Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue

Abstract

Abstract Background Maternal heart rate artefact is a signal processing error whereby the fetal heart rate is masked by the maternal pulse, potentially leading to danger by failure to recognize an abnormal fetal heart rate or a pre-existing fetal death. Maternal heart rate artefact may be exacerbated by autocorrelation algorithms in modern fetal monitors due to smooth transitions between maternal and fetal heart rates rather than breaks in the tracing. In response, manufacturers of cardiotocography monitors recommend verifying fetal life prior to monitoring and have developed safeguards including signal ambiguity detection technologies to simultaneously and continuously monitor the maternal and fetal heart rates. However, these safeguards are not emphasized in current cardiotocography clinical practice guidelines, potentially leading to a patient safety gap. Methods The United States Food and Drug Administration Manufacturer and User Facility Device Experience database was reviewed for records with event type “Death” for the time period March 31, 2009 to March 31, 2019, in combination with search terms selected to capture all cases reported involving cardiotocography devices. Records were reviewed to determine whether maternal heart rate artefact was probable and/or whether the report contained a recommendation from the device manufacturer regarding maternal heart rate artefact. Results Forty-seven cases of perinatal mortality were identified with probable maternal heart rate artefact including 14 with antepartum fetal death prior to initiation of cardiotocography, 14 with intrapartum fetal death or neonatal death after initiation of cardiotocography, and 19 where the temporal relationship between initiation of cardiotocography and death cannot be definitively established from the report. In 29 cases, there was a recommendation from the manufacturer regarding diagnosis and/or management of maternal heart rate artefact. Conclusions This case series indicates a recurring problem with undetected maternal heart rate artefact leading to perinatal mortality and, in cases of pre-existing fetal death, healthcare provider confusion. In response, manufacturers frequently recommend safeguards which are found in their device’s instructions for use but not in major intrapartum cardiotocography guidelines. Cardiotocography guidelines should be updated to include the latest safeguards against the risks of maternal heart rate artefact. An additional file summarizing key points for clinicians is included.

Keywords

• Fetal heart rate
• Cardiotocography
• Perinatal death
• Stillbirth
• Brain hypoxia-ischemia
• Product recalls and withdrawals