Clinical Use Safety Management and Equipment Maintenance of Medical Devices

2021 ◽  
2020 ◽  
Vol 3 ◽  
pp. 36
Author(s):  
Marina Zaki ◽  
Marie Galligan ◽  
Lydia O'Sullivan ◽  
Declan Devane ◽  
Eilish McAuliffe

Trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and powerful tool in trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results, with limited clinical use. The aim of this systematic literature review is to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of trials. This protocol will describe the methodological approach taken for the following: conducting a systematic and comprehensive search for relevant articles, applying eligibility criteria for the inclusion of such articles, extracting data and information, appraising the quality of the articles, and thematically synthesizing the data to illuminate the key factors influencing statistical aspects of trials.


2020 ◽  
Vol 2 (1) ◽  
pp. 174-182
Author(s):  
Agata Kielesińska

AbstractThe purpose of the paper is to present the issues of ensuring the safety of machinery and equipment in accordance with the requirements of the Machinery Directive 2006/42/EC of May 17, 2006 on the essential requirements for machines, with regard to the sphere of their import and distribution. This issue is related to the dynamically developing trade in cheaper new machines, mainly from countries outside the EEA (including China) and is a priority for ensuring safety and protecting the health and life of users of this type of equipment in accordance with EU regulations. The use of a variety of machines in industry, in addition to general safety requirements, which may also include quality criteria, care for the environment and industry-specific safety management requirements (e.g. food, automotive, medical devices).


2012 ◽  
pp. 307-354 ◽  
Author(s):  
Benjamin D. Brooks ◽  
Amanda E. Brooks ◽  
David W. Grainger

2004 ◽  
Vol 23 (1) ◽  
pp. 200-207 ◽  
Author(s):  
Larry Kessler ◽  
Scott D. Ramsey ◽  
Sean Tunis ◽  
Sean D. Sullivan
Keyword(s):  

Author(s):  
Alfa Omega Hutagalung ◽  
Sawarni Hasibuan

The best quality of services provided by health care facilities can be realized if medical devices are in a reliable and safe condition. A large number of medical devices and the use of various types of medical devices have been a problem for hospital management to decide the level of priority in carrying out medical equipment maintenance. The purpose of the maintenance is to increase their availability and to reduce maintenance costs. This study aims to show how to determine the priority level of medical device maintenance based on the calculation of the criticality scores of medical devices. The criticality scores are obtained based on the assessment of criteria, sub-criteria, and grade by using the method of Analytical Hierarchy Process (AHP). The devices with higher critical weight take higher priority for maintenance than devices with lower critical weight. The approach was applied for 20 medical devices at the Out Patient Department of Eye Hospital in Jakarta to describe how to prioritize the maintenance of medical devices.


Author(s):  
B. S. DHILLON

This paper presents facts and figures, directly or indirectly, related to medical equipment reliability and reviews various important aspects, directly or indirectly, concerned with medical equipment reliability including classifications of medical devices/equipment, human error in medical equipment, useful guidelines for reliability and other professionals to improve medical equipment reliability, and medical equipment maintenance. A number of methods considered useful for performing medical equipment reliability analysis are also presented. Useful sources and organizations for obtaining medical equipment failure-related data are listed.


2020 ◽  
Vol 11 (4) ◽  
pp. 83
Author(s):  
Mary Anne Melo

Fundamental scientific understanding of oral diseases associated with tissue-contacting dental and medical devices is primordial to facilitate pathways for their translation to clinical use [...]


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