Regulatory challenges facing closed-loop anesthetic drug infusion devices.
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.
Manberg
P J
PJ
Aspect Medical Systems, Norwood, Massachusetts, USA. pmanberg@aspectms.com
Vozella
C M
CM
Kelley
S D
SD
D000764:Anesthesia, Closed-Circuit / Q000295:instrumentation / Q000379:methods*; D000777:Anesthetics / Q000008:administration & dosage*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007260:Infusion Pumps; D014481:United States
D000777:Anesthetics