1. Electronic Fetal Monitors Case Study Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

2. Electronic Fetal Monitors What is it?What is it? A microprocessor based medical device that utilizes ultrasound transducers to measure and translate signals from a fetal heart. What is it used for?What is it used for? To monitor the heart rate of single or twin fetuses throughout labor and delivery. Nurses are primary users of this device.

3. How Does Electronic Fetal Monitors Work? Transducers are placed on the maternal abdomen and connected by cables to a monitorTransducers are placed on the maternal abdomen and connected by cables to a monitor Fetal heart rate data, translated from the transducer, is displayed on a monitor. This information is recorded on a strip of graph paperFetal heart rate data, translated from the transducer, is displayed on a monitor. This information is recorded on a strip of graph paper Some monitors provide alarms for fetal heart rates outside of limits set on the deviceSome monitors provide alarms for fetal heart rates outside of limits set on the device

4. Electronic Fetal Monitors Case Description A woman was about to deliver twins. Her nurse reported that an external and internal fetal monitor recorded two normal baseline heart rates. Subsequently, during a forceps delivery, it was discovered the first twin had died before birth (in utero). If a twin dies in utero, the monitor usually picks up the maternal heart rate. In this case, instead of the monitor recording both twins’ heart rates, the monitor picked up the mother’s and second twin’s heart rates. The second twin was delivered successfully. No technical failure of the monitor was identified following the event and information on the cause of fetal death was not reported.

5. Electronic Fetal Monitoring FDA Actions –Review and analysis of reported adverse events –Review of literature –Discussions with the Chair of the National Institutes of Child Health and Human Development Workshop –Discussions with Industry –Publish article in peer-reviewed clinical nursing journal –FDA Systematic Technology Assessment of Medical Products Workgroup

6. Review and analysis of reported adverse events associated with electronic fetal monitors

7. Review of the Literature Technical EvaluationsTechnical Evaluations –The Medical Devices Directorate (Northern Ireland) –The Medical Devices Agency (England) –ECRI product comparison report Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) educational program: Fetal Heart Rate Monitor Principles and PracticeAssociation of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) educational program: Fetal Heart Rate Monitor Principles and Practice American College of Obstetrics and Gynecology technical bulletin: Fetal Heart Rate Patterns: monitoring, interpretation, and managementAmerican College of Obstetrics and Gynecology technical bulletin: Fetal Heart Rate Patterns: monitoring, interpretation, and management International Federation of Gynecology and Obstetrics Committee on Intra-partum Surveillance proceedingsInternational Federation of Gynecology and Obstetrics Committee on Intra-partum Surveillance proceedings

8. Discussions with Users & Industry Discussions with the Chair of the National Institutes of Child Health and Human Development WorkshopDiscussions with the Chair of the National Institutes of Child Health and Human Development Workshop Discussions with IndustryDiscussions with Industry Published article in peer-reviewed clinical nursing journalPublished article in peer-reviewed clinical nursing journal

9. FDA Systematic Technology Assessment of Medical Products Workgroup (STAMP) –Convened to address fetal deaths and injuries associated with electronic fetal monitors Multidisciplinary committee membersMultidisciplinary committee members Specialized expertiseSpecialized expertise –laboratory (electronics and materials) science, –human factors science, –clinical (nursing and medicine)

10. STAMP Workgroup Recommendations to AWHONN Emphasize the importance of nurses learning how to operate monitors found in their own work setting.Emphasize the importance of nurses learning how to operate monitors found in their own work setting. Discuss adjusting monitor displays to minimize problems in viewing data.Discuss adjusting monitor displays to minimize problems in viewing data. Review how to verify the integrity of monitor cables.Review how to verify the integrity of monitor cables. Remind nurses its’ imperative they check the patient and monitor when alarms sound.Remind nurses its’ imperative they check the patient and monitor when alarms sound. Whenever a monitor doesn’t work as expected, follow the adverse event reporting policy for your institution. You can also submit a voluntary report to FDA’s Medwatch Program at 800- FDA-1088 or on the Internet at www.fda.gov/medwatch/report/hcp.htm.Whenever a monitor doesn’t work as expected, follow the adverse event reporting policy for your institution. You can also submit a voluntary report to FDA’s Medwatch Program at 800- FDA-1088 or on the Internet at www.fda.gov/medwatch/report/hcp.htm. www.fda.gov/medwatch/report/hcp.htm Talk to representatives from fetal monitoring companies, and request that they provide user friendly laminated or pullout cards with a capsule version of the operating manual attached to the front of the monitor.Talk to representatives from fetal monitoring companies, and request that they provide user friendly laminated or pullout cards with a capsule version of the operating manual attached to the front of the monitor.

11. Opportunities for Use Error Over-dependence on the monitor by healthcare practitionersOver-dependence on the monitor by healthcare practitioners Monitor substituted for direct careMonitor substituted for direct care Belief that an alarm will alert user to deteriorating patient conditionBelief that an alarm will alert user to deteriorating patient condition

12. Limitations Signal loss due to fetal movementSignal loss due to fetal movement Misreading due to maternal movementMisreading due to maternal movement Recording maternal heart rate vs. fetal heart rateRecording maternal heart rate vs. fetal heart rate Artifact mistaken for normal variability of fetal heart rate can conceal fetal statusArtifact mistaken for normal variability of fetal heart rate can conceal fetal status Only one fetal heartbeat can be heard on the loudspeaker at any timeOnly one fetal heartbeat can be heard on the loudspeaker at any time

13. Conclusion Nursing practice and literature on electronic fetal monitor use emphasize that monitoring should not replace a complete nursing assessment since the monitor may not detect and record fetal heart rates