Recurring concern

Inadequate controls for fire risks from paraffin-containing emollients

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First reported 11 Aug 2015•Latest report 12 Aug 2025

Definition

What this concern includes

Includes controls specifically dedicated to preventing, warning about, recognising or managing fire risks from paraffin-containing or low-paraffin emollient products, including product and prescription warnings, communication to patients and carers, healthcare-professional and care-home awareness, and related fire-safety advice.

Not included

  • Excludes general product-safety warnings where the asserted hazard is not fire risk from paraffin-containing emollients.
  • Excludes generic fire-safety, medication-safety or healthcare communication deficiencies that are not specifically tied to paraffin-containing emollient fire risks.
  • Excludes fire hazards from non-emollient products, including unrelated medicines, appliances and household chemicals.
  • Excludes failures in treating burns or responding to a fire after the emollient-related fire risk was adequately identified and controlled.
Reports
7

Distinct published reports

Individual concerns
19

A report can raise multiple concerns

Date range
2015–2025

First to latest report issue date

Stated actions
55

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Care Quality Commission3
Department of Health and Social Care3
National Fire Chiefs Council3
NHS England3
Medicines and Healthcare products Regulatory Agency2
Proprietary Association of Great Britain2
Alliance Pharmaceuticals Limited1
Arjo UK Limited1
Bayer plc1
Bradford District Care NHS Foundation Trust1
British Medical Association1
Homecare Association Limited1
Home Office1
Locala Community Partnerships C.I.C.1
National Institute for Health and Care Excellence1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. South Yorkshire (Eastern)

    AI-generated summary

    James William Rownsley · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    James William Rownsley died at home on 20 February 2025 after his clothing caught fire when he was sitting close to a gas fire. Emollient cream on his clothing was identified as a significant factor, contributing to the intensity and rapid development of the fire. The principal concerns were inadequate awareness and communication among professionals and the public about the ignition risks of emollient creams, and weaknesses in reporting deaths involving such creams.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Heightened emollient cream fire risk when elderly or lower-income people use alternative methods to heat their homes

    Wider context from the report

    “5. The risk seems to be heightened in situations where elderly persons or persons of lower income are using such methods to heat their homes to avoid the cost of putting central heating on of the entire property. ”

    Source location

    James William Rownsley · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Embed emollient fire-risk assessment and messaging within the Person-Centred Home Fire Safety Framework and Home Fire Safety Visits.

    Verbatim wording from the response

    “In 2020, NFCC partnered with MHRA to launch the joint national campaign 'Know the Fire Risk', supported by a multi-agency stakeholder group including fire services, clinicians, and academics. This campaign remains active and has recently been enhanced with new training materials, including a video titled 'Reducing Risk: Information for Carers and Support Workers'. In 2025, the Care Quality Commission (CQC) and the Homecare Association issued updated guidance to health and care providers on the safe use of emollients. NFCC has also embedded emollient-related fire risk into the Person-Centred Home Fire Safety Framework, which underpins prevention activity across all UK fire and rescue services.”

    Source location

    Response from National Fire Chiefs Council
    Page 1 · response
    Published 29 August 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Highlight emollient fire risk during winter preparedness campaigns for 2025/26.

    Verbatim wording from the response

    “We continue to recognise the heightened risk in vulnerable households, particularly among elderly residents, low-income families, and those using alternative heating methods. NFCC has embedded emollient fire risk into the Person-Centred Home Fire Safety Framework, and we will ensure this risk is highlighted during winter preparedness campaigns for 2025/26.”

