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[PMID]:28470445
[Au] Autor:Leroy A; Ribeiro S; Grossiord C; Alves A; Vestberg RH; Salles V; Brunon C; Gritsch K; Grosgogeat B; Bayon Y
[Ad] Endereço:Laboratoire des Multimatériaux et Interfaces, UMR 5615 CNRS-Université Lyon 1, Université de Lyon, 43 bd du 11 Novembre 1918, Villeurbanne, Cedex 69622, France.
[Ti] Título:FTIR microscopy contribution for comprehension of degradation mechanisms in PLA-based implantable medical devices.
[So] Source:J Mater Sci Mater Med;28(6):87, 2017 Jun.
[Is] ISSN:1573-4838
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The integration and evolution of implantable medical devices made of bioresorbable polymers and used for temporary biomedical applications are crucial criteria in the success of a therapy and means of follow-up after implantation are needed. The objective of this work is to develop and evaluate a method based on microscopic Fourier Transform InfraRed spectroscopy (FTIR) mappings to monitor the degradation of such polymers on tissue explant sections, after implantation. This technique provided information on their location and on both their composition and crystallinity, which is directly linked to their state of degradation induced predominantly by chain scissions. An in vitro study was first performed on poly(L-lactic acid) (PLLA) meshes to validate the procedure and the assumption that changes observed on FTIR spectra are indeed a consequence of degradation. Then, mappings of in vivo degraded PLLA meshes were realized to follow up their degradation and to better visualize their degradation mechanisms. This work further warrants its translation to medical implants made of copolymers of lactic acid and to other polyesters.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Poliésteres/química
Espectroscopia de Infravermelho com Transformada de Fourier
[Mh] Termos MeSH secundário: Animais
Materiais Biocompatíveis
Equipamentos e Provisões
Masculino
Coelhos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biocompatible Materials); 0 (Polyesters); 459TN2L5F5 (poly(lactide))
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1007/s10856-017-5894-7


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[PMID]:29203752
[Au] Autor:Gruber-Bzura BM
[Ad] Endereço:Zaklad Biochemii I Biofarmaceutykow; Narodowy Instytut Lekow, Warszawa Polska.
[Ti] Título:[Cytotoxicity in vitro as the principal parameter for evaluation of biocompatibility of medical devices].
[So] Source:Wiad Lek;70(5):977-981, 2017.
[Is] ISSN:0043-5147
[Cp] País de publicação:Poland
[La] Idioma:pol
[Ab] Resumo:According to the Polish Ministry of Health decree, the medical devices and all raw materials used for their manufacturing are in force to be compatible with biological tissues, cells and body fluids regarding its clinical use. It is defined as biocompatibility. The scope of the methods proposed in the norm PN-EN ISO 10993-1 makes possible to get full preclinical characteristics of the medical device and allows to form the opinion about safety of it to the patients after its marketing. The test directed as the principal to make, independently on characteristics, kind, contact duration and clinical use of the device is cytotoxicity in vitro. This test defines the impact of the device on the cells through microscopic evaluation or through activities of the enzymes specific for living cells. Toxicity of the material to the cells may be reflected in: change of single cells or whole cell culture morphology, change of cellular metabolic activity, DNA damage or disadvantage of cell proliferation. Biocompatibility of the medical devices is one of the main elements considered in a risk management process at the stage of designing and manufacturing as well of the raw materials as the final product and the critical point in this matter is sterilization.
[Mh] Termos MeSH primário: Materiais Biocompatíveis/normas
Equipamentos e Provisões/normas
Teste de Materiais/normas
Testes de Toxicidade/normas
[Mh] Termos MeSH secundário: Seres Humanos
Legislação de Dispositivos Médicos
Polônia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Biocompatible Materials)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171206
[St] Status:MEDLINE


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[PMID]:28463163
[Au] Autor:Connor MJ; Tringale K; Moiseenko V; Marshall DC; Moore K; Cervino L; Atwood T; Brown D; Mundt AJ; Pawlicki T; Recht A; Hattangadi-Gluth JA
[Ad] Endereço:Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California; University of California Irvine School of Medicine, Irvine, California.
[Ti] Título:Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.
[So] Source:Int J Radiat Oncol Biol Phys;98(2):438-446, 2017 06 01.
[Is] ISSN:1879-355X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. METHODS AND MATERIALS: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. RESULTS: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). CONCLUSIONS: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
[Mh] Termos MeSH primário: Recall de Dispositivo Médico
Radioterapia (Especialidade)/instrumentação
Software/estatística & dados numéricos
United States Food and Drug Administration/estatística & dados numéricos
[Mh] Termos MeSH secundário: Braquiterapia/instrumentação
Distribuição de Qui-Quadrado
Bases de Dados Factuais/estatística & dados numéricos
Equipamentos e Provisões/classificação
Equipamentos e Provisões/provisão & distribuição
Modelos Lineares
Vigilância de Produtos Comercializados/normas
Vigilância de Produtos Comercializados/estatística & dados numéricos
Radioterapia (Especialidade)/estatística & dados numéricos
Planejamento da Radioterapia Assistida por Computador/instrumentação
Planejamento da Radioterapia Assistida por Computador/estatística & dados numéricos
Estatísticas não Paramétricas
Fatores de Tempo
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1707
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status: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


