FLUID DYNAMIC STUDIES FOR THE YEAR-2000

The authors recommend changes to the paradigm employed in the current ISO Heart Valve Standard (ISO 5840) so that future patients who receiv e a heart valve prosthesis are assured ob: a device that will function with minimal complications for at least 25 years. Based on valve fail ures of the past decade, ft is clear that current standards are inadeq uate because present-day Standards and Regulatory agencies operate in a manner which inhibits innovation and creativity. Thus, engineers and scientists in this field react to problems, rather than proact. As we approach the new millennium, the authors consider it time to rethink the ground rules.