Safety of Electromedical Devices: Law - Risks - Opportunities - Softcover

Leitgeb, Norbert

Softcover

ISBN 10: 3211996826 ISBN 13: 9783211996829

Publisher: Springer, 2010

Synopsis

Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.

About this title

About the Author

Prof. Dipl.-Ing. Dr. Norbert Leitgeb is head of the Institute of Health Care Engineering at Graz University of Technology, Austria, and head of the European Notified Body of Medical Devices, PMG. His work areas comprise safety technology in regard to medical safety and patient's safety, biologic effects of non-ionising electromagnetic fields including field measurement and numerical dosimetry, risk assessment, risk perception and risk communication as well as analysis, development and assessment of new approaches for health care.

From the Back Cover

The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. It explains how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, the book describes which safety requirements are to be met and how they can be satisfied and tested.

Edition details

• Publisher: Springer
• Publication date: 2010
• Language: English
• ISBN 10: 3211996826
• ISBN 13: 9783211996829
• Binding: Paperback
• Number of pages: 244