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1.
Bull World Health Organ ; 98(3): 206-211, 2020 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-32132755

RESUMO

Problem: Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India. Approach: Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority. Local setting: Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme. Relevant changes: From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting. Lessons learnt: Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting.


Assuntos
Equipamentos e Provisões/efeitos adversos , Equipamentos e Provisões/estatística & dados numéricos , Gestão da Segurança/estatística & dados numéricos , Segurança de Equipamentos , Humanos , Índia , Notificação de Abuso , Vigilância de Produtos Comercializados , Sistema de Registros , Gestão da Segurança/legislação & jurisprudência
3.
Drug Saf ; 43(2): 83-93, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31845212

RESUMO

We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional." Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.


Assuntos
Equipamentos e Provisões/classificação , Equipamentos e Provisões/normas , Segurança de Equipamentos , União Europeia , Humanos , Legislação de Dispositivos Médicos , Estados Unidos
4.
Medicine (Baltimore) ; 98(48): e18137, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770249

RESUMO

RATIONALE: Recently, commercial indoor trampoline parks have been opened around the globe, and both the number of venues and the park users are increasing. Academic literatures have largely focused on home trampoline related injuries, and less is known about the injuries associated with trampoline parks due to the limited number of studies or cases reported. In this report, we present a complete spinal cord injury sustained at a commercial indoor trampoline park. PATIENT CONCERNS: A 26-year old male developed tetraplegia after plainly jumping on the trampolines and diving into one of the foam pits head first. DIAGNOSIS: C-spine CT revealed bilateral interfacetal dislocation on C6-7, and his C-spine MRI showed anterior translational injury at C6-7 with severe cord encroachment and complete discoligamentous complex disruption. He was diagnosed with complete spinal cord injury. INTERVENTIONS: The patient underwent 30 minutes each of physical therapy and occupational therapy twice a day for a total of 25 days of in-patient rehabilitation. Interventions included tilt table, passive range of motion exercises, functional electrical stimulation, sitting balance training, upper extremity strengthening exercise, and hand manipulation exercises. OUTCOME: Despite intensive rehabilitation and the patient's good spirit, there was no functional change in all physical examinations between evaluations at initial and at discharge. LESSONS: In conclusion, we aim to alert the risks associated with improper use of trampolines, promote safer entertainment environment, and aid in developing mandatory safety measures. We hope to alert the risks associated with improper use of trampolines, promote safer entertainment environment, and aid in developing mandatory safety measures.


Assuntos
Traumatismos em Atletas/complicações , Segurança de Equipamentos/normas , Quadriplegia/etiologia , Traumatismos da Medula Espinal/etiologia , Adulto , Traumatismos em Atletas/prevenção & controle , Traumatismos em Atletas/reabilitação , Humanos , Masculino , Parques Recreativos , Quadriplegia/prevenção & controle , Quadriplegia/reabilitação , Traumatismos da Medula Espinal/prevenção & controle , Traumatismos da Medula Espinal/reabilitação
6.
Radiologe ; 59(10): 875-884, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31591698

RESUMO

METHODICAL INNOVATIONS: In the present article, interactions associated with magnetic resonance (MR) procedures and MR test procedures for implants/devices are examined. PERFORMANCE: Since 2012, many interactions of items with MR procedures have been physically described and translated into standardized ASTM and ISO testing procedures. Despite the standardized procedures, the determination of the test method to use is an important decision. The MR user is also responsible for the transfer and interpretation of the individual technical parameters despite the MR Conditional labelling and therefore relatively unambiguous instruction. This includes the total MR examination duration, which often has no clinical practical duration, but is derived from the 15 min of the ASTM radiofrequency (RF) heating test. ACHIEVEMENTS: There has been an increasing standardization of the test methods as well as the MR labeling requirements and the advantageous transfer of the parameters to suitable input masks on the MR systems. PRACTICAL RECOMMENDATIONS: The current use of standardized MR test methods and MR marking represents the best possible state of the art from the point of view of the approval of medical devices as well as from a liability point of view for the manufacturers of implants-and for MR users in clinical practice. However, off-label decisions (i.e., deviations from the manufacturer's official MR marking) in everyday clinical practice can be medically justified.


Assuntos
Imagem por Ressonância Magnética , Próteses e Implantes , Segurança de Equipamentos , Espectroscopia de Ressonância Magnética , Rotulagem de Produtos
7.
Arq Bras Cir Dig ; 32(3): e1452, 2019.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31644672

RESUMO

BACKGROUND: In high-income countries, morbid obesity is a growing health problem that has already reached epidemic proportions. When performing a laparoscopic gastric bypass several operative methods exist. AIM: To describe the institutional experience using a knotless unidirectional barbed suture (V-Loc 180/Covidien, Mansfield, MA) to create a hand-sewn gastrojejunostomy (GJ) and jejunojejunostomy (JJ) during bariatric surgery. METHODS: Evaluation of a case series of 87 morbidly obese patients who underwent laparoscopic gastric bypass with a hand-sewn gastrojejunostomy (GJA) and jejunojejunostomy (JJA) between 01/2015 and 06/2017. The patients were divided into two groups: in group I, GJA und JJA sutures were performed using the knotless unidirectional barbed suture; in group II, GJA and JJA were sutured with resorbable multifilament thread (Vicryl® 3/0 Ethicon, Livingstone, UK). The recorded data on gender, age, BMI, ASA score, operative time, postoperative morbidity, length of hospital stay, and reoperation, were analyzed and compared. RESULTS: All procedures were completed laparoscopically with no mortality. The mean operative time was 123.23 (±30.631) in group I and 127.57 (±42.772) in group II (p<0.05). The postoperative complications did not differ significantly between the two groups. Early complications were observed for two patients (0.9%) in the barbed suture group and for one patient (0.42%) in the multifilament suture group (p<0.05). In group I two patients (0.9%) required reoperation: on the basis of jejunojejunal stenosis in one patient, and local abscess near the gastrojejunostomy, without a leakage, in the other. In group II one patient (0.42%) required reoperation due to stenosis of the GJA. The duration of hospital admission was similar for both groups: 3.36 (±0.743) days in group I vs. 3.38 (±1.058) days in group II (p<0.05). CONCLUSION: The novel anastomotic technique is a safe and effective method and can be applied to gastrojejunal anastomosis and jejunojejunal anastomosis in laparoscopic gastric bypass.


Assuntos
Cirurgia Bariátrica/instrumentação , Segurança de Equipamentos/instrumentação , Obesidade Mórbida/cirurgia , Técnicas de Sutura/instrumentação , Adulto , Anastomose Cirúrgica/instrumentação , Anastomose Cirúrgica/métodos , Cirurgia Bariátrica/métodos , Feminino , Derivação Gástrica/instrumentação , Derivação Gástrica/métodos , Humanos , Jejunostomia/instrumentação , Jejunostomia/métodos , Jejuno/cirurgia , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Poliglactina 910 , Complicações Pós-Operatórias , Estudos Prospectivos , Estômago/cirurgia , Resultado do Tratamento , Técnicas de Fechamento de Ferimentos/instrumentação
9.
Undersea Hyperb Med ; 46(4): 447-459, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31509901

RESUMO

Introduction: The mining and tunneling industries are historically associated with hazardous exposures that result in significant occupational health concerns. Occupational respiratory exposures causing pneumoconiosis and silicosis are of great concern, silicosis being non-curable. This work demonstrates that compressed-air workers (CAWs) performing tunnel hyperbaric interventions (HIs) may be at risk for hazards related to bentonite exposure, increasing the likelihood of developing harmful illnesses including cancer. Bentonite dust inhalation may result in respiratory levels of silica exceeding acceptable industrial hygiene standards. Methods: A qualitative observational exposure assessment was conducted on CAWs while they were performing their HI duties. This was followed by quantitative data collection using personal and area air sample techniques. The results were analyzed and interpreted using standard industrial hygiene principles and guidelines from NIOSH and OSHA. Results: Our work suggests bentonite dust exposure may be an emerging particulate matter concern among CAWs in the tunneling industry. Aerosolized bentonite particles may have potential deleterious effects that include pneumoconiosis and silicosis. Silicosis can result in the development of pulmonary carcinoma. Conclusions: The modern tunneling industry and required hyperbaric interventional tasks represent a potential public health and occupational concern for CAWs. This paper introduces the modern tunneling industry and the duties of CAWs, the hazardous environment in which they perform their duties, and describes the risks and potential harmful health effects associated with these hazardous exposures.


