Medical Device Risk Management For Performance Assurance Optimization and Prioritization

Performance assurance (PA) is an integral component of clinical engineering medical device risk management. For that reason, the clinical engineering (CE) community has made concerted efforts to define appropriate risk factors and develop quantitative risk models for efficient data processing and im...

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Bibliographic Details
Published inBiomedical instrumentation & technology Vol. 49; no. 6; pp. 446 - 451
Main Authors Gaamangwe, Tidimogo, Babbar, Vishvek, Krivoy, Agustina, Moore, Michael, Kresta, Petr
Format Journal Article
LanguageEnglish
Published United States Association for the Advancement of Medical Instrumentation, AAMI 01.11.2015
Subjects
Assurance
Automation
Biomedical Technology
Communities
Decision making
Humans
Inspection
Instrumentation
Maintenance and Engineering, Hospital
Management decisions
Medical devices
Medical equipment
Optimization
Quality Assurance, Health Care
Risk
Risk management
Risk Management - methods
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Summary:Performance assurance (PA) is an integral component of clinical engineering medical device risk management. For that reason, the clinical engineering (CE) community has made concerted efforts to define appropriate risk factors and develop quantitative risk models for efficient data processing and improved PA program operational decision making. However, a common framework that relates the various processes of a quantitative risk system does not exist. This article provides a perspective that focuses on medical device quality and risk-based elements of the PA program, which include device inclusion/exclusion, schedule optimization, and inspection prioritization. A PA risk management framework is provided, and previous quantitative models that have contributed to the advancement of PA risk management are examined. A general model for quantitative risk systems is proposed, and further perspective on possible future directions in the area of PA technology is also provided.
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ISSN:0899-8205
1943-5967
DOI:10.2345/0899-8205-49.6.446