Standards of evidence for the safety and effectiveness of critical care monitoring devices and related interventions. Coalition for Critical Care Excellence: Consensus Conference on Physiologic Monitoring Devices.

OBJECTIVE: To devise alternatives to randomized, controlled, clinical trials that clinicians and research experts might find acceptable for approval of devices used in critical care medicine.

DATA SOURCES: The Coalition for Critical Care Excellence (Coalition) of the Society of Critical Care Medicine organized a consensus conference in which recognized critical care researchers gave testimony to a panel of experts regarding the process for testing and approval of monitoring devices.

DATA SELECTION: The expert panel used testimony from the presenters as the basis of discussions on the testing and approval process. Guiding principles and specific recommendations were made based on the testimony given.

MAIN RESULTS: The panel determined the main constituents of the medical device approval process to be the Food and Drug Administration (FDA), the research and clinical community, and the device manufacturers. Distinctions were made between monitoring and interventional device categories. This document addresses only monitoring devices. Potential alternatives to randomized, blinded, controlled study designs for device testing are: a) nonblinded, randomized, management protocol-driven study; b) crossover study (n-of-one design); c) cluster-randomization (randomized by care unit); d) case-matched controls; e) mixed design; f) on/off design (before-after); and g) historical controls.

CONCLUSIONS: The panel agreed on the following major recommendations: a) the FDA should accelerate publication of specific guidances for physiologic monitoring products with the assistance of the Coalition (priorities and content); b) more multidisciplinary research should be incorporated into new device studies; c) commonly accepted clinical tools may not need to be tested for clinical utility--these accepted tools should be identified by the Coalition; and d) an independent council of researchers and clinicians should make themselves available to serve as consultants to manufacturers regarding appropriate study design for the testing of devices.