    Source location

    Response from National Fire Chiefs Council
    Page 3 · response
    Published 29 August 2025

    Open published response
  2. Staffordshire South

    AI-generated summary

    MAUREEN MILTON · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Maureen Milton, aged 74, died after her clothing caught fire while she was attempting to light a cigarette with a long match; petrol-based emollient cream on her clothing likely accelerated the fire, and she was pronounced dead at the scene. The principal concern was a lack of awareness among medical professionals, carers, victims and families about the fire risks associated with petrol-based emollients.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Fire ignition of clothing impregnated with petrol-based emollient cream

    Wider context from the report

    “Evidence given by fire investigators was that they are increasingly attending fires involving (mostly) the elderly where there is evidence of petrol based emollient cream in use. The petrol base is found in a significant number of prescribed creams and creams (such as moisturisers) which are readily available over the counter. This cream impregnates clothing and is not washed away during a normal washing programme. In the event of a fire the victim is rapidly engulfed by flames with little chance of survival. The cause of death is generally burns, not inhalation of smoke. The concern is the lack of awareness of this problem by medical professionals, carers, victims and their families. It is felt appropriate heighten awareness of this growing problem amongst health professionals and others who work in the field of prescribing such creams and those caring for patients using petrol based emollients. ”

    Source location

    MAUREEN MILTON · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Oversight of medicine and medical-product safety and product labelling falls outside the respondent’s role.

    Verbatim wording from the response

    “NICE does not have a role in overseeing the safety of medicines and medical products, or in ensuring appropriate warnings on the labels of such products. In the UK, this is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). In addition, NICE does not have a role in running safety awareness or educational campaigns aimed at professionals or patients and carers. The responsibility for this would rest with organisations such as the MHRA and other healthcare regulators, professional bodies and voluntary organisations and charities.”

    Source location

    2019-0396-Response-by-NICE
    Page 1 · response
    Published 28 December 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The MHRA is responsible for medicine and medical-product safety oversight and ensuring appropriate product warnings.

    Verbatim wording from the response

    “NICE does not have a role in overseeing the safety of medicines and medical products, or in ensuring appropriate warnings on the labels of such products. In the UK, this is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). In addition, NICE does not have a role in running safety awareness or educational campaigns aimed at professionals or patients and carers. The responsibility for this would rest with organisations such as the MHRA and other healthcare regulators, professional bodies and voluntary organisations and charities.”

    Source location

    2019-0396-Response-by-NICE
    Page 1 · response
    Published 28 December 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing prescriber information and warnings about emollient fire risks are considered adequate, leaving nothing specifically to add.

    Verbatim wording from the response

    “We consider that appropriate information and warnings are available to prescribers regarding the risks of fire associated with the use of paraffin-based emollient products, and that there is nothing specifically NICE can do to add to this. As explained above, an awareness or educational campaign for professionals, patients or carers on this important issue would not fall within our role.”

    Source location

    2019-0396-Response-by-NICE
    Page 2 · response
    Published 28 December 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    MHRA is better placed to respond to risks involving petroleum-based emollients and skin creams because they are medicines.

    Verbatim wording from the response

    “We have reviewed the report and Public Health England have no comments to add as the report refers to the risks of petroleum-based emollients/skin creams which have been implicated in fire deaths prescribed to the elderly, as they act as an additional fuel.”

    Source location

    2019-0396-Response-by-Public-Health-England
    Page 1 · response
    Published 28 December 2019

    Open published response
  3. London (West)

    AI-generated summary

    Kevin Freely · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Kevin Freely, aged 61, died at home on 12 October 2016 after a lighted cigarette caused his bedclothes to catch fire while he was bedbound and unable to escape. The principal concern was that warnings about the fire hazard associated with paraffin-based emollient skin products were not being heeded by patients and care organisations providing care in people’s homes.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure by patients and care organisations to heed safety guidance on fire hazards from paraffin-based skin products

    Wider context from the report

    “The NHS National Patient Safety Agency brought out a Rapid Response Report 4 on 26th November 2007 entitled “Fire hazard with paraffin based skin products on dressings and clothing”. I am concerned that this message within the 2007 Safety Report is not being heeded by patients and Care Organisations responsible for caring for patients in their own homes. ”

    Source location

    Kevin Freely · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report
  4. West Yorkshire (Western)

    AI-generated summary

    Brian Leonard Bicat · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Brian Leonard Bicat sustained severe burns at home on 22 September 2017 when his dressing gown caught fire while he was smoking a cigarette. He died later that day from his extensive cutaneous burns, with evidence indicating that paraffin-based emollient creams and ointments increased the speed and intensity of the fire. The principal concerns were that low-paraffin emollients may pose a fire hazard, that warnings were not displayed consistently on packaging or communicated by healthcare professionals, and that related prescribing alerts and incident data were inconsistent or incomplete.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases

    Wider context from the report

    “Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given ”

    Source location

    Brian Leonard Bicat · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams

    Wider context from the report

    “Health care professionals in both hospital and community setting may not be aware of the potential fire hazard poised by emollient creams which contain a low level of paraffin ”

    Source location

    Brian Leonard Bicat · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Fire hazard from paraffin-based ointments and low-paraffin emollient creams

    Wider context from the report

    “Paraffin based ointments and emollient creams which contain a low level of paraffin pose a potential fire hazard risk ”

    Source location

    Brian Leonard Bicat · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Update personnel communicating with healthcare professionals and the public on the assessment outcome and subsequent labelling changes.

    Verbatim wording from the response

    “Any and all personnel in contact with healthcare professionals and the general public will be updated appropriately to ensure communications are in line with, and convey, the correct message which communicates the outcome of the assessment and any subsequent labelling changes.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Issue safety reminders and warnings to healthcare professionals about fire risks from paraffin-based emollients.

    Verbatim wording from the response

    “In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency (NPSA) in 2007. This reminder was in the form of a “One Liner” which was published in issue 56. Since, at that time, as no adverse incident reports had been received, it was not considered necessary to issue any further communication.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Raise emollient fire risks with NHS Improvement, Medical Device Safety Officers and the Care Quality Commission for communication to relevant care staff and users.

    Verbatim wording from the response

    “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.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Produce and disseminate a fire hazard poster on paraffin-based products across clinical service areas and organisational communication channels.

    Verbatim wording from the response

    “2. The Trust has produced a fire hazard poster in relation to using paraffin-based products, which has been disseminated for display throughout clinical services areas and this has also been communicated electronically across the organisation.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Upload the leaflet and poster to the NHSI improvement hub and disseminate them nationally through NHSI.

    Verbatim wording from the response

    “3. The leaflet and poster have been uploaded onto the NHSI improvement hub website under the heading of patient safety. Communication has been undertaken with the Trust’s lead for CCG and NHSI. Work has been undertaken to disseminate this information nationally through NHSI.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Raise staff awareness of emollient risks and include the issue in all fire training.

    Verbatim wording from the response

    “4. Awareness has been raised with all staff within Bradford District Care Foundation Trust and this issue is included in all fire training.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Repeat staff awareness surveys every six months to identify concerns about emollient hazards.

    Verbatim wording from the response

    “6. The Trust has undertaken a survey of staff’s awareness of the hazards of emollients. This survey will be undertaken six monthly and any areas of concern will be addressed following the results”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Display emollient risk messages on Trust screens and repeat the messages twice yearly.

    Verbatim wording from the response

    “9. The message regarding the risks of using emollients have been shown on the Trusts computer screens on Screen savers. This will be repeated on a bi-annual basis within BDCFT to ensure that the risk of emollients remain paramount.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Maintain liaison with the Fire Service to update teams on laundering evidence and ongoing emollient hazards.

    Verbatim wording from the response

    “10. The fire officer for BDCFT will continue to liaise with the Fire service to ensure all teams are updated on the most recent evidence regarding the laundering of clothes and the ongoing hazards of emollients.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Write to manufacturers to include emollient fire risks in product risk analyses and provide packaging or instructions-for-use warnings.

    Verbatim wording from the response

    “However, in addition, we have written to manufacturers to raise awareness of this potential risk. This highlighted the need for the 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 (MDA/2013/073).”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Request UK manufacturers to review Class I devices and require Notified Bodies to ensure higher-risk devices undergo manufacturer review and risk assessment.

    Verbatim wording from the response

    “Working in collaboration with colleagues in the medicines regulatory part of the Agency in Spring 2017 MHRA Devices wrote to UK manufacturers of Class I 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.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Notify European regulatory colleagues and request dissemination to Notified Bodies overseeing manufacturers supplying the European market.

    Verbatim wording from the response

    “We also brought the issue to the notice of European regulatory colleagues to highlight the dangers internationally. All European Competent Authorities were asked to share the letter mentioned above to, with Notified Bodies they oversee to ensure coverage of all manufacturers with products in the European market.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review evidence on risks from paraffin-containing medicines and devices and obtain ad hoc Expert Group recommendations on appropriate regulatory action.

    Verbatim wording from the response

    “In response to more recent evidence regarding the risk with emollient products paraffin, including a number of fatalities reported since 2017 (many of which were historical), MHRA is reviewing the available evidence regarding the risk for a wider range of paraffin-containing medicines and devices and has convened an ad hoc Expert Group to advise on the appropriate regulatory action for both medicines and medical devices.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Produce and disseminate a patient safety leaflet on paraffin-based products and laundering clothing and bedding.

    Verbatim wording from the response

    “1. The Trust has produced a safety information leaflet for patients in relation to using paraffin-based products, in particular regarding the laundering of clothing and bedding. This leaflet has been disseminated locally across all Bradford Clinical Commissioning Groups and A cute Trust providers and Leeds Community Services.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Create a SystmOne alert identifying patients at risk when emollient treatment is entered in the clinical record.

    Verbatim wording from the response

    “5. An alert has been created on our clinical records system, SystmOne. This is an electronic icon indicating that a patient is at risk when emollient is entered into the clinical record.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Conduct annual community nursing audits of leaflet distribution and documented discussions of emollient hazards with patients.

    Verbatim wording from the response

    “7. A yearly audit will be undertaken within all community nursing services within BDCFT to demonstrate that staff distribute the safety leaflets on initial contact of patients who are prescribed emollients. The audit will also demonstrate that there is documented evidence of discussion by staff with patients regarding the hazards of emollients.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Provide existing community nursing patients with safety leaflets and advice about emollient risks.

    Verbatim wording from the response

    “8. A piece of work has been completed by the community nursing services to ensure that all existing patients have the relevant patient information leaflet and advice has been given by staff to patients regarding the risks of using emollients.”

    Source location

    2018-0277-Response-by-Bradford-District-Care-NHS-Trust
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Other recipients of the report will address concerns about healthcare warnings, prescribing systems, incident data and fire-safety training.

    Verbatim wording from the response

    “Bayer's response to items 1-5 is provided below. We understand that other recipients of the Report will address items 6-12.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 4 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    No further communication was considered necessary in 2008 because no adverse incident reports had been received.

    Verbatim wording from the response

    “In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency (NPSA) in 2007. This reminder was in the form of a “One Liner” which was published in issue 56. Since, at that time, as no adverse incident reports had been received, it was not considered necessary to issue any further communication.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response
  5. West Yorkshire (West)

    AI-generated summary

    Pauline Taylor · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Pauline Taylor, who was bedbound and living alone, died in her home after a fire developed around her bed on 30 May 2015. The report identified concerns about the fire risks of low-paraffin emollient creams, limited warnings and awareness of those risks, the contribution of the airflow mattress, and the absence of a further risk assessment after her circumstances changed.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Potential fire hazard from low-paraffin emollient creams

    Wider context from the report

    “(1) Zerobase and other emollient creams which contain a low level of paraffin pose a potential fire hazard risk. ”

    Source location

    Pauline Taylor · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to verbally inform over-the-counter purchasers of fire hazards from low-paraffin emollient creams

    Wider context from the report

    “(4) Members of the public are able to purchase emollient creams across the counter but are not verbally made aware of the potential fire hazards of emollient cream containing a low level of paraffin. ”

    Source location

    Pauline Taylor · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of healthcare professional awareness of fire hazards from low-paraffin emollient creams

    Wider context from the report

    “(3) Health care professionals both in a hospital and community setting may not be aware of the potential fire hazard posed by emollient creams which contain a low level of paraffin. ”

    Source location

    Pauline Taylor · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of care-home awareness of fire hazards from low-paraffin emollient creams

    Wider context from the report

    “(6) Care homes (in both the local authority and private sector) who provide residential/nursing care may not be aware of the potential fire hazard risk of emollient creams which contain low levels of paraffin. ”

    Source location

    Pauline Taylor · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to display fire-risk warnings on all product packaging

    Wider context from the report

    “(2) Warnings of such risks are not displayed on all product packaging. ”

    Source location

    Pauline Taylor · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Develop consistent, clear warning wording for paraffin-containing emollient packaging and patient information.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-PAGB
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Submit proposed warning wording for user-testing to assess whether consumers understand it clearly.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-PAGB
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Work with the Medicines and Healthcare products Regulatory Agency to implement a consistent standard warning on packaging and patient information leaflets after user-testing.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-PAGB
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Continue collaborative work with the Medicines and Healthcare products Regulatory Agency, fire brigades and stakeholders to provide clear, consistent risk information to healthcare and care professionals.

    Verbatim wording from the response

    “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 key 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.”

    Source location

    2017-0330-Response-by-PAGB
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Provide healthcare and care professionals with information on minimising and managing emollient-related fire risks with patients.

    Verbatim wording from the response

    “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 key 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.”

    Source location

    2017-0330-Response-by-PAGB
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Undertake an in-depth review of emollient instructions for use and reported adverse incidents.

    Verbatim wording from the response

    “It is recognised that there are differences in the labelling of these products and in light of this during 2017, both Medicines and Devices parts of MHRA are undertaking an in-depth review of instructions for use and reported adverse incidents.”

    Source location

    2017-0330-Response-by-MHRA
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Consider publishing additional safety advice after completing the emollient review, in conjunction with medicines colleagues.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Work with manufacturers to raise awareness of emollient fire risks.

    Verbatim wording from the response

    “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 (MDA/2013/073).”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Ask manufacturers and notified bodies to review products and undertake relevant fire-risk assessments.

    Verbatim wording from the response

    “In Spring 2017 MHRA wrote to UK manufacturers of Class I 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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Notify European regulatory colleagues about emollient fire dangers and request wider circulation to relevant notified bodies.

    Verbatim wording from the response

    “We also brought the issue to the notice of European regulatory colleagues to highlight the dangers internationally. All 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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Raise emollient fire risks with NHS Improvement and Medical Device Safety Officers.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Liaise with the Care Quality Commission to highlight emollient fire dangers to care-community users.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Continue reviewing methods for communicating important healthcare information to healthcare professionals and the public.

    Verbatim wording from the response

    “MHRA is continually reviewing methods of communicating important healthcare information to healthcare professionals and members of the public. However, communication to 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 independent/private 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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 3 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Highlight published NPSA emollient-fire safety work to healthcare workers.

    Verbatim wording from the response

    “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 highlight 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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Issue warnings about smoking and bed-fire dangers through a Medical Device Alert.

    Verbatim wording from the response

    “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 (MDA/2013/073).”

    Source location

    2017-0330-Response-by-MHRA
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Disseminated updated guidance and warnings about fire risks from paraffin-containing skin products to staff and relevant service users.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Updated staff training to cover the latest guidance on paraffin-based products.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Added paraffin-product risk assessment to requests for air products from Medequip.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Discussed paraffin-product and heightened air-mattress fire risks in community nursing team meetings.

    Verbatim wording from the response

    “This issue has also been discussed within team meetings amongst community nursing staff. This has also included warning concerning service users that use an air mattress, where the risk is further heightened.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Pilot and evaluate non-paraffin emollients as alternatives in the Dewsbury locality with local GP involvement.

    Verbatim wording from the response

    “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.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish and make available guidance on emollient-product fire risks for homecare providers.

    Verbatim wording from the response

    “I can confirm that United Kingdom Homecare Association has made the following information available to homecare providers (most recent first):”

    Source location

    2017-0330-Response-by-United-Kingdom-Home-Care-Association
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish an article warning homecare providers about the fire risks of emollient creams through the member magazine.

    Verbatim wording from the response

    “I can confirm that United Kingdom Homecare Association has made the following information available to homecare providers (most recent first):”

    Source location

    2017-0330-Response-by-United-Kingdom-Home-Care-Association
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Send members an email briefing highlighting the fire risks of paraffin-based emollients.

    Verbatim wording from the response

    “I can confirm that United Kingdom Homecare Association has made the following information available to homecare providers (most recent first):”

    Source location

    2017-0330-Response-by-United-Kingdom-Home-Care-Association
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Added residential-care assessment prompts requiring fire-risk assessment and discussion with patients who smoke, use air mattresses or use emollients.

    Verbatim wording from the response

    “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 and/or emollients.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 2 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Warnings on emollient packaging and to the general public are matters for other recipients with a broader remit.

    Verbatim wording from the response

    “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 a number of matters of concern relating to zerobase and other emollient creams which whilst containing potentially a 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.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 1 · response
    Published 21 July 2017

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    No further communication was considered necessary because no adverse incident reports had been received since the earlier safety publication.

    Verbatim wording from the response

    “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 highlight 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.”

    Source location

    2017-0330-Response-by-MHRA
    Page 1 · response
    Published 21 July 2017

    Open published response
  6. Leicester City and South Leicestershire

    AI-generated summary

    Michael Holyoake · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Michael Holyoake, who was bed bound with a terminal and inoperable brain tumour, died after a fire at his home while he was being cared for there. The fire was thought most likely to have involved his lighter and E45 emollient residue on his bedding and clothing, which acted as an accelerant. The principal concerns were a lack of awareness of E45’s flammability and the absence of fire hazard warnings on its prescription or packaging.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Highly flammable paraffin-based product with ignition risk

    Wider context from the report

    “1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself. This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable, with the potential risk of ignition. ”

    Source location

    Michael Holyoake · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of fire-hazard warnings on E45 prescriptions and product packaging

    Wider context from the report

    “1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself. This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable, with the potential risk of ignition. ”

    Source location

    Michael Holyoake · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to communicate E45 fire hazards by GPs

    Wider context from the report

    “1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself. This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable, with the potential risk of ignition. ”

    Source location

    Michael Holyoake · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Issue advice to healthcare professionals explaining that paraffin-based emollients can act as accelerants when clothing or bedding becomes saturated.

    Verbatim wording from the response

    “The MHRA issued advice to healthcare professionals in 2008 to inform them whilst paraffin based emollients in themselves are not flammable they can act as accelerants when used in large quantities and patients' clothes or bedding become saturated with these products. A reminder article, reiterating that healthcare professionals should advise patients not to smoke or use naked flames whilst emollients are in contact with their dressings, clothing or bedding was issued in our publication Drug Safety Update in April 2016. This article was linked to support materials published by NHS Improvement along with details of how to report incidents of harm. The article is attached at annex A.”

    Source location

    Response from Chief Fire Officers Association and MHRA
    Page 2 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish a reminder advising healthcare professionals to warn patients against smoking or using naked flames near emollient-treated dressings, clothing or bedding.

    Verbatim wording from the response

    “The MHRA issued advice to healthcare professionals in 2008 to inform them whilst paraffin based emollients in themselves are not flammable they can act as accelerants when used in large quantities and patients' clothes or bedding become saturated with these products. A reminder article, reiterating that healthcare professionals should advise patients not to smoke or use naked flames whilst emollients are in contact with their dressings, clothing or bedding was issued in our publication Drug Safety Update in April 2016. This article was linked to support materials published by NHS Improvement along with details of how to report incidents of harm. The article is attached at annex A.”

    Source location

    Response from Chief Fire Officers Association and MHRA
    Page 2 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Update the British National Formulary to identify the fire risk associated with predominantly paraffin-based topical medicines.

    Verbatim wording from the response

    “Separately the British National Formulary has been updated to make reference to this risk of fire with predominantly paraffin based topical medicines so that healthcare professionals could be alerted.”

    Source location

    Response from Chief Fire Officers Association and MHRA
    Page 2 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Add fire-risk label warnings to emollient products containing predominantly paraffin-based ingredients.

    Verbatim wording from the response

    “In 2009 on the basis of the evidence available at the time, the MHRA added label warnings to those emollient products which included predominantly paraffin based ingredients to warn patients and carers of the risks if used in large quantities of acting as an accelerant. The warning statement which appears on the outer packaging is:”

    Source location

    Response from Chief Fire Officers Association and MHRA
    Page 3 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Take regulatory action to require similar fire-risk warnings on all emollient medicines, including aqueous-based products such as E45 Cream.

    Verbatim wording from the response

    “Aqueous-based products such as E45 Cream were not included in this review. In light of this case we will now take action to ensure all emollient medicines, including those aqueous based products such as E45 Cream carry a similar warning statement. We aim to have completed regulatory action by the end of the year and will accompany this with appropriate communications to relevant healthcare professionals including nurses to reinforce the warning and advice.”

    Source location

    Response from Chief Fire Officers Association and MHRA
    Page 3 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Inform BNF editors that fire-risk warnings should cover less concentrated aqueous paraffin-containing products.

    Verbatim wording from the response

    “The British National Formulary (BNF) is a widely used resource that contains essential information on the safe and effective use of medicines that are prescribed, monitored, supplied and administered to patients by healthcare professionals. The BNF already provides important safety information on fire hazard for paraffin based emollients such as emulsifying ointment, white soft paraffin 50% and liquid paraffin 50% ointment in their online and paper based publications. NHS Improvement have informed the editors of the BNF that the risk also applies to less concentrated aqueous based paraffin containing products, and the BNF will in future include a revised warning that will inform healthcare professionals of the risk applying to all paraffin containing products.”

    Source location

    2016-0163-Response-by-NHS-Improvement
    Page 3 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Communicate the fire risk to the Medication Safety Officer network for dissemination and organisational action.

    Verbatim wording from the response

    “NHS England and the MHRA have a network of Medication Safety Officers (MSOs) working within NHS trusts and other providers of NHS-funded healthcare. The role of MSOs is to ensure that systems are in place to improve medication safety. This risk will be communicated by NHS Improvement to this MSO network so the risk can be appropriately communicated and addressed within their organisations.”

    Source location

    2016-0163-Response-by-NHS-Improvement
    Page 3 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Ask care-sector organisations and professional bodies to communicate the fire risk through suitable newsletters and bulletins.

    Verbatim wording from the response

    “Whilst the MHRA Bulletin, the MSO network and the changes to BNF are helpful for healthcare professionals, including GPs, as you are aware, E45 cream® is widely available to the general public without prescription. The changes of labelling will be important to ensure awareness of the risk reaches people who buy E45 cream® without prescription. We appreciate that similar risks may apply even to substances sold as moisturisers when these are used by less mobile adults and children. As this vulnerable group may not always have routine contact with NHS staff we have asked the Care Quality Commission, the Royal College of Nursing, and networks within the care home sector to communicate the risk via suitable newsletter and bulletin articles.”

    Source location

    2016-0163-Response-by-NHS-Improvement
    Page 3 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Conduct an additional safety assessment and reassess flammability labelling across the E45 product portfolio.

    Verbatim wording from the response

    “Despite regularly assessing our products we have taken this tragedy as a reason to conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As a result of our safety review, we will be submitting an application to the MHRA to update the labelling to include guidance on potential flammability, of the following medicinal product:”

    Source location

    2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
    Page 1 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Submit an MHRA variation application to add flammability warnings and safe-use guidance to specified E45 medicinal and cosmetic products.

    Verbatim wording from the response

    “Despite regularly assessing our products we have taken this tragedy as a reason to conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As a result of our safety review, we will be submitting an application to the MHRA to update the labelling to include guidance on potential flammability, of the following medicinal product:”

    Source location

    2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
    Page 1 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Release the specified E45 medicinal and cosmetic products with revised labels containing flammability warnings and safe-use guidance.

    Verbatim wording from the response

    “The below warning will be added to the product labelling:”

    Source location

    2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
    Page 2 · response
    Published 27 April 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Communicate the expanded emollient warning and related safety advice to relevant healthcare professionals, including nurses.

    Verbatim wording from the response

    “Aqueous-based products such as E45 Cream were not included in this review. In light of this case we will now take action to ensure all emollient medicines, including those aqueous based products such as E45 Cream carry a similar warning statement. We aim to have completed regulatory action by the end of the year and will accompany this with appropriate communications to relevant healthcare professionals including nurses to reinforce the warning and advice.”

    Source location

    Response from Chief Fire Officers Association and MHRA
    Page 3 · response
    Published 27 April 2016

    Open published response
  7. West Sussex

    AI-generated summary

    John Hills · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    John Hills, a resident of a nursing home, suffered fatal burns after his clothing and blankets caught fire while he was smoking in the conservatory. The report raised concerns about the failure to ensure he was wearing his fire-retardant apron and about insufficient awareness, communication and prevention of the fire risks associated with paraffin-based emollient creams such as Cetraben, particularly in community care settings.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to review and address fire risks of lower-paraffin emollient creams

    Wider context from the report

    “(5) The NPSA carried a Rapid Response Warning (and report) on 26 November 2007 providing background and recommendations on the use of paraffin based products, but focused (as does the BNF) on (non-proprietary emollient preparations, specifically) emulsifying ointments or 50% plus paraffin content emollients. It is not clear whether this has been recently reviewed or whether the potential risk of lower % paraffin content creams has been considered and addressed. ”

    Source location

    John Hills · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of community information about paraffin-emollient ignition risk

    Wider context from the report

    “(7) Cetraben and Diprobase are proprietary emollient preparations in wide application in non-hospital environments, notably care homes, but also in private nursing and home care. It appears that there is little information conveyed or publicised about the potential risk of ignition/fire outside of hospitals or other clinical treatment areas, particularly where the cream is in frequent application and clothing (or bedding) has a high risk of becoming soaked or soiled by repeated application and contact. (8) I am concerned about the potential risks associated with Cetraben (and associated lower % creams) and the level of awareness, communication and prevention of such risks in the community. I believe this should be considered, the risks assessed and action taken, as appropriate. ”

    Source location

    John Hills · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Fire hazard from paraffin-based emollients contacting clothing or dressings

    Wider context from the report

    “(2) Diprobase emollient cream (the next ‘greasy’ preparation product and next step up from Cetraben) contains 21% paraffin content (15% white soft paraffin and 6% liquid paraffin) but 7.2% alcohol, and carries a fire hazard warning on prescription: ‘Dressing and clothing in contact with this product are easily ignited by a naked flame – Keep away’ (the product bottle itself has not been examined for warnings during the course of my enquiries). (3) The British National Formulary does not list either product specifically as being flammable, but does contain a general warning for paraffin based emollients that reads: “Fire hazard with paraffin-based emollients: Emulsifying ointment or 50% liquid paraffin and 50% white soft paraffin ointment in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when these preparations are applied to large areas of the body, and clothing or dressings become soaked with the ointment. Patients should be kept away from fire or flames and not to smoke when using these preparations. The risk of fire should be considered when using large quantities of any paraffin-based emollient” ”

    Source location

    John Hills · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to consider paraffin-emollient fire risk when prescribing

    Wider context from the report

    “(4) Mr Hills was clearly recorded (in his medical notes) as being a chronic smoker with acute bronchitis. He was also recorded as being a pipe smoker (in his medical records on 13/10/14) yet had a repeat prescription for Cetraben 500 gram being recorded on 11/09/14. There is nothing to evidence that any risk was considered or communicated by either the GP surgery or the prescribing pharmacy. ”

    Source location

    John Hills · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to communicate paraffin-emollient fire risk to patients

    Wider context from the report

    “(4) Mr Hills was clearly recorded (in his medical notes) as being a chronic smoker with acute bronchitis. He was also recorded as being a pipe smoker (in his medical records on 13/10/14) yet had a repeat prescription for Cetraben 500 gram being recorded on 11/09/14. There is nothing to evidence that any risk was considered or communicated by either the GP surgery or the prescribing pharmacy. ”

    Source location

    John Hills · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report
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Data last updated 7 September 2026