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News Article
IVF clinic investigated over possible damaged eggs
Patient Safety Learning posted a news article in News
More than 100 patients who had eggs and embryos frozen at a leading clinic have been told they may have been damaged due to a fault in the freezing process. The clinic, at Guy's Hospital in London, said it may have unwittingly used some bottles of a faulty freezing solution in September and October 2022. But it said it did not know the liquid was defective at the time. One patient at a second clinic, Jessop Fertility in Sheffield, has also been affected, the BBC has learned. The fertility industry regulator, the Human Fertilisation and Embryology Authority (HFEA), said it believes the faulty batch was only distributed to those two clinics. It is believed that many of the patients affected have subsequently had cancer treatment since having their eggs or embryos frozen, which may have left them infertile. This means they now may not be able to conceive with their own eggs. Guy's Hospital's Assisted Conception Unit is now being investigated by the HFEA, because of a delay in informing people affected. Read full story Source: BBC News, 14 February 2024 -
Content ArticleOn 9 January 2024, the All-Party Parliamentary Group (APPG) on birth trauma in the UK Parliament will set up an inquiry to investigate the reasons for traumatic birth and to develop policy recommendations to reduce the rate of birth trauma. Research shows that about 4–5% of women develop post-traumatic stress disorder (PTSD) after giving birth – equivalent to approximately 25,000-30,000 women every year in the UK. Studies have also found that a much larger number of women – as many as one in three – find some aspects of their birth experience traumatic. Birth trauma affects 30,000 women across the country every year. 53% of women who experienced birth trauma are less likely to have children in the future and 84% of women who experienced tears during birth, did not receive enough information about birth injuries ahead of time.
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Content ArticleThis population-based cohort study from Sweden and Norway aimed to explore whether exposure to mRNA Covid-19 vaccination during pregnancy increases the risk of adverse events in newborn infants. The cohort included 94,303 infants exposed to Covid-19 vaccination during pregnancy and 102,167 control infants born between June 2021 and January 2023. The authors found that vaccination during pregnancy was associated with lower odds of neonatal intracranial haemorrhage, cerebral ischemia and hypoxic-ischemic encephalopathy, and neonatal mortality.
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Doctors issue warning after spike in ‘freebirthing’
Patient Safety Learning posted a news article in News
Doctors have warned of the risks of “freebirthing” – where a woman gives birth without the help of a medic or midwife. Unassisted births, or “freebirths”, are thought to have been on the increase since the start of the Covid pandemic, when people may have been worried about attending hospitals and home births were suspended in many areas. The practice is not illegal and women have the right to decline any care during their pregnancy and delivery. Some women hire a doula to support them during birth. The Royal College of Obstetricians and Gynaecologists (RCOG) said women should be supported to have the birth they choose, but “safety is paramount” and families need to be aware of the risks of going it alone. The Nursing and Midwifery Council (NMC) said it is in the early stages of collaboration with the Chief Midwifery Officer’s teams, the Royal College of Midwives (RCM) and the Department of Health to better understand professional concerns about freebirthing and what organisations may need to do. Its statement on unassisted births supports women’s choice, but notes that “midwives are understandably concerned about women giving birth at home without assistance, as it brings with it increased risks to both the mother and baby”. It also states that women need to be informed that a midwife may not be available to be sent out to their home during labour if they change their mind and wish to have help. Read full story Source: The Independent, 8 February 2024- Posted
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News ArticleCampaigners have accused the UK government of betraying them after a review of redress for victims of health scandals excluded families who may have been affected by the hormone pregnancy test Primodos. A report published on Wednesday by the patient safety commissioner, Dr Henrietta Hughes, found a “clear case for redress” for thousands of women and children who suffered “avoidable harm” from the epilepsy treatment sodium valproate and from vaginal mesh implants. But despite the commissioner wanting to include families affected by hormone pregnancy tests in her review, the Department of Health and Social Care (DHSC) told her they would not be included. Primodos was an oral hormonal drug used between the 1950s and 70s for regulating menstrual cycles, and as a pregnancy test. Hormone pregnancy tests stopped being sold in the late 1970s and manufacturers have faced claims that such tests led to birth defects and miscarriages. Last year, the high court dismissed a case brought by more than 100 families to seek legal compensation owing to insufficient new evidence. The Hughes report states: “Our terms of reference did not include the issue of hormone pregnancy tests. This was a decision taken by DHSC and should not be interpreted as representing the views of the commissioner on the avoidable harm suffered in relation to hormone pregnancy tests or the action required to address this. “The patient safety commissioner wanted them included in the scope but, nevertheless, agreed to take on the work as defined by DHSC ministers.” Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests, said the families of those who took the tests felt “left out in the cold” and betrayed that they were not included in the commissioner’s review. “I feel betrayed by the patient safety commissioner, by the IMMDS [Independent Medicines and Medical Devices Safety] review and by the secretary of state for health – all three have betrayed our families because, basically, they have just forgotten us. It’s a case of ‘it’s too difficult so we will just focus on valproate and mesh’,” Lyon said. Prof Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, who led a systematic review of Primodos in 2018, said: “It’s unclear to me how the commissioner can keep patients safe if they are blocked and don’t have the power to go to areas where patient safety matters.” Read full story Source: The Guardian, 7 February 2024
