A report today on RTE Morning Ireland announced that fetal monitoring in the Irish Maternity maternity services may have been unreliable and potentially unsafe since as far back as 2009.
Philips the manufacturer of the Avalon electronic festal monitoring units in question (Philips Avalon Fetal Monitors FM20, FM30, FM40, FM50), issued a safety alert in September 2009, followed by a field safety notice and product recall to the 11 maternity units using this equipment in November 2009. There were concerns raised that continued use could result in clinicians performing unnecessary interventions, such as cesarean delivery; clinicians failing to identify the need for interventions; or clinicians failing to identify fetal distress; all situations that could result in serious injury or death to the mother or fetus.
Problems included switching between the fetal and maternal heart rates; doubling of the fetal heart rate (FHR); halving of the FHR; a mismatch between audible and printed FHR; false decelerations; and erratic signals. Units were required to include additional instructions for all those using the equipment and were also required to respond to the manufacturer that the issues raised by Philips in the communique were understood, that they had been communicated to all staff and that appropriate measures had been taken in the continued use of the equipment as identified by Philips.We dont know if this was done.
Electronic Fetal monitoring is a routine intervention that women are expected to avail off in hospital settings. Whilst the Cochrane Review has never been able to find any evidence to support improved outcomes in mothers or babies (even high risk mothers and babies)w ho have EFM as opposed to those who have been intermittently monitored, it is still the standard policy in the majority of maternity units for all women irrespective of risk status.
Women have to opt out of this intervention if they do not wish to have it. Yet when women request, as per the evidence, to have internment Doppler monitoring they are quoted “hospital policy”, they are subject to coercive conversations, they are categorised as non compliant and most importantly, they are usually denied their “evidence based” choice. It now seems that once again it might be pertinent to listen to women and to “trust” them in the words of An Taoiseach
Concerns with fetal monitoring equipment have huge implications for those providing maternity care and for the confidence of those using maternity care.. If the monitoring of the baby and the mother are wrong then every decision that follows also has the potential to be wrong. In 2014, units were asked to check if the notices from Philips had been complied with. It appears that in some units this might not have been the case. This means that for the 11 hospitals affected, which we understand include all three large Dublin maternity hospitals Port Laoise, Cork and Limerick, readings could have prompted inappropriate care from before 2009 until now.
It is only now, in February 2018, that the HSE have put a Risk Assessment Committee in place to see if there were any adverse outcomes and whether these faulty devices are still being used in the 11 maternity units.
Speaking today AIMSI Chair Krysia Lynch said “The public need full accountability and transparency on this issue. We don’t know how many women who have gone through our maternity services may have been subject to incorrect or misinterpreted readings since 2009. Many of them may have had unnecessary intervention. Many of their babies may have also had unnecessary intervention, and in the worst possible scenario babies may even have died. People need to know. We still don’t know which the 11 hospitals in question are and this is causing concern and anxiety amongst service users”.”
Continuing Lynch said “This, in the same week that the National Maternity Hospital sought a court injunction to prevent an independent inquiry by HIQA into their actions leading to a maternal death in 2016. Is any aspect of our maternity services accountable?”
In conclusion Lynch stated “We also do not know the make up of the Risk Assessment Review Team, I wouldn’t be surprised if it didn’t include a service user, which it absolutely should, and also if it did include people who were directly responsible for knowingly continuing the inappropriate use of these fetal monitors. Self investigation is not uncommon in the Irish Maternity System, Neary taught us that.”