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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]:28895231
[Au] Autor:Ronquillo JG; Zuckerman DM
[Ad] Endereço:Western Michigan University Homer Stryker M.D. School of Medicine.
[Ti] Título:Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.
[So] Source:Milbank Q;95(3):535-553, 2017 Sep.
[Is] ISSN:1468-0009
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. CONTEXT: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. METHODS: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. FINDINGS: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety. CONCLUSIONS: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.
[Mh] Termos MeSH primário: Aprovação de Equipamentos/normas
Registros Eletrônicos de Saúde/normas
Recall de Dispositivo Médico/normas
Informática Médica/normas
Segurança do Paciente/normas
Vigilância de Produtos Comercializados/normas
Software/normas
[Mh] Termos MeSH secundário: Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171121
[Lr] Data última revisão:
171121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170913
[St] Status:MEDLINE
[do] DOI:10.1111/1468-0009.12278


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[PMID]:28501378
[Au] Autor:Gopal AD; Rathi VK; Teng CC; Del Priore L; Ross JS
[Ad] Endereço:Yale University School of Medicine, New Haven, Connecticut; Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut.
[Ti] Título:Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.
[So] Source:Ophthalmology;124(8):1237-1246, 2017 Aug.
[Is] ISSN:1549-4713
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA). DESIGN: Retrospective cross-sectional analysis using publicly available FDA data. PARTICIPANTS: Ophthalmic devices initially approved via the FDA's PMA pathway between January 1, 1979 and December 31, 2015. METHODS: We used the FDA's PMA Database to identify and characterize initial approvals and subsequent postmarket modifications to Class III ophthalmic devices. The FDA Recalls Database was used to identify associated safety events. MAIN OUTCOME MEASURES: Median iterated life span (timespan across which modifications occurred after initial PMA) and median number of supplements approved per device, by device type, and overall, stratified by regulatory pathway and modification type. RESULTS: Between 1979 and 2015, the FDA approved 168 original ophthalmic devices via the PMA pathway and 2813 subsequent modifications. More than one third (n = 64; 38%) of original approvals were intraocular lenses. Overall, devices underwent a median of 11 postmarket modifications (interquartile range [IQR], 3-24.8) across a median 10.0-year iterated life span (IQR, 4.1-16.7). The majority of devices (n = 144; 86%) underwent more than 1 postapproval modification, including more than 1 design modification (n = 84; 50%). The median number of changes altering device design or labeling was 3.5 (IQR, 1-9). Although manufacturing alterations (n = 834 of 2813; 30%) were the most frequent type of revision, changes involving device design (n = 667; 24%) and labeling (n = 417; 15%) were common. Recalled devices underwent more frequent postapproval modifications per year (median, 1.4; IQR, 0.7-2.3; mean, 1.5; 95% confidence interval, 1.1-1.9) in the period preceding recall than did nonrecalled devices (median, 0.5; IQR, 0.2-1.1; mean, 0.8; 95% confidence interval, 0.7-1.0) across their market approval period (P < 0.001). CONCLUSIONS: Most ophthalmic devices approved via the FDA's PMA pathway have undergone extensive revisions, including serial design and labeling changes, since their initial approvals, often without supporting clinical data. Ophthalmologists should take into consideration that cumulative revisions may render the clinical evidence that supported an original FDA approval less relevant to newer device models.
[Mh] Termos MeSH primário: Aprovação de Equipamentos
Desenho de Equipamento
Segurança de Equipamentos
Oftalmologia/instrumentação
Vigilância de Produtos Comercializados
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Estudos Transversais
Bases de Dados Factuais/estatística & dados numéricos
Seres Humanos
Recall de Dispositivo Médico
Rotulagem de Produtos
Estudos Retrospectivos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170731
[Lr] Data última revisão:
170731
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170515
[St] Status:MEDLINE


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[PMID]:28500861
[Au] Autor:Janetos TM; Ghobadi CW; Xu S; Walter JR
[Ad] Endereço:Northwestern University's Feinberg School of Medicine, Chicago, and Kellogg School of Management, Evanston, IL.
[Ti] Título:Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety.
[So] Source:Am J Obstet Gynecol;217(1):42-46.e1, 2017 Jul.
[Is] ISSN:1097-6868
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1-month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in women's health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.
[Mh] Termos MeSH primário: Segurança de Equipamentos/estatística & dados numéricos
Ginecologia/instrumentação
Recall de Dispositivo Médico
Obstetrícia/instrumentação
[Mh] Termos MeSH secundário: Equipamentos e Provisões/classificação
Feminino
Seres Humanos
Vigilância de Produtos Comercializados/normas
Fatores de Risco
Estados Unidos
United States Food and Drug Administration
Saúde da Mulher
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170821
[Lr] Data última revisão:
170821
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170514
[St] Status:MEDLINE