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Mesh and sodium valproate scandal victims need payouts soon, report says
Patient Safety Learning posted a news article in News
Families of children left disabled by an epilepsy drug and women injured by pelvic mesh implants should be given urgent financial help, England's patient safety commissioner has said. Dr Henrietta Hughes has called on the government to act quickly to help victims of the two health scandals. It follows a review which found lives had been ruined because concerns about some treatments were not listened to. It is estimated that, since the early 1970s, about 20,000 babies have been born with disabilities after foetal exposure to sodium valproate, which can harm unborn babies if taken in pregnancy. Scientific papers from as early as the 1980s suggested valproate medicines were dangerous to developing babies, yet warnings about the potential effects were not added to some packaging until 2016. Some families affected have been campaigning for decades to raise awareness of the potential effects of the drug, with some calling for compensation and a public inquiry. Dr Hughes was asked by the government to look into a potential compensation scheme for those affected by that scandal, as well as the one involving some 10,000 women who were injured by their pelvic mesh implants - a treatment for pelvic organ prolapse (POP) and incontinence. Read full story Source: BBC News, 7 February 2024- Posted
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‘Horrifying’ failure to provide safety warnings for high-risk medicine
Patient Safety Learning posted a news article in News
Concerns have been raised that patients may not be receiving “vital” safety information after HSJ discovered a high-risk medication was frequently not being dispensed as originally packaged. In 2018, the Medicines and Healthcare Products Regulatory Agency asked pharmacies to dispense valproate-containing medications in their original pack where possible, to ensure packages include safety warnings. It also asked manufacturers to produce smaller pack sizes and add pictorial warnings, while pharmacists were additionally asked to add stickered warnings to the outer box of any valproate-containing medication not dispensed in its original packaging. Yet, data obtained via freedom of information requests to the NHS Business Services Authority revealed that while the proportion and number of valproate-containing items dispensed as split packs – as opposed to whole packs – had decreased over the last five years, split packs still accounted for more than half of items dispensed in 2022-23. Emma Murphy, of campaign group In-Fact, said the figures on split pack dispensing were “quite horrifying” and showed “the system is not working”. She added: “Attitudes have got to change – prescribers, GPs etc need to be proactive and warn women of the risks because this isn’t just a side effect, this is harming real babies. As a mum of five affected children, the consequences of valproate in pregnancy on that baby is devastating.” Alison Fuller, of Epilepsy Action, said the high proportion of split packs being dispensed made it “clear why the change in guidance introduced in October 2023 was necessary”, adding: “The manufacturer’s original full pack always contains all the relevant information, which is why it’s the best option for patient awareness.” Read full story (paywalled) Source: HSJ,- Posted
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Scotland: Mother wrongly downgraded to low risk
Patient Safety Learning posted a news article in News
Doctors "failed to realise" that a first-time mother's pregnancy had become "much higher risk" because crucial warning signs were not properly highlighted in her medical records, an inquiry has heard. Nicola McCormick was obese and had experienced repeated episodes of bleeding and reduced foetal movement, but was wrongly downgraded from a high to low risk patient weeks before she went into labour. Her daughter, Ellie McCormick, had to be resuscitated after being born "floppy" with "no signs of life" at Wishaw General hospital on March 4 2019 following an emergency caesarean. She had suffered severe brain damage and multi-organ failure due to oxygen deprivation, and was just five hours old when her life support was switched off. A fatal accident inquiry (FAI) at Glasgow Sheriff Court was told that Ms McCormick, who was 20 and lived with her parents in Uddingston, should have been booked for an induction of labour "no later" than her due date of 26 February. Had this occurred, she would have been in hospital for the duration of the birth with Ellie's foetal heartbeat "continuously" monitored. In the event, Ms McCormick had been in labour for more than nine hours by the time she was admitted to hospital at 8.29pm on 4 March. A midwife raised the alarm after detecting a dangerously low foetal heartbeat, and Ms McCormick was rushed into theatre for an emergency C-section. Dr Rhona Hughes, a retired consultant obstetrician who gave evidence as an expert witness, told the FAI that Ellie might have survived had there been different guidelines in place in relation to the dangers of bleeding late in pregnancy, or had her medical history been more obvious in computer records. Read full story Source: The Herald, 24 January 2024 -
Content ArticleNew safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males. These safety and educational materials support the new regulatory measures announced in the National Patient Safety Alert. Healthcare professionals should review the new measures and materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing valproate.
