This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.
On 3/10/17 I opened an inquest into the death of Brian Leonard Bicat who, at the date of his death was aged 82 years old. The inquest was resumed and concluded on 18/7/18. I found that the cause of death to be: - 1a. Multi Organ Failure 1b Extensive Cutaneous Burns
After consideration of the evidence I arrived at a conclusion of Accident
Circumstances of the death
Mr Bicat lived with his wife at ████████ He had a longstanding history of skin allergies and at the time of his death was suffering with leg ulcers for which he was under the care of district nurses and was treated with daily applications of paraffin based Diprobase emollient cream and Hydromol ointment. On 22/9/17 Mr Bicat sustained severe burns at his home address, which he inadvertently caused as he smoked a cigarette, when a naked flame from his lighter came into the proximity of his dressing gown. Although he was immediately taken to hospital he succumbed and died from his extensive cutaneous burns later the same day. It was found more likely than not, that the speed and intensity of the fire was increased by the presence of paraffin based emollient ointment and cream present on his dressing gown and pyjamas. Fire Officers from West Yorkshire Fire and Rescue service undertook a number of controlled fire tests using similar night clothes worn by Mr Bicat and in some of the tests Diprobase emollient cream and Hydromol ointment were impregnated into the samples. The results revealed that the presence of the cream and ointment caused the fires to develop with much greater speed and intensity as compared to those tests where the cream and ointment was not present. The tests showed that the diprobase cream containing the least amount of paraffin had the fastest fire development of all the tests. West Yorkshire Fire and Rescue Service gave evidence at the inquest that the speed and the intensity of the fire was increased by the presence of the paraffin based emollient ointment and cream present on Mr Bicat’s dressing gown and pyjamas. Evidence presented at the inquest suggested that although fire risk of high content paraffin emollient creams was contained on alerts and guidance, this did not extend to lower emollient creams containing lower levels of paraffin. Evidence was heard at the inquest to suggest that the GP was not regularly updated with respect to the specific fire risks of paraffin based ointments.
Coroner’s concerns
• Paraffin based ointments and emollient creams which contain a low level of paraffin pose a potential fire hazard risk • Warnings of such risks are not displayed on all product packaging • Consider more prominent labels and alerts re fire hazard on product containers • 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 • To consider fire warning labelling on all emollients including those below 50% content, making clear the mechanisms of the risk • Health care professionals including pharmacists to verbalize product warnings at the point of prescription, dispensing or point of sale. • Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given • Review patients with repeat prescriptions for emollients and cross reference those that smoke. Give safety advice retrospectively and review prescriptions. • Raise awareness with health care professionals and include paraffin based skin products in annual continuing fire safety training • Review information sharing of burns data between hospitals, YAS and fire service so that incidents that didn’t receive a fire service attendance can be investigated fully. • The NHS prescribing systems (system One and Optimise) appear to be updated by individual CCG’s resulting inconsistent alerts and warnings. • Consider a review of the current effectiveness of obtaining fire incident reports involving paraffin based skin products since there is currently a lack of accurate national data involving paraffin based skin products
Concerns and recipient responses
Select any concern, action or position to view the source wording.
Report evidence summary
Concerns raised6
Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases
Request UK manufacturers to review Class I devices and require Notified Bodies to ensure higher-risk devices undergo manufacturer review and risk assessment.
Review evidence on risks from paraffin-containing medicines and devices and obtain ad hoc Expert Group recommendations on appropriate regulatory action.
Raise emollient fire risks with NHS Improvement, Medical Device Safety Officers and the Care Quality Commission for communication to relevant care staff and users.
Complete a Hydromol product-labelling review to improve warning prominence, clarity, content and consistency across paraffin concentrations.
Stated byAlliance Pharmaceuticals LimitedStated completedThe respondent said that this action was complete when they made their response on 30 October 2018.
Action
Launch Diprobase Cream with a fire-source warning on external packaging and in the patient information leaflet.
Stated byBayer plcStated plannedThe respondent said that this action was planned when they made their response on 30 October 2018.
Action
Undertake a cross-functional expert assessment of Hydromol labelling using information from the incident to identify further improvement opportunities.
Stated byAlliance Pharmaceuticals LimitedStated plannedThe respondent said that this action was planned when they made their response on 30 October 2018.
Action
Review proposed Hydromol labelling changes with user groups to confirm that the intended safety message is understandable.
Stated byAlliance Pharmaceuticals LimitedStated plannedThe respondent said that this action was planned when they made their response on 30 October 2018.
Stated byAlliance Pharmaceuticals LimitedStated plannedThe respondent said that this action was planned when they made their response on 30 October 2018.
Action
Reclassify Diprobase Cream as a Class 1 medical device and complete the associated conformity assessment.
Stated byBayer plcStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
Action
Engage West Yorkshire Fire Service to ensure Hydromol labelling clearly explains the mechanisms of fire risk.
Stated byAlliance Pharmaceuticals LimitedStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
Action
Work with the MHRA and PAGB to develop a consolidated fire-risk warning for all relevant product packaging across the industry.
Stated byAlliance Pharmaceuticals LimitedStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
Action
Update personnel communicating with healthcare professionals and the public on the assessment outcome and subsequent labelling changes.
Stated byAlliance Pharmaceuticals LimitedStated plannedThe respondent said that this action was planned when they made their response on 30 October 2018.
Action
Add a fire-risk warning to Hydromol product labelling, explaining ignition risks involving contaminated dressings, clothing and bedding.
Stated byAlliance Pharmaceuticals LimitedStated completedThe respondent said that this action was complete when they made their response on 30 October 2018.
Action
Display emollient risk messages on Trust screens and repeat the messages twice yearly.
Repeat staff awareness surveys every six months to identify concerns about emollient hazards.
Stated byBradford District Care NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
Action
Provide existing community nursing patients with safety leaflets and advice about emollient risks.
Maintain liaison with the Fire Service to update teams on laundering evidence and ongoing emollient hazards.
Stated byBradford District Care NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
Action
Upload the leaflet and poster to the NHSI improvement hub and disseminate them nationally through NHSI.
Other recipients of the report will address concerns about healthcare warnings, prescribing systems, incident data and fire-safety training.
Stated byBayer plcRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Changes to medicinal-product labelling require MHRA approval, which will not be granted until its labelling review is complete.
Stated byBayer plcUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
Other statements in published responses
These actions and other statements could not be clearly connected to one concern in this report.
Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2
1
Continue collaborating with the MHRA and PAGB on the Hydromol labelling review.
Stated byAlliance Pharmaceuticals LimitedStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
2
Update the Diprobase consumer website with the fire-source warning used for the medical-device labelling.
Stated byBayer plcStated in progressThe respondent said that this action was in progress when they made their response on 30 October 2018.
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