|
|
October 17-21, 2009 New Orleans, LA Home Abstract Archive Search Abstracts 2009 Session Grid 2009 Meeting Website Policy Statements ASA Website Feedback 
Visit Anesthesiology.org |
| Previous Abstract | Next Abstract |
| Printable Version |
|
A984
October 20, 2008 9:00 AM - 11:00 AM Room Hall E2-Area D, |
| Development of a Standard for Physiologic Closed Loop Controllers in Medical Devices |
|
Carl Wallroth, Ph.D., Julian Goldman, M.D., Jürgen Manigel, Ph.D., Dave Osborn, M.E., Dwayne Westenskow, Ph.D. Dräger Medical AG&Co.KG, Lübeck, Germany |
|
Introduction: Since the FDA clearance of IVAC's sodium nitroprusside controller in 1988, closed loop controllers have been added to ventilators, airway humidifiers, incubators and arrhythmia detection algorithms. Controllers enhance the human operators capability, particularly when the operator is tired, distracted or under stress. Methods: The collateral standard IEC 60601-1-10 specifies the requirements for the development of physiologic closed-loop controllers. The final draft standard has been submitted for a parallel approval vote in ISO and IEC. Results: New risks that are not directly addressed by previous standards are emerging in the development of medical equipment. Classical methods of software validation for physiologic closed-loop controllers can be insufficient to ensure performance with acceptable risks under all clinical and physiologic conditions. This collateral standard establishes a common taxonomy for physiologic closed loop controllers. It brought in a fallback mode of operation, into which the control system transitions due to detection of a fault, as well as the term mental model, which is an operator's conceptual model of how the physiologic closed-loop system works.[figure1]Conclusions: This collateral standard specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop as part of a physiologic closed-loop system in medical equipment and medical systems to control a physiologic variable. Its main objective is to specify general requirements that are in addition to those of the general standard and to serve as the regulatory pathway for safe application of this technology to patients. Reference: Medical electrical equipment —Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers, Final Draft ISO/TC 121/SC 3 – IEC 62A International Standard IEC/FDIS 60601-1-10. Voting terminates on 12 Oct 07. Anesthesiology 2008; 109 A984 |
Figure 1
 |