Medical Device Risk Management For Performance Assurance Optimization and Prioritization

Abstract

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.

Bioengineering cobalt chromium cardiovascular stent biomaterial for biofunctionalization

“…Tissue engineering surfaces that mimic physiological environment for biomimicry are one of the most basic principles of biological design. The in vitro model to assess hemocompatibility is an over-simplification of a very complex physiological system (Gaamangwe et al 2015). The modified chandler loop system was based on previous experimental standardizations (Gaamangwe et al 2015, Gardner 1974.…”

“…The in vitro model to assess hemocompatibility is an over-simplification of a very complex physiological system (Gaamangwe et al 2015). The modified chandler loop system was based on previous experimental standardizations (Gaamangwe et al 2015, Gardner 1974. Practically, hemodynamics play a quantitative role between stent implantation and thrombosis in vivo (Foin et al 2014), and should be taken into consideration during simulations in vitro.…”