Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 287
Filtrar
1.
Med Ultrason ; 25(2): 175-188, 2023 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-36047427

RESUMO

Diagnostic ultrasound in obstetrics and gynaecology has experienced a fantastic evolution during the past seven decades. Initial steps with A-mode technology were followed by B-mode and B-mode real-time imaging, then by Doppler and colour Doppler ultrasound, and finally by 3D/4D ultrasound. Other evolutionary steps were the development of high-resolution transabdominal and transvaginal transducers providing high quality images in the first, second and third trimesters of pregancy, as well as in gynaecology and breast imaging.The progression from two-dimensional (2D) to three-dimensional ultrasound (3D) and 3D real-time imaging (4D) has brought new options in displaying anatomical structures. In comparison with CT or MRI, it is not a static but functional technique, cheap and safe, and applicable at any time.


Assuntos
Ginecologia , Obstetrícia , Ultrassonografia , Ultrassonografia/história , Ultrassonografia/normas , Obstetrícia/história , Obstetrícia/instrumentação , Ginecologia/história , Ginecologia/instrumentação , Humanos , Feminino , Gravidez , Imageamento Tridimensional , Segurança de Equipamentos , História do Século XX , História do Século XXI
2.
Buenos Aires; CEDES. Centro de Estudios de Estado y Sociedad; 1a ed; 2022. 41 p. ilus.
Monografia em Espanhol | BINACIS, LILACS | ID: biblio-1418769

RESUMO

Este documento reúne los resultados de un estudio cualitativo realizado con Licenciadas en Obstetricia. Forma parte de la serie "El trabajo obstétrico en la salud sexual y reproductiva" que el CEDES desarrolla con la colaboración de Ipas como contribución a un mejor conocimiento de este colectivo profesional. También se enmarca en la estrategia conjunta que CEDES y UNFPA-Argentina desarrollan para fortalecer el trabajo de las/los obstétricas/os en la Argentina y en el plan 2022 del Grupo de Trabajo de Obstétricas de REDAAS. Su objetivo es visibilizar las voces de un conjunto de obstétricas sobre su trabajo institucional, sus trayectorias y sus visiones sobre la práctica profesional. En esas reflexiones se muestran algunos desafíos que viven quienes incursionaron en el campo de la salud sexual, reproductiva y no reproductiva y en las consejerías en opciones. También se señalan las dificultades y oportunidades enfrentadas en contextos de las relaciones de poder que atraviesan el ejercicio de sus funciones y competencias en los servicios de salud.


Assuntos
Humanos , Prática Profissional , Obstetrícia/instrumentação , Argentina , Trabalho , Saúde Reprodutiva , Serviços de Saúde
3.
BMC Pregnancy Childbirth ; 20(1): 674, 2020 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-33167939

RESUMO

BACKGROUND: Instrumental deliveries are an unavoidable part of obstetric practice. Dedicated training is needed for each instrument. To identify when a trainee resident can be entrusted with instrumental deliveries by Suzor forceps by studying obstetric anal sphincter injuries. METHODS: A French retrospective observational study of obstetric anal sphincter injuries due to Suzor forceps deliveries performed by trainee residents was conducted from November 2008 to November 2016 at Limoges University Hospital. Perineal lesion risk factors were studied. Sequential use of a vacuum extractor and then forceps was also analyzed. RESULTS: Twenty-one residents performed 1530 instrumental deliveries, which included 1164 (76.1%) using forceps and 89 (5.8%) with sequential use of a vacuum extractor and then forceps. Third and fourth degree perineal tears were diagnosed in 82 patients (6.5%). Residents caused fewer obstetric anal sphincter injuries after 23.82 (+/- 0.8) deliveries by forceps (p = 0.0041), or after 2.36 (+/- 0.7) semesters of obstetrical experience (p = 0.0007). No obese patient (body mass index> 30) presented obstetric anal sphincter injuries (p = 0.0013). There were significantly fewer obstetric anal sphincter injuries after performance of episiotomy (p <  0.0001), and more lesions in the case of the occipito-sacral position (p = 0.028). Analysis of sequential instrumentation did not find any additional associated risk. CONCLUSION: Training in the use of Suzor forceps requires extended mentoring in order to reduce obstetric anal sphincter injuries. A stable level of competence was found after the execution of at least 24 forceps deliveries or after 3 semesters (18 months) of obstetrical experience.


