PFD report

Pauline Taylor · Prevention of Future Deaths report

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Issued 21 Jul 2017•West Yorkshire (West)

Report record

Published report and response evidence

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.

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Concerns
9

Raised in this report

Recipients
9

Named on the report

Responses found
5

Of 9 recipients

Stated actions
31

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised9

  1. Potential fire hazard from low-paraffin emollient creams
    Part of recurring concern: Inadequate controls for fire risks from paraffin-containing emollients
  2. Failure to verbally inform over-the-counter purchasers of fire hazards from low-paraffin emollient creams
    Part of recurring concern: Failure to provide safety warnings at point of sale for hazardous products and equipmentPart of recurring concern: Inadequate controls for fire risks from paraffin-containing emollients
  3. Fire escalation hazard from polyurethane coating on Nimbus 6 airflow mattress coverings
    Part of recurring concern: Uncontrolled fire escalation risks from polyurethane materials in consumer products
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.27

  1. Action

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

    Stated by PAGBStated in progressThe respondent said that this action was in progress when they made their response on 21 July 2017.
  2. Action

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

    Stated by PAGBStated in progressThe respondent said that this action was in progress when they made their response on 21 July 2017.
  3. Action

    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.

    Stated by PAGBStated in progressThe respondent said that this action was in progress when they made their response on 21 July 2017.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    The mattress system’s therapeutic benefits generally outweigh fire risks, which are mitigated by labelling and instructions against smoking or naked flames.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

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. ”

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients.

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 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. ”

Is this part of a recurring concern?

Yes — Failure to provide safety warnings at point of sale for hazardous products and equipment; Inadequate controls for fire risks from paraffin-containing emollients.

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 escalation hazard from polyurethane coating on Nimbus 6 airflow mattress coverings

Wider context from the report

“(7) The polyurethane coating used in the outer covering of the nimbus 6 airflow mattress appears to have contributed to the speed of the fires development and also its intensity. ”

Is this part of a recurring concern?

Yes — Uncontrolled fire escalation risks from polyurethane materials in consumer products.

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 provide private community-care companies with alerts about relevant medicines and medical devices

Wider context from the report

“(5) Private companies who provide carers in the community do not receive alerts with regard to medicines and medical devices which could impact on the risk assessments and the manner in which carers working in the private sector provide care. ”

Is this part of a recurring concern?

Yes — Unreliable clinical safety-alert systems; Unreliable dissemination of safety alerts to relevant recipients.

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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 offer a further fire-risk-assessment referral or review after a major change in circumstances

Wider context from the report

“(9) A further fire risk assessment referral/review was not offered to Mrs Taylor by Locala following a major change in her circumstance (she had become bedbound in March 2017.) ”

Is this part of a recurring concern?

Yes — Fire risk assessment processes failing to respond to material changes.

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 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. ”

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients.

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 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. ”

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients.

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

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

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients; Inadequate product safety warnings about serious hazards.

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 undertake a further risk assessment after a significant change in circumstances

Wider context from the report

“(8) Following a significant change in Mrs Taylor's circumstances in March 2015 a further risk assessment had not been undertaken by Locala. ”

Is this part of a recurring concern?

Yes — Failure to update risk assessments after material changes or safety events.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Complete further risk assessments when relevant patients experience changes in health, circumstances or environment.

Verbatim wording from the response

“The first two points on the action plan seek to address the issue you have raised concerning further risk assessment: the action Locala will seek to achieve is that further risk assessments will be completed on all patients who smoke and/or have emollients in use with or without air products, at any stage where there is a change in their physical, physiological or mental health condition or circumstances, and a change in their environment or as a result. In addition, a flowchart is being designed to enable staff to identify patients that are frail or living with changing circumstances and documentation and training is being worked up to implement this throughout the organisation.”

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

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

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

Audit records for missed further risk assessments and manage findings through community nursing team leaders.

Verbatim wording from the response

“In relation to undertaking further risk assessments records are being audited to see that this happening, and situations are not being missed, and this is being managed through the community nursing team leaders group. They are responsible within their teams for ensuring staff understand the need for further risk assessment when circumstances change.”

Source location

2017-0330-Response-by-Locala_Redacted
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

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

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 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

Design a frailty and changing-circumstances flowchart and develop documentation and training for organisation-wide implementation.

Verbatim wording from the response

“The first two points on the action plan seek to address the issue you have raised concerning further risk assessment: the action Locala will seek to achieve is that further risk assessments will be completed on all patients who smoke and/or have emollients in use with or without air products, at any stage where there is a change in their physical, physiological or mental health condition or circumstances, and a change in their environment or as a result. In addition, a flowchart is being designed to enable staff to identify patients that are frail or living with changing circumstances and documentation and training is being worked up to implement this throughout the organisation.”

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

The mattress system’s therapeutic benefits generally outweigh fire risks, which are mitigated by labelling and instructions against smoking or naked flames.

Verbatim wording from the response

“The therapeutic benefits of the mattress system will generally have been found to outweigh the likelihood and consequences of a fire, in part mitigated by the labelling and instructions for use, advising against smoking or using naked flames whilst in bed.”

Source location

2017-0330-Response-by-MHRA
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

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

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

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.4

  1. 1

    Submit a written submission to the Commission on Human Medicines through the Medicines and Healthcare products Regulatory Agency by 30 September 2017.

    Stated by PAGBStated plannedThe respondent said that this action was planned when they made their response on 21 July 2017.
  2. 2

    Submit adverse-event data associated with paraffin-containing products to the Medicines and Healthcare products Regulatory Agency review.

    Stated by PAGBStated completedThe respondent said that this action was complete when they made their response on 21 July 2017.
  3. 3

    Submit a written submission to the Medicines and Healthcare products Regulatory Agency by 30 September 2017 regarding the warning implementation process.

    Stated by PAGBStated plannedThe respondent said that this action was planned when they made their response on 21 July 2017.
  4. 4

    Undertake work with the Medicines and Healthcare Regulatory Agency and other organisations in response to the reported safety concerns.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 21 July 2017.

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 a written submission to the Commission on Human Medicines through the Medicines and Healthcare products Regulatory Agency by 30 September 2017.

Verbatim wording from the response

“PAGB has been advised that following this MHRA review, expert advice will be sought from the Commission on Human Medicines (CHM), the timescale for this is autumn 2017. As mentioned previously, PAGB will be providing a written submission to the CHM (via MHRA) by 30 September 2017 and we hope to have the opportunity to meet with MHRA officials after that date.”

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 adverse-event data associated with paraffin-containing products to the Medicines and Healthcare products Regulatory Agency review.

Verbatim wording from the response

“PAGB member companies have already submitted data on adverse events associated with paraffin-containing products to the MHRA review, which is currently underway.”

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 a written submission to the Medicines and Healthcare products Regulatory Agency by 30 September 2017 regarding the warning implementation process.

Verbatim wording from the response

“PAGB requested a meeting with MHRA to discuss this process in May 2017, we have been given the opportunity to make a written submission to the agency, which we will do by 30th September 2017 and we hope to have the opportunity to meet with MHRA officials thereafter.”

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 work with the Medicines and Healthcare Regulatory Agency and other organisations in response to the reported safety concerns.

Verbatim wording from the response

“I can confirm that the NHS Patient Safety Team was in fact notified of Mrs Taylor’s tragic death in 2015 by the local fire safety officer. Considerable work has subsequently been undertaken by the team in conjunction with the Medicines and Healthcare Regulatory Agency (MHRA) and other organisations in response to the concerns you describe in your report.”

Source location

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

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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
5/9

Data last updated 7 September 2026