Prevention of Future Deaths reports · 2018
Regulation 28 report to prevent future deaths, reference 2018-0367, written 22 Nov 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 22 Nov 2018 |
|---|---|
| Reference | 2018-0367 |
| Deceased | Savannah-Rose Owen |
| Coroner | Alison Mutch |
| Coroner area | Manchester South |
| Category | Child Death (from 2015) · Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Secretary of State for Health, Secretary of State for Business CORONER | am Alison Mutch, Senior Coroner, for the Coroner area of South Manchester CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 INVESTIGATION and INQUEST On 23rd April 2018 | commenced an investigation into the death of Savannah-Rose Michelle Owen. The investigation concluded on 7th November 2018 and the conclusion was one of Natural Causes. The medical cause of death was 1a) Unascertained (4 | Savannah-Rose Michelle Owen was a healthy baby born on 16th February 2018. On 22nd April 2018 she fell asleep on a nursing pillow on the sofa at her home address. Her parents realised she had become unresponsive and an ambulance was called. Attempts to resuscitate her were unsuccessful. A post- mortem did not find a cause of death but did exclude any third party involvement or suspicious circumstances and on the balance of probabilities would have been due to natural causes. CORONER'S CONCERNS During the course of the inquest, the evidence revealed matters giving rise to concern. In my opinion, there is a risk that future deaths will occur unless action is taken. In the circumstances, it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — The inquest heard that: Savannah-Rose’s mother had purchased the multi-purpose nursing pillow from a well-known supermarket chain. There were warnings about its use on a card that came with the pillow but was not attached to it. On the warning/information leaflet were 5 pictures of a baby positioned on the pillow. In only 2 images was the baby with an adult. On the other 3 the baby was alone. The inquest heard that sleeping unsupervised on such pillows was not consistent with the safe sleeping advice given to new parents. However: 1. Unlike many items associated with babies/young children such as high chairs/cots there was no specific safety regulation for such items. Instead manufacturers had to interpret the all-embracing safety policy. This risked inconsistent safety warnings/labelling; 2. It was unclear if Health Visitors/ Midwives in the community seeing multi-use pillows being used were flagging up the risks of allowing babies to be propped on them for naps and that their use in such a way was wholly inconsistent with safe sleeping advice; 3. On the warning/information leaflet were 5 pictures of a baby positioned on the pillow. In only 2 images was the baby with an adult. On the other 3 the baby was alone. The inquest was told that this could be misleading as to the importance of never leaving a baby unattended on the pillow; and 4. The warning label was not attached to the item therefore; once the package had been opened, there was a high risk that the warning label would be lost. On resale/ recycling of baby items this meant that second hand users/purchasers were unlikely to see the warning. ACTION SHOULD BE TAKEN In my opinion, action should be taken to prevent future deaths and | believe you have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 17" January 2019. |, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely i a0 aa: deceased’s parents, who may find it useful or of Interest. | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. Alison Mutch OBE HM Senior Coroner 22.11.2018 iD
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
pas Kelly Tolhurst MP Department for Business, Energy & Department for ‘'vectora Steet Business, Energy Sane & Industrial Strategy T +44 (0) 20 7215 5000 E enquiries@beis.gov.uk Alison Mutch OBE a HM Senior Coroner Our ref: aepeosernees- Coroner’s Court 1 Mount Tabor Street [4 December 2018 Stockport SK1 3AG RECEIVED 24 DEC 2018 Thank you for your letter and Regulation 28 Report to Prevent Future Deaths, dated 22 November 2018, following your investigation and inquest into the death of baby Savannah- Rose Michelle Owen on 22 April 2018, who died after falling asleep on a nursing pillow on the sofa and becoming unresponsive. | am responding as the Minister responsible for product safety policy in the Department for Business, Energy and Industrial Strategy (BEIS). 1 would first like to say how sorry | was to hear about this terrible incident. If you have the opportunity, please convey my deepest sympathies to Savannah-Rose’s family. The death of baby Savannah-Rose was unexplained and ruled on the balance of probabilities to be death by natural causes. However, we must do everything we can to ensure that our product safety system continues to function effectively for the safety of products used by babies and new parents, so as Minister for product safety policy |! am addressing the points you have raised regarding the nursing pillow on which Savannah-Grace fell asleep. You raise the concern that there are no specific safety regulations for nursing pillows. The safety of nursing pillows, along with many other products, is regulated by the General Product Safety Regulations 2005 (GPSR). Under the GPSR, products are required to be safe in normal or reasonably foreseeable use when placed on the market. Before the product is placed on the market, manufacturers must ensure products are safe. Distributors and retailers must act with due care and must not supply a product which they know or ought to know is unsafe. In this case, you have raised concerns that the product was sold with safety use warnings on a leaflet that was not attached to the product. Furthermore, three out of five images on the warning leaflet showed a baby using the product without an adult figure, which is not consistent with safe sleeping