Assuntos
Canal Anal/lesões , Extração Obstétrica/educação , Lacerações/epidemiologia , Complicações do Trabalho de Parto/cirurgia , Forceps Obstétrico/efeitos adversos , Períneo/lesões , Adulto , Competência Clínica , Episiotomia/estatística & dados numéricos , Extração Obstétrica/instrumentação , Extração Obstétrica/estatística & dados numéricos , Feminino , França , Humanos , Internato e Residência , Lacerações/etiologia , Lacerações/prevenção & controle , Obstetrícia/educação , Obstetrícia/instrumentação , Períneo/cirurgia , Gravidez , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
4.
Rev Bras Enferm ; 73(4): e20190159, 2020.
Artigo em Inglês, Português | MEDLINE | ID: mdl-32578739

RESUMO

OBJECTIVES: to construct and validate an instrument for the classification of mother-baby binomials that subsidizes personnel Staffing in in-rooming units. METHOD: methodological study. The construction was based on theoretical and legal references. Content validity was performed by experts through the content validity index measurement. Then, the instrument was applied to a sample of 122 binomials, and exploratory factor analysis was performed using the principal components analysis. RESULTS: the instrument consisted of seven care indicators: Birth route; Maternal morbidity; Neonatal morbidity; Breastfeeding; Social aggravating factors; Care guidance; and interaction and bonding. All with content validity index of 1. The construct was composed of 3 domains, with Cronbach's alpha of 0.62, 0.85 and 0.89. CONCLUSIONS: the classification instrument of mother-baby binomials allows the classification of mother-baby binomials and may support personnel Staffing in in-rooming units.


Assuntos
Recursos Humanos de Enfermagem/classificação , Obstetrícia/instrumentação , Admissão e Escalonamento de Pessoal/classificação , Humanos , Recursos Humanos de Enfermagem/estatística & dados numéricos , Obstetrícia/métodos , Admissão e Escalonamento de Pessoal/estatística & dados numéricos , Reprodutibilidade dos Testes , Recursos Humanos/classificação , Recursos Humanos/normas , Recursos Humanos/estatística & dados numéricos
5.
Rev. bras. enferm ; 73(4): e20190159, 2020. tab
Artigo em Inglês | LILACS, BDENF - Enfermagem | ID: biblio-1101544

RESUMO

ABSTRACT Objectives: to construct and validate an instrument for the classification of mother-baby binomials that subsidizes personnel Staffing in in-rooming units. Method: methodological study. The construction was based on theoretical and legal references. Content validity was performed by experts through the content validity index measurement. Then, the instrument was applied to a sample of 122 binomials, and exploratory factor analysis was performed using the principal components analysis. Results: the instrument consisted of seven care indicators: Birth route; Maternal morbidity; Neonatal morbidity; Breastfeeding; Social aggravating factors; Care guidance; and interaction and bonding. All with content validity index of 1. The construct was composed of 3 domains, with Cronbach's alpha of 0.62, 0.85 and 0.89. Conclusions: the classification instrument of mother-baby binomials allows the classification of mother-baby binomials and may support personnel Staffing in in-rooming units.


RESUMEN Objetivos: elaborar y validar un instrumento para clasificación de binomios puerperio neonatal que subsidie el dimensionamiento de personal en unidades de alojamiento conjunto. Métodos: estudio metodológico. La construcción ha sido basada en referencias teóricas y legales. La validez de contenido ha sido realizada por expertos por medio de medición del índice de validez de contenido. Luego, el instrumento ha sido aplicado en una muestra de 122 binomios, y ha sido realizado análisis factorial exploratoria por el método de componentes principales. Resultados: el instrumento ha quedó constituido por siete indicadores de cuidado: Vía de parto; Morbilidad materna; Morbilidad neonatal; Amamantamiento; Agravantes sociales; Orientación de cuidados; e Interacción y vínculo. Todos con índice de validez de contenido iguales a 1. El constructo ha sido compuesto por 3 dominios, con Alfa de Cronbach de 0,62, 0,85 y 0,89. Conclusiones: el instrumento para la clasificación de binomios puerperio neonatal permite la clasificación de binomios puerperio neonatal y podrá basarse el dimensionamiento de personal en alojamiento conjunto.


