Implementation of ST-segment criteria in clinical monitoring devices. Implications of criteria from field trials and the federal regulatory process.
Manufacturers are challenged with providing ST-segment monitoring devices in a timely manner that meet the needs of clinicians and that satisfy the purview of the Federal Drug Administration (FDA) Office of Device Evaluation. The initial challenge is to explain the intended use for the product; are clinicians using the monitoring device to view measured ST-segment values or are they attempting to detect ischemic changes? A device that has only been tested by the manufacturer for its accuracy in detecting ST level changes may only be used for that purpose. A "field trial" of several months at clinical sites is typically conducted to confirm the accuracy of the St-segment measurement and to validate the device's "ease of use." If the monitoring device is intended for detecting ischemic changes, it must be clinically tested to demonstrate this capability. A "clinical trial" to detect ischemic changes could start to approach the scope and time one might expect for the clinical testing of a drug. Alarming for an ST-segment level change provides a dilemma for manufacturers. The FDA has questioned the rationale for providing ST alarms. The question comes from the position that ST-segment level changes have a low positive predictive accuracy for detecting "ischemia" (implications: clinical trial, etc.) and that many ST-segment level changes are not clinically significant.(ABSTRACT TRUNCATED AT 250 WORDS)
Kotilainen
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PW
Hewlett-Packard Company, Andover, Massachusetts 01810-1099.
D018795:Device Approval; D004562:Electrocardiography / Q000706:statistics & numerical data; D006801:Humans; D008991:Monitoring, Physiologic / Q000706:statistics & numerical data; D017202:Myocardial Ischemia / Q000175:diagnosis; D014481:United States; D014486:United States Food and Drug Administration