadores privados provenientes de ISAPRES (Instituciones de salud previsional). (5) La ley Nacional del Cáncer recibe el nombre del doctor Claudio Mora a modo de homenaje póstumo, pues él encarnó la dualidad de paciente oncológico y profesional al ser tratado por un cáncer de páncreas, junto al Dr. Jorge Jiménez de la Jara, y la senadora Carolina Goic, quienes fueron grandes impulsores de esta ley, que cuenta con $80 mil millones de pesos anuales ($20 mil millones para infraestructura y $60 mil millones para tratamientos que hoy no son cubiertos por el GES ni por la Ley Ricarte Soto), además de $200 millones anuales por ocho años para la construcción de la Red Nacional Oncológica.(6) La ley nacional del cáncer es un proyecto a largo plazo que requiere de una red oncológica integrada de profesionales y de la coordinación de un equipo interdisciplinario que presenta deficiencias tanto en el número como en la especializaciónde sus equipos médicos. En el presente contexto de la pandemia por coronavirus iniciada en Chile el 1 de marzo de 2020, contrapuesto a lo anterior la disminución de los diagnósticos de cáncer es un hecho, como consecuencia directa de la priorización de camas crítica como camas básicas y de intermedio para atender pacientes infectados por coronavirus, a pesar de lo anterior ha entrado en vigencia la Ley Nacional de Cáncer, es decir, la nueva Ley 21.258, que pretende asegurar que se proporcione un óptimo diagnóstico, tratamiento y seguimiento a los pacientes. (7)


Assuntos
Política Pública , Programas Médicos Regionais , Legislação Médica , Neoplasias/mortalidade , Chile , Justicia, Planta , Equidade , COVID-19 , Oncologia
12.
MD Advis ; 13(2): 38-44, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33352024
13.
New Bioeth ; 26(4): 328-350, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33196403

RESUMO

United States law recognizes adult reproductive liberty and many states view surrogacy services through that lens. During the COVID-19 pandemic in March, 2020, New York State enacted the Child-Parent Surrogacy Act (CPSA) into law, after feminists and their allies had caused its defeat in 2019. Just before approval of the CPSA, a group of legislators introduced the Alternative Surrogacy Bill (ASB). This article is a case study that examines how the CPSA and not the ASB became law, examining surrogate rights, the best interests of the child, and the ethical issues related to adult donor-conceived and surrogacy born children's rights to information about their ancestry.


Assuntos
Comércio/legislação & jurisprudência , Direitos Humanos , Legislação Médica/ética , Técnicas Reprodutivas/legislação & jurisprudência , Controle Social Formal , Mães Substitutas/legislação & jurisprudência , Acesso à Informação , Adulto , COVID-19 , Criança , Proteção da Criança , Comércio/ética , Infecções por Coronavirus/epidemiologia , Dissidências e Disputas , Família , Feminino , Humanos , Indústrias/ética , Indústrias/legislação & jurisprudência , Mães , New York/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Gravidez , Técnicas Reprodutivas/economia , Técnicas Reprodutivas/ética , Direitos da Mulher
14.
Soins Psychiatr ; 41(328): 16-18, 2020.
Artigo em Francês | MEDLINE | ID: mdl-33039085

RESUMO

Management of compulsory care is the source of many legal questions for caregivers who have to make decisions. In the eyes of the texts and case law, the patient is believed as a subject of law. Thus, no act of care can be applied without their free and enlightened consent. In applying the care programme, the patient preserves their freedom, and therefore the freedom to continue or not the care programme. Faced with complex clinical situations, and to avoid uncertain decisions, ethics must make it possible to find the appropriate answers.


Assuntos
Ética Médica , Legislação Médica , Humanos
15.
Curr Opin Pediatr ; 32(6): 765-771, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33105272

RESUMO

PURPOSE OF REVIEW: The purpose of this review is to describe ethical and legal issues that arise in the management of patients with disorders of consciousness ranging from the minimally conscious state to the coma state, as well as brain death. RECENT FINDINGS: The recent literature highlights dilemmas created by diagnostic and prognostic uncertainties in patients with disorders of consciousness. The discussion also reveals the challenges experienced by the disability community, which includes individuals with severe brain injury who are classified as having a disorder of consciousness. We review current guidelines for management of patients with disorders of consciousness including discussions around diagnosis, prognosis, consideration of neuropalliation, and decisions around life sustaining medical treatment. SUMMARY: In the setting of uncertainty, this review describes the utility of applying a disability rights perspective and shared decision-making process to approach medical decision-making for patients with disorders of consciousness. We outline approaches to identifying surrogate decision makers, standards for decision-making and decision-making processes, specifically addressing the concept of futility as a less useful framework for making decisions. We also highlight special considerations for research, innovative and controversial care, brain death, organ donation, and child abuse and neglect.


Assuntos
Transtornos da Consciência , Ética Médica , Legislação Médica , Transtornos da Consciência/terapia , Humanos
16.
Int J Law Psychiatry ; 72: 101601, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32889420

