Wednesday, 6 November 2013

A Matter of Public Interest - AIMSI calls on transparency & accountability following details into death of Bimbo Onanuga. Press Release: Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today, according to maternity advocacy group. AIMS Ireland calls for accountability and clinical review following verdict of misadventure as a matter of 'public interest'

Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today, according to maternity advocacy group

 

AIMS Ireland calls for accountability and clinical review following verdict of medical misadventure


Press Release:




(Tuesday, November 5, 2013) The Association for Improvements in the Maternity Services Ireland (AIMS Ireland) today petitioned for accountability, a review into clinical care practices, and national guidelines on the use of the drug misoprostol (cytotec) following the verdict of medical misadventure returned at the inquest into the death of Bimbo Onanuga at the Dublin Coroner’s Court today. Bimbo Onanuga's inquest has once again exposed underlying critical flaws in basic clinical care within an Irish maternity unit, echoing concerns raised following reports into the deaths of both Savita Halapanavar and Tania McCabe.

The HIQA report into the death of Savita Halapanavar published last month found ‘The most basic means of identifying any patient at risk of clinical deterioration is to observe the patient’s general condition and regularly monitor and track their clinical observations. This should be a basic component of caring for any patient.’ Abiola Adesina, Bimbo Onanuga’s partner, told the inquest yesterday that Bimbo was rolling around and in constant pain following admission to the Rotunda Hospital in March 2010 and that attempts to raise concerns were disregarded as a normal progression of labour. Bimbo, who had a number of risk factors in relation to the intrauterine foetal death, had received misprostol (cytotec) to induce labour.

Krysia Lynch, Co-Chair of AIMS Ireland, commented "The parallels between Savita, Tania, and now, Bimbo, are staggering. We see once again a catalogue of basic fundamental failures from a lack of documentation to basic clinical observations. Most crucially, we once again see a comprehensive failure by health care providers to listen to women. This is a reoccurring complaint from women contacting AIMS Ireland - they do not feel their concerns are acknowledged or listened to. In a critical medical event, this can be the difference between recovery or death."

On the issue of the use of the drug cytotec, Lynch added "Misoprostol has been linked to uterine rupture  in women with and without scarred uteri and is not recommended for use in induction. The Royal College of Physicians in Ireland (RCPI) guidelines on cytotec use sit outside those of the Royal College of Obstetricians and Gynaecologists (RCOG) in the UK, which raises a red flag and unanswered questions. AIMS Ireland is calling for full accountability and transparency. We ask the Rotunda, did Bimbo receive the basic care, monitoring and a care plan consistent with her clinical needs? Was she appropriately and effectively monitored given the use of the drug misoprostol? Has the Rotunda taken proper and appropriate steps to update staff about the use of the drug misoprostol? Why do their guidelines continue to sit outside those of the RCOG? We also raise concerns regarding queries to the disclosure of Bimbo's previous termination at the inquest. Our sources have revealed that this history was fully disclosed and this information was available to care providers. From the onset, the Rotunda hospital has made attempts to conceal information relevant to the case - including a litany of errors, mishaps, and failures of basic care to Bimbo. We publicly call on the Rotunda to clarify on these matters. This is a matter of public interest."

Concluding, Lynch said “We very much welcome this verdict of medical misadventure from the Coroner Brian Farrell. Despite significant efforts to hide the circumstances of Bimbo’s death, the truth is now on public record. After fighting for many years for this inquest and to have her story heard, Bimbo’s family is finally vindicated.”



ENDS
 
For further information, contact:
Krysia Lynch, AIMS Ireland 087 754 3751
Jene Hinds Kelly, AIMS Ireland 087 681 9095




UK & Irish guidelines on the use of Cytotec/Misoprostol for medical induction of labour after an intrauterine foetal death (IUFD)

RCOG Guideline

The RCOG Green-top Guideline No.55 Late Intrauterine Fetal Death and Stillbirth, published in October 2010 recommends the use of low doses of misoprostol (50 or 100 micrograms depending upon gestational age) when inducing labour:

“The RCOG is aware that protocols employing much larger doses of misoprostol are still being employed in the UK, with consequent potentially associated adverse effects. Each maternity unit is advised to review their protocol for the management of induction of labour under these circumstances and to adopt the recommended misoprostol dosaging. Currently, misoprostol is only available in the form of a 200 microgram tablet; however the required dosage of 50 or 100 micrograms can be obtained by cutting the tablet or by dilutional methods. Your hospital pharmacist will be able to assist you with this if necessary.”
http://www.rcog.org.uk/...

RCPI Guidelines

Royal College of Physicians I reland (RCPI) Guideline: #4 Intrapartum fetal heart rate monitoring - Appendix 4:
http://www.rcpi.ie/article.php?locID=1.5.71.492


On the day of diagnosis of IUFD
Mifepristone 200mg PO
36-48 hours after diagnosis
24-34 weeks Misoprostol 200mcg PV followed by 200mcg PO 3 hourly x 4 doses
>34 weeks Misoprostol 100mcg PV followed by 100mcg PO 3 hourly x 4 doses
A second course may be started after 24 hours and with medical review

Cytotec (Misoprostol) drug label: http://www.rxlist.com/cytotec-drug.htm

Cytotec/Misoprostol - Research

A 2006 Cochrane Review of Misoprostol for induction showed that while oral use of Misoprostol was shown to be an effective induction method, this is not without increased risks. Misoprostol increases risk of uterine hyperstimulation. The uterus may contract too frequently (more than five contractions in 10 minutes), the contractions may last too long (2 minutes or more per contraction), or the uterus may not relax enough between contractions. A casual relationship between uterine rupture and use of Misoprostol in scarred and unscarred uteri is acknowledged, Cochrane notes this requires further investigations but is a cause for concern.




