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

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

2. Electronic Fetal Monitors 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? To monitor the heart rate of single or twin fetuses throughout labor and delivery. Nurses are primary users of this device. 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. It is used primarily by nurses to monitor the heart rate of single or twin fetuses throughout labor and delivery; however, the monitor is limited in evaluating fetal heart rate (FHR) because of possible signal loss due to fetal movement, misreading due to maternal movement, artifact mistaken for normal variability of FHR, 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.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. It is used primarily by nurses to monitor the heart rate of single or twin fetuses throughout labor and delivery; however, the monitor is limited in evaluating fetal heart rate (FHR) because of possible signal loss due to fetal movement, misreading due to maternal movement, artifact mistaken for normal variability of FHR, 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.

3. How Does Electronic Fetal Monitors Work? Transducers 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 paper Some monitors provide alarms for fetal heart rates outside of limits set on the device Fetal monitors provide both internal and external methods of monitoring single and twin fetuses. 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 that are outside of the limits that are set. Fetal monitors provide both internal and external methods of monitoring single and twin fetuses. 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 that are outside of the limits that are set.

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. A woman 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 usually picks up the maternal heart rate (MHR). If the MHR and FHR coincide, the monitor is not able to differentiate between the two. 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 and information on the cause of fetal death was not reported. A woman 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 usually picks up the maternal heart rate (MHR). If the MHR and FHR coincide, the monitor is not able to differentiate between the two. 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 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 Review and analysis of adverse events Adverse events reported to FDA are consistent with those reported in the literature: false FHR that masked a fetus is distress, stillbirths that resulted during maternal and fetal monitoring, delivery of an infant in distress without previous signs of distress on the monitor, presentation of MHR as FHR, inaccurate interpretation and recording of labor progress. Review and analysis of adverse events Adverse events reported to FDA are consistent with those reported in the literature: false FHR that masked a fetus is distress, stillbirths that resulted during maternal and fetal monitoring, delivery of an infant in distress without previous signs of distress on the monitor, presentation of MHR as FHR, inaccurate interpretation and recording of labor progress.

7. Review of the Literature Technical 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 Practice American 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 proceedings Review of the clinical and scientific literature: Technical Evaluations The Medical Devices Directorate (Northern Ireland) published an evaluation on cardiotocographs (CTGs) (another name for electronic fetal monitors), manufactured by two different firms in 1991 and 1993. Evaluation results; no agreed upon performance standards for CTGs, FHR switching to MHR during gross fetal movement or when optimum Doppler signal not located, difficulty interpreting recordings, and differentiating between FHR of twins when their heart rates were similar. The Medical Devices Agency�s March 1998 safety notice: Cardiotocograph (CTG) monitoring of foetus during labor. Models of CTG devices which do not include the facility of recording MHR have an increased potential for confusing MHR with that of the fetus. ECRI (a non-profit agency focused on healthcare technology and patient safety research) published a product comparison report on fetal monitors in February and May 1998. Problems reported; false FHR, masked fetal arrhythmias, presentation of MHR as FHR, and false FHR decelerations during uterine contraction.Review of the clinical and scientific literature: Technical Evaluations The Medical Devices Directorate (Northern Ireland) published an evaluation on cardiotocographs (CTGs) (another name for electronic fetal monitors), manufactured by two different firms in 1991 and 1993. Evaluation results; no agreed upon performance standards for CTGs, FHR switching to MHR during gross fetal movement or when optimum Doppler signal not located, difficulty interpreting recordings, and differentiating between FHR of twins when their heart rates were similar. The Medical Devices Agency�s March 1998 safety notice: Cardiotocograph (CTG) monitoring of foetus during labor. Models of CTG devices which do not include the facility of recording MHR have an increased potential for confusing MHR with that of the fetus. ECRI (a non-profit agency focused on healthcare technology and patient safety research) published a product comparison report on fetal monitors in February and May 1998. Problems reported; false FHR, masked fetal arrhythmias, presentation of MHR as FHR, and false FHR decelerations during uterine contraction.

