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  1 / 9828 MEDLINE  
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[PMID]:29412565
[Au] Autor:Williams PAH
[Ti] Título:Standards for Safety, Security, and Interoperability of Medical Devices in an Integrated Health Information Environment.
[So] Source:J AHIMA;88(4):32-4, 2017 04.
[Is] ISSN:1060-5487
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Segurança Computacional/normas
Prestação Integrada de Cuidados de Saúde
Segurança de Equipamentos/normas
Equipamentos e Provisões/normas
Troca de Informação em Saúde/normas
Integração de Sistemas
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:H
[Da] Data de entrada para processamento:180208
[St] Status:MEDLINE


  2 / 9828 MEDLINE  
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[PMID]:29212354
[Au] Autor:Kim HG; Choi JW; Yoon SH; Lee S
[Ad] Endereço:1 Department of Radiology, Ajou University School of Medicine, Ajou University Medical Center , Yeongtong-gu, Suwon , Korea.
[Ti] Título:Image quality assessment of silent T PROPELLER sequence for brain imaging in infants.
[So] Source:Br J Radiol;91(1083):20170680, 2018 Feb.
[Is] ISSN:1748-880X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: Infants are vulnerable to high acoustic noise. Acoustic noise generated by MR scanning can be reduced by a silent sequence. The purpose of this study is to compare the image quality of the conventional and silent T2 PROPELLER sequences for brain imaging in infants. METHODS: A total of 36 scans were acquired from 24 infants using a 3 T MR scanner. Each patient underwent both conventional and silent T2 PROPELLER sequences. Acoustic noise level was measured. Quantitative and qualitative assessments were performed with the images taken with each sequence. RESULTS: The sound pressure level of the conventional T2 PROPELLER imaging sequence was 92.1 dB and that of the silent T2 PROPELLER imaging sequence was 73.3 dB (reduction of 20%). On quantitative assessment, the two sequences (conventional vs silent T2 PROPELLER) did not show significant difference in relative contrast (0.069 vs 0.068, p value = 0.536) and signal-to-noise ratio (75.4 vs 114.8, p value = 0.098). Qualitative assessment of overall image quality (p value = 0.572), grey-white differentiation (p value = 0.986), shunt-related artefact (p value > 0.999), motion artefact (p value = 0.801) and myelination degree in different brain regions (p values ≥ 0.092) did not show significant difference between the two sequences. CONCLUSION: The silent T2 PROPELLER sequence reduces acoustic noise and generated comparable image quality to that of the conventional sequence. Advances in knowledge: This is the first report to compare silent T2 PROPELLER images with that of conventional T2 PROPELLER images in children.
[Mh] Termos MeSH primário: Aumento da Imagem/métodos
Imagem por Ressonância Magnética/métodos
Neuroimagem/métodos
Ruído
[Mh] Termos MeSH secundário: Segurança de Equipamentos
Feminino
Seres Humanos
Lactente
Masculino
Razão Sinal-Ruído
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171208
[St] Status:MEDLINE
[do] DOI:10.1259/bjr.20170680


  3 / 9828 MEDLINE  
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[PMID]:29172678
[Au] Autor:Sharma RA; Fumi L; Audisio RA; Denys A; Wood BJ; Pignatti F
[Ad] Endereço:1 Department of Oncology, NIHR Oxford Biomedical Research Centre, University of Oxford , Oxford , UK.
[Ti] Título:Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?
[So] Source:Br J Radiol;91(1083):20170643, 2018 Feb.
[Is] ISSN:1748-880X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Whereas clinical trials of cancer drugs have methodological standards and conventional primary endpoints, these are not necessarily applicable to the clinical development of loco-regional treatments and new medical devices. The current challenge is to generate high-level clinical evidence for loco-regional treatments to define the benefits for patients. In this article, we argue that, to generate convincing evidence of clinical efficacy and safety, the collective coherence of the entire data package is often more important than the primary endpoint of one clinical trial. We also propose that, when a comprehensive clinical data package is not feasible, limited clinical data can be supplemented with other types of evidence. Emerging life science companies often define the "valley of death" after securing initial investment to translate an early medical device concept to a development stage that is attractive to funders. Unfortunately for this industry, there is a second "valley of death" if the focus and goal is only regulatory approval, to the neglect of clinical acceptance and reimbursement. For the emerging specialism of interventional oncology, it is critical to plan a clear line of sight for each new medical device to avoid the valleys of death and to demonstrate the clinical benefit. Increased international guidance to establish realistic yet convincing standards in this area may avoid attrition of potentially beneficial devices and therapeutic procedures in the valleys of death.
[Mh] Termos MeSH primário: Equipamentos e Provisões/economia
Oncologia
Neoplasias/terapia
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Aprovação de Equipamentos
Segurança de Equipamentos
Seres Humanos
Investimentos em Saúde
Segurança do Paciente
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.1259/bjr.20170643