RESUMO Objetivos: construir e validar um instrumento para classificação de binômios puérpera-neonato que subsidie o dimensionamento de pessoal em unidades de alojamento conjunto. Métodos: estudo metodológico. A construção foi embasada em referenciais teóricos e legais. A validade de conteúdo foi realizada por expertos por meio de mensuração do índice de validade de conteúdo. Em seguida, o instrumento foi aplicado em uma amostra de 122 binômios, e foi realizada análise fatorial exploratória pelo método de componentes principais. Resultados: o instrumento ficou constituído por sete indicadores de cuidado: Via de parto; Morbidade materna; Morbidade neonatal; Aleitamento; Agravantes sociais; Orientação de cuidados; e Interação e vínculo. Todos com índice de validade de conteúdo iguais a 1. O constructo foi composto por 3 domínios, com Alfa de Cronbach de 0,62, 0,85 e 0,89. Conclusões: o instrumento para a classificação de binômios puérpera-neonato permite a classificação de binômios puérpera-neonato e poderá embasar o dimensionamento de pessoal em alojamento conjunto.


Assuntos
Humanos , Admissão e Escalonamento de Pessoal/classificação , Recursos Humanos de Enfermagem/classificação , Obstetrícia/instrumentação , Admissão e Escalonamento de Pessoal/estatística & dados numéricos , Reprodutibilidade dos Testes , Recursos Humanos/classificação , Recursos Humanos/normas , Recursos Humanos/estatística & dados numéricos , Recursos Humanos de Enfermagem/estatística & dados numéricos , Obstetrícia/métodos
6.
Int J Gynaecol Obstet ; 146(1): 25-28, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31055829

RESUMO

OBJECTIVE: Adequate obstetric care requires the availability of essential diagnostic and management equipment; however, for centers with budget restrictions, the acquisition and maintenance of these devices can pose major challenges. The purpose of the present paper is to disseminate knowledge about the availability of affordable and low-maintenance obstetric devices, which might help to save lives in low- and medium-resource countries. METHOD: Over the course of 2015-2018, the International Federation of Gynecology and Obstetrics (FIGO) Safe Motherhood and Newborn Health Committee acquired information from different clinical and commercial sources regarding the availability of affordable and low-maintenance essential obstetric devices. RESULTS: The Committee identified several devices that met the criteria of low cost and ease of maintenance: a winding handheld Doppler device for intermittent auscultation; a portable continuous fetal heart rate monitor; a validated semi-automated blood pressure monitor; the Foley catheter balloon for labor induction in women with an unfavorable cervix; reusable metal and plastic vacuum cups and manual pumps; an intrauterine tamponade balloon; and the non-pneumatic anti-shock garment. CONCLUSION: Several affordable and low-maintenance obstetric devices are currently available that offer the potential to save lives in resource-constrained settings.


Assuntos
Obstetrícia/instrumentação , Oclusão com Balão/instrumentação , Determinação da Pressão Arterial/instrumentação , Cardiotocografia/instrumentação , Feminino , Humanos , Recém-Nascido , Trabalho de Parto Induzido/instrumentação , Obstetrícia/economia , Gravidez , Ultrassonografia Doppler/instrumentação , Cateterismo Urinário/instrumentação , Vácuo-Extração/instrumentação
7.
Buenos Aires; s.n; 2019. 27 p.
Não convencional em Espanhol | BINACIS, UNISALUD, InstitutionalDB | ID: biblio-1147167

