Development of a portable closed-loop atracurium infusion system: systems methodology and safety issues.

Safety of closed-loop drug infusion systems is an issue often raised as a matter of concern. As a result, many closed-loop control systems are reported in the literature merely as computer simulation studies and few ever reach the stage of physical realisation and formal clinical evaluation. We address the safety issues involved with such systems by describing the development of a portable closed-loop control system for atracurium-induced muscle relaxation. This is a safety-critical system particularly when applied to brain and eye surgery where movement could have serious deleterious effects. The benefits of closed-loop muscle relaxation in providing stable surgical operating conditions over a wide range of patient sensitivities while infusing the minimum amount of drug makes this a worthwhile aim and serves to demonstrate safety issues which are generally applicable to other closed-loop drug infusion systems. It is hoped that the described methodology will facilitate and encourage the clinical application of closed-loop drug infusion systems so that clinical staff and patients may receive the benefits of closed-loop drug therapy.