Assuntos
Bentonita/toxicidade , Ar Comprimido , Materiais de Construção/toxicidade , Poeira , Arquitetura de Instituições de Saúde , Exposição Ocupacional/efeitos adversos , Poluentes Ocupacionais do Ar/química , Poluentes Ocupacionais do Ar/toxicidade , Bentonita/química , Indústria da Construção , Materiais de Construção/análise , Segurança de Equipamentos , Filtração/instrumentação , Humanos , Pressão , Pesquisa Qualitativa , Dispositivos de Proteção Respiratória , Estados Unidos , United States Occupational Safety and Health Administration/normas
10.
BMC Public Health ; 19(1): 1257, 2019 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-31510988

RESUMO

BACKGROUND: Media advocacy plays an important role in public health initiatives, as it can provide vital information to target populations, policy makers, or other relevant stakeholders. Unfortunately, little is currently known about the use of media advocacy to promote occupational safety and health programs. This study explores media coverage related to the Rollover Protection Structure (ROPS) Rebate Programs, which were designed to encourage the use of rollover protection on agricultural tractors, thus reducing the risk of tractor overturn fatalities. The Program's portrayal in the media, as well as the role that the media has played in implementing and sustaining these Programs. METHODS: Media articles pertaining to any of the state-based or National ROPS Rebate Programs and published between November 1, 2006 and October 31, 2018 were included for review. Discourse analysis was used to understand the messages portrayed by the media and how those messages shaped the outcomes of the ROPS Rebate Programs. RESULTS: During the study period, 212 unique articles were published about the ROPS Rebate Programs. While these articles all portrayed the ROPS Rebate Programs in a largely positive light, they were used at different stages, from pre-implementation through sustainment of the ROPS Rebate Programs, and to different extents. CONCLUSIONS: Media articles have played an important role in implementing and sustaining the ROPS Rebate Programs. Based on the results of this study, more robust and continuous media coverage are important for the longevity and success of public health programs.


Assuntos
Acidentes de Trabalho/prevenção & controle , Agricultura/estatística & dados numéricos , Promoção da Saúde/métodos , Saúde do Trabalhador/estatística & dados numéricos , Pessoal Administrativo , Segurança de Equipamentos , Humanos , Estados Unidos
12.
Int J Med Inform ; 131: 103932, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31557700

RESUMO

BACKGROUND: Poorly designed infusion pumps can lead to user errors and adverse incidents. Therefore, assessments of their usability and performance that can inform managerial decisions about the selection of appropriate medical devices are essential. OBJECTIVE: This study aimed to identify design deficiencies and evaluate the usability and performance of four infusion pump models and thus inform decisions about infusion pump selection. METHODS: Four evaluators evaluated the interface designs of the pumps according to a series of design principles in a heuristic evaluation in order to identify pump design deficiencies. Additionally, 60 registered nurses participated in simulated use testing to perform a series of tasks using the pumps in order to examine the pump performances. Outcome measures included task completion time, frequency of deviations, frequency of requests for assistance, and nurses' perceptions. RESULTS: Design issues identified included system status visibility, information access, and error prevention. The results of simulated use testing favored some pumps over others, depending on which outcome measures were considered. CONCLUSIONS: Heuristic evaluations and simulated use testing can provide information about the basic usability of medical devices and related operational issues. However, practitioners should select appropriate evaluation principles, testing tasks, and outcome measures based on the tested medical devices and contexts.


Assuntos
Segurança de Equipamentos/métodos , Heurística , Bombas de Infusão/estatística & dados numéricos , Erros Médicos/prevenção & controle , Enfermeiras e Enfermeiros/estatística & dados numéricos , Garantia da Qualidade dos Cuidados de Saúde/normas , Gestão da Segurança/organização & administração , Simulação por Computador , Segurança de Equipamentos/normas , Humanos , Variações Dependentes do Observador
13.
Bioelectromagnetics ; 40(7): 458-471, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31396987

