Clinical Engineering Handbook

Contributors xiii Introduction xvii Section I Clinical Engineering 1(2) Introduction Raymond P. Zambuto Clinical Engineering: Evolution of a Discipline 3(4) Joseph D. Bronzino History of Engineering and Technology in Health Care 7(4) Malcolm G. Ridgway George I. Johnston Joseph P. McClain The Health Care Environment 11(3) Lee O. Welter Enhancing Patient Safety: The Role of Clinical Engineering 14(2) A Model Clinical Engineering Department 16(2) Caroline A. Campbell Clinical Engineering in an Academic Medical Center 18(8) Ira Soller Regional Clinical Engineering Shared Services and Cooperatives 26(2) J. Tobey Clark Nationwide Clinical Engineering System 28(6) Diego Bravar Teresa dell' Aquila Clinical Engineering and Biomedical Maintenance in the United States Military 34(2) Joseph P. McClain Careers, Roles, and Responsibilities 36(3) Nicholas Cram Clinical Engineering at the Bedside 39(2) Saul Miodownik The Clinical Engineer as Consultant 41(2) J. Sam Miller The Clinical Engineer as Investigator and Expert Witness 43(6) Jerome T. Anderson Careers in Facilities 49(4) Bruce Hyndman Section II Worldwide Clinical Engineering Practice Introduction 51(2) Enrico Nunziata World Clinical Engineering Survey 53(5) Mariana Glouhova Nicolas Pallikarakis Clinical Engineering in the United Kingdom 58(4) Stuart J. Meldrum Clinical Engineering in Canada 62(3) William M. Gentles Clinical Engineering in Estonia 65(2) Siim Aid Ole Golubjatnikov Clinical Engineering in Germany 67(2) Vera Dammann Clinical Engineering in Brazil 69(3) Lucio Flavio de Magalhaes Brito Clinical Engineering in Colombia 72(6) Jorge Enrique Villamil Gutierrez Clinical Engineering in Ecuador 78(2) Juan Gomez Clinical Engineering in Mexico 80(4) Adriana Velasquez Clinical Engineering in Paraguay 84(3) Pedro Galvan Clinical Engineering in Peru 87(2) Luis Vilcahuaman Javier Brandan Clinical Engineering in Venezuela 89(2) Ricardo Silva Luis Lara-Estrella Clinical Engineering in Japan 91(2) Hiroshi Kanai Clinical Engineering in Mozambique 93(4) Enrico Nunziata Momade Sumalgy Clinical Engineering in the Middle East 97(4) Hashem O. Al-Fadel Section III Health Technology Management Introduction 99(2) Thomas M. Judd Introduction to Medical Technology Management Practices 101(7) Yadin David Thomas M. Judd Raymond P. Zambuto Good Management Practice for Medical Equipment 108(2) Michael Cheng Joseph F. Dyro Health Care Strategic Planning Utilizing Technology Assessment 110(4) Nicholas Cram Technology Evaluation 114(4) Gary H. Harding Alice L. Epstein Technology Procurement 118(4) Gary H. Harding Alice L. Epstein Equipment Control and Asset Management 122(2) Matthew F. Baretich Computerized Maintenance Management Systems 124(6) Ted Cohen Nicholas Cram Maintenance and Repair of Medical Devices 130(3) James McCauley A Strategy to Maintain Essential Medical Equipment in Developing Countries 133(2) Michael Cheng Outsourcing Clinical Engineering Service 135(2) Peter Smithson David Dickey New Strategic Directions in Acquiring and Outsourcing High-Tech Services by Hospitals and Implications for Clinical Engineering Organizations and ISOs 137(10) Donald F. Blumberg Vendor and Service Management 147(6) Joseph F. Dyro Health Care Technology Replacement Planning 153(2) J. Tobey Clark Donation of Medical Device Technologies 155(4) Joseph F. Dyro National Health Technology Policy 159(4) Thomas M. Judd The Essential Health Care Technology Package 163(8) Peter Heimann Andrei Issakov S. Yunkap Kwankam Impact Analysis 171(10) Thomas M. Judd Section IV Management Introduction 179(2) Alfred M. Dolan Industrial/Management Engineering in Healthcare 181(7) George