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[PMID]:28110952
[Au] Autor:Oshika T; Eguchi S; Goto H; Ohashi Y
[Ad] Endereço:Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: oshika@eye.ac.
[Ti] Título:Outbreak of Subacute-Onset Toxic Anterior Segment Syndrome Associated with Single-Piece Acrylic Intraocular Lenses.
[So] Source:Ophthalmology;124(4):519-523, 2017 Apr.
[Is] ISSN:1549-4713
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To report the results of a clinical investigation after an outbreak of subacute-onset toxic anterior segment syndrome (TASS) after implantation of single-piece acrylic intraocular lenses (IOLs), which then were recalled voluntarily from the market. DESIGN: Retrospective, multicenter, observational case series. PARTICIPANTS: Cases reported to the manufacturer from January 2015 through March 2016 of unusual ocular inflammation after cataract surgery using AcrySof ReSTOR, ReSTOR toric, or AcrySof IQ toric SN6AT6-9 IOLs (Alcon Laboratories, Inc., Fort Worth, TX). METHODS: The independent investigation committee, not Alcon, directly requested the surgeons for data on 304 eyes from 184 facilities. RESULTS: Consent for data collection was obtained for 201 eyes from 130 facilities. By excluding cases with infectious endophthalmitis and inconclusive cases, the investigation committee identified 147 cases of subacute-onset TASS. AcrySof ReSTOR or ReSTOR toric IOLs and AcrySof IQ toric SN6AT6-9 IOLs were implanted in 94 eyes (63.9%) and 53 eyes (36.1%), respectively. The mean onset time was 13.1±16.4 days after surgery (range, 1-88 days), with 84 eyes (57.1%) demonstrating symptoms within 7 days after surgery. Typical clinical symptoms were mild to moderate exacerbation of inflammation in the anterior chamber after an uneventful clinical course for a few days after surgery. One hundred four eyes (70.7%) were treated with medication alone, and 43 eyes (29.3%) underwent surgery, including irrigation of the anterior chamber, vitrectomy, and removal of the IOL. The mean best-corrected visual acuity (BCVA) at the final visit (-0.012±0.175 logarithm of the minimum angle of resolution [logMAR]) was significantly better than the BCVA at the onset of TASS (0.158±0.351 logMAR) and did not differ from that before inflammation developed (-0.004±0.162 logMAR). Overall treatment outcomes were favorable. CONCLUSIONS: A large-scale outbreak of subacute-onset TASS developed after implantation of a specific model of IOL.
[Mh] Termos MeSH primário: Resinas Acrílicas/efeitos adversos
Segmento Anterior do Olho/patologia
Surtos de Doenças
Endoftalmite/epidemiologia
Lentes Intraoculares/efeitos adversos
[Mh] Termos MeSH secundário: Doença Aguda
Adulto
Idoso
Idoso de 80 Anos ou mais
Antibacterianos/uso terapêutico
Endoftalmite/diagnóstico
Endoftalmite/tratamento farmacológico
Contaminação de Equipamentos
Feminino
Seres Humanos
Implante de Lente Intraocular
Masculino
Recall de Dispositivo Médico
Meia-Idade
Procedimentos Cirúrgicos Oftalmológicos
Facoemulsificação
Desenho de Prótese
Reoperação
Estudos Retrospectivos
Fatores de Tempo
Acuidade Visual/fisiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Acrylic Resins); 0 (Anti-Bacterial Agents)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170707
[Lr] Data última revisão:
170707
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170124
[St] Status:MEDLINE