Unfortunately, it is almost impossible to show true risks of misoprostol in induction of labour, because according to the Cochrane review (2010) - "It is not registered for induction of labour, and has therefore not undergone the systematic testing for appropriate dosage and safety required for registration".

The 'off label' use makes it a drug that has never been through rigorous clinical trials and it is, by proxy, not subject to reporting of adverse reactions or outcomes.
 
How many maternal deaths invoving Cytotec have to happen before it is removed from 'off label' use?
 
We'll never know, because no one records Cytotec as a cause or a factor in these deaths.


In the inquest of Bimbo Onanuga, Rotunda's Sam Coulter-Smith is on record as saying:


"Dr Coulter-Smith said there are risks when using misoprostal if there has been previous scarring or perforation of the uterus, but there was nothing in Ms Onanuga's medical notes to indicate such a risk." (RTE news)

"A post-mortem examination later revealed that there was scarring due to a previous termination of pregnancy. But that knowledge came only in hindsight." (RTE news)

AIMS Ireland Counter-Points:

* Undisclosed sources to AIMS Ireland report that Bimbo Onanuga was upfront about her previous termination and report that this information is in her booking notes.

* The occurrence of uterine hyperstimulation and instances of uterine rupture following Misoprostol have been reported in women with scarred and unscarred uterus.

From the Cochrane Review 2010:


"There have been several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section (Bennett 1997; Sciscione 1998; Blanchette 1999; Matthews 1999; Khosla 2002). One unpublished case of uterine rupture occurred in a nulliparous woman following misoprostol use (EM Smith, personal communication). At term plus 12 days she received misoprostol 100 mcg vaginally. After six hours her cervix was found to be 7 cm dilated, and she progressed to full dilatation within a further 70 minutes. Fetal distress was suspected. Ventouse application produced no descent, so delivery was effected by caesarean section. The infant showed no signs of life at birth. After resuscitation, life was sustained for a few hours only. A posterior uterine tear arising from the cervix and spiraling up the posterior aspect of the uterus was discovered and repaired. because such uterine tears are rare in nulliparous women without prolonged labour or syntocinon use, a causal relationship with the use of misoprostol must be considered."

 
 
 
And:
 
 
"In a subsequent abstract (Merrell 1996), they described labour inductions with vaginal misoprostol in 345 women with live fetuses and 86 with intrauterine deaths. There was one unexplained maternal death; two uterine ruptures, one of which followed a previous caesarean section; eight caesarean sections for fetal distress and one for uterine hyperstimulation; and 10 perinatal deaths."
 
 
See More: Vaginal misoprostol for cervical ripening and induction of labour - Cochrane 2010 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000941.pub2/full 
 
Matter of Public Interest
 
The Rotunda made significant efforts to conceal the circumstances in this case and the initial request into an inquest into Bimbo's death was denied. It was only after constant pressure and support from whistleblowers, advocacy groups, politician Clare Daly who put forward the PQs, and Bimbo's amazing and strong family that the coroner granted an inquest and the lithany of errors and failures of basic clinical care contributing to the circumstances surrounding Bimbo's death began to emerge. It is a matter of public interest that the details of these circumstances are acknowledged.

AIMSI is currently finalizing a catalogue of these errors to be published later today.
 






 



 
References:

RTE News: Medical misadventure ruling at Onanuga inquest http://www.rte.ie/news/2013/1105/484745-inquest-bimbo-onanuga/

November 5, 2013 - Coroner rules Bimbo Onanuga (pictured above) died by 'medical misadventure'
Is induction of labour with Cytotec (Misoprostol) worth the risk? 

AIMS Ireland welcomes the verdict of ‘medical misadventure’ delivered in the Dublin Coroner’s Court in the case of Bimbo Onanuga, who died in the Rotunda Maternity Hospital in March 2010. The term ‘medical misadventure’ means that Bimbo Onanuga died of “an unintended result of an intended action” (RTE TV News, November 5, 2013). The Coroner welcomed changes in practice that had taken place in the Rotunda since Bimbo’s death but he also questioned various medical witnesses on the drug Cytotec (Misoprostol) and its off label use for induction of labour. While the administration of Cytotec will not be recorded as a cause of death in the case of Bimbo - or any other woman or baby who dies after being exposed to this 'off label' drug - it is still worthy of note that the Coroner's inquest focused on its use for induction of labour in Ireland and questioned the safety and efficacy of its 'off label' use.

Cytotec (Misoprostol) is a drug that is indicated for use in reducing gastric ulcers. It also has the side effect of producing uterine contractions and after it was approved by the FDA in the USA, it began to be used ‘off label’ for induction of labour in maternity services. This ‘off label’ use of approved medications is supported by the FDA and other similar medicines agencies worldwide as long as this use is based on sound medical evidence. 

