Pauline Taylor

‘Locala’

Community Partnerships

Locala

Beckside Court
286 Bradford Road
Batley

PRIVATE & CONFIDENTIAL WF17 5PW
030 3003 4529

Mrs M Burke

HM Assistant Coroner ein
(Western District) City Courts

The Tyrls

Bradford 13 September 2017
West Yorkshire

BD1 1LA

Dear Ma’am

INQUEST TOUCHING UPON THE DEATH OF PAULINE TAYLOR DECEASED -
REGULATION 28 REPORT RESPONSE

Thank you for your letter dated 21 July 2017 attaching the Regulation 28 report to prevent
future deaths that you issued following the conclusion of the Inquest you held touching upon
the death of Pauline Taylor.

This is the Response of Locala Community Partnerships. As an organisation we have
considered the content of your report very carefully. We note that at section 5 you have raised
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.

Within Locala, we have undertaken work to share the learning from this case in relation to
the risks posed by any cream, lotion or other substance that contains any amount of paraffin.
As was evident from the evidence given at the Inquest there are potentially a large number
of such products that are regularly in use.

In May 2017, within our monthly medicines management report that goes to all business
units, we specifically raised the issue concerning paraffin containing skin products and made
reference to a guidance document produced by the South West Yorkshire Area Prescribing
Committee, advising staff this must be adhered to when prescribing or treating patients with
paraffin based emollients. The Prescribing Committee’s advice note was attached to our
medicines update and a copy of this is attached. In particular, this document identifies that
any paraffin containing product poses a risk, regardless of the amount of paraffin contained
within it.

Caving for you, locally

Locala Community Partnerships C1.C. ve

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Registered Office: Beckside Court, Bradford Road, Batley, WF17 5PW & Co \ iv IN PEOPLE
Registered in England and Wales. Company No: 07584906 Asay nd

This does represent a shift in emphasis as compared some previous guidance that had been
issued about paraffin containing products. This advice note has been disseminated within
Locala.

Training has also been updated to include reference to this latest guidance note regarding
the use of paraffin based products and the use of such products now forms part of the risk
assessment that has to be completed when requesting any air products from the supplier,
Medequip.

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

When Locaia 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.

Locaia Live is a bulletin that goes to all staff and the Area Prescribing Guidance was also
attached to this bulletin via a link, with a note advising staff of the risk associated with skin
products containing paraffin. Staff were reminded relevant service users need to be advised
of the risks.

Additionally, we are piloting a project in the Dewsbury locality where we are evaluating the
use of non-paraffin based emollients as alternatives to those with paraffin. Local GPs are
being involved and this project is to be evaluated in October 2017.

Many of these points are encapsulated on the attached action plan. There were two further
specific concerns raised, at points 8 and 9 of the Regulation 28 report, concerning the fact
no further risk assessment had been undertaken following a significant change in the
Deceased’s circumstances as at March 2015. It is perhaps noteworthy that the Deceased’s
underlying medical condition had not deteriorated as such, but it is acknowledged that there
was a gradual change in her preferences in terms of the fact that whilst still being encouraged
from time to time to leave her bed, the Deceased very largely preferred to remain within her
bed in her last weeks.

There was no further specific risk assessment around March 2015. We note the evidence at
the Inquest conceming the Deceased’s capacity for decision making and also the
acknowledgement that professional staff and family members were continuing to raise with
the Deceased the dangers associated with her continued smoking of cigarettes in her bed.

The first two points on the action plan seek to address the issue you have raised concerning
further risk assessment: the action Locala will seek to achieve is that further risk assessments
will be completed on all patients who smoke 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 habits as a result.
In addition, a flowchart is being designed to enable staff to identify patients that are
deteriorating with changing circumstances and documentation and training is being worked
up to implement this throughout the organisation.

Caving for you, locally

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

May | thank you again for raising these matters. CQC have contacted us concerning the
Regulation 28 report and we trust that it is in order that we have provided them with a copy
of this response and our action plan.

Yours sincerely
ye KMOWK

Director or Operations

Caving for you, locally

13 SEP 2017

MHRA

Regulating Medicmes and Medical Devices

Medicines & Healthcare products

Regulatory Agency

H.M Coroner MHRA

For the West Yorkshire (Western) Coroner Area 151 Buckingham Palace Road
City Courts London

The Tyris SW1W 98Z

BRADFORD United Kingdom

ea www.gov.uk/mhra

12 September 2017

Dear Ms Burke
Regulation 28 Report concerning Pauline Taylor — Ref: HK/1067-2015

Thank you for your letter of 21July 2017, with the attached Regulation 28: Report to Prevent Future
Deaths, to the MHRA regarding the death of Pauline Taylor. This response deals with medical
device aspects, relating to both the issues raised regarding emollients and mattresses. A response
dealing with the medicines aspects of emollients will be supplied to you separately, in line with your
request.

