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1.
Bull Cancer ; 106(1S): S83-S91, 2019 Jan.
Artigo em Francês | MEDLINE | ID: mdl-30528618

RESUMO

JACIE (Joint Accreditation Committee ISTC EBMT) regulations and standards impose a quality and safety requirement for graft reinjection by nurses. However, the standards do not provide a step-by-step graft reinjection procedure. Because of high medical team turnover, the opening of new transplant centers, and continual questions from colleagues trying to decipher the JACIE standards, the need for a specific procedure goes without saying. We collected graft reinjection procedures from each SFGM-TC center that participated in our survey, thus creating an inventory of the different steps that make up graft reinjection. In addition to reviewing the main regulatory texts and JACIE standards, we sought advice from medical and cellular therapy experts. We observed that most centers use a mix of practices and some unjustified practices. In some transplant units, it is still standard practice to defrost cell therapy products in the transplant unit. Caregivers are aware of the need for a rigorous application of the regulatory requirements and are willing to administer a procedure that provides specific steps for each stage of the process. In this workshop, we questioned each stage of the graft reinjection procedure, which helped us define clear methods of implementation. In the form of a checklist, we offer bone marrow and stem cell transplant units a step-by-step procedure.


Assuntos
Transplante de Medula Óssea/normas , Transplante de Células-Tronco Hematopoéticas/normas , Retratamento/normas , Transplante de Medula Óssea/legislação & jurisprudência , Transplante de Medula Óssea/métodos , Criopreservação , França , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/métodos , Humanos , Sistemas de Identificação de Pacientes/métodos , Pré-Medicação/métodos , Pré-Medicação/normas , Retratamento/efeitos adversos , Retratamento/métodos , Sociedades Médicas , Temperatura
2.
Bull Cancer ; 103(11S): S198-S200, 2016 Nov.
Artigo em Francês | MEDLINE | ID: mdl-27842861

RESUMO

Within the context of the SFGM-TC's 6th workshop series on the harmonization of clinical practices, our workshop proposes a standardization of the informed consent process for hematopoietic stem cell donors and recipients leading up to an autologous or allogenic transplantation. All informed consent was for bone marrow or peripheral stem cell donors, and mononuclear/lymphocyte donors according to usual procedures. The informed consent for autologous and allogenic related or unrelated adults and pediatric transplantation patients have been included. A first step has been conducted for collecting in advance the informed consent forms used routinely in all francophone transplantation centers. In a second step, a comprehensive version has been re-written by a multidisciplinary team. For the purposes of understanding the risks and advantages, language has been carefully considered and streamlined. In the third step, texts were sent to stem cell transplantation experts, experts at the French biomedical agency (agence de la biomédecine [ABM]), law specialists, members of the ethical committee of the French society of hematology and several transplant recipients to be edited and proofread.


Assuntos
Conferências de Consenso como Assunto , Termos de Consentimento/normas , Transplante de Células-Tronco Hematopoéticas/normas , Sociedades Médicas/normas , Doadores de Tecidos , Adulto , Criança , Família , França , Células-Tronco Hematopoéticas , Humanos , Linfócitos , Projetos Piloto , Estudos de Validação como Assunto
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