RESUMO

The coronavirus pandemic, referred to here as Covid-19, has brought into sharp focus the increasing divergence of devolved legislation and its implementation in the United Kingdom. One such instance is the emergency health and social care legislation and guidance introduced by the United Kingdom Central Government and the devolved Governments of Wales, Scotland and Northern Ireland in response to this pandemic. We provide a summary, comparison and discussion of these proposed and actual changes with a particular focus on the impact on adult social care and safeguarding of the rights of citizens. To begin, a summary and comparison of the relevant changes, or potential changes, to mental health, mental capacity and adult social care law across the four jurisdictions is provided. Next, we critique the suggested and actual changes and in so doing consider the immediate and longer term implications for adult social care, including mental health and mental capacity, at the time of publication.several core themes emerged: concerns around process and scrutiny; concerns about possible changes to the workforce and last, the possible threat on the ability to safeguard human rights. It has been shown that, ordinarily, legislative provisions across the jurisdictions of the UK are different, save for Wales (which shares most of its mental health law provisions with England). Such divergence is also mirrored in the way in which the suggested emergency changes could be implemented. Aside from this, there is also a wider concern about a lack of parity of esteem between social care and health care, a concern which is common to all. What is interesting is that the introduction of CVA 2020 forced a comparison to be made between the four UK nations which also shines a spotlight on how citizens can anticipate receipt of services.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Reforma dos Serviços de Saúde/legislação & jurisprudência , Legislação Médica/tendências , Transtornos Mentais/epidemiologia , Serviços de Saúde Mental/legislação & jurisprudência , Pneumonia Viral/epidemiologia , COVID-19 , Internação Compulsória de Doente Mental/legislação & jurisprudência , Humanos , Competência Mental/legislação & jurisprudência , Transtornos Mentais/terapia , Irlanda do Norte/epidemiologia , Pandemias , SARS-CoV-2 , Reino Unido/epidemiologia
17.
Nature ; 587(7834): 377-386, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32894860

RESUMO

Here we describe the LifeTime Initiative, which aims to track, understand and target human cells during the onset and progression of complex diseases, and to analyse their response to therapy at single-cell resolution. This mission will be implemented through the development, integration and application of single-cell multi-omics and imaging, artificial intelligence and patient-derived experimental disease models during the progression from health to disease. The analysis of large molecular and clinical datasets will identify molecular mechanisms, create predictive computational models of disease progression, and reveal new drug targets and therapies. The timely detection and interception of disease embedded in an ethical and patient-centred vision will be achieved through interactions across academia, hospitals, patient associations, health data management systems and industry. The application of this strategy to key medical challenges in cancer, neurological and neuropsychiatric disorders, and infectious, chronic inflammatory and cardiovascular diseases at the single-cell level will usher in cell-based interceptive medicine in Europe over the next decade.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Atenção à Saúde/métodos , Atenção à Saúde/tendências , Medicina/métodos , Medicina/tendências , Patologia , Análise de Célula Única , Inteligência Artificial , Atenção à Saúde/ética , Atenção à Saúde/normas , Diagnóstico Precoce , Educação Médica , Europa (Continente) , Feminino , Saúde , Humanos , Legislação Médica , Masculino , Medicina/normas
18.
Int J Drug Policy ; 85: 102940, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32947138

RESUMO

OBJECTIVES: Since 25th March 2020 India went into a complete and extended lockdown. Alcohol production, sales, and purchase were barred with this overnight prohibition order. We conducted a qualitative analysis of the media reports published within the first month of the nationwide lockdown with the objectives (a) using the media reports as indications of possible public health impact and population response of a sudden alcohol prohibition in India, (b) suggesting areas for future research. METHODS: We performed thematic and content analysis of 350 articles published online in national newspapers between the 26th March, 2020 and 25th April, 2020. Initial inductive, followed by deductive coding was done in this exploratory thematic analysis. RESULTS: The thematic analysis revealed four main themes: the beneficial aspects of the policy, the harmful aspects of the policy, non-compliance and attempts to change and / or subvert the policy, popularity and level of public buy-in of the policy. We generated relevant sub-themes under main themes. Two additional themes, not directly related to the sudden prohibition, were use of stigmatizing language and ethical concerns. The content analysis showed the frequency of the appearance of the main themes and proportions of sub-themes and codes under those main themes. CONCLUSION: The harms, perceived from the media reports, should be balanced against the potential benefits. Absence of a national-level alcohol policy was made apparent by the reflexive, disconnected, and conflictual measures. Future research could systematically examine the potential ramifications of alcohol prohibition on public health, social, and economic aspects.


Assuntos
Consumo de Bebidas Alcoólicas/legislação & jurisprudência , COVID-19 , Jornais como Assunto , Pandemias , Política Pública , Quarentena/psicologia , Bebidas Alcoólicas , Alcoolismo/epidemiologia , Alcoolismo/terapia , Humanos , Índia , Internet , Legislação Médica , Aceitação pelo Paciente de Cuidados de Saúde , Saúde Pública , Grupos de Autoajuda
19.
S Afr Med J ; 110(8): 812-815, 2020 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-32880312

RESUMO

The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. The purpose of this article, the first of three in a series, is to explore the nature, role and clinical application of FMT in SA in order to determine, from a legal perspective, the appropriate regulatory pathways governing FMT as a procedure that may combine approaches for the treatment of drugs, human tissue for transplantation, or clinical treatment as part of the practice of medicine. FMT has been shown to be a novel, safe and effective treatment for recurrent Clostridioides difficile infection (CDI). Stool banks are instrumental in enabling access to FMT for patients and clinicians and help to catalyse research in the microbiome. However, the regulatory landscape in SA remains unclear. Microbial therapies such as FMT are necessary, especially in a time of rising microbiome-associated inflammatory diseases and increasing resistance to traditional antibiotics. FMT is now considered as part of the standard of care for recurrent CDI overseas, but is currently only being used for research purposes in a minority of clinical cases of CDI in SA. This article, which lays the foundation for consideration of this question in three parts, suggests that the relevant regulatory system would depend on the categorisation of human stool as tissue, the exact composition of the FMT, how it is administered to patients, and the relevant levels of manipulation of the stool for FMT-derived products.


Assuntos
Transplante de Microbiota Fecal , Legislação Médica , Bancos de Espécimes Biológicos/legislação & jurisprudência , Fezes , Microbioma Gastrointestinal , Humanos , África do Sul
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