RESUMO

The Virtual Population (ViP) phantoms have been used in many dosimetry studies, yet, to date, anatomical phantom uncertainty in radiofrequency (RF) research has largely been neglected. The objective of this study is to gain insight, for the first time, regarding the uncertainty in RF-induced fields during magnetic resonance imaging associated with tissue assignment and segmentation quality and consistency in anatomical phantoms by evaluating the differences between two generations of ViP phantoms, ViP1.x and ViP3.0. The RF-induced 10g-average electric (E-) fields, tangential E-fields distribution along active implantable medical devices (AIMD) routings, and estimated AIMD heating were compared for five phantoms that are part of both ViP1.x and ViP3.0. The results demonstrated that differences exceeded 3 dB (-29%, +41%) for local quantities and 1 dB (±12% for field, ±25% for power) for integrated and volume-averaged quantities (e.g., estimated AIMD-heating and 10 g-average E-fields), while the variation across different ViP phantoms of the same generation can exceed 10 dB (-68% and +217% for field, -90% and +900% for power). In conclusion, the anatomical phantom uncertainty associated with tissue assignment and segmentation quality/consistency is larger than previously assumed, i.e., 0.6 dB or ±15% (k = 1) for AIMD heating. Further, multiple phantoms based on different volunteers covering the target population are required for quantitative analysis of dosimetric endpoints, e.g., AIMD heating, which depend on patient anatomy. Phantoms with the highest fidelity in tissue assignment and segmentation should be used, as these ensure the lowest uncertainty and possible underestimation of exposure. To verify that the uncertainty decreases monotonically with improved phantom quality, the evaluation of differences between phantom generations should be repeated for any improvement in segmentation. Bioelectromagnetics. 2019;40:458-471. © 2019 Bioelectromagnetics Society.


Assuntos
Simulação por Computador , Metais/metabolismo , Modelos Anatômicos , Próteses e Implantes/efeitos adversos , Radiação Eletromagnética , Desenho de Equipamento , Segurança de Equipamentos , Humanos
14.
Eur J Radiol ; 118: 96-100, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31439265

RESUMO

PURPOSE: Low-field magnetic resonance imaging (MRI), i.e. MRI with a static magnetic field strength <0.5 T, has been reported to be safe in patients with pacemakers, however there are no data about the safety of low-field MRI in patients with implantable cardioverter defibrillators (ICD) and/or cardiac resynchronization therapy (CRT). We aimed to investigate the safety and diagnostic efficiency of routine low-field MRI in patients with different devices for cardiac rhythm management (i.e. pacemakers and ICD, including devices with CRT). METHOD: MRI scans of 446 regions of interest were evaluated with field strength of 0.2 T in 338 patients (62% male; age at MRI scan 76.1 ± 9.2 years; time since device implantation 4.1 ± 3.2 years) with cardiac rhythm management devices (298 pacemakers, 25 ICD, 8 CRT-ICD, and 7 CRT pacemakers). This analysis included 62 pacemaker-dependent patients (18.3%), 52 patients with 1.5-Tesla-MR conditional pacemakers (15.4%) and 13 patients with abandoned leads (3.9%). RESULTS: Except for one examination, which was interrupted because of recurrent severe nausea, all MRI scans could be analyzed efficiently. No induction of arrhythmia or inhibition of pacemaker function occurred. Compared to the device interrogation before MRI, there were no significant changes in battery voltage, pacing capture threshold, sensing of intrinsic ECG, lead impedance, as well as shock impedance in ICD devices after completed examination. CONCLUSIONS: Low-field MRI examinations (0.2 T) were efficient and safe regarding clinical and technical complications in patients with devices for cardiac rhythm management, even in case of pacemaker-dependency or the presence of abandoned leads.


Assuntos
Desfibriladores Implantáveis , Imagem por Ressonância Magnética/efeitos adversos , Marca-Passo Artificial , Adulto , Idoso , Idoso de 80 Anos ou mais , Arritmias Cardíacas/terapia , Segurança de Equipamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Estudos Retrospectivos , Adulto Jovem
15.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(4): 286-289, 2019 Jul 30.
Artigo em Chinês | MEDLINE | ID: mdl-31460723

RESUMO

This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.