  4 / 9828 MEDLINE  
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[PMID]:28747272
[Au] Autor:Choi IY; Kim PN; Lee SG; Won HJ; Shin YM
[Ad] Endereço:Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.
[Ti] Título:Efficacy and Safety of Radiofrequency Ablation for Focal Hepatic Lesions Adjacent to Gallbladder: Reconfiguration of the Ablation Zone through Probe Relocation and Ablation Time Reduction.
[So] Source:J Vasc Interv Radiol;28(10):1395-1399, 2017 Oct.
[Is] ISSN:1535-7732
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To evaluate the safety and efficacy of radiofrequency (RF) ablation for treatment of focal hepatic lesions adjacent to the gallbladder with electrode relocation and ablation time reduction. MATERIALS AND METHODS: Thirty-nine patients who underwent RF ablation for focal hepatic lesions adjacent to the gallbladder (≤ 10 mm) were evaluated retrospectively from January 2011 to December 2014 (30 men and 9 women; age range, 51-85 y; mean age, 65 y). Of 36 patients with hepatocellular carcinoma, 3 had a second treatment for recurrence (mean tumor size, 15 mm ± 6). Patients were divided into 2 subgroups based on lesion distance from the gallbladder: nonabutting (> 5 mm; n = 19) and abutting (≤ 5 mm; n = 20). Electrodes were inserted parallel to the gallbladder through the center of a tumor in the nonabutting group and through the center of the expected ablation zone between a 5-mm safety zone on the liver side and the gallbladder in the abutting group. Ablation time was decreased in proportion to the transverse diameter of the expected ablation zone. RESULTS: Technical success and technical effectiveness rates were 89.7% and 97.4%, respectively, with no significant differences between groups (P = 1.00). Local tumor progression was observed in 3 patients (1 in the nonabutting group and 2 in the abutting group; P = 1.00). There were no major complications. The gallbladder was thickened in 10 patients, with no significant difference between groups (P = .72). Biloma occurred in 1 patient in the nonabutting group. CONCLUSIONS: RF ablation with electrode relocation and reduction of ablation time can be a safe and effective treatment for focal hepatic lesions adjacent to the gallbladder.
[Mh] Termos MeSH primário: Carcinoma Hepatocelular/cirurgia
Ablação por Cateter/métodos
Vesícula Biliar/lesões
Neoplasias Hepáticas/cirurgia
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Progressão da Doença
Segurança de Equipamentos
Feminino
Seres Humanos
Masculino
Meia-Idade
Duração da Cirurgia
Segurança do Paciente
Ondas de Rádio
Estudos Retrospectivos
Resultado do Tratamento
Ultrassonografia de Intervenção
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170728
[St] Status:MEDLINE


  5 / 9828 MEDLINE  
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Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
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[PMID]:29281579
[Au] Autor:Nazarian S; Hansford R; Rahsepar AA; Weltin V; McVeigh D; Gucuk Ipek E; Kwan A; Berger RD; Calkins H; Lardo AC; Kraut MA; Kamel IR; Zimmerman SL; Halperin HR
[Ad] Endereço:From the Department of Medicine-Cardiology, University of Pennsylvania Perelman School of Medicine, Philadelphia (S.N.); and the Departments of Medicine-Cardiology (S.N., R.H., A.A.R., V.W., D.M., E.G.I., A.K., R.D.B., H.C., A.C.L., H.R.H.), Epidemiology (S.N.), Radiology (A.C.L., M.A.K., I.R.K., S.
[Ti] Título:Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.
[So] Source:N Engl J Med;377(26):2555-2564, 2017 12 28.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). METHODS: We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). RESULTS: No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. CONCLUSIONS: We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter-defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896 .).
[Mh] Termos MeSH primário: Desfibriladores Implantáveis
Segurança de Equipamentos
Imagem por Ressonância Magnética/efeitos adversos
Marca-Passo Artificial
[Mh] Termos MeSH secundário: Idoso
Fontes de Energia Elétrica
Falha de Equipamento
Feminino
Seguimentos
Seres Humanos
Masculino
Meia-Idade
Estudos Prospectivos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180207
[Lr] Data última revisão:
180207
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171228
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1604267