RESUMO

El presente trabajo es producto de un relevamiento realizado por el Programa Nacional de Prevención de Cáncer Cervicouterino con el aporte de una residente de la Residencia Interdisciplinaria de Educación y Promoción de la Salud (RIEPS) que realizó su rotación electiva en el mismo. El presente relevamiento tiene la intención de ser una primera aproximación al rol de las/os Licenciadas/os en Obstétricia en esta problemática, para pensar las contribuciones y aportes, así como también la articulación profesional con otras disciplinas y con los programas provinciales y nacionales. (AU)


Assuntos
Prevenção Primária/instrumentação , Prevenção Primária/métodos , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/terapia , Educação em Saúde , Internato e Residência , Internato não Médico , Programas Nacionais de Saúde/organização & administração , Programas Nacionais de Saúde/tendências , Obstetrícia/instrumentação
8.
J Healthc Eng ; 2018: 7273451, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29666671

RESUMO

Obstetric electronic medical records (EMRs) contain massive amounts of medical data and health information. The information extraction and diagnosis assistants of obstetric EMRs are of great significance in improving the fertility level of the population. The admitting diagnosis in the first course record of the EMR is reasoned from various sources, such as chief complaints, auxiliary examinations, and physical examinations. This paper treats the diagnosis assistant as a multilabel classification task based on the analyses of obstetric EMRs. The latent Dirichlet allocation (LDA) topic and the word vector are used as features and the four multilabel classification methods, BP-MLL (backpropagation multilabel learning), RAkEL (RAndom k labELsets), MLkNN (multilabel k-nearest neighbor), and CC (chain classifier), are utilized to build the diagnosis assistant models. Experimental results conducted on real cases show that the BP-MLL achieves the best performance with an average precision up to 0.7413 ± 0.0100 when the number of label sets and the word dimensions are 71 and 100, respectively. The result of the diagnosis assistant can be introduced as a supplementary learning method for medical students. Additionally, the method can be used not only for obstetric EMRs but also for other medical records.


Assuntos
Diagnóstico por Computador/métodos , Registros Eletrônicos de Saúde , Obstetrícia/instrumentação , Obstetrícia/métodos , Adulto , Algoritmos , China , Análise por Conglomerados , Interpretação Estatística de Dados , Mineração de Dados , Feminino , Humanos , Armazenamento e Recuperação da Informação , Linguística , Idade Materna , Pessoa de Meia-Idade , Processamento de Linguagem Natural , Gravidez , Projetos de Pesquisa
9.
Obstet Gynecol Surv ; 73(4): 231-241, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29701868

RESUMO

IMPORTANCE: Measurement of cervical dilation is one of the major indicators of labor progression. At present, the criterion standard for this evaluation is digital examination, which results are sometimes inaccurate and extremely dependent on the subject (ie, obstetrician or midwife) experience. OBJECTIVE: In this systematic and meta-analysis review, the authors have gathered the vast majority of the instruments used for measuring cervical dilation and their clinical application; main features, potentialities, and the most significant constraints are underlined for each device. EVIDENCE ACQUISITION: Three of the most popular databases (ie, Web of Science, PubMed, and ClinicalTrials.gov) were used to identify all available cervimeters, by using single or combinations of the following keywords: "cervical," "dilation or dilatation," "cervimetry," "cervix," "uterine," "measurement," "labour or labor," "birth," and "monitoring." Only articles describing the design or a specific clinical application of an instrument for cervical dilation measurement during labor were selected. RESULTS: Twenty-five articles were deeply investigated by classifying them in 4 different homogenous groups on the basis of the method proposed for measuring cervical dilation. Suitable devices have not been realized yet, and this is the reason why nowadays the gynecologist/obstetrician still evaluates labor progression by digital examination. CONCLUSIONS AND RELEVANCE: Based on a critical analysis of the selected devices, ultrasound seems to be the most promising technology for future cervimetry realization; ultrasound is accurate in distance measurement, and the behind technology can be miniaturized. However, additional studies are necessary for optimizing the technology and developing an optimal solution.