A Cochrane review in 2010 of ‘Vaginal Misoprostol for cervical ripening and induction of labour’ raised serious questions about the evidence that supports ‘off label’ use of misoprostol. This review posits that what is of particular concern in the ‘off label’ use of misoprostol are “several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section”. It also suggests that “in countries in which misoprostol is being used for non-registered obstetric indications, there is a need for health authorities and professional organisations to clarify the medico-legal implications”. In other words, it is of great importance that health authorities, such as the HSE. publish clear guidelines for practitioners to ensure the safety of a drug - particularly one that lacks well designed clinical trials that support efficacy and safety of use. 

In an article called The Freedom to Birth - The Use of Cytotec to Induce Labour: A Non-Evidence Based Intervention published in the Journal of Perinatal Education (2009) the author, Madeline Oden, discusses the need to be aware of the evidence-based interventions that are used in childbirth. The American College of Obstetricians and Gynecologists (ACOG) makes recommendations that have become the standard of care for labor and birth and Oden expalins that these recommendations sometimes deviate from the evidence-based ones supported by published research. The routine practices of episiotomies, induction, and denying food to the mother during labor without true medical indication have all been shown to be unnecessary interventions and can contribute to a spiraling effect of adverse events up to and including deaths of the mothers and/or infants. The off-label use of Cytotec (misoprostol) to induce labor and soften the cervix is an excellent example of an unnecessary intervention that is not supported by research (Enkin et al., 2000) (see Table) yet is rapidly becoming the standard of care, despite the evidence demonstrating the catastrophic events that can occur when it is used.

A Mother’s story - Madeline Oden discusses her experience of Cytotec
In December 2001, my 32-year-old daughter, Tatia Oden French, entered a well-known hospital in Oakland, California, to have her first child. She was in perfect health. The baby was in perfect health. The pregnancy was “unremarkable.” Tatia was almost 2 weeks past the due date, and the doctor wanted to induce her. After much stalling on Tatia's part, she reluctantly agreed to submit to induction. The agent used was Cytotec (misoprostol). None of the medical staff told us anything about Cytotec. When I asked what Cytotec was, I was told it is “the standard of care… we use it all the time.” Tatia said it was “not approved by the FDA [U.S. Food and Drug Administration] for use in labor.” Nothing else was said about the potential side effects, the dangers to the mom and child, or the alternatives. However, phrases such as “You don't want to go home with a dead baby, do you?” were said. The pressure was on. Tatia conceded. She told me to go home and that she would call me, believing it would be a long night. We told each other we loved each other and, having not decided on which specialty she would focus on in medical school, she smiled and said, “Maybe I'll be an OB/GYN.”
Ten hours after Tatia was induced with Cytotec, both she and her baby girl, Zorah, were dead. When I asked Tatia's doctor what happened, she just said, “It was a very rare adverse effect of Cytotec, but it does happen.” Still not comprehending what had just happened, I heard myself ask the doctor, “Could you at least tell me that you will not use that drug again?” Surprised, she looked at me and said, “No, I cannot promise that.” Finally, my two sons, Tatia's dad, Tatia's husband, and I were allowed into the operating room where Tatia and Zorah were lying perfectly still. We gathered and said a prayer around both of them. When I left the hospital, it was raining and gray and cold. I heard myself say out loud, “That drug is going to go away.”
After her daughter’s untimely death, Madeline Oden began to campaign for the cessation of the use of Cytotec for the induction of labour. She founded the Tatia Oden French Memorial Foundation in an effort to empower women around the issues of childbirth and pregnancy. The main focus of the foundation is on maternal mortality, ‘off label’ use of drugs, such as Cytotec, and informed consent. The danger of using a drug like Cytotec as an ‘off label’ medication is that no accurate statistics are kept on adverse events when it is used to induce labor. Oden says: “Pregnant women are still being given Cytotec, and some come through unscathed. However, many women and babies are permanently harmed.”
For more information about The Tatia Oden French Memorial Foundation, log on to the organization's Web site (http://www.tatia.org/)
For more information on Bimbo Onanuga and the AIMSI campaign to have her case heard at the Coroner’s Court, see http://nocountryforpregnantwomen.blogspot.ie/2013/11/inquest-into-death-of-bimbo-onanuga.html

Monday, 4 November 2013

Inquest into the death of Bimbo Onanuga - Rotunda Hospital

Introduction


In 2010, AIMS Ireland were contacted over the recent death of a woman in the Rotunda hospital in Dublin. We were asked to look into the woman's death and the circumstances in which the woman died due to their concerns regarding the care the woman received. The woman's name was Bimbo Onanuga.

The following is a summery of events to seek justice for her death.

Synopsis in Brief - Salome Mbugua CEO -AkiDwA


Bimbo Onanuga was a Nigerian woman, mother to Nellie who was born with severe cerebral palsy in Limerick Regional Hospital in 2003. Bimbo was Nellie’s fulltime carer. In 2010, Bimbo was pregnant with her second child. On 1 March, 2010, her GP referred Bimbo to the Rotunda Hospital with a suspected intrauterine death. Bimbo was seen in the hospital on the 1 March when the IUD was confirmed. She was told to return to the hospital on Thursday the 4 March for treatment. Bimbo was then over seven months pregnant.  Bimbo began to experience severe pain on the night of the 3 March and was taken to the Rotunda by ambulance.  Throughout that night and into the following day, Thursday the 4 March, Bimbo’s partner, Abiola Adesina, was increasingly alarmed at Bimbo’s deteriorating condition. He attempted repeatedly to raise his concerns with hospital staff, but felt that his warnings were ignored.  Bimbo was transferred in critical condition to the nearby Mater Hospital on the 4th March where she died later that night. 