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News ArticleHealthcare workers are being told not to report women to the police if they believe their patients may have illegally ended their own pregnancy. The Royal College of Gynaecologists and Obstetricians (RCOG) says "deeply traumatised" women are being prosecuted following abortions. By law, patients' data must not be disclosed without their consent. The new guidance follows a recent rise in police investigations into abortions. NHS staff can breach confidentiality rules to give information to the police about possible crimes, but only if it is in the "public interest". The RCOG says it is "never" in the public interest to report women who have abortions, and that they must be safeguarded. In the first official guidance issued of its kind, a healthcare worker must "justify" any disclosure of patient data or "face potential fitness to practice proceedings". The organisation says it is "concerned" by the rising number of police investigations following abortions and pregnancy loss, and the effect this might have on "especially vulnerable" patients. Dr Jonathan Lord, RCOG's medical director, told the BBC: "A law that was originally designed to protect a woman is now being used against her. "We have witnessed life-changing harm to women and their wider families as a direct result of NHS staff reporting women suspected of crimes, and we just don't think that would happen in other areas of healthcare. "We deal with the most vulnerable groups who may be concerned about turning to regulated healthcare at all, and we need them to trust us". .Read full story Source: BBC News, 22 January 2024
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Content ArticleIn this article, Claire Brader summarises the recent findings on the performance of NHS maternity services in England, as well as recent government and NHS policies aimed at improving the quality of maternity care.
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News Article
Why are so many women dying during pregnancy and what can be done?
Patient Safety Learning posted a news article in News
The number of women dying during pregnancy or soon after childbirth has reached its highest level in almost 20 years, according to new data. Experts have described the figures as “very worrying”. Between 2020 and 2022, 293 women in the UK died during pregnancy or within 42 days of the end of their pregnancy. With 21 deaths classified as coincidental, 272 in 2,028,543 pregnancies resulted in a maternal death rate of 13.41 per 100,000. This is a steep rise from the 8.79 deaths per 100,000 pregnancies in 2017 to 2019, the most recent three-year period with complete data. The death rate has increased to levels not seen since 2003 to 2005. The data comes from MBRRACE-UK, which conducts surveillance and investigates the causes of maternal deaths, stillbirths and infant deaths as part of the national Maternal, Newborn and Infant Clinical Outcome Review Programme (MNI-CORP). Urgent action is needed to bolster the quality of maternal healthcare, ensure it is accessible to all, and repair the damage inflicted by the pandemic on women’s healthcare services more generally. Clea Harmer, the chief executive of bereavement charity Sands, said improving maternity safety also needs to be at the top of the UK’s agenda. The government said it was committed to ensuring all women received safe and compassionate care from maternity services, regardless of their ethnicity, location or economic status. Anneliese Dodds, the shadow women and equalities secretary, said Labour would seek to reverse the “deeply concerning” maternal mortality figures by training thousands more midwives and health visitors and incentivising continuity of care for women during pregnancy. Read full story Source: The Guardian, 11 January 2024- Posted
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News ArticleWomen who experience depression during pregnancy or in the year after giving birth are at a higher risk of suicide and attempting suicide, researchers have warned. The British Medical Journal study warned that women who develop perinatal depression are twice as likely to die compared to those who don’t experience depression. Suicide was the leading cause of death for women in the UK in 2022 between six weeks and one year after birth, while deaths from psychiatric causes accounted for almost 40 per cent of maternal deaths overall, according to a Perinatal Mortality Surveillance report. Last year an analysis by Labour revealed 30,000 women who were pregnant were on waiting lists for specialist mental health support. The number of women waiting rose by 40 per cent between August 2022 and March 2023. The most recent NHS data shows in September 2023, 61,000 women accessed perinatal mental health services. For 2023-24, the health service must hit a target to have 66,000 women accessing care. In August 2023, the Royal College of Midwives published a research warning half of anxiety and depression cases among new and expectant mothers were being missed amid NHS staff shortages in maternity care. Read full story Source: The Independent, 11 January 2024
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Content ArticleThis study published in the BMJ found that women with clinically diagnosed perinatal depression were associated with an increased risk of death, particularly during the first year after diagnosis and because of suicide. Women who are affected, their families, and health professionals should be aware of these severe health hazards after perinatal depression.