Assuntos
Colo do Útero/fisiologia , Primeira Fase do Trabalho de Parto , Obstetrícia/instrumentação , Feminino , Humanos , Exame Físico/métodos , Gravidez , Ultrassonografia Pré-Natal , Monitorização Uterina/métodos
10.
J Minim Invasive Gynecol ; 25(7): 1281-1288, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29653261

RESUMO

STUDY OBJECTIVE: To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes. DESIGN: A retrospective observational study (Canadian Task Force classification II-2). SETTING: Clinical settings in the United States that use obstetric and gynecologic devices. SUBJECTS: Two thousand two hundred forty-nine Food and Drug Administration-approved obstetric and gynecologic devices that were recalled between November 1, 2002, and December 31, 2017. MEASUREMENTS AND MAIN RESULTS: The class of device, class of recall, date of recall, and original approval process were obtained for each device. These were compared against the total number of approved devices during this time period in the PMA and 510(k) processes. Recall proportions of each process were calculated and compared. A total of 685 devices were approved via the PMA process, and 1564 devices were approved via the 510(k) process in the observed time period. Of these, 1.17% of the PMA-approved devices and 15.98% of the 510(k)-approved devices were recalled (p < .001). There was an overall increase in absolute device recall numbers over time in the 510(k) process, whereas the number of recalls in the PMA process did not change with time. CONCLUSION: The recall event rate for the 510(k) approval process is 13.6 times the rate for the PMA approval process for obstetric and gynecologic devices. Analysis of the results suggests improper device risk classification, inappropriate assignment of the approval process, increased device malfunctions, recalls by the 510(k) process and, therefore, increased risk to patients by these devices. This warrants a call for improvement and increased scrutiny in the 510(k) approval process for devices used in obstetrics and gynecology.


Assuntos
Ginecologia/instrumentação , Recall de Dispositivo Médico/normas , Obstetrícia/instrumentação , United States Food and Drug Administration , Aprovação de Equipamentos , Feminino , Humanos , Vigilância de Produtos Comercializados , Estudos Retrospectivos , Estados Unidos
11.
J Perinat Med ; 46(3): 279-286, 2018 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-28622144

RESUMO

OBJECTIVE: To describe an innovative electronically-controlled vacuum extractor (VE) in detail and to illustrate its performance characteristics, as observed in a laboratory study. DESIGN: Thirty simulated, vacuum-assisted deliveries. MAIN OUTCOME MEASURE(S): (1) The ability to measure in real-time of the pull applied and to sound an alert, when the traction approaches the negative pressure under the cup, to prevent its detachment. (2) The recording and printing of a graphic representation of the pull applied (vacuum delivery graph). (3) The emission of a warning signal when the 15-min time limit of continuous cup application on the fetal scalp, is reached. RESULTS: No cup detachment occurred in any of the 15 vacuum-assisted deliveries, in which traction was kept below the adhesive force of the cup [44 lb (20 kg)], except in three cases, due to loss of negative pressure. In the remaining 15 tests, in which traction was greater than the adhesive force of the cup, "pull-offs" inevitably occurred. Furthermore, upon reaching the 15-min time limit of continuous cup application on the fetal cephalic model, a warning signal was emitted, as programmed. Conclusions We demonstrated that the electronically-controlled VE, with its distinctive pull-sensing handle, performs suitably for its intended purposes. The ability of the modernized device to decrease the incidence of cup detachment, secondary to the inadvertent application of excessive traction, may result in considerable safety, medico-legal and didactic advantages.


