A model for technology assessment as applied to closed loop infusion systems

Abstract

Closed loop infusion systems may have a role in critical care practice. However, for most applications, further development is required to move this technology from the innovation phase to the point where it can be evaluated so that its role in critical car practice can be defined. Each application of closed loop infusion systems must be independently validated by appropriately designed research studies. Users should be provided with the clinical parameters driving each closed loop system so that they can ensure that it agrees with their opinion of acceptable medical practice. Clinical researchers and leaders in industry should collaborate to perform the scientifically valid, outcome-based research that is necessary to evaluate the effect of this new technology. The original model we developed for technology assessment required the addition of several more questions to produce a complete analysis of an emerging technology. An emerging technology should be systematically assessed (using a model such as the model developed by the Society of Critical Care Medicine), before its introduction into clinical practice in order to provide a focus for human outcome validation trials and to minimize the possibility of widespread use of an unproven technology.

The Ethics of Rationing of Critical Care Services: Should Technology Assessment Play a Role?

“…In particular, working with industry in a constructive fashion to make improvements can be done without any “conflicts of interest.” Feedback to the clinician at the bedside is important. The Society of Critical Care Medicine has suggested a closed-loop type of system [25] in which information could be provided to the clinician on outcomes of trials before implementation of the technology.…”

Control aspects of clinical support systems

“…Currently and in the past, many researchers have designed automatic closedloop controllers; see Katona (1982), Linkens andHacisalihzade (1990), O'Hara et al (1992), Isaka and Sebald (1993) and Jastremski et al (1995) for a review. Most control designs that have been tested clinically mainly concerned postoperative systemic hypertension in cardiac surgical patients.…”