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Content Article
MBRRACE-UK: Maternal mortality 2020-2022
Patient Safety Learning posted an article in Maternity
MBRRACE have released their latest UK maternal mortality figures. The maternal death rate in 2020-22 was 13.41 per 100,000 maternities. This is significantly 53% higher than the rate of 8.79 deaths per 100,000 maternities in the previous three year period (2017-19).- Posted
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News ArticleMylissa Farmer’s pregnancy was doomed. But no one would help her end it. Over the course of a few days in August 2022, Farmer visited two hospitals in Missouri and Kansas, where doctors agreed that because the 41-year-old’s water had broken just 18 weeks into her pregnancy, there was no chance that she would give birth to a healthy baby. Continuing the pregnancy could risk Farmer’s health and life – yet the doctors could not act. Weeks earlier, the US supreme court had overturned Roe v Wade and abolished the national right to abortion. It was, legal counsel at one hospital determined, “too risky in this heated political environment to intervene”, according to legal filings. In immense pain and anguish, Farmer ultimately traveled several hours to Illinois, where abortion is legal. There, doctors were able to end her pregnancy. Farmer’s account is detailed in a legal complaint she filed against the hospitals, arguing that they broke a federal law that requires hospitals to treat patients in medical emergencies. In a first-of-its-kind investigation, the US government sided with Farmer and declared that the two hospitals had broken the law. The future of the government’s ability to invoke that law to protect women seeking emergency abortions is now in question. The law, the Emergency Medical Treatment and Labor Act (Emtala), is at the heart of the US supreme court’s latest blockbuster abortion case, which comes out of Idaho. Read full story Source: The Guardian, 9 January 2024
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Content ArticleThe maternal mortality rate (MMR) in the United States continues to increase despite medical advances and is exacerbated by stark racial disparities. Black women are disproportionately affected and are three times more likely to experience a pregnancy-related death (PRD) compared to Non-Hispanic White (NHW) women. Keisha E. Montalmant and Anna K. Ettinger carried out a literature review to examine the racial disparities in the United States' MMR, specifically among pregnant Black women. The review highlights that maternal health disparities for Black women are further impacted by both structural racism and racial implicit biases. Cultural competence and educational courses targeting racial disparities among maternal healthcare providers (MHCP) are essential for the reduction of PRDs and pregnancy-related complications among this target population. Additionally, quality and proper continuity of care require an increased awareness surrounding the risk of cardiovascular diseases for pregnant Black women.
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Content ArticleThe Professional Standards Regulatory Body are holding a series of webinars in January 2024 designed for professionals working in or with maternity services where they will review the updated Digital Maternity Record Standard. Each session will focus on different aspects of maternity care. Having access to the right information at the right time helps professionals make decisions for safer, more personalised care and supports people using services to manage their own information. Health and care professionals, organisations that support people during and after pregnancy, IT system suppliers and people who use maternity services are welcome at these sessions. Find out more about the sessions and how to sign up via the link below.