8. Discussions with Users & Industry Discussions with the Chair of the National Institutes of Child Health and Human Development Workshop Discussions with Industry Published article in peer-reviewed clinical nursing journal Discussions with the Chair of the National Institutes of Child Health and Human Development Workshop-Electronic Fetal Heart Rate Monitoring: Research Guidelines for Interpretation (1995). Workshop members agreed on definitions related to fetal monitors; however, they were not able to agree on management guidelines for fetal monitors. Discussions with industry: manufacturer follow-up explained the reported events were caused by inexperienced users or devices not used as labeled. In some events user facilities quarantined or discarded the device, which prevented manufacturers from conducting device failure analysis. Article to alert users to fetal deaths: Swayze, S. C. (1998, January). Electronic Fetal Monitors: Are you monitoring mother or fetus? Nursing 98, 28 (1):120. Discussions with the Chair of the National Institutes of Child Health and Human Development Workshop-Electronic Fetal Heart Rate Monitoring: Research Guidelines for Interpretation (1995). Workshop members agreed on definitions related to fetal monitors; however, they were not able to agree on management guidelines for fetal monitors. Discussions with industry: manufacturer follow-up explained the reported events were caused by inexperienced users or devices not used as labeled. In some events user facilities quarantined or discarded the device, which prevented manufacturers from conducting device failure analysis. Article to alert users to fetal deaths: Swayze, S. C. (1998, January). Electronic Fetal Monitors: Are you monitoring mother or fetus? Nursing 98, 28 (1):120.

9. FDA Systematic Technology Assessment of Medical Products Workgroup (STAMP) Convened to address fetal deaths and injuries associated with electronic fetal monitors Multidisciplinary committee members Specialized expertise laboratory (electronics and materials) science, human factors science, clinical (nursing and medicine) The CDRH Electronic Fetal Monitor Systematic Technology Assessment of Medical Products (STAMP) Committee convened to address the fetal deaths and injuries associated with electronic fetal monitors (EFMs). We reviewed adverse events, device labeling and the literature, and talked with users. During our discussions we recognized that we needed more information to better understand use of the device. Since nurses are the primary users of EFMs, we met with AWHONN to discuss our concerns and reviewed their educational and training materials, designed for labor and delivery nurses and includes information on clinical competencies, educational guides, and skills necessary for FHR monitoring. Although a section on instrumentation is included in the training materials, we offered recommendations on instrumentation and suggested AWHONN include them in their educational and training materials to help practitioners use EFMs more safely and effectively. AWHONN published the recommendations in their July 2000 edition of the Beat Goes On, a quarterly newsletter sent to AWHONN�s Principle and Practice Instructors. The CDRH Electronic Fetal Monitor Systematic Technology Assessment of Medical Products (STAMP) Committee convened to address the fetal deaths and injuries associated with electronic fetal monitors (EFMs). We reviewed adverse events, device labeling and the literature, and talked with users. During our discussions we recognized that we needed more information to better understand use of the device. Since nurses are the primary users of EFMs, we met with AWHONN to discuss our concerns and reviewed their educational and training materials, designed for labor and delivery nurses and includes information on clinical competencies, educational guides, and skills necessary for FHR monitoring. Although a section on instrumentation is included in the training materials, we offered recommendations on instrumentation and suggested AWHONN include them in their educational and training materials to help practitioners use EFMs more safely and effectively. AWHONN published the recommendations in their July 2000 edition of the Beat Goes On, a quarterly newsletter sent to AWHONN�s Principle and Practice Instructors.

10. STAMP Workgroup Recommendations to AWHONN 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. Review how to verify the integrity of monitor cables. 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. 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 practitioners Monitor substituted for direct care Belief that an alarm will alert user to deteriorating patient condition To summarize, adverse event problems associated with electronic fetal monitors most often represent opportunities for use error associated with the following factors: Over-dependence on the monitor Monitor substituted for direct care Belief that an alarm will alert user to deteriorating patient conditionTo summarize, adverse event problems associated with electronic fetal monitors most often represent opportunities for use error associated with the following factors: Over-dependence on the monitor Monitor substituted for direct care Belief that an alarm will alert user to deteriorating patient condition

12. Limitations Signal loss due to fetal movement Misreading due to maternal movement Recording maternal heart rate vs. fetal heart rate Artifact mistaken for normal variability of fetal heart rate can conceal fetal status Only one fetal heartbeat can be heard on the loudspeaker at any time The limitations of electronic fetal monitors need to be recognized and acknowledged by users: Signal loss due to fetal movement Misreading due to maternal movement Recording MHR instead of FHR Artifact mistaken for normal variability of FHR can conceal fetal status Only one fetal heartbeat can be heard on the loudspeaker at any timeThe limitations of electronic fetal monitors need to be recognized and acknowledged by users: Signal loss due to fetal movement Misreading due to maternal movement Recording MHR instead of FHR Artifact mistaken for normal variability of FHR can conceal fetal status Only 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