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[PMID]:27992643
[Au] Autor:Maurer-Ertl W; Friesenbichler J; Holzer LA; Leitner L; Ogris K; Maier M; Leithner A
[Ti] Título:Recall of the ASR XL Head and Hip Resurfacing Systems.
[So] Source:Orthopedics;40(2):e340-e347, 2017 Mar 01.
[Is] ISSN:1938-2367
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:At the beginning of the 21st century, use of large-diameter, metal-on-metal devices was a popular procedure for hip replacement in young and physically active patients; however, within a few years, the number of revisions increased, resulting in a worldwide recall for the articular surface replacement (ASR) system. Complication rates for the ASR devices implanted at the authors' department are reported, with revision rates of 32% and 30% in the ASR XL Head and ASR Resurfacing groups, respectively. Reasons for revision surgery were serum metal ion elevation, luxation or subluxation, aseptic loosening, soft tissue compromise (adverse reactions to metal debris [ARMD]), and infection. The calculated implant survival for the ASR XL Head system and the ASR Resurfacing device (DePuy Orthopaedics Inc, Warsaw, Indiana) in the current series was 79% and 90%, respectively, at 60 months. Symptomatic patients with metal-on-metal devices, with or without elevated metal ion concentrations, should undergo cross sectional imaging to exclude ARMD. In cases of increased metal ion concentrations, local pain, or ARMD, revision surgery has to be evaluated. In the future, closer monitoring of new implants is needed to prevent high failure rates, as seen with the ASR design. Furthermore, the withdrawal of the device highlights the importance of national implant registries. [Orthopedics. 2017; 40(2):e340-e347.].
[Mh] Termos MeSH primário: Artroplastia de Quadril/instrumentação
Prótese de Quadril/efeitos adversos
Recall de Dispositivo Médico
Próteses Articulares Metal-Metal/efeitos adversos
Falha de Prótese
Infecções Relacionadas à Prótese
Reoperação/estatística & dados numéricos
[Mh] Termos MeSH secundário: Adulto
Idoso
Artroplastia de Quadril/estatística & dados numéricos
Feminino
Seguimentos
Seres Humanos
Masculino
Meia-Idade
Avaliação de Resultados (Cuidados de Saúde)
Desenho de Prótese
Infecções Relacionadas à Prótese/diagnóstico
Infecções Relacionadas à Prótese/epidemiologia
Infecções Relacionadas à Prótese/cirurgia
Estudos Retrospectivos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170522
[Lr] Data última revisão:
170522
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161220
[St] Status:MEDLINE
[do] DOI:10.3928/01477447-20161213-04


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[PMID]:27765174
[Au] Autor:Sharma PK; Willems TP; Touw DJ; Woudstra W; Erasmus ME; Ebels T
[Ad] Endereço:Department of Biomedical Engineering, University Medical Center Groningen, University of Groningen, Groningen, Netherlands. Electronic address: p.k.sharma@umcg.nl.
[Ti] Título:Implant Failure: STRATOS System for Pectus Repair.
[So] Source:Ann Thorac Surg;103(5):1536-1543, 2017 May.
[Is] ISSN:1552-6259
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Three European centers have recently reported dramatic failures of the STRATOS titanium system, approved in Europe and the United States since 2007 and meant for pectus repair, without detailed exploration of its causes. METHODS: Failed implants (fractures or loosened crimp connectors) were surgically explanted from 12 patients and biopsies taken from surrounding discolored tissue. Detailed failure analysis was performed to find the cause of failures. Inductively coupled mass spectroscopy, scanning electron microscopy, and energy dispersive radiograph spectroscopy was used to determine titanium and to visualize titanium wear debris in histologic sections. RESULTS: Implants failed in all patients by fracture of connecting bar, fracture of lateral bar at reduced cross-section, loosening of crimp connector, or different combinations of these. All fracture surfaces were clean and smooth without any signs of plastic deformation. Failure already started at 10 months after implantation and continued for 2.5 years. Biopsy of discolored tissue around the failures showed 0.4 mg to 105 mg titanium per gram tissue, and close observation showed titanium wear debris. CONCLUSIONS: Combined tensile, compressive, bending, and torsional loading on the implant during each breathing cycle caused loosening and fatigue fractures, which led to failure. Excessive rubbing at the fracture and loosening site caused the release of large amounts of titanium in the surrounding tissue, which may lead to metallosis. Long and sharp pieces of failed implant in the cardiothoracic region is a grave danger to vital organs. All patients should be closely followed, and in our opinion, all implants should be removed. Serious reconsideration for clinical use of this implant is necessary.
[Mh] Termos MeSH primário: Placas Ósseas
Tórax em Funil/cirurgia
Pectus Carinatum/cirurgia
Falha de Prótese
Titânio/análise
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Feminino
Seres Humanos
Masculino
Espectrometria de Massas
Teste de Materiais
Recall de Dispositivo Médico
Meia-Idade
Músculo Esquelético/química
Radiografia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
D1JT611TNE (Titanium)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170811
[Lr] Data última revisão:
170811
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:161022
[St] Status:MEDLINE


