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Regulatory Challenges Facing Closed‐Loop Anesthetic Drug Infusion Devices
Author(s) -
Manberg PJ,
Vozella CM,
Kelley SD
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.79
Subject(s) - anesthetic , drug , clinical pharmacology , closed loop , consistency (knowledge bases) , medicine , anesthesia , risk analysis (engineering) , pharmacology , business , intensive care medicine , computer science , engineering , control engineering , artificial intelligence
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. Clinical Pharmacology & Therapeutics (2008); 84 , 1, 166–169 doi: 10.1038/clpt.2008.79