Medical Device Risk Management For Performance Assurance Optimization and Prioritization

Area of Science:

• Clinical Engineering
• Biomedical Engineering
• Healthcare Technology Management

Background:

• Performance assurance (PA) is critical for medical device risk management within clinical engineering (CE).
• Existing efforts focus on defining risk factors and developing quantitative models for PA programs.
• A unified framework for quantitative risk systems in PA is currently lacking.

Purpose of the Study:

• To provide a perspective on medical device quality and risk-based elements of PA programs.
• To introduce a PA risk management framework.
• To propose a general model for quantitative risk systems.

Main Methods:

• Review of previous quantitative models for PA risk management.
• Development of a PA risk management framework.
• Proposal of a general model for quantitative risk systems.

Main Results:

• A PA risk management framework is presented.
• Previous quantitative models are examined.
• A general model for quantitative risk systems is proposed.

Conclusions:

• A common framework is needed for quantitative risk systems in PA.
• The proposed framework and model can improve medical device quality and PA program decision-making.
• Future directions in PA technology are discussed.