<title>Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness</title>

Abstract

Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: Fault/Failure Analysis, Medical Literature Surveillance, Premarket Testing/ Device/Patient Registries Clinical Trials Device Performance Monitoring Post-Approval Studies Returned Product Analysis Manufacturer Sponsored Autopsy Program Hospital Studies Emergency Treatment Funds/ Product Labeling Interim Compensation Establishment Inspections Product Liability Problem Reporting Program Alternative Compensation Mandatory Hospital Reporting Mechanisms Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.