As you may be aware, The Medicines and Healthcare products Regulatory Agency (MHRA) is an
executive agency of the Department of Health. The aim of the MHRA Devices Division is to take
all reasonable steps to protect the public’s health and safeguard the interests of patients and
users by ensuring that medical devices and equipment meet appropriate standards of safety,
quality and performance and that they comply with relevant Directives of the European Union.

One major area of MHRA Devices’ responsibilities is the investigation of adverse incidents. An
adverse incident is an event involving a medical device, which produces, or has the potential to
produce, unwanted effects involving the safety of patients, users and other persons. These
effects may arise from shortcomings in the device, its operating instructions, user practice or
conditions of use.

We have addressed the points relevant to medical device aspects in our response below.

MHRA received the first adverse incident reports of fires involving emollients in March 2017.
However, we were aware of the work undertaken by the National Patient Safety Agency (NPSA)
in 2007 and highlighted this work to healthcare workers when it was published. In the form of a
“One Liner” publication in March 2008, issue 56. Since that time, as no adverse incident reports
were received. it was not considered necessary to issue any further communication.

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

Medicines & Healthcare products
Regulatory Agency

MHRA

Regulating Medicines and Medical Devices

We aim to have completed our review by the end of 2017 and will consider the need for
publication of any additional safety advice at this time in conjunction with our medicine
colleagues.

Additionally, we have worked with manufacturers to raise awareness of this potential risk. This
work highlighted the need for risk of fire to be included in their product risk analysis and ensuring
warnings of the potential risk were placed either on packaging or included in the device’s
instructions for use. We have previously issued warnings regarding the dangers around smoking
and bed fires (MDA/2013/073).

Medical devices must be CE marked before they are placed on the market in the UK and
throughout the EU. MHRA’s expectation is that, when CE marking and placing a medical device
on the market, manufacturers will have evaluated the potential risks that could occur, including
that of fire.

The CE mark demonstrates that the medical device is fit for its stated intended purpose and
meets legislation relating to safety. This requires the manufacturer to demonstrate their medical
device meets the requirements in the Medical Devices Directive (MDD) by carrying out a
conformity assessment. Additionally, higher risk medical devices require certification from a third
party conformity assessment body (“Notified Body”) prior to being placed on the market. MHRA
is responsible for the oversight of UK Notified Bodies and has a post-market role in investigating
reported safety issues.

Emollients may fall into any of the risk classes according to their constituents and mode of action.
The paraffin content of these products varies over a wide range, also, from as little as 5%, in
some cases and has no bearing on whether the product is classed as a device or as a medicine.
This difference is due to their mode of action.

in Spring 2017 MHRA wrote to UK manufacturers of Class | medical devices (the lowest risk
category) directly and asked them to undertake a review of their products. In addition, we asked
the UK Notified Bodies to ensure that a review and risk assessment was undertaken by
manufacturers of higher risk classification medical devices.

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

The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs).
The fatter are individuals in each NHS Trust in England who ensure safety information is made
available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the
potential dangers to users within the care community.

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

Polyurethane (PU) is the industry standard cover material on most types of healthcare mattress,
including pressure reduction mattress systems, such as the ArjoHuntleigh Nimbus 3. The cover

Medicines & Healthcare products
Regulatory Agency

MHRA

Regulating Medicines and Medical Devices

material of healthcare mattresses has to withstand heavy use, must be impervious to liquid
ingress and withstand frequent exposure to decontamination agents.

MHRA has contacted the manufacturer, ArjoHuntleigh, to confirm that their current risk mitigation
factors are appropriate. This includes meeting the standard BS7175:1989, (Methods of test for
the ignitability of bedcovers and pillows by smouldering and flaming ignition sources) and the
product labelling and instructions for use, which contain the warming about fire risk.

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.

Yours sincerely

Director of Devices

) 27 SEP 2047

NHS

improvement
Your ref: HK/1067-2015
Senior Administrator
City Courts
The Tyrls
Bradford BD1 1LA
19 September 2014

Dear

Re: Pauline Taylor, deceased

Thank you for your letter of 21 July enclosing a report sent under the provisions of
Regulation 28 of the Coroners (Investigations) Regulations 2013.

| can 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.

