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

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