Some current requirements under the FDA medical device regulations.

The Medical Device Amendments of 1976 define the increasingly important role of the FDA in the medical device manufacturer-user relationship. The new requirements imposed on the manufacturer, modifier and produce user must be implemented gradually. Guidance during this initial period is hard to come by, for many situations have not been clearly spelled out and tested. It is hoped that this article will shed some light on what has become an important legal and technical aspect of our profession.

A newly developed therapeutic surgical and cardiac intensive care monitor.

A computerized intensive care monitor patterned after a clinical system operating at the University of Alabama has been developed. The system, which has been operating in an intensive care unit since February 1973, is equipped with conventional bedside biomedical instrumentation, special-purpose devices, and keyboard/display terminals interfaced with a minicomputer. Measurement of vital parameters as well as the automatic infusion of blood controlled by the computer in a closed loop feedback mode is available. Communication with the computer via the bedside terminals permits the display and retrieval of clinical data, entry of blood gas measurements and pressure limits for blood infusion, the revision of measurement status, and the control of the computer in measuring cardiac output. The administration of blood and intravenous fluid may be achieved under computer or manual option.