Under current legislation, maternity hospitals and maternity units are required to report a maternal death to the local coroner’s office, but an inquest is not automatically forthcoming.  Internal inquiries are generally held in hospitals but their contents and findings are not necessarily disclosed to family members. More recently, since 2008, the HSE has instituted a national critical incident review policy, but these reports are not necessarily made public either.  On the basis of the hospital’s report to the Dublin City Coroner, the Coroner determined that there was no necessity to hold an inquest.

However, Abiola felt there were pressing questions about Bimbo’s care that were never responded to by the hospital and put in repeated requests to the coroner’s office about holding an inquest.  

The results of the Rotunda’s internal inquiry were not made public and it was only after parliamentary privilege was exercised on the floor of the Dáil by Clare Daly TD in May, 2011, that the HSE disclosed most, although not all recommendations arising from its inquiry into Bimbo’s death. Parts of that report were redacted. The HSE then issued a public apology to Bimbo’s partner and family via a press release but were not in direct contact with them. The family had not heard from the hospital nor the HSE from the time of Bimbo’s death, March 2010, up to the night the questions about the inquiries were answered in the Dáil in May, 2011.
The Dublin City Coroner has now gathered documentation and determined that an inquest be held and this will happen on the 18th April, 2013.

Bimbo’s daughter, Nellie, died in December 2010 as a result of complications with her cerebral palsy. Abiola is now in London where Bimbo’s brother also lives.

The presence of both Abiola and Bimbo’s brother at the forthcoming inquest is vital.  Abiola is owed a full and public hearing about the circumstances of Bimbo’s death. He will have full legal representation at the inquest.

Full Details Thus Far:


Correspondence with Rotunda Hospital regarding Maternal Death
In late April, 2010, AIMSI wrote to the Master of the Rotunda Hospital, Sam Coulter-Smith expressing concern in relation to the death in March, of Bimbo Onanuga, an Irish-Nigerian woman who was seven months pregnant and had been told days earlier that her unborn child had died. AIMSI raised several points of concern, including the responsibility of maternity hospitals to take into account the specific needs of migrant women, and the need for clear and empathic communication with women and their families.  While the response received was not specific to the case, AIMSI was pleased to receive a swift reply from Mr. Coulter-Smith acknowledging the importance of issues raised. AIMSI are aware that Amnesty International has expressed an interest in this case, in light of suggestions that race and ethnicity may have played a role in the care and treatment of Ms. Onanuga. The investigation was ongoing. While we tried to chase Sam Coulter-Smith for more information, we were told that nothing would be released.
 
Contact with the Coroner's office informed us that as Bimbo had died of 'natural causes' there would be no inquest.
 
The HSE said there would be not internal inquiry into Bimbo's death.
 
 
 Another Foreign National Maternal Death and an Irish Maternal Death....

On April 13, 2011 AIMSI were informed that there had been another maternal death in the Rotunda - in March 2011 - and the woman was once again non-national. The details AIMSI received were that she was a Polish woman, went in with pain and had an emergency section at 34 wks. The baby was rushed to NICU and she was later rushed to Mater, where she died. AIMSI were very concerned; if this report proved true, this would be the second maternal death of a non-national woman in a year.Attempts to verify this have been through the Rotunda and the Mater hospital, in which we were told they could neither deny nor verify.
 
April 28, 2011, AIMSI received further information - that a Polish woman had died 6 weeks previous in the Mater following a perimortum section in Rotunda. Cause of death pulmonary embolism.
 
 On April 28th,  supporters of justice for Bimbo discussed the issues and decided that a  Parliamentary Question (PQ) into the death of Bimbo Onanuga, an un-named Polish woman, and to find out why there was no HSE inquiry for these Rotunda deaths as compared with the response to the death of Monaghan woman in Our Lady of Lourdes.
 
Parliamentary Questions
 
On May 9, 2011, AIMSI wrote to TDs Caoimhghin O'Caolain and Clare Daly asking them to support and initiate a PQ on the issue of maternal deaths in Ireland, foreign national maternal death and maternity care, and why some maternal deaths are given full inquiries and others do not.

AIMSI wrote:

 AIMSI are writing to you asking you to support this PQ and to initiate a PQ on this issue in the Dáil through the People Before Profit party.

As you are aware, the HSE recently responded and apologised following an inquiry of a maternal death at Our Lady of Lourdes Drogheda - Tanya McCabe. The HSE have also recently responded to media reports of a second maternal death at Our Lady of Lourdes Drogheda, in which they have requested a full internal inquiry into the death.

AIMS Ireland wants to know why the HSE have not requested a full internal inquiry into the death of a foreign national woman at the Rotunda last year (March 2010). Her name was Bimbo Onanuga and the circumstances of her death are concerning. In fact, the only reason we know about it was that concerned Rotunda staff contacted AIMSI and a small local paper called the African Voice. It was not covered in the mainstream media. You can read more about Bimbo Onanuga's story here: http://www.theafricanvoice.ie/articles/latest.php

We are extremely concerned with the fact that this death is not having a proper inquiry. These concerns are further intensified by the fact that AIMSI have been contacted to report that a SECOND non-national woman, this time a Polish woman, has died in the Rotunda this past March 2011. Attempts to verify this story with the Master of the Rotunda and the Mater (where the woman was transported to die) have not been fruitful. We have been told that as we do not have the full name of this woman, they can neither confirm nor deny


On May 13, 2011, Clare Daly responded that she would ask a PQ on these issues.

On May 19th, Clare Daly contacted AIMSI with the following response:


QUESTION NO:  152




DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
by Deputy Clare Daly
for WRITTEN ANSWER on 19/05/2011  


 
 *  To ask the Minister for Health and Children the reason the Health Service Executive has not requested a full internal inquiry into the death of a person (details supplied) in 2010.

                                                                                          - Clare Daly

Details Supplied: Bimbo Onanugaw in the Rotunda Hospital in March 2010


 
REPLY.
When the case was received by HSE, it was assessed using the Investigation Procedure and Toolkit under the HSE established National Incident Management Protocol

The level of the investigation was decided by reference to the National Incident Protocol in light of the information on the case received  by HSE.  The case has therefore been investigated under that protocol by the HSE. Factors that contributed to this maternal death were identified in this review. To address these contributory factors and to prevent future harm arising from them 11 actions were recommended.

The hospital has indicated that 8 of the 11 recommendations have been implemented. Work on the outstanding 3 recommendations is in progress and due for completion shortly.



QUESTION NO:  153



DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
by Deputy Clare Daly
for WRITTEN ANSWER on 19/05/2011  


 
 *  To ask the Minister for Health and Children if a maternal death of a non-national woman occurred in a hospital (details supplied); and if an investigation is being carried out into the case.

                                                                                          - Clare Daly

Details Supplied: the Rotunda in March 2011


 
REPLY.
I am informed that a non-national patient who attended the Rotunda Hospital collapsed and was transferred to the Mater Hospital. She subsequently passed away in Intensive Care Unit in the Mater Hospital on March 8 of this year. A full adverse incident review by the HSE is currently in progress.

This PQ reply provoked more questions.

What are the 11 actions were which were implemented?
Why were the last 3 that haven't yet been implemented over a year later?
Can we see this report? Can it be requested through FOI?


On May 20, 2011, Clare Daly put in a THIRD PQ to request information on the recommendations from the Rotunda following the death of Bimbo Onanuga.



QUESTION NO:  109
    DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
    by Deputy Clare Daly
    for WRITTEN ANSWER on 26/05/2011  

     
     *  To ask the Minister for Health and Children if he will outline the 11 recommendations made in the investigation into the death of a person (details supplied) and the reason three of the recommendations have not yet been implemented over a year after the death.

                                                                                              - Clare Daly

    Details Supplied: Bimbo Onanuga in the Rotunda Hospital in March 2010


     
    REPLY.
    This case was investigated under the National Incident Protocol by the HSE, using the Investigation Procedure and Toolkit to identify factors that contributed to this maternal death. To address these contributory factors and to prevent future harm arising from them 11 actions were recommended.
    Recommendations were made in relation to the need to identify clinical pathways for the management of such cases.

    The recommendations are as follows :
    1. The need to identify clinical pathways relating to management of women with an intrauterine death in third trimester to complement existing medical management policy.
    2. The Guidelines for Medical Management of Intrauterine Death should be revised in line with a review of the medical literature.
    3. Details of all patients for Induction of Labour, regardless of place of induction should be centrally documented.
    4. This recommendation cannot be disclosed as it contains personal, private, sensitive and confidential  information relating to the individual patient.
    5. Develop a brief operational outline of the Gynaecology Department to assist staff who are sent there on an occasional/intermittent basis.
    6. Due to the complexity of work, there is a need for an updated training needs analysis of all midwifery and nursing staff on the gynaecology ward.
    7. There should be a designated individual with responsibility for coordinating, monitoring and auditing the Basic Life Support attendance and Advanced     Life Support Skills attendance, ideally a designated Resuscitation Training Officer.
    8. An Obstetric Early Warning System should be introduced and evaluated.
    9. Install additional phone lines in the ward.
    10. A review of the possibility of emergency call bells or designated phones for emergencies in each room should be carried out and measures taken to address this.
    11. Hospital wide analysis of all doorways in clinical areas to establish the feasibility of moving a bed in a critical event. 

    The HSE confirm that all but the 7th recommendation have now been implemented.
    Discussions are underway in the HSE to bring the implementation of this recommendation to conclusion.

    It was now determined that the HSE did undergo an internal inquiry into the death of Bimbo Onanuga, but it had been done extremely quietly. It also appeared that recommendations following the inquiry were not to be published publicly. As this PQ reply did not address the issue of the report into the publication of Bimbo's death and so yet another PQ was initiated by Clare Daly.

    Apology

    On May 27, 2011, the day after the Dáil reports of AIMSI PQs are published and it is reported in Irish Health.com, a HSE statement expressed it sincere sympathies to the family involved. However, the family were not contacted directly and are unaware of the statement.

    Fourth PQ

    June 3, 2011, AIMSI received the following reply.
     
    QUESTION NO:  137
      DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
      by Deputy Clare Daly
      for WRITTEN ANSWER on 02/06/2011  

       
       *  To ask the Minister for Health and Children if he will publish the full report of the investigation into the death of a person (details supplied)..

                                                                                              - Clare Daly T.D.

      Details Supplied: Bimbo Onanuga at the Rotunda


       
      REPLY.
      The question of publishing the report is a matter for the HSE. I understand that the full report cannot be released as it specifically relates to the patient care and personal circumstances of an individual whose rights must be respected. However, all of the recommendations of the report have been released other than one which relates to the individual patient. Details of these recommendations are included in my reply to you of 26th May 2011 in response to Parliamentary Question 109 .

      QUESTION NO:  106
        DÁIL QUESTION addressed to the Minister for Justice and Equality (Mr. Shatter)
        by Deputy Clare Daly
        for WRITTEN on Thursday, 2nd June, 2011.  

         
         *  To ask the Minister for Justice and Equality if he will implement procedures that require every maternal death, regardless of circumstance, should be submitted to a coroner's inquest.

                                                                    - Clare Daly

           
          REPLY.
            The requirement to report a death to a coroner and whether to subsequently conduct an inquest is set out in sections 17 and 18 of the Coroners Act 1962. Under Coroners'  Rules of Practice, as outlined on the Coroners website www.coroners.ie, maternal deaths relating to childbirth are required to be reported to the coroner. The Coroners Bill 2007, confirms this by providing, inter-alia, in the Third Schedule on Deaths Reportable to Coroner, for the reporting of "any maternal death that occurs during or following pregnancy (up to a period of six weeks post-partum) or that might be related to pregnancy".  

            Fortunately, maternal deaths are exceptionally rare and this State has one of the lowest maternal mortality rates in the world. However, where such deaths occur, they are reported to a coroner and an autopsy would normally be held. It is then a matter for the coroner to decide, having regard to the circumstances of the maternal death, whether an inquest is necessary to determine the circumstances. There may be cases where an inquest would be unnecessary and leaving it to the discretion of the coroner is, therefore, considered to be the most appropriate public policy position.

          Investigations into Cytotec

          In early June, following PQs, some supporters of Bimbo began querying if she had been given cytotec to induce her labour. Cytotec has been shown to be linked with uterine rupture and death. Cytotec is a drug which was developed for the treatment of stomach ulcers and is not approved by the FDA for use in maternity purposes. Cytotec is used in maternity care to induce labour and manage excess bleeding following birth (PPH).

          June 5, 2011, Catherine Reilly writes an article looking further into the death of Bimbo Onanuga and the suspected use of cytotec.

          Inquiry Request

          June 2011 - Bimbo's partner, Abioloa,  writes to the Dublin Coroner's Office to request an inquest into Bimbo's death.

          November 2011 - Rotunda PR responses
           
          November 2011 saw several articles in which the Rotunda PR machine began commenting on the case from the view of overstretched maternity wards to blame for Bimbo's death
           
           
          And an interview with the Sunday Business post with Sam Coulter-Smith provoked the following letter to the editor:
           
          The Association for Improvements in the Maternity Services Ireland (AIMS Ireland) wish to highlight grave concerns re Maternal Death following your article (13.11.11), Dr Sam Coulter-Smith, master of the Rotunda Hospital. In the article, Mr. Coulter-Smith alludes to two maternal deaths of non nationals which occurred in the Rotunda Hospital over a 12 month period. Mr. Coulter-Smith states that investigations were undertaken and that the results were published.

          AIMSI wrote repeatedly to Dr. Sam Coulter Smith requesting information regarding the two incidences. At no point was any information made public. Furthermore neither death was reported in the national media. Neither death received a full HSE inquiry. Neither death received a public apology.

          Eventually, AIMSI were reduced to requesting THREE separate Parliamentary Questions to establish that the deaths had occurred and that there were recommendations associated with the multiple system failures following Bimbo Onanuga’s death and the unnamed East European at the Rotunda Hospital.

          By contrast, following a maternal death of an Irish woman in Our Lady of Lourdes, Drogheda during the same time period; a full HSE inquiry was immediately initiated, an apology to the family by the HSE was immediately given, and a full report of events appeared in all national media outlets

          Is the contrast due to poor management at the Rotunda, or due to the fact that the death of non National women in childbirth does not require the same accountability as the death of an Irish woman?
           
          Inquest Granted - Jan 2013
           
          In January of 2013 word was received that the Dublin City Coroner had granted an inquest into the death of Bimbo Onanuga. The inquest date was set for April 2013.
           


          April 2013 would see THREE inquests into maternal death in Ireland

           
          1. Jennifer Crean.
          2. Savita Hallapanavar.
          3. Bimbo Onanuga.
           
           
          At the Inquest - April 2013
           
          *At inquest, it was determined Bimbo had a uterine rupture due to induction
          *It was confirmed that cytotec was administered.
          *A 'serious doctoring' of notes was discussed
          * key witnesses were not present - those who cared for Bimbo on the day of her death
          *demands have been made that critical witness be subpoenaed - 'we need actual witness'
           
          The inquest was adjourned until July 5, 2013 with the hope to call 'critical' witnesses. '
          Critical witnessess' include doctor, HCP who witnessed death, a nurse, and Bimbo's partner.




          In July, the Inquest was adjourned to resume November 4/5th.
           



          Findings of Relevance for the Inquest for Bimbo Onanuga

          from the HIQA Report on the Death of Savita Halappanavar
          The HIQA report found:
           
          ‘A general lack of provision of basic, fundamental care, for example, not following up on blood tests as identified in the case of Savita Halappanavar’
           
          The HIQA report found:
           
          ‘The most basic means of identifying any patient at risk of clinical deterioration is to observe the patient’s general condition and regularly monitor and track their clinical observations. This should be a basic component of caring for any patient.’



          The HIQA report found:
           
          ‘Patients and members of the public are entitled to expect the highest level of healthcare. When the delivery of care falls below that level, they are entitled to ask why and be assured that measures have been taken to protect them and future patients from harm.’

          ‘It was also noted that there were many areas where maternity service needs were not being fully met at the time of the investigation. This finding reinforces the Authority’s concerns in relation to the inconsistency in the provision of maternity services in Ireland and the need to ensure that all pregnant women have appropriate access to the right level of care and support at any given time.’
           

          Key Questions about Bimbo Onanuga’s Care
            Did Bimbo Onanuga, who had a number of risk factors in relation to the intrauterine fetal death, receive the basic care, monitoring and a care plan consistent with her clinical needs?



          Was she appropriately and effectively monitored given the use of the drug misoprostol?

          Is the Rotunda prepared to fully divulge to the public the steps they have taken since Ms Onanuga’s death to reform care plans and retrain staff, in line with the international evidence on the use of misoprostol and to explain why their guidelines differ from those of the RCOG Greentop 55?
           
          ‘The RCOG is aware that protocols employing much larger doses of misoprostol are still being employed in the UK, with consequent potentially associated adverse effects. Each maternity unit is advised to review their protocol for the management of induction of labour under these circumstances and to adopt the recommended misoprostol dosaging.’ RCOG, 2010
           http://www.rcog.org.uk/womens-health/clinical-guidance/late-intrauterine-fetal-death-and-stillbirth-green-top-55



          You can read more about Bimbo Onanuga's story http://www.theafricanvoice.ie/articles/latest.php
           

          Safety flaws highlighted in maternal death probe http://www.irishhealth.com/article.html?id=19216
           
          ‘They told me she was exaggerating - now she’s gone’ - Rotunda neglected care of Bimbo Onanuga says partner: http://metroeireann.com/article/they-told-me-she-was-exaggerating,2747


          Maternal Death Inquiry - Bimbo Onanuga: http://www.imt.ie/news/latest-news/2013/01/inquest-into-death-at-the-rotunda-is-likely-in-april.html



                               
           

           
           
           
           
           
           
           
           

           

          Friday, 11 October 2013

          Media and Politicians please make informed decisons. Review of Maternity Services is an opportunity for change & reform - not more of the same.

          PLEASE READ AND SHARE to media and politicians: 
           
          AIMS Ireland published a press release following the HIQA report yesterday. We note it was printed in several media outlets, thank you! However, we are dismayed to see that in ALL instances, bar the blog of Clare Daly, the need for reform of Ireland's maternity care model has been left out. We have heard numerous reports from obstetricians and politicians in the past 24 hrs using this report to call for more obstetricians. This presents a big problem - its a reactionary plaster which in the long run, WILL fail. More obstetricians will not save mothers or babies. It will cost more. This is an opportunity for CHANGE. The maternity services need REFORM away from an obstetric care model.

          Here's why:

          The obstetric led care model is NOT evidence based. It is shown time and time again to cost MORE and to be LESS SAFE for the majority of mothers and babies.

          Pregnancy is not an illness. The majority of pregnancies and births are healthy and low risk - these women do NOT need surgical health care providers who specialise in high risk pregnancy/birth looking after them (obstetric care model). In fact, research shows that when healthy women in healthy pregnancies and birth are attended by an obstetrician, risk INCREASES. This leads to a DOMINO effect - increasing demands on our services and introduces risks to women and babies.

          EXAMPLES:
           

          1)Adverse affects from interventions and surgical births mean that MORE women will require medical aftercare for physical and mental health reasons.

          2) More interventions and surgical births means that MORE women will NEED specialized care in future pregnancies = requiring more specialists on specialist wages, more surgeries, more postnatal beds as women stay for longer durations, and more NICU funding.

           3) Increase in surgical births significantly increases risks for WOMEN in current birth AND for future pregnancies. Surgical birth makes women more likely to suffer a severe maternal morbidity and require admission for high dependency units. Many interventions and surgical birth leads to an increase in NICU admission for babies.

          Obstetricians are surgeons and experts in high risk complications. Having a maternity system that requires ALL women to see a specialist surgeon/obstetricians takes specialist surgeons/obstetricians AWAY from the very women who genuinely need this specialized expert care.

          Midwives are the experts of healthy pregnancy and birth. Not obstetricians. Obstetricians are highly skilled and play and important role in maternity services - but they are NOT QUALIFIED to provide care or create policy for the majority of healthy women enjoying healthy pregnancies and births.

           Midwife led care models have been shown time and time again to be of MORE benefit to women, have less adverse affects, and are more cost efficient. Midwife led care is the RECOMMENDED care model for the large majority of women - backed by HIGH QUALITY and robust research.

          The medical (obstetric) care model is not working. We have hired the wrong person for the job and it is having a negative affect on the physical and psychological health of women and babies.

          We need REFORM - not more of the same.

          The media and politicians hold incredible power - they control what information is presented to the public and create policies that directly affect the care women receive in maternity care. Please be INFORMED. Make INFORMED DECISONS.

          Information:

          Midwives, not medicine, promote healthier pregnancies and births in Sweden: http://www.examiner.com/article/midwives-not-medicine-promote-healthier-pregnancies-and-births-sweden

          Midwife led care delivers best outcomes, Cochrane review finds: http://www.bmj.com/content/347/bmj.f5321

          Midwife-led versus other models of care for childbearing
          women (Review): http://apps.who.int/rhl/reviews/CD004667.pdf

          An evaluation of midwifery-led care -The Report of the MID-U Study (HSE): http://www.hse.ie/eng/services/Publications/services/Hospitals/midwifery%20north%20east.pdf

          Who should provide routine antenatal care for low-risk women, and how often? A systematic review of randomised controlled trials: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-3016.12.s2.6.x/full

          Thursday, 10 October 2013

          AIMS Ireland welcomes HIQA Savita report and recommendations: Condemning Irish Maternity Services as being 'outdated', 'patently unsafe', and a 'geographic lottery.'


          PRESS STATEMENT
           
          AIMS Ireland welcomes HIQA Savita report and recommendations: Condemning Irish maternity services as being 'outdated', 'patently unsafe', and a 'geographic lottery'. 
           
          (Wednesday 9 October 2013) The Association for Improvements in the Maternity Services Ireland (AIMS Ireland) today welcomed the HIQA report into the safety, quality and standards of care of Savita Halappanavar and called for the HSE to immediately conduct a full review of maternity services as recommended in the report.
           
           Commenting on the report, Krysia Lynch, Co-chair of AIMS Ireland said:  "The findings of the HIQA report indicate a failure at all strata of responsibility to provide basic levels of adequate and appropriate care to Savita Halappanavar which would have saved her life. What is also of grave concern to AIMS Ireland is the number of failures at national level identified in the report including timely access to maternity services, inadequate staffing levels for safe care, a maternity care model that hasn't been revised in 59 years despite numerous national and international reports and recommendations, a lack of accountability and governance, an absence of reviews of clinical practices in units and the lack of a national maternity services strategy, all of which we have seen recommended on previous inquests without reform. "
           
          The 2007 Safer Childbirth Document recommends that midwife to woman staffing levels are never to exceed 1:28 for low risk women and 1:25 for high risk women, in order to ensure that women are safely looked after and not left alone in labour.  Irish ratios drastically exceed these recommendations and were seen to be contributing factors into the deaths of Tania McCabe, Bimbo Onanuga, and now, Savita Halappanavar.   Recent research in Ireland has shown that there is are marked regional variations in obstetrical intervention for hospital birth, therefore, it is difficult to determine how and where interventions are more or less frequently adhered to within maternity services. Regional variations in obstetric interventions across Ireland essentially present women with a ‘geographic lottery’ in terms of their maternity care. There is no standardized care.
           
          Krysia Lynch "The HSE and Department of Health have seen numerous recommendations and reports of unsafe practice in Irish maternity services in the recent decade, all of which have fallen on deaf ears. Ireland purports to be one of the safest Countries to have a baby... yet these incidents of gross neglect continue. The current midwife to woman ratio is patently unsafe. Maternity units have reported midwife to woman ratios of 1:43, failing not only international recommendations but those resulting from previous investigations following the deaths of Tania McCabe and Bimbo Onanuga." Lynch continues, "Ireland is a nation of numerous reports and recommendations. Report , after report, after report come to the same conclusions with  absolutely no preventative action from the HSE or Department of Health." 
           

          AIMS Ireland strongly refutes the calls today to increase the number of obstetricians in the Irish maternity services as a reactionary measure to this report. AIMS Ireland states, "We need an over-haul of the maternity care model in Ireland. Our maternity services are 90% obstetric-led and lack continuity of carer. Outdated practices are of no benefit to the majority of women. High quality robust evidence, including the recently published Cochrane Review on midwife-led care, shows that the large majority of women benefit from a Midwifery-Led care model, not obstetric. Obstetric-led care has a very important place in Irish maternity services and should be available for women who want or need this type of maternity care, however, in failing to provide evidence based care options, valuable resources are being over-utilized as women have no option but birth in under-staffed and over-crowded consultant led units."
           
           
          AIMS Ireland stresses, "Today we  have heard repeated calls for yet more of the same - an increase in obstetricians. Where are the midwife led units and birth centres? Ireland needs to wake up and listen to the evidence. This is an opportunity to review our maternity care model and provide women with evidence based midwife led care models in every Irish unit."
           ENDS 
           
          For further information:
          Krysia Lynch
          087 754 3751   
           
          About AIMS Ireland
          AIMS Ireland is a consumer-led voluntary organisation dedicated to improvement in maternity services in Ireland. Our mission is to highlight normal birth practices, which are supported by evidence-based research and international best practices, and campaign for recognition of maternal autonomy and issues surrounding informed choice and informed refusal for women in all aspects of the maternity services and maternal health.  
          AIMS Ireland campaigns on the grounds that birth choice is a basic human right as declared at the International Conference of Human Rights and Childbirth.
          AIMS Ireland offer independent, confidential, non-judgemental support and information on maternity choices and care to women and their families. We assist in complaints and run a closed online Birth Healing support group for women following difficult and/or traumatic birth.
          Our day-to-day contact with service users, consumer interest groups and healthcare practitioners helps us stay informed of key issues in maternity care and services which we can directly feedback to service providers, media, HSE and Government in an effort to improve maternity services on a local and national level.
          AIMS Ireland is run solely by volunteers and funded through donations and fundraising. Volunteers cover their own costs (travel to meetings, parking, childminding, phone costs). All money donated to AIMS Ireland goes directly back to women and support.
          For more information please visit our website, www.aimsireland.com