Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 4 de 4
Filtrar
1.
Ann Emerg Med ; 65(4): 400-3, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25128009

RESUMO

The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.


Assuntos
Serviços Médicos de Emergência , Equipamentos e Provisões/normas , Regulamentação Governamental , United States Food and Drug Administration/organização & administração , Pesquisa Biomédica/métodos , Serviços Médicos de Emergência/métodos , Equipamentos e Provisões/efeitos adversos , Humanos , Monitorização Fisiológica/instrumentação , Estados Unidos
3.
Ann Thorac Surg ; 104(4): 1237-1242, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28821331

RESUMO

BACKGROUND: Disseminated nontuberculous mycobacterium infections have occurred following surgical procedures involving extracorporeal circulation; contaminated water from heater-cooler devices (HCDs) has been implicated as the source. The purpose of this review was to evaluate the public health concern and to educate physicians who care for this patient population. METHODS: The Food and Drug Administration Medical Device Reporting (MDR) database was queried for reports received between January 2010 and August 2016 for patient infections and device contaminations associated with the use of HCDs. Reports were reviewed for type of infection, patient demographics or outcome, reporting country, HCD manufacturer, and the time to event occurrence. RESULTS: A total of 339 MDR reports involving 99 facilities and 5 HCD manufacturers were found. MDR reports originated within (n = 154) and outside the United States (n = 185), and included 107 MDR reports describing patient infections involving at least 86 patients and 232 MDR reports describing HCD contamination without known patient infections. The MDR reports identified the surgical procedure in 94 reports and infection location in 83 reports. The time from surgical procedure using an HCD to infection diagnosis was calculable in 67 reports and was reported up to 60 months following the initial surgery. Nontuberculous mycobacterium was the most frequent organism identified, with M. chimaera being the predominate isolate. CONCLUSIONS: Nontuberculous mycobacterium infections associated with HCDs used during cardiothoracic surgery may have a long latency period and may be lethal. Cardiothoracic surgeon awareness or involvement in this issue is critical in helping to mitigate this emerging public health concern.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Infecção Hospitalar/etiologia , Contaminação de Equipamentos , Máquina Coração-Pulmão/microbiologia , Infecções por Mycobacterium não Tuberculosas/etiologia , Micobactérias não Tuberculosas/isolamento & purificação , Circulação Extracorpórea , Máquina Coração-Pulmão/efeitos adversos , Humanos
4.
J Burn Care Res ; 32(3): 435-41, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21436717

RESUMO

Reducing diabetes mellitus complications has been a major focus for Healthy People 2010. A prior retrospective cohort of our burn center's admissions revealed worse outcomes among diabetic patients, that is, increased infection rates, grafting and graft complications, and increased length of hospital stay. Therefore, a prospective study has been designed to carefully assess wound repair and recovery of diabetic and nondiabetic burn patients. Our long-term aim is to determine the characteristics of the wound milieu along with global responses to injury that may predict poor outcome among diabetic patients. This is an initial phase of a larger observational study of in-hospital diabetic (types 1 and 2) and nondiabetic patients, prospectively matched for age (18-70 and >70 years) and burn size (<5, 5-15, and 16-25%). Time (days) to complete index wound closure, documented through serial photography, is the main outcome measure. Secondary measures compare delays in presentation, prevalence of infections, graft rates, wound and graft complications, adverse events, and length of hospital stay. Detailed history, physical, and baseline hemoglobin A1C are elicited from all subjects who are assessed daily over the initial 72 hours poststudy entry, then weekly until complete index wound closure, and finally monthly through 3 months. Forty subjects are presented herein, 24 diabetic and 16 nondiabetic patients. Time to index wound closure was significantly prolonged in diabetic patients, despite increased grafting. These findings suggest that excision and grafting in diabetic patients may not alone be sufficient to ensure rapid closure, as graft complications may contribute to protracted closure. Evaluating graft need may be more complex among diabetic patients, suggesting the need for alternative management strategies. The current prospective study confirms our previous retrospective analysis, notably manifested by significant delays in index wound closure. Our efforts continue in identifying the most important predictors of outcome, especially modifiable factors that would create a basis of intervention to improve care.


Assuntos
Queimaduras/epidemiologia , Diabetes Mellitus/epidemiologia , Infecção da Ferida Cirúrgica/epidemiologia , Cicatrização/fisiologia , Adolescente , Adulto , Idoso , Queimaduras/diagnóstico , Queimaduras/cirurgia , Estudos de Casos e Controles , Comorbidade , Desbridamento/métodos , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/fisiopatologia , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença , Transplante de Pele/efeitos adversos , Transplante de Pele/métodos , Infecção da Ferida Cirúrgica/diagnóstico , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA