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1.
Recurso na Internet em Português | LIS - Localizador de Informação em Saúde | ID: lis-LISBR1.1-46750

RESUMO

A Organização Pan-Americana da Saúde (OPAS) publicou recentemente a versão atualizada da Lista de Dispositivos Médicos Prioritários para o primeiro nível de atenção que pode ajudar os países da Região das Américas a priorizar ferramentas críticas e a responder efetivamente aos principais problemas de saúde enfrentados por sua população.


Assuntos
Equipamentos e Provisões , Atenção Primária à Saúde
2.
Stud Health Technol Inform ; 264: 1538-1539, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438220

RESUMO

In hospital management, health technology assessment techniques are being increasingly developed. This paper presents a comparison of the results obtained using two models for replacement priority value calculation applied to the Galliera hospital in Genoa (Italy). One the models was developed at the Galliera Hospital along the lines of the model by Fennigkoh and addresses four primary replacement issues: equipment service and support, equipment function, cost benefits and clinical efficacy, by a "yes-no" scheme. This model is compared with a model based on fuzzy logic. The comparison between the two models shows a conservative behaviour by the Galliera model, according to which 77.4% of the analysed instrumentation is maintained, whereas the classification by the fuzzy model allows for a better discrimination among the devices.


Assuntos
Lógica Fuzzy , Modelos Lineares , Equipamentos e Provisões , Itália
3.
Stud Health Technol Inform ; 264: 1620-1621, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438261

RESUMO

The purpose of this study is to extract similar term definitions used in the terminology of Japanese medical device adverse events. We employed Levenshtein and Jaro-Winkler distances as edit distances and Skip-gram, continuous-bag of words, and fast text to produce distributed representations in Word2Vec. A comparison of the accuracies of the models showed that Levenshtein distance had higher specificity whereas Skip-gram had higher sensitivity as compared to the other models.


Assuntos
Equipamentos e Provisões/efeitos adversos , Terminologia como Assunto
5.
Lima; Perú. Ministerio de Salud; 20190700. 22 p. tab.
Monografia em Espanhol | LILACS, LIPECS | ID: biblio-1007321

RESUMO

Contribuir a la mejora del acceso de la población a los dispositivos médicos identificados como esenciales en la prevención, tratamiento y control de las enfermedades prevalentes del pais, a traves de mecanismos para su disponibilidad y utilización en los establecimientos de salud, en concordancia con lo establecido en la Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios.


Assuntos
Prevenção Primária , Terapêutica , Controle de Doenças Transmissíveis , Equipamentos e Provisões
6.
Expert Rev Med Devices ; 16(7): 603-616, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31154869

RESUMO

INTRODUCTION: Blood-recirculating medical devices, such as mechanical circulatory support (MCS), extracorporeal membrane oxygenators (ECMO), and hemodialyzers, are commonly used to treat or improve quality of life in patients with cardiac, pulmonary, and renal failure, respectively. As part of their regulatory approval, guidelines for thrombosis evaluation in pre-clinical development have been established. In vitro testing evaluates a device's potential to produce thrombosis markers in static and dynamic flow loops. AREAS COVERED: This review focuses on in vitro static and dynamic models to assess thrombosis in blood-recirculating medical devices. A summary of key devices is followed by a review of molecular markers of contact activation. Current thrombosis testing guidance documents, ISO 10993-4, ASTM F-2888, and F-2382 will be discussed, followed by analysis of their application to in vitro testing models. EXPERT OPINION: In general, researchers have favored in vivo models to thoroughly evaluate thrombosis, limiting in vitro evaluation to hemolysis. In vitro studies are not standardized and it is often difficult to compare studies on similar devices. As blood-recirculating devices have advanced to include wearable and implantable artificial organs, expanded guidelines standardizing in vitro testing are needed to identify the thrombotic potential without excessive use of in vivo resources during pre-clinical development.


