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David H. Darnel, B.S.E., M.S., CCE, J.D.

Licenses	Admitted to the Bars of New York and District of Columbia
Certification	Certified Clinical Engineer International Certification Commission, since 1983 Healthcare Technology Certification Commission 2004
Consulting	Medical Product Liability / Patient Injury Investigations
Hospital Experience	Stony Brook University Hospital SUNY at Stony Brook, Stony Brook, NY Director Biomedical Engineering Department, since 1980
	Downstate Medical Center SUNY at Brooklyn, Brooklyn, NY Biomedical Engineer, 1979, 1980
Teaching Experience	Graduate School of Engineering SUNY at Stony Brook, Stony Brook, NY Adjunct Professor Technology and Society Department 1989-2002
Education	Duke University, Durham, NC School of Engineering B.S.E. Biomedical Engineering, 1979 State University of NY at Stony Brook Stony Brook, NY College of Engineering M.S. Technology Systems Management, 1987
	Touro College, Huntington, NY Jacob D. Fuchsberg Law Center J.D., 1995
Peer Review	ECRI, Plymouth Meeting, PA Clinical Reviewer for Health Device Alerts since 2003 AAMI Co-chair, Medical Device Investigation Session, 2001 Invited Speaker, Accident Investigation Session, 2000 Midwest Biomedical Engineering Society Invited Speaker, Device Risk Management, 2003 Graduate School of Engineering University of Connecticut, Torrs, CT Invited Lecturer Biomedical Engineering Program 2001-2003
Experience – Clinical Engineering Director, Hospital Biomedical Engineering Stony Brook University Hospital, SUNY at Stony Brook •  Investigate medical device incidents for hospital's              risk management and legal counsel. •  Responsible for Quality Assurance and Patient              Safety of medical devices and health              care products. •  Supervise department of 20 biomedical engineers              and technicians in a 500 bed teaching hospital. •  Develop and install documentation systems on IBM              mainframe, PC's, and Networks. •  Produce and deliver ongoing training program on              medical device safety for hospital staff. •  Coordinate hospital product recalls and reporting of              technology safety issues to regulatory agencies:              FDA, OSHA, JCAHO, NY State Health              Department. Biomedical Engineer, Scientific and Medical Instrumentation Center SUNY at Brooklyn, New York •  Tested medical devices before hospital acceptance              and at scheduled intervals. •  Developed technical procedures to test medical              devices for safety and performance. •  Assisted medical and nursing staff with proper use              of medical equipment. Honors: Commendation at NY State Health Department /JCAHO accreditation reviews 2003, 2000, 1997, 1994, 1991, 1989 FDA Regulations -Established SUNY University Hospital program in 1996 for FDA Safe Medical Device Act Designed and implemented first application of Bar Codes on Hospital Mainframe/PC System "IBM Hospital Visitors Program" Sept. 12, 1985 p.6. "IBM Quarterly" Dec. 12, 1985 p.33. Specialized Training - Clinical Engineering American College of Clinical Engineering (ACCE) Association for the Advancement of Medical Instrumentation (AAMI) ECRI (formerly the Emergency Care Research Institute) Joint Commission for the accreditation of Healthcare Organizations and Joint Commission Resources (JCAHO) 2005: Engineering • Clinical Alarms, JCAHO • Infusion Devices, JCAHO • Medical Device User Error, AAMI Risk Management • Hospital Standards 2005, JCAHO • National Patient Safety Goals, JCAHO • Risk Management Update, AAMI 2004: Engineering • Clinical Engineering Management, ECRI • Environment of Care Standards, JCAHO Risk Management • Medical Equipment Risk Management, AAMI 2003: Engineering • Clinical Engineering for Patient Safety, AAMI • Implantable Replacement Heart, AAMI • Nanotechnology for Clinical Engineers, AAMI • Surgical Fires, ECRI • Surgical Robots, AAMI • Wireless Hospitals, AAMI Risk Management • Clinical Alarm Management for Patient Safety, AAMI • Clinical Alarm Safety, ECRI • Regulatory Compliance 2003 Standards, JCAHO • Training Users to Identify Product Problems, AAMI 2002: Engineering • Clinical Engineering Management, AAMI • Information Technology for Biomedical Engineers, AAMI Risk Management • Regulatory Affairs, AAMI • Risk Management Update, AAMI 2001: Engineering • Technology Operations and Support for Electromagnetic Spectrum, AAMI Risk Management • Systems approach to Error Reduction, AAMI 2000: Engineering • Hazard Analysis, AAMI Risk Management • Managing the Risks of Homecare Equipment, AAMI • Medical Device Use and Risk Management, AAMI • Root Cause Analysis of Device-Related Adverse Events • JCAHO Safety Management Plans, AAMI 1999: Technical Service • Contingency Planning for Y2K, AAMI • Ultrasound Imaging Service, AAMI Risk Management • Accident Investigations, AAMI • Accident Case Studies, AAMI • Operator Related Errors, AAMI Human Factors and Usability Engineering • Managing Electromagnetic Interference and Medical Devices, AAMI 1998: Technical Service • Draeger Anesthesia Machines, AAMI • Electrosurgical Units, AAMI • Laparoscopes, AAMI Risk Management • Accident Investigations, Health Tech • Equipment Control Programs, Health Tech • FDA Reporting Regulations • Incident Investigation, AAMI Recent Investigations – summary available upon request

Hospital
Based
Practice

Hands-on
Biomedical
Engineer

Exclusively
Medical
Devices

International
Certification
as Clinical
Engineer

First CCE/JD