  6 / 9828 MEDLINE  
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[PMID]:29241902
[Au] Autor:Olberg B; Fuchs S; Panteli D; Perleth M; Busse R
[Ad] Endereço:Berlin University of Technology, Germany; Federal Joint Committee, Berlin, Germany. Electronic address: britta.olberg@googlemail.com.
[Ti] Título:Scientific Evidence in Health Technology Assessment Reports: An In-Depth Analysis of European Assessments on High-Risk Medical Devices.
[So] Source:Value Health;20(10):1420-1426, 2017 12.
[Is] ISSN:1524-4733
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The aim of this study was to examine the scientific evidence on clinical effectiveness and safety used in health technology assessments (HTAs) of high-risk medical devices (MDs) in Europe. METHODS: We applied a systematic approach to identify European institutions involved in HTA and to select reports assessing MDs considered high-risk according to the definition in the new German health care regulation §137h. Reports published between 2010 and 2015 were considered in our subsequent analysis. We used a structured tool based on widely accepted methodologic principles from Drummond's framework to extract key information on the clinical evidence considered in the reports. RESULTS: Out of 1376 identified reports, 93 were eligible for analysis. All reports based their assessment primarily on direct evidence, in most cases (68%) identified through an independent systematic literature search. In more than half the identified studies considered in the reports, clinical evidence for demonstration of effectiveness and safety was of moderate or low quality. Even when systematic reviews and randomized controlled trials were available for assessment, most studies showed an unclear or high risk of bias. CONCLUSIONS: This study confirms that the quality of scientific evidence used in HTA of high-risk MDs is low and therefore the use of evidence needs improvement. The European Commission recently updated the regulation on MDs but mainly focused on the safety of materials and the CE (Conformité Européene [European Conformity]) mark. Our results show that additional changes are necessary, specifically with regard to the marketing authorization process of MDs, with stricter quality requirements based on methodologically robust trials, possibly in combination with other evidence sources.
[Mh] Termos MeSH primário: Segurança de Equipamentos
Equipamentos e Provisões
Avaliação da Tecnologia Biomédica/métodos
[Mh] Termos MeSH secundário: Proteínas de Arabidopsis
Carboidratos Epimerases
Equipamentos e Provisões/efeitos adversos
Europa (Continente)
Seres Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Arabidopsis Proteins); EC 5.1.3.- (Carbohydrate Epimerases); EC 5.1.3.- (GER1 protein, Arabidopsis)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180202
[Lr] Data última revisão:
180202
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


  7 / 9828 MEDLINE  
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[PMID]:29320138
[Au] Autor:Food and Drug Administration, HHS.
[Ti] Título:Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer. Final order.
[So] Source:Fed Regist;83(4):600-2, 2018 Jan 05.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the absorbable perirectal spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Implantes Absorvíveis/classificação
Segurança de Equipamentos/classificação
Radiologia/classificação
Radiologia/instrumentação
Reto
[Mh] Termos MeSH secundário: Seres Humanos
Masculino
Neoplasias da Próstata/radioterapia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE


  8 / 9828 MEDLINE  
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[PMID]:29319946
[Au] Autor:Food and Drug Administration, HHS.
[Ti] Título:Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.
[So] Source:Fed Regist;83(2):232-4, 2018 Jan 03.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Neoplasia Intraepitelial Cervical/diagnóstico
Segurança de Equipamentos/classificação
Histologia/classificação
Histologia/instrumentação
Patologia/classificação
Patologia/instrumentação
[Mh] Termos MeSH secundário: Biomarcadores Tumorais
Neoplasia Intraepitelial Cervical/patologia
Feminino
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biomarkers, Tumor)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE


  9 / 9828 MEDLINE  
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[PMID]:29319945
[Au] Autor:Food and Drug Administration, HHS.
[Ti] Título:Medical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor Device. Final order.
[So] Source:Fed Regist;83(1):22-4, 2018 Jan 02.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Segurança de Equipamentos/classificação
Instrumentos Cirúrgicos/classificação
Irrigação Terapêutica/classificação
Irrigação Terapêutica/instrumentação
[Mh] Termos MeSH secundário: Seres Humanos
Cirurgia Plástica/classificação
Cirurgia Plástica/instrumentação
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE


  10 / 9828 MEDLINE  
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[PMID]:29319944
[Au] Autor:Food and Drug Administration, HHS.
[Ti] Título:Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System. Final order.
[So] Source:Fed Regist;83(1):20-2, 2018 Jan 02.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Diagnóstico por Computador/classificação
Diagnóstico por Computador/instrumentação
Segurança de Equipamentos/classificação
Hematologia/classificação
Hematologia/instrumentação
Microscopia/classificação
Microscopia/instrumentação
Patologia/classificação
Patologia/instrumentação
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE



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