Seaman Financial Management of Clinical Engineering Services 188(11) Binseng Wang Cost-Effectiveness and Productivity 199(3) Larry Fennigkoh Clinical Engineering Program Indicators 202(4) Dennis Autio Personnel Management 206(6) James O. Wear Skills Identification 212(1) Nicholas Cram Management Styles and Human Resource Development 213(6) Alice L. Epstein Gary H. Harding Quality 219(8) Thomas M. Judd Section V Safety Introduction 225(2) Marvin Shepherd Patient Safety and the Clinical Engineer 227(8) Bryanne Patail Risk Management 235(6) Alice L. Epstein Gary H. Harding Patient Safety Best Practices Model 241(2) Paul Vegoda Carl Abramson Hospital Safety Programs 243(3) Matthew F. Baretich Systems Approach to Medical Device Safety 246(3) Marvin Shepherd Interactions Between Medical Devices 249(2) Saul Miodownik Single Use Injection Devices 251(3) Michael Cheng Electromagnetic Interference with Medical Devices: In Vitro Laboratory Studies and Electromagnetic Compatibility Standards 254(9) Kok-Swang Tan Irwin Hinberg Electromagnetic Interference in the Hospital 263(6) W. David Paperman Yadin David James Hibbetts Accident Investigation 269(12) Joseph F. Dyro The Great Debate on Electrical Safety---In Retrospect 281(6) Malcolm G. Ridgway Section VI Education and Training Introduction 285(2) James O. Wear Academic Programs in North America 287(7) Tim Baker Clinical Engineering Education in Germany 294(3) Vera Dammann Clinical Engineering Internship 297(2) Izabella A. Gieras Frank R. Painter Biomedical Engineering Technology Program 299(2) Bruce J. Morgan Advanced Clinical Engineering Workshops 301(4) Joseph F. Dyro Thomas M. Judd James O. Wear Advanced Health Technology Management Workshop 305(4) Thomas M. Judd Joseph F. Dyro James O. Wear Distance Education 309(3) James O. Wear Alan Levenson Emerging Technologies: Internet and Interactive Video conferencing 312(3) Albert Lozano-Nieto In-Service Education 315(2) James O. Wear Technical Service Schools 317(4) Manny Roman Clinical Engineering and Nursing 321(7) Thomas J. Bauld III Joseph F. Dyro Stephen L. Grimes Retraining Programs 328(4) James Gilchriest Techno-Bio-Psycho-Socio-Medical Approach to Health Care 332(7) T. G. Krishnamurthy Section VII Medical Devices: Design, Manufacturing, Evaluation, and Control Introduction 337(2) Gary H. Harding Alice L. Epstein Evolution of Medical Device Technology 339(3) Nandor Richter Technology in Health Care 342(4) Jonathan A. Gaev Medical Device Design and Control in the Hospital 346(4) Joel R. Canlas Jay W. Hall Pam Shuck-Holmes Medical Device Research and Design 350(3) P. Ake Oberg Human Factors: Environment 353(2) William A. Hyman Valory Wangler Medical Devices: Failure Modes, Accidents, and Liability 355(4) Leslie A. Geddes Medical Device Software Development 359(7) Richard C. Fries Andre E. Bloesch Comparative Evaluations of Medical Devices 366(3) James P. Keller Evaluating Investigational Devices for Institutional Review Boards 369(4) Salil D. Balar Section VIII Medical Devices: Utilization and Service Introduction 371(2) Joseph F. Dyro Intensive Care 373(3) Saul Miodownik Operating Room 376(8) Chad J. Smith Raj Rane Luis Melendez Anesthesiology 384(8) Luis Melendez Raj Rane Imaging Devices 392(9) David Harrington Machine Vision 401(9) Eric Rosow Melissa Burns Perinatology 410(7) Vinnie DeFrancesco Cardiovascular Techniques and Technology 417(4) Gerald Goodman General Hospital Devices: Beds, Stretchers, and Wheelchairs 421(15) Joseph F. Dyro Medical Device Troubleshooting 436(15) Joseph F. Dyro Robert L. Morris Section IX Information Introduction 449(2) Elliot B. Sloane Information Systems Management 451(5) Elliot B. Sloane