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[PMID]:27352914
[Au] Autor:Hwang TJ; Sokolov E; Franklin JM; Kesselheim AS
[Ad] Endereço:Faculty of Arts and Sciences, Harvard University, Cambridge, MA, USA Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
[Ti] Título:Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.
[So] Source:BMJ;353:i3323, 2016 Jun 28.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE:  To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union. DESIGN:  Cohort study. SETTING:  Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010. DATA SOURCES:  Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug Administration and European regulatory authority databases for US approvals and safety alerts and recalls; and Medline, Embase, and Web of Science for peer reviewed publications. MAIN OUTCOME MEASURES:  We categorized the novelty of the devices in the study sample as a "major innovation" or an "other change," and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential EU and US approvals. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the EU and devices approved only in the EU. RESULTS:  67% (206/309) of devices identified were approved in both the US and the EU, of which 63% (129/206) were approved first in the EU. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% five years after approval. CONCLUSIONS:  Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls. Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment.
[Mh] Termos MeSH primário: Segurança de Produtos ao Consumidor/normas
Aprovação de Equipamentos
Equipamentos e Provisões
Recall de Dispositivo Médico
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Estudos de Coortes
Bases de Dados Factuais
Equipamentos e Provisões/classificação
Equipamentos e Provisões/normas
Equipamentos e Provisões/estatística & dados numéricos
União Europeia
Seres Humanos
Terapias em Estudo/instrumentação
Estados Unidos
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:160630
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.i3323


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[PMID]:27247003
[Au] Autor:Vurma M; Dang L; Brunner-La Rocca HP; Sütsch G; Attenhofer-Jost CH; Duru F; Scharf C
[Ad] Endereço:Cardiology Practice Stadelhofen, Goethestr. 20, 8001 Zurich, Switzerland.
[Ti] Título:Safety and efficacy of the nMARQ catheter for paroxysmal and persistent atrial fibrillation.
[So] Source:Europace;18(8):1164-9, 2016 Aug.
[Is] ISSN:1532-2092
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIMS: Circular irrigated radiofrequency ablation using the nMARQ catheter has recently been introduced for the treatment of atrial fibrillation (AF). The aim of this study is to report the safety and efficacy of catheter ablation using this technology in patients with paroxysmal and persistent AF. METHODS AND RESULTS: The data of a prospective registry describing the experience of a single operator using this technology on 327 consecutive patients were analysed. The mean procedure time was 69 ± 22 min for paroxysmal AF (n = 228) and 75 ± 23 min for persistent AF (n = 97). Follow-up was available for 206 (63%) patients for 6 ± 5 months (range 1-23, median 3.3). Single procedure success off antiarrhythmic drugs was 75% in paroxysmal AF and 52% in persistent AF. Including the 5% redo cases and those on antiarrhythmic medication, freedom from AF was documented in 90 and 83% of paroxysmal and persistent AF patients, respectively. There were no serious complications in the first 325 patients, but the last two consecutive patients (0.6%) developed atrio-oesophageal fistulas and had a fatal outcome. The catheter has been recalled from market. CONCLUSION: The nMARQ catheter is a highly effective tool for treatment of paroxysmal and persistent AF. Nevertheless, the occurrence of life-threatening oesophageal fistulas is of major concern and requires further investigation.
[Mh] Termos MeSH primário: Fibrilação Atrial/terapia
Ablação por Cateter/instrumentação
Fístula Esofágica/fisiopatologia
Recall de Dispositivo Médico
[Mh] Termos MeSH secundário: Idoso
Antiarrítmicos/uso terapêutico
Fibrilação Atrial/classificação
Ablação por Cateter/efeitos adversos
Desenho de Equipamento
Feminino
Seguimentos
Seres Humanos
Modelos Logísticos
Masculino
Meia-Idade
Duração da Cirurgia
Estudos Prospectivos
Inibidores da Bomba de Prótons/uso terapêutico
Veias Pulmonares/cirurgia
Suíça
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Arrhythmia Agents); 0 (Proton Pump Inhibitors)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170921
[Lr] Data última revisão:
170921
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160602
[St] Status:MEDLINE
[do] DOI:10.1093/europace/euw048


