Source · Prevention of Future Deaths

Savannah-Rose Owen

Ref: 2018-0367 Date: 22 Nov 2018 Coroner: Alison Mutch Area: Manchester (South) 2 responses identified · 2 indexed addressees View PDF

AI-generated concerns summaryThe coroner noted concerns regarding the absence of specific safety regulations for multi-purpose nursing pillows, which led to inconsistent warnings. The product's warning label was not attached, and some leaflet images could mislead parents about leaving babies unattended on the pillow.

Date 22 Nov 2018
56-day deadline 5 Jul 2019 est. estimated from the Judiciary.uk publication date
Responses identified 2 of 2
Child Death (from 2015) Product related deaths

Coroner's concerns

AI summary
The coroner noted concerns regarding the absence of specific safety regulations for multi-purpose nursing pillows, which led to inconsistent warnings. The product's warning label was not attached, and some leaflet images could mislead parents about leaving babies unattended on the pillow.
View full coroner's concerns
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 warninglinformation 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 babieslyoung children such as high chairslcots 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/ Midwivves 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 warninglinformation 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 resalel recycling of baby items this meant that second hand userslpurchasers were unlikely to see the warning:

Responses

2 respondents

Department for Business Energy Industrial Strategy

Central Government
Indexed date: 22 Nov 2018 PDF
AI-classified response stance Action Planned
AI-generated response summary

• The Minister referred the concerns regarding the nursing pillow to the Office for Product Safety and Standards (OPSS) Product Safety Enforcement Team. • The Minister requested that the Coroner provide further details of the specific product to OPSS to assist their assessment.

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Kelly Tolhurst MP Department for Business, Energy & Department for inidictoria Sireetegy London Business; Energy SW1H OET & Industrial Strategy +44 (0) 20 7215 5000 engulres@beis govuK W #MWgQKuk Alison Mutch OBE HM Senior Coroner Our ref: #eee Coroners Court Mount Tabor Street (C December 2018 Stockport SK1 3AG RECEIVED ` 2 4 DEC 2018 Qocl/ Ms Muleh Ch 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): would first like to say how sory 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, s0 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 product which 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 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. ` ` they

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 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 infomation that would assist their assessment, would be grateful if you could 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 Yors Sncoily KELLY TOLHURST MP Minister for Small Business, Consumers & Corpfrate Responsibility they pass

Department of Health Social Care

Central Government
PDF
AI-classified response stance Noted
AI-generated response summary

• Health visitors and midwives receive training on Sudden Infant Death Syndrome (SIDS) and advise parents on safe sleep environments, including the use of nursing pillows. • Public Health England (PHE) and The Lullaby Trust jointly published guidance in March 2018 to help parents make safer choices for sleeping products. • PHE and The Lullaby Trust are developing new resources and co-producing information sheets for parents and professionals to describe the evidence base for safer sleep spaces.

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From Jackie Doyle-Price MP Parliamentary Under Secretary of State for Mental Health; Department Inequalities and Suicide Prevention of Health & Social Care 39 Victoria Street London SW1H OEU RECEIVED 020 7210 4850 Your Ref: 10179/CH 16 JAN 20,3 Our Ref: PFD-1158107 CH Ms Alison Mutch OBE HM Senior Coroner; Manchester South HM Coroner's Court 1 Mount Tabor Street Stockport Joualy 20/9 SKI 3AG Jeov L Mutz Thank you for your correspondence of 22 November to Matt Hancock about the death of Savannah-Rose Michelle Owen: Iam replying as Minister with responsibility for child health: Ihave 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, 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) Idfa Energy

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 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 ofhow to reduce the risk of SIDS. The campaign this runs 1[-17 March 2019. PHE is working with The Lullaby Trust to develop new resources that will be showcased during Safer 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 inforation online, including to the Lullaby Trust'$ website. In addition, the NHS Choices website contains factsheets on minimising the risk of SIDSJ4, that include the importance of https: www lullabytrust org uk/wp-contenUuploads[The-Lullby-Trust-Produc_-Guideapdf https: WWML nhsuklstartdlife http: _ Www nhs uklconditions sudden infant-death-syndromelpages/introduction aSpX http:l www nhs uklconditions pregnancy-and-babv pageslreducing-risk-cot-deathaspx: key - year Sleep

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 [ hope this information is helpful. TO JACKAE DOYLE-PRICE

Report sections

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 17th 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:

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Report details

Reference
2018-0367
Date of report
22 November 2018
Coroner
Alison Mutch
Coroner area
Manchester (South)

Responses identified

Responses identified 2 of 2
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 5 Jul 2019 (estimated from the Judiciary.uk publication date).

Sent to

Department for Business
Department of Health and Social Care

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