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Content ArticleIf you’ve recently used maternity services, or if you’re pregnant at the moment, the Professional Records Standards Body (PRSB) would like to invite you to join one of their online workshops in January 2024. Each session will last no longer than 1 hour 30 minutes and you’ll receive a £25 shopping voucher to thank you for your time if you attend. The PRSB are working with the NHS to improve how information about your health is recorded and shared during your pregnancy and after your baby has been born. This could include information about treatment or advice you’ve received, tests and scans you’ve had or decisions you’ve made about your maternity care. Find out more about the project, and how to book onto a workshop via the link below.
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Content ArticleProblems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, authors of this study, published in BMJ Quality and Safety, sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk.
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News Article
GPs to offer more mental health support for mothers in England after giving birth
Patient Safety Learning posted a news article in News
Mothers in England will be asked in detail if pregnancy or giving birth has affected their mental health as a result of new NHS guidance to GPs. The move is part of a drive by NHS England to improve support for women suffering postnatal depression or other mental health problems linked to their pregnancy or childbirth. Under the new guidance GPs will ask women more questions than before about how they are feeling when they attend their postnatal health check six to eight weeks after giving birth. Family doctors will look for any sign that the woman may have a condition such as postnatal PTSD as a result of experiencing a traumatic birth or psychosis induced by bearing a child. Anyone who the GP feels needs help with their mental wellbeing will be referred to specialist maternal mental health services, which have been expanded in recent years. Read full story Source: The Guardian, 18 December 2023- Posted
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Content ArticleSince the launch of the national Perinatal Mortality Tool (PMRT) in early 2018, over 23,000 reviews have been started. This fifth annual report presents the findings for reviews completed from March 2022 to February 2023 coinciding with the third year of the global health emergency due to the COVID-19 virus.
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NHSE warns widely used EPR could pose ‘serious risks to patient safety’
Patient Safety Learning posted a news article in News
NHS England has issued a national alert to all trusts providing maternity services after faults were discovered in IT software that could pose “potential serious risks to patient safety”. According to the alert, the Euroking electronic patient record provided by Magentus Software could be displaying incorrect patient information to clinicians. The Euroking EPR is used in the maternity departments of at least 15 trusts according to information held by HSJ. These organisations have been asked to “consider if Euroking meets their maternity service’s needs” and to “ensure their local configuration is safe”. Trusts with different maternity EPR providers have also been asked to reassess the clinical safety of their solutions. The potential “serious risks” relate to a fault in the Euroking EPR which allows new patient information to overwrite previously recorded information, which could lead to “incorrect management of the pregnancy and subsequent harm”. Read full story (paywalled) Source: HSJ, 8 December 2023 -
Content ArticlePotential serious risks to patient safety have been identified with the use of Magentus Software Limited’s Euroking maternity information system. These concern specific data fields: certain new patient information, recorded during a patient contact, can overwrite ('back copy') information previously recorded in the patient’s pregnancy record. certain pregnancy-level data (information relevant only to a specific pregnancy event) can be saved at a patient level (where information relevant throughout a person's life is recorded), causing new information to overwrite (‘back copy’) previously recorded data across an entire patient record. certain recorded pregnancy-level data can pre-populate into new pregnancy records (‘forward copy’), which can mean clinicians will see incorrect patient information, and attempts to correct this can result in the issue described at (ii) above.
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News ArticlePregnant women have been urged to get vaccinated following a spike in suspected whooping cough cases in England and Wales. Official figures show doctors reported some 716 suspected cases between July and November - up from 217 in the previous period last year. Whooping cough, or pertussis, is a bacterial infection of the lungs and breathing tubes that spreads easily and infected tens of thousands of people before vaccines were introduced. It is easily preventable, experts say, but can sometimes cause serious problems for babies and children. Dr Gayatri Amirthalingam, consultant epidemiologist at the UKHSA, said the rise in suspected cases of whooping cough was “expected” due to low immunity as a result of the Covid pandemic. Despite vaccinations being available in the UK the infection hasn’t gone away “completely” but immunisation can provide “life-long protection”. “Social distancing and lockdown measures imposed across the UK during the COVID-19 pandemic had a significant impact on the spread of infections, including whooping cough,” Dr Amirthalingam added. “As expected, we are now seeing cases of whooping cough increase again so it’s vital pregnant women ensure they get vaccinated to protect their baby.” Read full story Source: The Independent, 7 December 2023