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[PMID]:27121872
[Au] Autor:Donahue GS; Lindgren V; Galea VP; Madanat R; Muratoglu O; Malchau H
[Ad] Endereço:Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA.
[Ti] Título:Are Females at Greater Risk for Revision Surgery After Hip Resurfacing Arthroplasty With the Articular Surface Replacement Prosthesis?
[So] Source:Clin Orthop Relat Res;474(10):2257-65, 2016 Oct.
[Is] ISSN:1528-1132
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Female patients undergoing hip resurfacing arthroplasties may be at greater risk of revision surgery than males, but it is unclear whether this is related to sex or other factors. We focused our analysis on data from a prospective multicenter cohort study monitoring the ASR(TM) hip resurfacing arthroplasty prosthesis on the potential association of sex on patient-reported outcome measures (PROMs), metal ion levels, revision surgery, and presence of adverse local tissue reaction. As thousands of patients with the ASR(TM) prosthesis are still undergoing followup it is critical to optimize the protocol for monitoring these patients. QUESTIONS/PURPOSES: We wished (1) to assess the associations between sex and implant survival, and adverse local tissue reaction; and (2) to report the differences between sexes in metal ion levels and patient-reported outcome measures. METHODS: One thousand two hundred fifty-two patients (1390 hips) who underwent hip resurfacing arthroplasty with implantation of the ASR(TM) prosthesis from April 2003 to July 2010 were eligible for enrollment in a multicenter followup study of the ASR(TM) Hip Resurfacing System after the voluntary recall of this device was initiated by DePuy in 2010. Nine hundred seventy patients (1098 hips) were enrolled at a mean of 7 years after surgery, with a mean followup of 2 years (range, 1-3.5 years). Nine hundred fifty-eight patients (1084 hips) met the inclusion criteria: ability to provide informed consent, complete PROMs, and continued routine followup. A subset of patients (150 patients, 171 hips), who all were from one center, with annual metal artifact reduction sequence MRI were analyzed. Ninety-three percent of patients from this center had routine MRI performed. The EuroQoL (EQ-5D), Harris hip score (HHS), University of California Los Angeles (UCLA) activity score, VAS pain, radiographs, patient and surgery details, and blood cobalt and chromium levels were obtained. Cox regression analysis was conducted to identify factors associated with implant survival, using any revision as the end point, and presence of adverse local tissue reaction. RESULTS: In patients who had unilateral surgery, the only variable found to be associated with revision surgery was HHS (hazard ratio [HR], 0.96; 95% CI, 0.94-0.97; p < 0.001). In patients who had bilateral surgery, only HHS (HR, 0.93; 95% CI, 0.90-0.97; p < 0.001) and cobalt level (HR, 1.02; 95% CI, 1.01-1.03; p < 0.001) were associated with risk for revision. In patients with metal artifact reduction sequence MRI, the only variable found to be associated with presence of adverse local tissue reaction was cobalt level (HR, 1.06; 95% CI, 1.02-1.10; p = 0.001). Cobalt and chromium concentrations were greater in female patients than in male patients (cobalt, median 1.89 versus median 1.12 parts per billion [ppb], p < 0.001; chromium, median 2.03 versus median 1.17 ppb, p < 0.001). Slight differences were observed between males and females in HHS (males median 96 versus females median 94, p < 0.001) and UCLA scores (median 8 versus median 6, p < 0.001); however, there was no difference between sexes for VAS pain (median 0.5 versus median 0.5, p = 0.405). Differences were identified between males and females in the distribution of EQ-5D scores, yet the medians were the same (median 1.0 versus median 1.0, p < 0.001). CONCLUSIONS: Male and female patients who had hip resurfacing arthroplasty with implantation of the ASR(TM) prosthesis should be followed with equal vigilance as both are at similar risk of revision surgery and adverse local tissue reaction. Metal ion levels and HHS should be obtained at followup to monitor for risk of revision and as a screening tool for MRI. Further research is necessary to evaluate if these relationships persist in patients with other metal-on-metal prostheses. LEVEL OF EVIDENCE: Level II, therapeutic study.
[Mh] Termos MeSH primário: Artroplastia de Quadril/efeitos adversos
Artroplastia de Quadril/instrumentação
Articulação do Quadril/cirurgia
Prótese de Quadril
Falha de Prótese
Reoperação
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Austrália
Boston
Distribuição de Qui-Quadrado
Europa (Continente)
Feminino
Articulação do Quadril/diagnóstico por imagem
Articulação do Quadril/fisiopatologia
Seres Humanos
Estimativa de Kaplan-Meier
Imagem por Ressonância Magnética
Masculino
Recall de Dispositivo Médico
Metais/sangue
Meia-Idade
Medição da Dor
Dor Pós-Operatória/diagnóstico
Dor Pós-Operatória/cirurgia
Modelos de Riscos Proporcionais
Estudos Prospectivos
Desenho de Prótese
Medição de Risco
Fatores de Risco
Fatores Sexuais
África do Sul
Propriedades de Superfície
Fatores de Tempo
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Metals)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:171001
[Lr] Data última revisão:
171001
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:160429
[St] Status:MEDLINE
[do] DOI:10.1007/s11999-016-4860-x



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