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[PMID]:29370201
[Au] Autor:Fang H; Jiang D; Yang T; Fang L; Yang J; Li W; Zhao J
[Ad] Endereço:Department of Military Logistics, Army Logistics University, Chongqing, China.
[Ti] Título:Network evolution model for supply chain with manufactures as the core.
[So] Source:PLoS One;13(1):e0191180, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Building evolution model of supply chain networks could be helpful to understand its development law. However, specific characteristics and attributes of real supply chains are often neglected in existing evolution models. This work proposes a new evolution model of supply chain with manufactures as the core, based on external market demand and internal competition-cooperation. The evolution model assumes the external market environment is relatively stable, considers several factors, including specific topology of supply chain, external market demand, ecological growth and flow conservation. The simulation results suggest that the networks evolved by our model have similar structures as real supply chains. Meanwhile, the influences of external market demand and internal competition-cooperation to network evolution are analyzed. Additionally, 38 benchmark data sets are applied to validate the rationality of our evolution model, in which, nine manufacturing supply chains match the features of the networks constructed by our model.
[Mh] Termos MeSH primário: Equipamentos e Provisões
Indústria Manufatureira
[Mh] Termos MeSH secundário: Comércio
Simulação por Computador
Marketing
Modelos Teóricos
[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:IM
[Da] Data de entrada para processamento:180126
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0191180


  6 / 13947 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


  7 / 13947 MEDLINE  
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[PMID]:29284777
[Au] Autor:Bebeshko V; Homolyako I; Grynchyshyn V
[Ad] Endereço:Institute of Clinical Radiology, National Center for Scientific Research of Radiation Medicine, National Academy of Medical Sciences of Ukraine, Kyiv 02000, Ukraine.
[Ti] Título:Assessment of the effect of wave device application on morphological changes in organs and cells of irradiated animals.
[So] Source:Exp Oncol;39(4):281-285, 2017 Dec.
[Is] ISSN:1812-9269
[Cp] País de publicação:Ukraine
[La] Idioma:eng
[Ab] Resumo:AIM: To study the effect of the Device for wave influence on biological objects on the prevention of the development of acute radiation sickness and chronic radiation syndrome in vivo. MATERIALS AND METHODS: The studies were performed on white rats irradiated at a dose of 8 Gy. The experimental group of irradiated rats was treated with a wave Device (Patent of Ukraine No. 53568) once, for 2.5 min, 1.5 h after irradiation. Their organs were processed by standard histologic methods. RESULTS: In the demagnetized rats, dystrophic changes in cells and tissues of liver, lungs, kidneys, brain, bone marrow and spleen were insignificant in 60 days compared to the control non-demagnetized group of animals. CONCLUSION: The Device reduced the magnetic charge of magneto-containing elements and their compounds in the organism of the irradiated animals, and decreased the formation of reactive oxygen species, which play a key role in the development of radiation-induced diseases.
[Mh] Termos MeSH primário: Equipamentos e Provisões
Lesões por Radiação/prevenção & controle
[Mh] Termos MeSH secundário: Animais
Radiação Eletromagnética
Ratos
Espécies Reativas de Oxigênio/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Reactive Oxygen Species)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171230
[St] Status:MEDLINE


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[PMID]:29241615
[Au] Autor:Betrán AP; Bergel E; Griffin S; Melo A; Nguyen MH; Carbonell A; Mondlane S; Merialdi M; Temmerman M; Gülmezoglu AM; WHO Antenatal Care Trial in Mozambique Research Group
[Ad] Endereço:UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland. Electronic address: betrana@who.int.
[Ti] Título:Provision of medical supply kits to improve quality of antenatal care in Mozambique: a stepped-wedge cluster randomised trial.
[So] Source:Lancet Glob Health;6(1):e57-e65, 2018 Jan.
[Is] ISSN:2214-109X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. METHODS: We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. FINDINGS: Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81-1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56-2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70-2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites. INTERPRETATION: A supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies. FUNDING: Government of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
[Mh] Termos MeSH primário: Equipamentos e Provisões/provisão & distribuição
Cuidado Pré-Natal/normas
Melhoria de Qualidade/estatística & dados numéricos
[Mh] Termos MeSH secundário: Adulto
Análise por Conglomerados
Feminino
Seres Humanos
Moçambique
Gravidez
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180221
[Lr] Data última revisão:
180221
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:29361662
[Au] Autor:White RS; Thomson Reuters Accelus.
[Ti] Título:Pharmaceuticals and Medical Devices: FDA Oversight.
[So] Source:Issue Brief Health Policy Track Serv;2017:1-33, 2017 12 26.
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Equipamentos/legislação & jurisprudência
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Segurança Computacional
Contaminação de Equipamentos
Falha de Equipamento
Equipamentos e Provisões/efeitos adversos
Equipamentos e Provisões/classificação
Honorários e Preços/legislação & jurisprudência
Testes Genéticos/instrumentação
Regulamentação Governamental
Interoperabilidade da Informação em Saúde
Seres Humanos
Kit de Reagentes para Diagnóstico
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Reagent Kits, Diagnostic)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180219
[Lr] Data última revisão:
180219
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE


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[PMID]:28467179
[Au] Autor:Fonseca V; Grunberger G
[Ad] Endereço:Co-Chairs, AACE/ACE Consensus Conference Writing Committee.
[Ti] Título:LETTER TO THE EDITOR.
[So] Source:Endocr Pract;23(5):629-632, 2017 05.
[Is] ISSN:1530-891X
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Glicemia/análise
Equipamentos e Provisões/normas
Registros Médicos/normas
[Mh] Termos MeSH secundário: Automonitorização da Glicemia/métodos
Automonitorização da Glicemia/normas
Consenso
Endocrinologistas/organização & administração
Seres Humanos
Projetos de Pesquisa/normas
Sociedades Médicas
[Pt] Tipo de publicação:LETTER
[Nm] Nome de substância:
0 (Blood Glucose)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:180208
[Lr] Data última revisão:
180208
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE
[do] DOI:10.4158/1934-2403-23.5.629



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