Assuntos
Vácuo-Extração/instrumentação , Eletrônica Médica , Obstetrícia/instrumentação
12.
IEEE Trans Biomed Circuits Syst ; 11(4): 849-857, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28715339

RESUMO

OBJECTIVE: In this paper, we present the design of low-cost medical ultrasound scanners aimed at the detection of maternal mortality risk factors in developing countries. METHOD: Modern ultrasound scanners typically employ a high element count transducer array with multichannel transmit and receive electronics. To minimize hardware costs, we employ a single piezoelectric element, mechanically swept across the target scene, and a highly cost-engineered single channel acquisition circuit. Given this constraint, we compare the achievable image quality of a monostatic fixed focus scanner (MFFS) with a monostatic synthetic aperture scanner (MSAS) using postfocusing. Quantitative analysis of image quality was carried out using simulation and phantom experiments, which were used to compare a proof-of-concept MSAS prototype with an MFFS device currently available on the market. Finally, in vivo experiments were performed to validate the MSAS prototype in obstetric imaging. RESULTS: Simulations show that the achievable lateral resolution of the MSAS approach is superior at all ranges compared to the fixed focus approach. Phantom experiments verify the improved resolution of the MSAS prototype but reveal a lower signal to noise ratio. In vivo experiments show promising results using the MSAS for clinical diagnostics in prenatal care. CONCLUSION: The proposed MSAS achieves superior resolution but lower SNR compared to an MFFS approach, principally due to lower acoustic energy emitted. SIGNIFICANCE: The production costs of the proposed MSAS could be an order of magnitude lower than any other ultrasound system on the market today, bringing affordable obstetric imaging a step closer for developing countries.


Assuntos
Obstetrícia/instrumentação , Ultrassonografia/instrumentação , Desenho de Equipamento , Feminino , Humanos , Mortalidade Materna , Imagens de Fantasmas , Gravidez , Fatores de Risco , Razão Sinal-Ruído , Transdutores
13.
BMC Pregnancy Childbirth ; 17(1): 187, 2017 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-28610569

RESUMO

BACKGROUND: Although uterine tamponade is an effective treatment for postpartum hemorrhage (PPH), current methods have key limitations in their use, particularly in low resource settings. The XStat™ Mini Sponge Dressing (MSD) is approved for the management of non-compressible wounds in the battlefield/trauma setting. The MSD applies highly compressed medical sponges capable of stopping high-flow arterial bleeding within seconds. The objective of our study was to adopt the MSD for use in managing PPH. METHODS: We performed desktop testing using a uterine model with pressure sensors to compare key design elements of the obstetrical prototype MSD (fundal pressure achieved, reduction in fluid loss, time to deploy, and time to remove) with alternativetechniques (uterine packing, balloon tamponade). To evaluate safety, we delivered the fetus of pregnant ewes by cesarean section and used the prototype to deliver the MSD into one uterine horn, and closed the hysterotomy. We followed the clinical recovery of animals (n = 3) over 24 h, and then removed the reproductive tract for histologic evaluation. To evaluate late effects, we surgically removed the MSDs after 24 h, and followed the clinical recovery of animals (n = 6) for an additional seven days before tissue removal. RESULTS: The obstetrical prototype has a long tapered delivery system designed to be deployed during vaginal examination, and administers three times the volume of the approved MSD trauma bandage. The MSD are deployed within a mesh bag to facilitate removal by vaginaltraction. On desktop testing, the MSD resulted in the highest average fundal pressure (113 mmHg), followed by the MSD bag device (85.8 mmHg), gauze packing (15.5 mmHg), and the uterine balloon (8.2 mmHg). The MSD bag test group achieved the largest fluid flow reduction of -74%, followed by gauze packing (-55%), MSD (-35%), and uterine balloon (-19%). Animal testing demonstrated good uterine fill with no evidence of adverse clinical recovery, uterine trauma or infection at 24 h, or up to 7 days following device removal. CONCLUSION: We adapted a highly effective trauma dressing and applicator for use in the treatment of severe PPH. Preliminary desktop and animal testing provide a basis for initial clinical trials in women.


Assuntos
Obstetrícia/instrumentação , Tampões de Gaze Cirúrgicos , Animais , Bandagens , Remoção de Dispositivo , Modelos Animais de Doenças , Desenho de Equipamento , Feminino , Obstetrícia/métodos , Hemorragia Pós-Parto/terapia , Gravidez , Ovinos , Tampões de Gaze Cirúrgicos/efeitos adversos , Transdutores de Pressão , Tamponamento com Balão Uterino
14.
Am J Obstet Gynecol ; 217(1): 42-46.e1, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28500861

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.


