Title: Regulatory Challenges Facing Closed-Loop Anesthetic Drug Infusion Devices
Abstract: Clinical Pharmacology & TherapeuticsVolume 84, Issue 1 p. 166-169 Public Policy Regulatory Challenges Facing Closed-Loop Anesthetic Drug Infusion Devices PJ Manberg, PJ Manberg [email protected] Aspect Medical Systems, Norwood, Massachusetts, USASearch for more papers by this authorCM Vozella, CM Vozella Aspect Medical Systems, Norwood, Massachusetts, USASearch for more papers by this authorSD Kelley, SD Kelley Aspect Medical Systems, Norwood, Massachusetts, USASearch for more papers by this author PJ Manberg, PJ Manberg [email protected] Aspect Medical Systems, Norwood, Massachusetts, USASearch for more papers by this authorCM Vozella, CM Vozella Aspect Medical Systems, Norwood, Massachusetts, USASearch for more papers by this authorSD Kelley, SD Kelley Aspect Medical Systems, Norwood, Massachusetts, USASearch for more papers by this author First published: 07 May 2008 https://doi.org/10.1038/clpt.2008.79Citations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat 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. Clinical Pharmacology & Therapeutics (2008); 84, 1, 166–169 doi:10.1038/clpt.2008.79 References 1Bazaral, M.G. & Ciarkowski, A. Food and Drug Administration regulations and computer-controlled infusion pumps. Int. Anesthesiol. Clin. 33, 45–63 (1995). 2Egan, T.D. Target-controlled drug delivery: progress toward an intravenous "vaporizer" and automated anesthetic administration. 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Medical Device Recalls Class 1 Recall Alaris Pump Module (formerly Medley Pump Module) Z-0460-2008 (Food and Drug Administration, Washington, DC, 2007). 22De Smet, T., Struys, M.M., Greenwald, S., Mortier, E.P. & Shafer, S.L. Estimation of optimal modeling weights for a Bayesian-based closed-loop system for propofol administration using the bispectral index as a controlled variable: a simulation study. Anesth Analg 105, 1629–1638 (2007). 23Nunes, C., Mendonca, T., Bras, S., Ferreira, D. & Amorim, P. Modeling anesthetic drugs' pharmacodynamic interaction on the bispectral index of the EEG: the influence of heart rate. Conf Proc IEEE Eng Med Biol Soc 2007, 6479–6482 (2007). 24Nunes, C., Mendonca, T., Lemos, J. & Amorim, P. Control of Depth of Anesthesia Using MUSMAR—Exploring Electromyography and the Analgesic Dose as Accessible Disturbances. Conf Proc IEEE Eng Med Biol Soc 2007, 1574–1577 (2007). 25Glass, P.S. & Rampil, I.J. Automated anesthesia: fact or fantasy? Anesthesiology 95, 1–2 (2001). Citing Literature Volume84, Issue1AnesthesiologyJuly 2008Pages 166-169 ReferencesRelatedInformation
Publication Year: 2008
Publication Date: 2008-05-07
Language: en
Type: review
Indexed In: ['crossref', 'pubmed']
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Cited By Count: 34
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