advice given to new parents. In determining whether a product is safe under GPSR, one of the factors is the presentation of the product, including any labelling, warnings and instructions for use. Both the Office for Product Safety (OPSS) and Local authority Trading Standards have powers to act where unsafe products are identified including, requiring changes to safety information and instructions for use and, where appropriate, issuing a recall of the product. | have passed your concerns regarding the nursing pillow on to OPSS’s Product Safety Enforcement Team but in order to investigate further they have asked that any details you have of the specific product involved, including information about the distributor be shared with them. If you have any further information that would assist their assessment, | would be grateful if you could pass it directly to Graham Russell, Chief Executive, OPSS, Victoria Square House, Birmingham B2 4AJ. This would allow OPSS to work with Local Authority Trading Standards to determine whether further action is needed, based on all the evidence available. Thank you for bringing this issue to my attention. | hope | have reassured you that the Government takes product safety issues seriously and is working with its partners to continually improve the level of safety for children and babies. KELLY Minister for Small Business, Consumers & Corp§rate Responsibility
Me From Jackie Doyle-Price MP D epartm ent Parliamentary Under Secretary of State for Mental Health, inequalities and Suicide Prevention of Health & i 39 Victoria Street Social Care a Street SW1H OEU RECE IVED | 020 7210 4850 16 JAN 20:3 Your Ref: 10179/CH Our Ref: PFD-1158107 Ms Alison Mutch OBE HM Senior Coroner, Manchester South HM Coroner's Court 1 Mount Tabor Street Stockport wonTy 26 SK1 3AG iphh yonwmry 1 Deo, Ly Match Thank you for your correspondence of 22 November to Matt Hancock about the death of Savannah-Rose Michelle Owen. I am replying as Minister with responsibility for child health. I have noted carefully the concerns in your report. Firstly, I should clarify that nursing pillows are not classified as medical devices and are therefore outside the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA). Safety regulation in this case is a matter for the Department for Business, Energy and Industrial Strategy and I note you have issued your report to the Secretary of State. With regard to guidance given by health visitors and midwives on safe sleeping and nursing pillows, discussions with parents about safe sleeping are a part of maternity care, both antenatal and post-natal, as is the support offered by health visitors. We know that health visitors and midwives are a trusted resource for parents. Health visitors and midwives are crucial in supporting a healthy pregnancy, safe birth and support for health and wellbeing for both the parents and child. This includes support for a healthy weight during pregnancy, breast feeding and safer sleeping advice, all of which can reduce the risk of Sudden Infant Death Syndrome (SIDS). Health visitors and midwives receive in-depth training in pre- and post-registration development programmes, about SIDS and the evidence describing what works to reduce the incidence and minimise the risk of SIDS occurring. SIDS is multi- factorial. However, ensuring parents have the most recent evidence available can help to maintain the momentum in decreasing the number of babies dying. Health visitors and midwives advise and guide parents about safe sleep environments and work with parents regarding unsafe practices and how to reduce a risk to their baby, including the use of nursing pillows, supporting parents to make the safest choice for their baby. We acknowledge it can be very difficult for parents to know which products are safe for their baby. Confusion around product safety was highlighted by a recent survey of new and expectant parents commissioned by The Lullaby Trust. 91 per cent of parents who responded stated compliance with safer sleep advice was a very important consideration when buying a product. In March 2018, Public Health England (PHE) and The Lullaby Trust jointly published guidance to help new and expectant parents make safer choices when deciding on sleeping products for their baby'. It aims to provide parents with some key pieces of advice when choosing sleeping products. Safer Sleep Week is The Lullaby Trust’s annual national awareness-raising campaign. It aims to make sure parents, carers and health professionals know the importance of safer sleep and are aware of how to reduce the risk of SIDS. The campaign this year runs 11-17 March 2019. PHE is working with The Lullaby Trust to develop new resources that will be showcased during Safer Sleep Week. PHE and The Lullaby Trust are collaborating and co-producing information sheets for parents and detailed fact sheets for professionals to further describe the evidence base for safer sleep spaces and drive down the incidence of SIDS. Finally, other sources of advice for parents are the NHS’ Start4Life Information Service for Parents”, which provides information via email on keeping babies safe. This includes guidance on preventing SIDS, with links to further information online, including to the Lullaby Trust’s website. In addition, the NHS Choices website contains factsheets on minimising the risk of SIDS*, that include the importance of ? https://www.nhs.uk/start4life 2 http://www.nhs.uk/conditions/sudden-infant-death-syndrome/pages/introduction.aspx 4 http://www.nhs.uk/conditions/pregnancy-and-baby/pages/reducing-risk-cot-death,aspx, using a baby mattress that is firm, flat, well-fitting, clean and waterproof on the outside, and that the mattress is covered with a single sheet. Parents are advised not to use duvets, quilts, baby nests, wedges, bedding rolls or pillows. I hope this information is helpful. E DOYLE-PRICE
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