Value of fault/failure analysis in the medical device regulatory process: the case of the Bjork-Shiley heart valve

Allen A. Hughes; Henry R. Piehler

doi:10.1117/12.225319

27 October 1995 Value of fault/failure analysis in the medical device regulatory process: the case of the Bjork-Shiley heart valve

Allen A. Hughes, Henry R. Piehler

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Proceedings Volume 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions; (1995) https://doi.org/10.1117/12.225319
Event: Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, 1995, Arlington, VA, United States

Abstract

A framework of sixteen attributes has been developed for evaluating the effectiveness of the risk management system for FDA regulatory Class III medical devices. Fault/failure analysis was identified as a potentially cost-beneficial attribute. Mechanical heart valves are FDA regulatory Class III devices in that they are considered life-sustaining when working properly, but life-threatening in the event of failure. The benefit-cost difference (net benefit) has been suggested as a measure of effectiveness for individual attributes and defined as the value of averted patient morbidity and mortality. In this paper, the Bjork-Shiley 60 degree convexo- concave mechanical heart valve is subjected to a retrospective benefit-cost analysis for the fault/failure analysis attribute. A general finding is that fault/failure analysis would have been relatively inexpensive for enhancing the risk management system for the Bjork-Shiley heart valve -- less than $25,000 -- while having the potential to avert 151 mortalities. Even without placing a value-of-life figure on averted mortalities, fault/failure analysis would have been cost-beneficial in reducing the risk of morbidity from mechanical heart valve failure.

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Allen A. Hughes and Henry R. Piehler "Value of fault/failure analysis in the medical device regulatory process: the case of the Bjork-Shiley heart valve", Proc. SPIE 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, (27 October 1995); https://doi.org/10.1117/12.225319

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