Assuntos
Equipamentos e Provisões , Modelos Biológicos , Trombose/diagnóstico , Materiais Biocompatíveis/farmacologia , Biomarcadores/metabolismo , Humanos , Qualidade de Vida , Trombose/terapia
8.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(3): 197-201, 2019 May 30.
Artigo em Chinês | MEDLINE | ID: mdl-31184078

RESUMO

The reliability of domestic medical equipment is one of the main factors that restrict the competitiveness of domestic medical devices. It is also an important factor that endangers the safety of patients and a blind spot in safety risk management. By analyzing the core elements of reliability and the situation of domestic medical device industry, this paper sorts out and analyzes the problems existing in the reliability of medical device industry, and puts forward the key points and problems to be solved to improve the reliability of domestic medical equipment products.


Assuntos
Desenho de Equipamento , Equipamentos e Provisões , Indústrias , Gestão de Riscos , Gestão da Segurança , Segurança de Equipamentos , Humanos , Reprodutibilidade dos Testes
9.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(3): 205-208, 2019 May 30.
Artigo em Chinês | MEDLINE | ID: mdl-31184080

RESUMO

OBJECTIVE: To improve the monitoring mode of in vitro diagnostic medical devices adverse events. METHODS: By discussing the objective laws of the characteristics, performances and causes of in vitro diagnostic medical devices adverse events, the key points of monitoring work were clarified. RESULTS: The whole-process cloud monitoring mode for adverse events of in vitro diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated. CONCLUSIONS: The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of in vitro diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.


Assuntos
Equipamentos e Provisões , Kit de Reagentes para Diagnóstico , Gestão de Riscos , China
10.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(3): 209-213, 2019 May 30.
Artigo em Chinês | MEDLINE | ID: mdl-31184081

RESUMO

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.


Assuntos
Segurança de Equipamentos , Equipamentos e Provisões , Indústrias , Padrões de Referência
11.
Issues Law Med ; 34(1): 77-92, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31179672

RESUMO

Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.


Assuntos
Equipamentos e Provisões/efeitos adversos , Recall de Dispositivo Médico , United States Food and Drug Administration , Estados Unidos
13.
Hu Li Za Zhi ; 66(3): 106-111, 2019 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-31134606

RESUMO

Medical Device Related Pressure Injury was incorporated into the redefinition of pressure injuries during the National Pressure Ulcer Advisory Panel 2016 Staging Consensus Conference. It is evident that this type of iatrogenic injury is gradually receiving more attention. Unlike pressure injuries over a bony prominence, which may be alleviated by repositioning different body parts, injuries that require non-retractable medical devices to be securely fastened to an injury site carry a higher risk of causing pressure injuries and of requiring subsequent care in a clinical setting. Furthermore, facial skin and mucosal membranes are the most common sites of Medical Device Related Pressure Injuries. Once these injuries occur, they easily result in damage to appearance, loss of function, and even bone exposure and infection, which may lead to medical disputes. Therefore, in recent years, research and exploration in this field has increased in many countries. However, discussions regarding Medical Device Related Pressure Injuries in Taiwan are still lacking. Thus, the aim of this article is to discuss the definition, risk factors, damage classification, and prevention strategies of Medical Device Related Pressure Injuries by combining domestic and international literature reviews and clinical verifications for the purpose of providing knowledge to medical staffs in hopes of reducing the incidence of Medical Device Related Pressure Injuries and degree of damage.


Assuntos
Equipamentos e Provisões/efeitos adversos , Lesão por Pressão/etiologia , Lesão por Pressão/prevenção & controle , Humanos , Literatura de Revisão como Assunto , Fatores de Risco , Taiwan
15.
Ann Pharm Fr ; 77(3): 232-240, 2019 May.
Artigo em Francês | MEDLINE | ID: mdl-30961889

