David Eric Lees, M.D. a Director of the Anesthesia Patient Safety Foundation, was recently honored with an appointment as a member of the Anesthesiology and Respiratory Therapy Devices Panel of the Food and Drug Administration. The Panel consists of seven members serving four-year terms. Members are chosen from recognized authorities in clinical medicine, engineering, and related professions.
This panel reviews and evaluates available information concerning the safety and effectiveness of anesthesiology and respiratory therapy devices. Presently medical devices are classified into one of three regulatory categories: Class I where only general controls are necessary, such as good manufacturing Practices, Class 11 where performance standards are necessary, and Class III where premarketing approval is required before a device is released on the market. The Panel also advises the Commissioner of the MA regarding the recommended classification of a new device and the priority for the application of regulatory requirements in Class 11 (Standards) or III devices (Premarket Approval). In addition, the Panel advises on any possible health risks associated with the use of a device and the possible necessity to ban a device. The Panel also responds to requests from the MA to review and make recommendations on specific issues or problems concerning the saw and effectiveness of various devices.
Dr. Lees has been a member and Director of the APSF since its inception in 1985. He also serves as Chairman of the Committee on Equipment and Standards of the ASA. Dr. Lees is Professor and Chairman of the Department of Anesthesiology at the New York Medical College and serves as the Medical Director of the Westchester County Medical Center.