Report evidence summary
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
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
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
PFD Monitor interpretation Lack of accurate national data on fire incidents involving paraffin-based skin products
Wider context from the report “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
” Is this part of a recurring concern? No recurring-concern membership is currently published.
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
PFD Monitor interpretation Inconsistent fire-risk alerts and warnings across NHS prescribing systems
Wider context from the report “The NHS prescribing systems (system One and Optimise) appear to be updated by individual CCG’s resulting inconsistent alerts and warnings .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
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
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
PFD Monitor interpretation Failure to display fire-risk warnings on all product packaging
Wider context from the report “Warnings of such risks are not displayed on all product packaging
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
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
” Open source report
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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 Complete a Hydromol product-labelling review to improve warning prominence, clarity, content and consistency across paraffin concentrations.
Verbatim wording from the response “We have completed a product labelling review to improve prominence, clarity and content as well as ensuring consistency across the Hydromol range, regardless of paraffin content. The revised product labelling, website and promotional materials is expected to be available throughout the remainder of 2018 and 2019.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 collaborating with the MHRA and PAGB on the Hydromol labelling review.
Verbatim wording from the response “We continue to work with the MHRA and PAGB to input into the labelling review. If changes are recommended by the MHRA, we commit to further updates, in addition to the changes we have already implemented.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 Launch Diprobase Cream with a fire-source warning on external packaging and in the patient information leaflet.
Verbatim wording from the response “However, Bayer is in the process of re-classifying Diprobase Cream as a Class 1 medical device under the Medical Devices Regulations 2002 and has conducted a conformity assessment in accordance with such Regulations. In compliance with the Regulations, Bayer may apply warnings to the labelling of medical devices without external regulatory approval. When the re-classified product is launched in the UK (anticipated around February 2019) Diprobase Cream will include the warning “Keep fabric which has been in contact with this product away from sources of fire including lit cigarettes”. The warning will be visible on the external labelling/packaging of the product as well” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 a cross-functional expert assessment of Hydromol labelling using information from the incident to identify further improvement opportunities.
Verbatim wording from the response “We will undertake an assessment of the labelling throughout the remainder of this year, this activity will review all information from this event to determine any further opportunities for improvement of the current labelling. The assessment will be performed by a cross functional group of experts who have knowledge and experience of Hydromol and its use. We will implement any required changes to the product, product labelling or promotional materials which the risk assessment identifies. We will also apply required labelling amendments to marketed paraffin containing products, regardless of paraffin content.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 proposed Hydromol labelling changes with user groups to confirm that the intended safety message is understandable.
Verbatim wording from the response “Furthermore, any proposed changes to the labelling will be reviewed by user groups who will support us in ensuring the intended message is understandable. We are also engaging with West Yorkshire Fire Service to ensure the mechanisms of risk are clearly stated on our labelling.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 revised Hydromol labelling, website content and promotional materials incorporating improved fire-risk information.
Verbatim wording from the response “We have completed a product labelling review to improve prominence, clarity and content as well as ensuring consistency across the Hydromol range, regardless of paraffin content. The revised product labelling, website and promotional materials is expected to be available throughout the remainder of 2018 and 2019.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 Reclassify Diprobase Cream as a Class 1 medical device and complete the associated conformity assessment.
Verbatim wording from the response “However, Bayer is in the process of re-classifying Diprobase Cream as a Class 1 medical device under the Medical Devices Regulations 2002 and has conducted a conformity assessment in accordance with such Regulations. In compliance with the Regulations, Bayer may apply warnings to the labelling of medical devices without external regulatory approval. When the re-classified product is launched in the UK (anticipated around February 2019) Diprobase Cream will include the warning “Keep fabric which has been in contact with this product away from sources of fire including lit cigarettes”. The warning will be visible on the external labelling/packaging of the product as well” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 Engage West Yorkshire Fire Service to ensure Hydromol labelling clearly explains the mechanisms of fire risk.
Verbatim wording from the response “Furthermore, any proposed changes to the labelling will be reviewed by user groups who will support us in ensuring the intended message is understandable. We are also engaging with West Yorkshire Fire Service to ensure the mechanisms of risk are clearly stated on our labelling.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 MHRA and PAGB to develop a consolidated fire-risk warning for all relevant product packaging across the industry.
Verbatim wording from the response “We are proactively working with the MHRA and PAGB to ensure a consolidated warning is displayed on all product packaging, across industry. And we further commit to revisiting warnings on the product packaging, or any supporting processes, if additional information from the MHRA, trade bodies or any other expert groups becomes available.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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
Open published response
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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 a fire-risk warning to Hydromol product labelling, explaining ignition risks involving contaminated dressings, clothing and bedding.
Verbatim wording from the response “The labelling now states:” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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 Diprobase consumer website with the fire-source warning used for the medical-device labelling.
Verbatim wording from the response “In addition to the measures described, Bayer operates a consumer-facing website for Diprobase products, which includes a warning in respect of the risk of flammability associated with the use of Diprobase Cream. Following receipt of your letter in relation to Mr Bicat, Bayer is in the process of updating the content of the website to include the same warning as that which will be included on the labelling for Diprobase Cream as a medical device, namely “Keep fabric which has been in contact with this product away from sources of fire including lit cigarettes”. The updating of the website will be completed no later than the end of October 2018.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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
Open published response
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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 Changes to medicinal-product labelling require MHRA approval, which will not be granted until its labelling review is complete.
Verbatim wording from the response “In 2017, the MHRA commenced a review of the labelling of paraffin-containing emollients and the instructions for use provided in relation to such products, with a view to determining consistent warnings to apply to all such products, where appropriate. Bayer has co-operated fully with this review, but understands that it has not yet been completed.” Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
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