Revision Study on Medical Device Management within Health Quality Standards

机译：符合卫生质量标准的医疗器械管理修订研究

获取原文

页面导航

摘要
著录项
相似文献
相关主题

摘要

The 'Health Quality Standards (HQS)', established by the Quality and Accreditation Department in Ministry of Health for the evaluation of the quality of health services, guides the auditor health professional in hospital audits. The evaluation criteria under the standards form the rating criteria of the auditor. Performing of the calibration, labeling and certification in according to the international standards and the examination of the competence of the companies that make the calibration of the medical devices are the points that must be taken into account in the quality studies. However, it is observed that there are nonstandard calibration studies in the sector because of the insufficient control mechanism. It is emphasized that calibration should be made in the HQS evaluation criteria, but there is no detailed guidance information on the quality and adequacy of these measurements. Calibration studies carried out only on the label, which are out of standard, pass the inspection according to the currently used 'Medical Device Management' evaluation criteria. Performing the auditing mechanism required for the calibration on the HQS evaluation criteria will increase the quality of the calibration service received from the health institution from outside and thus the quality of the health service. Such an inspection mechanism can only be achieved by revising the current HQS 'Medical Device Management' standard and evaluation criteria. In this statement, HQS 'Medical Device Management' standards and evaluation criteria were examined and necessary points for revision were determined.

机译：卫生部质量和认证部门制定的“健康质量标准（HQS）”旨在评估卫生服务的质量，指导审计师健康专业人员进行医院审计。这些标准下的评估标准构成了审核员的评估标准。根据国际标准进行校准，标签和认证以及对进行医疗器械校准的公司的能力进行检查是质量研究中必须考虑的重点。但是，由于控制机制不足，因此在该领域中存在非标准的校准研究。需要强调的是，应该在HQS评估标准中进行校准，但是没有关于这些测量的质量和充分性的详细指导信息。仅对不符合标准的标签进行的校准研究才根据当前使用的“医疗器械管理”评估标准通过检查。根据HQS评估标准执行校准所需的审核机制将提高从卫生机构从外部获得的校准服务的质量，从而提高卫生服务的质量。只有通过修订当前的HQS“医疗设备管理”标准和评估标准才能实现这种检查机制。在此声明中，检查了HQS“医疗设备管理”标准和评估标准，并确定了必要的修订要点。

著录项

来源
《Medical Technologies National Congress》|2018年|1-4|共4页
会议地点 Magusa(CY)
作者
Mana Sezdi;
展开▼
作者单位

Biyomedikal Cihaz Teknolojisi Programı İstanbul Üniversitesi - Cerrahpaşa Büyükçekmece Kampüsü Teknik Bilimler Meslek Yüksekokulu İstanbul Türkiye;

展开▼
会议组织
原文格式 PDF
正文语种
中图分类
关键词
Standards; Calibration; Performance evaluation; Inspection; Accreditation; Hospitals; Labeling;

机译：标准；校准;绩效评估；检查;认证；医院；贴标;

相似文献

外文文献
中文文献
专利

1. Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management) [J] . Stehlik Josef, Estep Jerry D., Selzman Craig H., Circulation. Heart failure . 2017,第6期

机译：患者报告的健康相关的生活质量是随着路线图研究（左心室辅助设备和医学管理的风险评估和比较有效性）的医学管理结果，与左心室辅助装置治疗的动态心力衰竭患者的预测因素。
2. Medical devices Harmonizing quality management requirements - Ensuring worldwide quality for medical devices [J] . Elizabeth A.Bridgman, Hillary Woehrle ISO Bulletin . 2002,第7期

机译：医疗设备协调质量管理要求-确保医疗设备的全球质量
3. Medical devices Harmonizing quality management requirements - Quality management and the medical field A comparison between ISO 9001-2000 and ISO 13485 [J] . Ed Kimmelmann ISO Bulletin . 2002,第7期

机译：医疗设备协调质量管理要求-质量管理和医学领域ISO 9001-2000与ISO 13485之间的比较
4. Revision Study on Medical Device Management within Health Quality Standards [C] . Mana Sezdi Medical Technologies National Congress . 2018

机译：健康质量标准中医疗设备管理的修订研究
5. Developing a harmonized medical device design control program within the framework of the Quality System Regulation [D] . Piel, Felicia 2012

机译：在质量体系法规框架内制定统一的医疗器械设计控制程序
6. Randomized Controlled Trial of the Safety and Efficacy of Daptomycin versus Standard-of-Care Therapy for Management of Patients with Osteomyelitis Associated with Prosthetic Devices Undergoing Two-Stage Revision Arthroplasty [O] . Ivor Byren, Shruta Rege, Ed Campanaro, 2012

