RESUMO
Late preterm (LPT) infants are at an increased risk for hyperbilirubinemia. Accurate identification and early treatment are needed for optimal health outcomes. In a newborn nursery at an academic medical center, bilirubin levels were drawn at 24 hours of life, per protocol. These infants were rarely treated at this time. Rather, predischarge bilirubin levels (at about 48 hours of life) would indicate treatment, often leading to increased length of hospital stay. The practice change evaluation was conducted using retrospective medical record review. Practice change to test serum bilirubin levels at 36 hours of life rather than 24 hours of life. Compliance with the practice change was achieved (P < .05). More LPT infants were identified and treated for hyperbilirubinemia without an increase in length of stay. Readmissions for hyperbilirubinemia and blood draw rates also declined. Although more LPT infants were identified and treated for hyperbilirubinemia, there is room for improvement, and increased adherence to the policy might yield an even greater impact on quality and safety of care surrounding bilirubin management.
Assuntos
Bilirrubina/sangue , Procedimentos Clínicos/organização & administração , Hiperbilirrubinemia Neonatal , Recém-Nascido Prematuro/sangue , Triagem Neonatal , Medição de Risco/métodos , Tempo para o Tratamento/organização & administração , Feminino , Idade Gestacional , Humanos , Hiperbilirrubinemia Neonatal/sangue , Hiperbilirrubinemia Neonatal/diagnóstico , Hiperbilirrubinemia Neonatal/terapia , Recém-Nascido , Tempo de Internação/estatística & dados numéricos , Masculino , Triagem Neonatal/métodos , Triagem Neonatal/organização & administração , Inovação Organizacional , Avaliação de Processos e Resultados em Cuidados de Saúde , Gravidez , Nascimento Prematuro , Melhoria de QualidadeRESUMO
Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion.
Assuntos
Cardiologia/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Aprovação de Equipamentos/normas , Educação Médica/legislação & jurisprudência , Consulta Remota/legislação & jurisprudência , Consulta Remota/normas , Cardiologia/normas , Educação Médica/ética , Educação Médica/normas , Humanos , Terapias em Estudo/normas , Estados UnidosRESUMO
Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion.