Dear Ms Burke Re: Regulation 28: Report to Prevent Future Deaths Thank you for your letter of 21 July 2017. Safety is of paramount importance to the consumer healthcare industry and we are extremely concerned about incidents where emollient creams and ointments have been found to have contributed to the intensity of accidental fires with grave and fatal consequences PAGB, together with member companies that manufacture emnollient medicires and medical devices, acknowledges the seriousness of this situation and we are committed to what we can to address the concerns you raise in your letter and ensure people are aware of the potential risks_ Paraffin-containing emollient products are the first line of treatment for helping people manage dry or scaly skin conditions , such as eczema and psoriasis_ When severe , these conditions can be highly debilitating and it is important for people to have access to effective emollients to manage these conditions. Paraffin based oils such as liquid paraffin and white soft paraffin have been carefully chosen for use in emollients because extensive clinical experience has shown these particular ingredients to be effective for softening and moisturising medically dry skin conditions and are well tolerated by sensitive skin. It is important to note that paraffin-containing emollients are not flammable in and of themselves_ However; repeated applications of larger quantities of these products can lead to a build-up of residue on clothing and bedding, which results in the fabric becoming more flammable: If an individual is then subsequently exposed to a naked flame, for example a lighted match or cigarette, there is an increased risk of fire_ Having considered the issues raised in your letter, PAGB and its member companies have identified three areas where we feel we have a role to play in reducing the likelihood of future incidents. By ensuring there is an accurate and meaningful warning statement on product packaging 2 By helping to effectively communicate the potential risk to consumers, healthcare professionals and care workers Registered Address: Vernon House Sicilian Avenue London WCIA 2QS Telephone 020 7242 8331 Fax 020 7405 7719 info@pagb.co.uk www_pagb.co.uk Proprietary Association of Great Britain is a Company Limited by Guarantee and Registered in England Registration No. 375216 doing

3. By providing Information and evidence t0 the reguiator, the Meaicines ana Healthcare products Regulatory Agency (MHRA) wiil adaress these points in turn: 1, Accurate and meaningful warning statement PAGB and its member companies recognise that clear information needs to be made available to warn of the risk of increased flammability of clothing and bedding which has been in contact with paraffin-containing emollients In addition to ensuring warning statements are included on the packaging of all appropriate products, it is imperative that these warnings are consistent as well as clear and meaningful to members of the public who will read them PAGB has been working with its member companies to develop wording which we will submit for user-testing to ensure its clarity_ User-testing is a vital part of this process: It is important that users are involved in the drafting of any waming statements, such that we can be confident they will be clearly understood when placed on packaging Following the results of user-testing, PAGB will work with MHRA to ensure there is consistency in implementation of a standard warning for packaging and patient information leaflets_ PAGB requested a meeting with MHRA to discuss this process in May 2017, we have been given the opportunity to make a written submission to the agency, which we will do by 30th September 2017 and we hope to have the opportunity to meet with MHRA officials thereafter.
2. Communicate the potential risk effectively The Coroner's report of Mrs Taylor's accidental death highlights that repeated advice of the fire hazards from healthcare professionals and family members was ignored It is therefore important that; in addition to the inclusion of an appropriately worded warning on packaging and on patient information leaflets, the risk is adequately communicated to healthcare professionals, care workers and other professional groups_ PAGB will continue to work collaboratively with MHRA, Fire Brigades and other stakeholders to ensure there is clear and consistent communication, and those health and care professionals have appropriate information on how to minimise and manage the risk with their patients.
3. Provide information and evidence to MHRA PAGB member companies have already submitted data on adverse events associated with paraffin-containing products to the MHRA review; which is currently underway: PAGB has been advised that following this MHRA review, expert advice will be sought from the Commission on Human Medicines (CHM), the timescale for this is autumn 2017 _ As mentioned previously, PAGB will be providing a written submission to the CHM (via MHRA) by 30 September 2017 and we hope to have the opportunity to meet with MHRA officials after that date_ To conclude, would like to reassure you that together with our member companies, we are taking this issue seriously and working hard to ensure we take all the appropriate actions we can as an industry to prevent future incidents from occurring_ key

Please do not hesitate to contact me if you have any further questions or require any additional information _

Dear Ms Burke Regulation 28 Report concerning Pauline Taylor Ref: HK/1O67-2015 Thank You for your letter of 21July 2017 , with the attached Regulation 28: Report to Prevent Future Deaths, to the MHRA regarding the death of Pauline Taylor: This response deals with medical device aspects, relating to both the issues raised regarding emollients and mattresses: A response dealing with the medicines aspects of emollients will be supplied to you separately, in line with your request: As you may be aware; The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health. The aim of the MHRA Devices Division is to take all reasonable steps to protect the public's health and safeguard the interests of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union: One major area of MHRA Devices' responsibilities is the investigation of adverse incidents An adverse incident is an event involving a medical device, which produces, or has the potential to produce, unwanted effects involving the safety of patients, users and other persons. These effects may arise from shortcomings in device, its operating instructions, user practice or conditions of use We have addressed the points relevant to medical device aspects in our response below: MHRA received the first adverse incident reports of fires involving emollients in March 2017. However; we were aware of the work undertaken by the National Patient Safety Agency (NPSA) in 2007 and highlighted this work to healthcare workers when it was published. In the form of a "One Liner" publication in March 2008, issue 56. Since that time, as no adverse incident reports were received, it was not considered necessary to issue any further communication It is recognised that there are differences in the labelling of these products and in light of this 2017 , both Medicines and Devices parts of MHRA are undertaking an in-depth review of instructions for use and reported adverse incidents_ the during

Medicines & Healthcare products MHRA Requlating Medicine; and Hedical Devices Regulatory Agency We aim to have completed our review by the end of 2017 and will consider the need for publication of any additional safety advice at this time in conjunction with our medicine colleagues. Additionally; we have worked with manufacturers to raise awareness of this potential risk. This work highlighted the need for risk of fire to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in the device's instructions for use We have previously issued warnings regarding the dangers around smoking and bed fires (MDA2013/073). Medical devices must be CE marked before are placed on the market in the UK and throughout the EU. MHRA's expectation is that; when CE marking and placing a medical device on the market, manufacturers will have evaluated the potential risks that could occur; including that of The CE mark demonstrates that the medical device is fit for its stated intended purpose and meets legislation relating to safety: This requires the manufacturer t0 demonstrate their medical device meets the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment. Additionally, higher risk medical devices require certification from a third party conformity assessment body ("Notified Body") prior to placed on the market; MHRA is responsible for the oversight of UK Notified Bodies and has a post-market role in investigating reported safety issues. Emollients may fall into any of the risk classes according to their constituents and mode of action. The paraffin content of these products varies over a wide range, also, from as little as 5%, in some cases and has no bearing on whether the product is classed as a device or as a medicine This difference is due to their mode of action_ In Spring 2017 MHRA wrote to UK manufacturers of Class medical devices (the lowest risk category) directly and asked them to undertake a review of their products. In addition; we asked the UK Notified Bodies to ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification medical devices_ We also brought the issue to the notice of European regulatory colleagues to highlight the dangers internationally: AIl European Competent Authorities were asked to share the letter mentioned above with Notified Bodies they oversee to ensure coverage of all manufacturers with products in the European market The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs): The latter are individuals in each NHS Trust in England who ensure safety information is made available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers to users within the care community: The therapeutic benefits of the mattress system will generally have been found to outweigh the likelihood and consequences of a fire, in part mitigated by the labelling and instructions for use, advising against smoking or using naked flames whilst in bed. Polyurethane (PU) is the industry standard cover material on most types of healthcare mattress, including pressure reduction mattress systems, such as the ArjoHuntleigh Nimbus 3. The cover they : fire. being

Medicines & Healthcare products MHRA Regulating Medicines and Medkal Devices Regulatory Agency material of healthcare mattresses has to withstand heavy use, must be impervious to liquid ingress and withstand frequent exposure to decontamination agents. MHRA has contacted the manufacturer, ArjoHuntleigh, to confirm that their current risk mitigation factors are appropriate. This includes meeting the standard BS7175:1989, (Methods of test for the ignitability of bedcovers and pillows by smouldering and flaming ignition sources) and the product labelling and instructions for use, which contain the warning about fire risk MHRA is continually reviewing methods of communicating important healthcare information to healthcare professionals and members of the public. However, communication t0 the general public is a challenging area for all aspects of healthcare. The MHRA does publish Medical Device Alerts and Drug Alerts issued via the Central Alerting System (CAS) Within CAS there are thousands of subscribers from organisations in the independentlprivate sectors, with frequent requests received at the helpdesk to add new subscribers and alter existing records This is a well-established and effective mechanism for communicating important safety information to healthcare professionals throughout the NHS and private health sectors.

Dear Ma'am INQUEST TOUCHING UPON THE DEATH OF PAULINE TAYLOR DECEASED REGULATION 28 REPORT RESPONSE Thank you your letter dated 21 July 2017 attaching the Regulation 28 report to prevent future deaths that you issued following the conclusion of the Inquest you held touching upon the death of Pauline Taylor: This is the Response of Locala Community Partnerships. As an organisation we have considered the content of your report very carefully. We note that at section 5 you have raised number of matters of concern relating to zerobase and other emollient creams which whilst containing potentially relatively low level of paraffin, still pose a potential fire hazard risk We note the recommendations concerning warnings on the packaging and to members of the public at large, who as you note are able to purchase many such creams over the counter. Locala would support the raising of awareness in this area and if it is permissible, would be interested to see the responses that you obtain from the other recipients of your Regulation 28 report that have a broader remit. Within Locala; we have undertaken work to share the learning from this case in relation to the risks posed by any cream, lotion or other substance that contains any amount of paraffin. As was evident from the evidence given at the Inquest there are potentially a large number of such products that are regularly in use_ In 2017, within our monthly medicines management report that goes to all business units, we specifically raised the issue concerning paraffin containing skin products and made reference to a guidance document produced by the South West Yorkshire Area Prescribing Committee, advising staff this must be adhered to when prescribing or treating patients with paraffin based emollients_ The Prescribing Committee's advice note was attached to our medicines update and a copy of this is attached. In particular; this document identifies that any paraffin containing product poses a risk, regardless of the amount of paraffin contained within it; for Jou, locally Locala Community Partnerships CIC. INVESTORS Registered Office: Beckside Court, Bradford Road, Batley; WF17 SPW NHS Registered in England and Wales: Company No: 07584906 O15abl s IN PEOPLE for May Caring

This does represent a shift in emphasis as compared some previous guidance that had been issued about paraffin containing products. This advice note has been disseminated within Locala: Training has also been updated to include reference to this latest guidance note regarding the use of paraffin based products and the use of such products now forms part of the risk assessment that has to be completed when requesting any air products from the supplier, Medequip. This issue has also been discussed within team meetings amongst community nursing staff. This has also included warnings concerning service users that use an air mattress, where the risk is further heightened: When Locala shares care of service users that are within a residential home there is a prompt on the form that has to be completed in relation to assessment of an individual's skin the prompt tells staff to ensure appropriate fire risk assessments have been completed and the risk discussed with any patient that smokes, uses an air mattress andloremollients. Locala Live is a bulletin that goes to all staff and the Area Prescribing Guidance was also attached to this bulletin via a link, with a note advising staff of the risk associated with skin products containing paraffin. Staff were reminded relevant service users need to be advised of the risks Additionally, we are piloting a project in the Dewsbury locality where we are evaluating the use of non-paraffin based emollients as alternatives to those with paraffin. Local GPs are being involved and this project is to be evaluated in October 2017 . Many of these points are encapsulated on the attached action plan. There were two further specific concerns raised, at points 8 and 9 of the Regulation 28 report; concerning the fact no further risk assessment had been undertaken following significant change in the Deceased's circumstances as at March 2015. It is perhaps noteworthy that the Deceased s underlying medical condition had not deteriorated as such, but it is acknowledged that there was a gradual change in her preferences in terms of the fact that whilst still being encouraged from time to time to leave her bed; the Deceased very largely preferred to remain within her bed in her last weeks_ There was no further specific risk assessment around March 2015. We note the evidence at the Inquest concerning the Deceased's capacity for decision making and also the acknowledgement that professional staff and family members were continuing to raise with the Deceased the dangers associated with her continued smoking of cigarettes in her bed. The first two points on the action plan seek to address the issue you have raised concerning further risk assessment: the action Locala will seek to achieve is that further risk assessments will be completed on all patients who smoke andlor have emollients in use with or without air products, at any stage where there is change in their physical, physiological or mental health condition or circumstances, and a change in their environment or habits as a result: In addition, a flowchart is being designed to enable staff to identify patients that are deteriorating with changing circumstances and documentation and training is worked up to implement this throughout theorganisation. for gou, locallv being- Caring

In relation to undertaking further risk assessments records are being audited to see that this happening; and situations are not being missed, and this is being managed through the community nursing team leaders group: They are responsible within their teams for ensuring staff understand the need for further risk assessment when circumstances change: May thank you again for raising these matters. CQC have contacted us concerning the Regulation 28 report and we trust that it is in order that we have provided them with a copy of this response and our action plan:

Dear Re: Pauline Taylor, deceased Thank you for your letter of 21 July enclosing a report sent under the provisions of Regulation 28 of the Coroners (Investigations) Regulations 2013. can confim that the NHS Patient Safety Team was in fact notified of Mrs Taylors tragic death in 2015 by the local fire safety officer. Considerable work has subsequently been undertaken by the team in conjunction with the Medicines and Healthcare Regulatory Agency (MHRA) and other organisations in response to the concerns you describe in your report. The actions taken in response to Mrs Taylor's death were included in the Patient safety review and response report (page 17) published by NHS Improvement in June 2017 . am enclosing a copy of the Report for ease of reference_ am grateful to you for bringing this matter to my attention and hope this response is helpful:

MTR United Kingdom Homecare Association The professional association for homecare providers UKHCA- UNITED KINGDOM HOME CARE ASSOCIATION coroners Office The Courts Bradford BD1 1LA Your ref: August 2018 Pauline Tavlorzdeceased_Report to prevent further deaths Thank You for your contact with this office regarding the above. This organisation is aware of the circumstances of Pauline Taylor's death and would like to extend our condolences to members of her family. Ican confirm that United Kingdom Homecare Association has made the following information available to homecare providers (most recent first):
1. A fact sheet, "UKHCA Guidance; Emollient Products Guidance for homecare providers" was prepared for UKHCA by London Fire Brigade and published in January 2018. It can be downloaded http;LLwww ukhca co.ukldownloads,aspx?ID-565. A copy is enclosed 2 An article, "Fire Chiefs issue warning on dangers of emollient creams" was published in the November 2017 issue of our bi-monthly magazine, "Homecarer"_ The magazine has a print circulation of around 3,000 copies and further 4,000 copies are send in PDF format: A copy is enclosed (please see pages 8 and 9).
3. An e-mail briefing was sent to around 2,000 of our member organisations entitled "Fatality highlights fire risks of using paraffin-based emollient" in June 2016. The text of this briefing is reproduced at the end of this letter. Page 1 UKHCA, 020 8661 8188 enqulresuiukhca co uk @@ukhca Sutton Business Centre; Restmor Way; Wallington , Surrey SM6 7AH 020 8669 7100 membershipoukhca co uk WWW ukhica co.uk United Kingdom Homecare Association Limited Registered in England under number: 03083104 Registered Office: Sutton Business Centre, Restmor Way; Wallington, Surrey SM6 7AH 0 8 AVG 2018' City from

Text Of e-maii alert sent to UKHCA members, June 2016 Fatality_highlights fire risks of using paraffin-based emollient A coroner's accidental death review has highlighted the dangers of using E45 emollient, which is highly flammable (although this Is not displayed on the packaging). In the case In question, the deceased was smoking in bed and the Fire Officer considered that, as the bedding and clothing were covered in E45 residue; the emollient acted as an accelerant; increasing the intensity and speed with which the fire took hold, NHS England's helpful note on the coroner's review includes points for action and learning for professional staff involved in patient or client care. (Thank you to Westminster Homecare for drawing this to our attention:) We suggest that homecare providers caring for service users who use E45 or another paraffin-based emollient (prescribed or not) risk assess and discuss switching to a non-Inflammable alternative with their community pharmacist, where appropriate. More about emollients: http:LLWWW nhs uklconditionslemollients/Pages/Introduction aspx Page 3 key