Physiologic Monitoring and Clinical Information Systems 456(8) Sunder Subramanian Advanced Diagnostics and Artificial Intelligence 464(12) Donald F. Blumberg Real-Time Executive Dashboards and Virtual Instrumentation: Solutions for Health Care Systems 476(8) Eric Rosow Joseph Adam Telemedicine: Clinical and Operational Issues 484(3) Yadin David Picture Archiving and Communication Systems (PACS) 487(5) Ted Cohen Wireless Medical Telemetry: Addressing the Interference Issue and the New Wireless Medical Telemetry Service (WMTS) 492(6) Donald Witters Caroline A. Campbell Health Insurance Portability and Accountability Act (HIPAA) and its Implications for Clinical Enginerring 498(8) Stephen L. Grimes Y2K and Clinical Engineering 506(3) Stephen L. Grimes The Integration and Convergence of Medical and Information Technologies 509(6) Ted Cohen Colleen Ward Section X Engineering the Clinical Environment Introduction 513(2) Matthew F. Baretich Physical Plant 515(2) Bruce Hyndman Heating, Ventilation, and Air Conditioning 517(3) Bruce Hyndman Electrical Power 520(2) Matthew F. Baretich Medical Gas Systems 522(3) William Frank Support Services 525(2) Nicholas Cram Construction and Renovation 527(2) Matthew F. Baretich Radiation Safety 529(3) Jadwiga (Jodi) Strzelczyk Sanitation 532(14) Lucio Flavio de Magalhaes Brito Douglas Magagna Water Systems in Health Care Facilities 546(3) Diogenes Hernandez Disaster Planning 549(8) Gary H. Harding Alice L. Epstein Section XI Medical Device Standards, Regulations, and the Law Introduction 555(2) David A. Simmons Primer on Standards and Regulations 557(2) Michael Cheng Medical Device Regulatory and Technology Assessment Agencies 559(6) Mark E. Bruley Vivian H. Coates Health Care Quality and ISO 9001:2000 565(3) David A. Simmons Hospital Facilities Safety Standards 568(2) Gerald Goodman JCAHO Accreditation 570(3) Britt Berek Medical Equipment Management Program and ANSI/AAMI EQ56 573(3) Ethan Hertz Clinical Engineering Standards of Practice for Canada 576(2) Tony Easty William M. Gentles Regulations and the Law 578(4) Michael Cheng European Union Medical Device Directives and Vigilance System 582(4) Nicolas Pallikarakis United States Food & Drug Administration 586(4) F. Blix Winston Tort Liability for Clinical Engineers and Device Manufacturers 590(5) Edward P. Richards, III Charles Walter Section XII Professionalism and Ethics Introduction 593(2) Gerald Goodman Professionalism 595(3) Gerald Goodman Clinical Engineering Advocacy 598(2) Thomas J. O'Dea American College of Clinical Engineering 600(10) Jennifer C. Ott Joseph F. Dyro The New England Society of Clinical Engineering 610(3) Nicholas T. Noyes New York City Metropolitan Area Clinical Engineering Directors Group 613(4) Ira Soller Michael B. Mirsky Clinical Engineering Certification in the United States 617(2) Thomas Nicoud Eben Kermit Clinical Engineering Certification in Germany 619(4) Vera Dammann Section XIII The Future Introduction 621(2) Jennifer C. Ott The Future of Clinical Engineering: The Challenge of Change 623(4) Stephen L. Grimes Virtual Instrumentation---Applications to Health Care 627(17) Eric Rosow Clinical Engineers in Non-Traditional Roles 644(2) Eben Kermit Clinical Support: The Forgotten Function 646(1) Stan Scahill Postmarket Surveillance and Vigilance on Medical Devices 647(2) Michael Cheng Small Business Development: Business Plan Development Fundamentals for the Entrepreneur 649(3) Peter W. Dyro Engineering Primary Health Care: The Sickle Cell Business Case 652(3) Yancy Y. Phillips Thomas M. Judd Global Hospital in 2050---A Vision 655(6) Yasushi Nagasawa Edward Sivak Errki Vauramo Appendices 661(4) Index 665