Assuntos
Segurança de Equipamentos , Segurança de Equipamentos/métodos , Guias como Assunto
16.
Am Surg ; 85(6): 563-566, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-31267894

RESUMO

Since their development in 1908, surgical staplers have been used as a method of "mechanical suturing" in efforts to divide hollow viscera and create anastomoses in an efficient and sterile manner. The concept for the surgical stapler was first developed by Humér Hultl, a Hungarian professor and surgeon, and designed by Victor Fischer, a Hungarian businessman and designer of surgical instruments. The design was highly acclaimed; however, it was bulky, cumbersome, and expensive to manufacture. In 1920, Aladár Petz, a student of Hultl, incorporated two innovations to the Fischer-Hultl stapler to create a more lightweight model, which was named the Petz clamp. In 1934, Friedrich of Ulm designed what would be the predecessor to the modern-day linear stapler. In the 1950s, Russian and American staplers began to emerge. Throughout the 1960s, a variety of stapling instruments were developed in the United States, manufactured by the United States Surgical Corporation. In the 1970s, Johnson & Johnson Ethicon brand joined the market. The United States Surgical Corporation was later bought by Tyco Healthcare and became Covidien in 2007. Through the collaboration of Felicien Steichen, Mark Ravitch, and Leon Hirsch, surgical staplers were further modified to incorporate interchangeable cartridges with various designs. With the advent of minimally invasive surgery began production of laparoscopic surgical staplers. Since its inception, the surgical stapler has provided a means to efficiently create safe and effective visceral and vascular anastomoses. The surgical stapler design continues to evolve while still maintaining the basic principles that were implemented in the original design.


Assuntos
Desenho de Equipamento/história , Grampeadores Cirúrgicos/história , Grampeamento Cirúrgico/história , Segurança de Equipamentos , História do Século XX , Humanos , Hungria , Internacionalidade , Procedimentos Cirúrgicos Minimamente Invasivos/história , Federação Russa , Estados Unidos
17.
Radiologe ; 59(10): 885-893, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31273421

RESUMO

BACKGROUND: Examining patients with cardiac pacemakers and implantable cardioverter-defibrillator systems (ICD) requires special cautions und preparations in order to assure patient safety. OBJECTIVES: Is it possible for pacemaker and ICD patients to safely undergo MRI examination? MATERIALS AND METHODS: This review provides information on interaction between the pacemaker and MRI systems, provides a review on the evidence published so far and describes how to perform a safe MRI examination in a patient with an implanted pacemaker device. CONCLUSION: MRI in patients with cardiac pacemaker and ICD systems is safe under specified conditions and should be offered to patients with a given indication for a MRI.


Assuntos
Desfibriladores Implantáveis , Imagem por Ressonância Magnética , Marca-Passo Artificial , Contraindicações , Segurança de Equipamentos , Humanos , Imagem por Ressonância Magnética/efeitos adversos , Segurança do Paciente
18.
Value Health ; 22(7): 754-761, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31277820

RESUMO

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable." In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies. With a focus on regulatory science, the MDIC has been assessing how to apply real-world evidence (RWE) regulatory science to medical devices. A key goal of this project is to review the history of RWE regulatory science, define terms, and explain why and how RWE is being considered across the total product life cycle, including regulatory assessment. Unique considerations of real-world data for in vitro diagnostics are also taken into account. We envision that these activities will help ensure a high level of rigor and integrity of RWE necessary for regulatory use cases and demonstrate where RWE can be successfully used for regulatory decision making. The ISPOR, FDA, and MDIC are providing the needed leadership in ensuring that diverse stakeholders share a meaningful voice in determining RWE use and, by so doing, are improving the quality and efficiency of care, enhancing health outcomes, and addressing broader societal concerns of reducing health disparities and costs.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Equipamentos e Provisões , Medicina Baseada em Evidências/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Segurança do Paciente/legislação & jurisprudência , Formulação de Políticas , United States Food and Drug Administration/legislação & jurisprudência , Segurança de Equipamentos , Equipamentos e Provisões/efeitos adversos , Regulamentação Governamental , Humanos , Comunicação Interdisciplinar , Cooperação Internacional/legislação & jurisprudência , Vigilância de Produtos Comercializados , Parcerias Público-Privadas/legislação & jurisprudência , Medição de Risco , Terminologia como Assunto , Estados Unidos
19.
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
20.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(3): 202-204, 2019 May 30.
Artigo em Chinês | MEDLINE | ID: mdl-31184079

RESUMO

This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and in vitro diagnostic reagents.


Assuntos
Segurança de Equipamentos
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