Assuntos
Segurança de Equipamentos/estatística & dados numéricos , Ginecologia/instrumentação , Recall de Dispositivo Médico , Obstetrícia/instrumentação , Equipamentos e Provisões/classificação , Feminino , Humanos , Vigilância de Produtos Comercializados/normas , Fatores de Risco , Estados Unidos , United States Food and Drug Administration , Saúde da Mulher
15.
Arch Iran Med ; 20(3): 193-195, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28287815

RESUMO

The subject of this paper is the story of an ancient medical instrument. This instrument is a wooden vaginal speculum used in classical and Islamic medicine. Its drawings can be found in Abulcasis al-Zahrawi's and Serefeddin Sabuncuoglu's illustrated books of surgery.


Assuntos
Desenho de Equipamento/história , Ginecologia/história , Obstetrícia/história , Instrumentos Cirúrgicos/história , Exame Ginecológico/instrumentação , Ginecologia/instrumentação , História do Século XV , História Antiga , História Medieval , Humanos , Manuscritos Médicos como Assunto , Obstetrícia/instrumentação
16.
Fed Regist ; 82(248): 61446-8, 2017 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-29319942

RESUMO

The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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.


Assuntos
Parto Obstétrico/classificação , Parto Obstétrico/instrumentação , Obstetrícia/classificação , Obstetrícia/instrumentação , Pressão , Próteses e Implantes/classificação , Cesárea , Segurança de Equipamentos/classificação , Feminino , Humanos , Trabalho de Parto , Gravidez
17.
Obstet Gynecol ; 128(5): e237-e240, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27776075

RESUMO

Checklists are used in medical and nonmedical settings as cognitive aids to ensure that users complete all the items associated with a particular task. They are ideal for tasks with many steps, for tasks performed under stressful circumstances, or for reminding people to perform tasks that they are not routinely accustomed to doing. In medicine, they are ideal for promoting standardized processes of care in situations in which variation in practice may increase patient risk and the chance of medical errors. Checklists also can be used to enhance teamwork and communication. It is a good idea to include frontline individuals who are involved in completing the procedure in the selection and development of the checklist. To be optimally effective, those who create checklists need to carefully plan for their design, implementation, evaluation, and revision. Checklists are valuable cognitive aids to help health care teams provide complete and timely care to patients, but checklists should be only one tool in the armamentarium to ensure that practitioners do the right thing for the right patient at the right time.


Assuntos
Lista de Checagem , Ginecologia/instrumentação , Obstetrícia/instrumentação , Lista de Checagem/estatística & dados numéricos
18.
J Gynecol Obstet Biol Reprod (Paris) ; 45(8): 827-834, 2016 Oct.
Artigo em Francês | MEDLINE | ID: mdl-27496571

RESUMO

OBJECTIVE: Assessing inter- and intra- observer agreement in the reading of fetal heart rate (FHR) between two different paper speeds (1 and 2cm/min) using FIGO classification. MATERIAL AND METHODS: Single-centre experimental study consisting in reading 60minutes FHR tracings by six readers (3 midwives and 3 obstetricians) during 1cm and 2cm/min sessions within a period of three weeks. The reading guideline was based on FIGO classification. Inter- and intra-observer agreement was assessed thanks to Kappa coefficient (K) and percentage of agreement (PA) using the classification of FHR tracings drawn up by readers. RESULTS: Intra-observer agreement reached 60% between the two paper speeds, and PA ranged from 48 to 67%. Inter-observer agreement was poor to moderate (K=0.42 for 1cm/min sessions and K=0.38 for 2cm/min sessions). Inter-observer agreement was significantly higher for normal tracings (PA ranged from 55.2% for 2cm/min sessions to 57.4% for 1cm/min sessions). The preterminal category had the lowest concordance rates (PA=19% for 1cm/min sessions and 20, 7% for 2cm/min sessions). CONCLUSION: This study did not highlight significant differences in intra- and inter-observer variability between the two FHR paper speeds. The 1cm/min paper speed, which is commonly used in France, is more economical and gives a better bedside overview of FHR. Therefore, it should be recommended.


