Public Policy
Clinical Pharmacology & Therapeutics (2008); 84, 1, 166–169 doi:10.1038/clpt.2008.79
Regulatory Challenges Facing Closed-Loop Anesthetic Drug Infusion Devices
PJ Manberg1, CM Vozella1 and SD Kelley1
1Aspect Medical Systems, Norwood, Massachusetts, USA
Correspondence: PJ Manberg, (pmanberg@aspectms.com)
Received 29 February 2008; Accepted 11 March 2008; Published online 7 May 2008.
Abstract
Closed-loop anesthetic drug infusion devices show great promise for improving the consistency and safety of general anesthesia. Despite the numerous reports demonstrating the feasibility and potential advantages of these systems in a research setting, a wide range of regulatory, business, and clinical issues will need to be resolved before a closed-loop anesthesia delivery product can be successfully introduced into the market and incorporated into general practice.