RESUMO

OBJECTIVES: As a university teaching hospital, the call for tender for dental medical devices (dental implants and consumables) is done with the help of a team of hospital pharmacists and users. In order to optimize the definition of needs and evaluation criteria, an exhaustive review of the products was carried out. METHODS: Dental medical devices suppliers were consulted in 2017 for reviewing their products. Their technical, clinical and economic data were compared. The products have been gathered into categories and its results had been submitted to a commission of dental experts of our university hospital for clinical opinion. RESULTS: More than 30,000 references from 30 different suppliers were analyzed (orthodontics, dental implants, membranes and bone substitutes, various dental consumables). Relating to oral implantology, the opinions converged on clinical studies. On the contrary, diverging opinions have been proffered on the systematic use of single-use drills and customized guides for surgery and on the implant's choice. The definition of needs has been specified for orthodontics and consumables. Other criteria played a great role: single packaging (unit doses), product's sterility, paediatric needs, presence of allergens, traceability of devices and supplier diversity. CONCLUSIONS: This review led to the identification of new needs in more precise terms. The complexity and diversity of dental products and techniques requires this careful review and a better collaboration with practitioners.


Assuntos
Odontologia/normas , Equipamentos e Provisões/normas , Alérgenos/análise , Substitutos Ósseos , Implantes Dentários , Instrumentos Odontológicos , França , Hospitais Universitários , Humanos , Ortodontia/instrumentação , Farmacêuticos , Serviço de Farmácia Hospitalar , Esterilização/normas , Cirurgia Bucal/instrumentação
17.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(2): 118-121, 2019 Mar 30.
Artigo em Chinês | MEDLINE | ID: mdl-30977610

RESUMO

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.


Assuntos
Segurança de Equipamentos , Equipamentos e Provisões , China , Estados Unidos , United States Food and Drug Administration
18.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(2): 126-128, 2019 Mar 30.
Artigo em Chinês | MEDLINE | ID: mdl-30977612

RESUMO

This article summarizes the attribute conditions to the combination products designation from 2009 to 2018 in China,analyzes the common problems of combination products attribution definition.It is hoped to be helpful for researchers and manufacturers of combination products.


Assuntos
Equipamentos e Provisões , China , Terminologia como Assunto
19.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(2): 150-153, 2019 Mar 30.
Artigo em Chinês | MEDLINE | ID: mdl-30977619

RESUMO

Based on the Kraljic model,this paper established the scoring standard system for medical equipment procurement,and determined the weight coefficients of each evaluation factor by the analytic hierarchy process (AHP),then the procurement classification model of medical equipment was successfully established.It is proved that this model can classify medical equipment effectively,which enables the purchasing personnel to adopt corresponding purchasing strategies according to different classification.This model can be extended to all medical equipment procurement,realizing the delicacy and individualized procurement management of the equipment,which has strong operability and guiding significance.


Assuntos
Equipamentos e Provisões , Equipamentos e Provisões/economia , Modelos Teóricos
20.
Klin Padiatr ; 231(4): 177-182, 2019 Jul.
Artigo em Alemão | MEDLINE | ID: mdl-30974467

RESUMO

BACKGROUND: In May 2018, the commission on infection prevention and control in Germany (KRINKO) of the RKI published a guidance document providing recommendations on the prevention of catheter-associated infections in premature children and newborns. AIM: Summarized presentation, explanation and discussion of the KRINKO recommendations. METHODS: The recommendations of the KRINKO were summarized and discussed with reference to the original sources. RESULTS: In particular, statements were formulated for the insertion and maintenance of vascular catheters and for the preparation of infusions. Overall, however, the evidence of the recommendations is low. About 26% (19 out of 74) are classified under category IA or IB. However, 40% of the recommendations are category II only and therefore based on indicative clinical or epidemiological studies or comprehensible theoretical justifications. Accordingly, there is a lack of urgently needed clinical trials. DISCUSSION: Prevention strategies were discussed in detail and practical issues were addressed. The high number of recommendations, sometimes with low evidence levels, suggests a shared assessment of the infection control team and clinicians to ensure a successful implementation in practice and a focus on key content adapted to the local situation.


Assuntos
Infecções Relacionadas a Cateter/prevenção & controle , Controle de Doenças Transmissíveis , Equipamentos e Provisões , Higiene/normas , Equipamentos e Provisões/microbiologia , Alemanha , Humanos , Recém-Nascido , Recém-Nascido Prematuro
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