Assuntos
Cardiotocografia/normas , Frequência Cardíaca Fetal/fisiologia , Trabalho de Parto/fisiologia , Tocologia/normas , Obstetrícia/normas , Médicos/normas , Adulto , Cardiotocografia/instrumentação , Feminino , Humanos , Obstetrícia/instrumentação , Gravidez
19.
J Gynecol Obstet Biol Reprod (Paris) ; 45(9): 1186-1193, 2016 Nov.
Artigo em Francês | MEDLINE | ID: mdl-27312098

RESUMO

OBJECTIVES: To evaluate French residents in Obstetrics and Gynaecology's training in instrumental deliveries in 2015. PATIENTS AND METHODS: We conducted a national descriptive survey among 758 residents between December 2014 and January 2015. Respondents were invited by email to specify their University Hospital, their current university term, the number of instrumental deliveries performed by vacuum extractor, forceps or spatulas, and whether they made systematic ultrasound exams before performing the extraction. RESULTS: Response rate was 34.7 % (n=263). There were important differences between regions in terms of type of instruments used. Vacuum extractor was the most commonly used instrument for instrumental deliveries by French residents (56.9 %), more than forceps (25.2 %) and spatulas (17.9 %). At the end of the residency, all the residents had been trained in instrumental deliveries with at least two instruments. CONCLUSION: The training of difficult techniques as well as their perfect control is required for instrumental deliveries. Yet, we are forced to note that there are substantial differences in the French residents' training in instrumental deliveries depending on their region. So, teaching at least two techniques seems essential as well as improving the training capacities and standardizing practices. A greater systematization of the teaching of the mechanics and obstetric techniques might be a solution to be considered too.


Assuntos
Parto Obstétrico/estatística & dados numéricos , Internato e Residência/estatística & dados numéricos , Forceps Obstétrico/estatística & dados numéricos , Obstetrícia , Vácuo-Extração/estatística & dados numéricos , Adulto , Feminino , França , Humanos , Obstetrícia/educação , Obstetrícia/instrumentação , Obstetrícia/métodos , Obstetrícia/estatística & dados numéricos , Gravidez
20.
Stud Health Technol Inform ; 221: 8-12, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27071866

RESUMO

A better monitoring of pregnant women, mainly during the third trimester of pregnancy and an easy communication between physician and patients are very important for the prevention and good health of baby and mother. The paper presents an integrated system as support for the Obstetrics - Gynaecology domain consisting in two modules: a mobile application, ObGynCare, dedicated to the pregnant women and a new component of the Obstetrics-Gynaecology Department Information System dedicated to the physicians for a better monitoring of the pregnant women. The mobile application informs the pregnant women about their status, permits them to introduce glycaemia and weight values and has as option pulse and blood pressure acquisition from a smart sensor and provides results in a graphic format. It also provides support for easy patient-doctor communication related to any health problems. ObGyn Care offers nutrition recommendations and gives the pregnant women the possibility to enter a social space of common interests using social networks (Facebook) to exchange useful and practical information. Data collected from patients and from sensor are stored on the cloud and the physician may access the information and analyse it. The extended module of the Obstetrics-Gynaecology Department Information System already developed supports the physicians to visualize weekly, monthly, or on a trimester, the patient data and to discuss with her through the chat module. The mobile application is in test by pregnant women and medical personnel.


Assuntos
Aplicativos Móveis , Monitorização Ambulatorial/métodos , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/prevenção & controle , Consulta Remota/métodos , Smartphone , Diagnóstico por Computador/métodos , Feminino , Ginecologia/instrumentação , Ginecologia/métodos , Humanos , Registros Médicos , Monitorização Ambulatorial/instrumentação , Obstetrícia/instrumentação , Obstetrícia/métodos , Gravidez , Consulta Remota/instrumentação , Integração de Sistemas , Interface Usuário-Computador
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...