Automation Technology and Human Performance: Current Research and Trends

By Mark W. Scerbo | Go to book overview
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TECHNOLOGY AND NURSING: ELECTRONIC FETAL MONITORS

Sonia C. Swayze

Center for Devices and Radiological Health, Food and Drug Administration

Fetal deaths associated with electronic fetal monitors have been reported to the Food and Drug Administration (FDA). The electronic fetal monitor is a microprocessor based medical device that uses ultrasound transducers to measure and translate signals from the fetal heart. The transducers are positioned on the maternal abdomen and/or thigh and connected by cables to a monitor. Fetal heart information translated from the transducer is displayed on the monitor panel and can be recorded and printed on a strip or trace. Some monitors provide alarm surveillance for fetal heart rates (FHR) that are outside of the limits set. The fetal monitor is used primarily by nurses to monitor the heart rate of single or twin fetuses throughout labor and delivery. The monitor is limited in evaluating FHR because of possible signal loss due to fetal movement, misreading due to maternal movement, and possible recording of maternal heart rate (MHR) instead of FHR. The fetal deaths reported to FDA involved single and twin fetuses and have raised concern about the monitor and whether it detects and records the FHR as it should.

One report involved a woman who was about to deliver twins. Her nurse reported that an external and internal fetal monitor recorded two normal baseline heart rates. During a forceps delivery, an external fetal monitor was used to monitor both twins. The first twin had died before birth (in utero) 48 hours earlier. When a twin dies in utero, the monitor automatically picks up the MHR. If the MHR and FHR coincide, the monitor is not able to differentiate between the two. There are other distinct limitations in detecting FHR: artifact may be mistaken for normal variability of the FHR and conceal a change in fetal status and with some monitors only one fetal heartbeat can be heard on the loudspeaker at any time. The channel monitoring the other fetal heartbeat for sound can only be accessed if the nurse presses a key. In this case, the nurse assumed the monitor was recording the twins' heart rates; however, it was apparently monitoring the mother's and the second twin's heart rate. The second twin was delivered alive and without incidence. No technical failure of the monitor was identified following the event.

Information on the cause of fetal death was not reported. Death may have been caused by lack of observation or misinterpretation of relevant information, or because the monitor failed to detect a change in the first twin's FHR. This underscores the importance of human monitoring technology. Nursing practice as well as literature on use of electronic fetal monitors emphasize, that monitoring should not replace a complete nursing assessment since the monitor may not detect and record the FHR.


PROBLEM IDENTIFICATION IN COMPLEX AUTOMATED MEDICAL SYSTEMS

Debbie Blum

Center for Devices and Radiological Health, Food and Drug Administration

Many of today's medical devices are "system" devices. They are comprised of multiple components and or accessories (devices) which must each work independently and feed into the system to result in one unified outcome. Understanding of the intended uses of the system are critical, but equally important is a knowledge and understanding of the mechanics of the system. Very often minicomputers are incorporated into the medical device system, such as those found in permanent implanted pacemakers. Also standard in automated medical device systems are various switches to permit the user to initiate new programming, override internal standard programming, turn off annoying warnings and alarms, and buttons to shut off everything at once. If the power supply fails, many systems, such as some IV pumps, even have battery backup to assure that the device will continue to function. Many complex systems, such as a fetal vacuum extractor, actually necessitate multiple persons be involved with the device system to assure proper and safe

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