机译：达托霉素与护理标准疗法联合进行两阶段翻修的假体治疗相关的骨髓炎患者的安全性和有效性与护理标准治疗的随机对照试验
7. Poster Session 3The imaging examination and quality assessmentP626Value of mitral and tricuspid annular displacement to assess the interventricular systolic relationship in severe aortic valve stenosis : a Pilot studyP627Follow-up echocardiography in asymptomatic valve disease: assessing the potential economic impact of the European and American guidelines in a dedicated valve clinic, compared to standard care.P628The tricuspid valve: identification of optimal view for assessing for prolapseP629Right atrial volume by two-dimensional echocardiography in healthy subjectsP630Disturbance of inter and intra atrial conduction assessed by tissue doppler imaging in patients with medicaly controlled hypertension and prehypertension.P631Liver stiffness by shear wave elastography, new noninvasive and quantitative tool for acute variation estimation of central venous pressure in real-time?P632Weak atrial kick contribution is associated with a risk for heart failure decompensationP633Usefulness of wave intensity analysis in predicting the response to cardiac resynchronization therapyP634Early subclinical left ventricular systolic and diastolic dysfunction in gestational hypertension and preeclampsiaP635Clinical comparison of three different echocardiographic methods for left ventricular ejection fraction and LV end diastolic volume measurementP636Assessment of right ventricular-arterial coupling parameters by 3D echocardiography in patients with pulmonary hypertension receiving specific vasodilator therapyP637Prediction of right ventricular failure after left ventricular assist device implant: assessing usefulness of standard and strain echocardiographyP638Kinematic analysis of diastolic function using the novel freely available software Echo E-waves - feasibility and reproducibilityP639Evaluation of coronary flow velocity by Doppler echocardiography in the treatment of hypertension with the ARB: correlation to the histological cardiac fibrosisP640The clinical significance of limited apical ischaemia and the prognostic value of stress echocardiography - A contemporary study from a high volume centerP641Effects of intermediate stenosis of left anterior descending coronary artery on survival in patients with chronic total occlusion of right coronary arteryP642Left ventricular remodeling after a first myocardial infarction in patients with preserved ejection fraction at dischargeP643Left atrial size and acute coronary syndromes. Let is make simple.P644Influence of STEMI reperfusion strategy on systolic and diastolic functionP645Aortic valve resistance risk-stratifies low-gradient severe aortic stenosisP646Does permanent pacemaker implantation complicate the prognosis of patients after transcatheter aortic valve implantation?P647Influence of metabolic syndrome and diabetes on progression of calcific aortic valve stenosis - The COFRASA - GENERAC StudyP648Low referral for aortic valve replacement accounts for worse long-term outcome in low versus high gradient severe aortic stenosis with preserved ejection fractionP649The impact of right ventricular function from aortic valve replacement: A randomised study comparing minimally invasive aortic valve surgery and conventional open heart surgery [O] . T. Ota, DNS Senaratne, NK. Preston, 2016

机译：海报课程3年度成像检查和质量评估P626尺寸二尖瓣环形位移，评估严重主动脉瓣狭窄中的间隔收缩系统关系：无症状瓣膜病的先导术627推翻超声心动图：评估欧洲和美国指南的潜在经济影响专用阀门诊所，与标准Care.P628相比，Tricuspid阀门：鉴定通过在医疗主题的Hystantsp630中，通过组织多普勒成像在医疗和术语中的癌细胞癌和术语患者进行评估，通过二维超声心动图进行评估的最佳视图。 .p631抗剪力波弹性凝视，新的非侵入性和定量工具，用于实时急性变异估计中央静脉压力的急性变化？P632Weak心房踢贡献与心力衰竭分数的风险有关波强度分析预测心脏重新同步的响应治疗634亚临床左心室收缩和舒张性功能障碍，妊娠期高血压分数的三种不同超声心动仪和LV端舒张型方法的比较，3D超声心动图右心室凝血率测量3636分类在患有肺动脉高压的患者中，左心室辅助装置植入后接受特异性血管扩张器治疗637预测右心室失效：评估使用新颖的自由可用的软件回声电子波的标准和菌株超声心动图338云分析的标准和菌株超声心动图638云分析 - 可行性和再现冠状动脉速度的可行性和再现率。多普勒超声心动图在治疗高血压与arb中：相关性与组织学心肌纤维化p640的相关性李的临床意义紧张的缺血性和应激超声心动图的预后价值 - 一种高批量中心的当代研究，来自左前期下降冠状动脉中间狭窄患者中间狭窄患者急性闭塞患者患者患者患者第一次心肌梗死后的慢性冠状动脉间梗死患者存活的现代研究排出的射血分数在排出的343夜心房尺寸和急性冠状动脉综合征处。让令人生意的是STEMIESTOMELETERIC功能的STEMIEST.P644。在收缩和舒张功能上进行STEMI和舒张型阀门电阻危险危险率低梯度严重主动脉鼻窦646doe永久性起搏器植入使经截觉管主动脉瓣植入后的患者预后复杂化吗？P647型综合征和糖尿病患者的进展主动脉瓣狭窄 - Cofrasa - Generac STOMP648LOW用于主动脉瓣膜置换术的转诊表明，低梯度严重主动脉狭窄的更差的长期结果，并具有射血瓣膜置换术射精术中的抗锻术术造成的影响：随机研究比较微创主动脉阀门手术和常规开放式心脏手术
8. Study to Determine an Effective Administrative and/or Organizational System within Which to Implement Effective Quality Assurance Functions of the Pharmacy at Letterman Army Medical Center, That Meet JCAH and HSC Standards. (Final Report, July 1985-July 1 [R] . Foster, M. J. 1986

机译：研究确定一个有效的行政和/或组织系统，以实施符合JCaH和HsC标准的莱特曼陆军医疗中心药房的有效质量保证功能。（最终报告，1985年7月至7月1日

Revision Study on Medical Device Management within Health Quality Standards

摘要

著录项

相似文献

相关主题

期刊订阅