Safety considerations in intravenous infusion devices: the IVAC approach

The safety-related circuits and characteristics of IVAC Models 260 and 560 are reviewed, with a discussion of how basic safety and reliability philosophies have been incorporated into the design of these instruments. The uses of IV fluid delivery instruments have expanded from traditional fluid replacement to nutritional, electrolyte, and potent cardiovascular drug therapy, creating the need for and forcing the development of safer and more reliable IV instruments. Standards organizations and regulatory agencies, such as AAMI and Germany's TUV, are implementing more exacting standards for new IV instruments. New designs must begin with a basic safety philosophy and then integrate that philosophy into hardware and software. Critical design areas include flow control mechanism, flow detection, microprocessor failsafe, battery operation, user interface, and software tests of the instrument and the microprocessor itself.