The actions taken in response to Mrs Taylor's death were included in the Patient
safety review and response report (page 17) published by NHS Improvement in June
2017. | am enclosing a copy of the Report for ease of reference.

| am grateful to you for bringing this matter to my attention and hope this response is
helpful.

Yours sincerely,

DR KATHY MCLEAN
EXECUTIVE MEDICAL DIRECTOR

i13 SEP 2017

Representing the
Consumer Healthcare
Industry since 1919

PAGB

12 September 2017 Your ref: HK/1067-2015

Pawtuhe FT Bgl ¢
Ms M Burke

Assistant Coroner

Her Majesty’s Coroner

West Yorkshire (Western) Coroner Area
City Courts

The Tyrls

Bradford BD1 1LA

Dear Ms Burke
Re: Regulation 28: Report to Prevent Future Deaths
Thank you for your letter of 21 July 2017.

Safety is of paramount importance to the consumer healthcare industry and we are
extremely concerned about incidents where emollient creams and ointments have been
found to have contributed to the intensity of accidental fires with grave and fatal
consequences.

PAGB, together with member companies that manufacture emollient medicines and medical
devices, acknowledges the seriousness of this situation and we are committed to doing what
we can to address the concerns you raise in your letter and ensure people are aware of the
potential risks.

Paraffin-containing emollient products are the first line of treatment for helping people
manage dry or scaly skin conditions, such as eczema and psoriasis. When severe, these
conditions can be highly debilitating and it is important for people to have access to effective
emollients to manage these conditions. Paraffin based oils such as liquid paraffin and white
soft paraffin have been carefully chosen for use in emollients because extensive clinical
experience has shown these particular ingredients to be effective for softening and
moisturising medically dry skin conditions and are well tolerated by sensitive skin.

It is important to note that paraffin-containing emollients are not flammable in and of
themselves. However, repeated applications of larger quantities of these products can lead
to a build-up of residue on clothing and bedding, which results in the fabric becoming more
flammable. If an individual is then subsequently exposed to a naked flame, for example a
lighted match or cigarette, there is an increased risk of fire.

Having considered the issues raised in your letter, PAGB and its member companies have
identified three areas where we feel we have a role to play in reducing the likelihood of future
incidents.

1. By ensuring there is an accurate and meaningful warning statement on product
packaging

2. By helping to effectively communicate the potential risk to consumers, healthcare
professionals and care workers

Registered Address: Vernon House Sicilian Avenue London WC1A 2QS Telephone 020 7242 8331 Fax 020 7405 7719
info@pagb.co.uk www.pagb.co.uk

Proprietary Association of Great Britain is a Company Limited by Guarantee and Registered in England. Registration No. 375216

3. By providing information and evidence to the regulator, the Medicines and Healthcare
products Regulatory Agency (MHRA).

| will address these points in turn.
1. Accurate and meaningful warning statement

PAGB and its member companies recognise that clear information needs to be made
available to warn of the risk of increased flammability of clothing and bedding which has
been in contact with paraffin-containing emollients.

in addition to ensuring warning statements are included on the packaging of all appropriate
products, it is imperative that these warnings are consistent as well as clear and meaningful
to members of the public who will read them. PAGB has been working with its member
companies to develop wording which we will submit for user-testing to ensure its clarity.

User-testing is a vital part of this process. It is important that users are involved in the
drafting of any warning statements, such that we can be confident they will be clearly
understood when placed on packaging.

Following the results of user-testing, PAGB will work with MHRA to ensure there is
consistency in implementation of a standard warning for packaging and patient information
leaflets.

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

2. Communicate the potential risk effectively

The Coroner's report of Mrs Taylor's accidental death highlights that repeated advice of the
fire hazards from healthcare professionals and family members was ignored.

It is therefore important that, in addition to the inclusion of an appropriately worded warning
on packaging and on patient information leaflets, the risk is adequately communicated to
healthcare professionals, care workers and other 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.

3. Provide information and evidence to MHRA

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

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

To conclude, | would like to reassure you that together with our member companies, we are
taking this issue seriously and working hard to ensure we take all the appropriate actions we
can as an industry to prevent future incidents from occurring.

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

Yours sincerely

Kilbane

P Bonn Smith
Chief Executive Officer

United Kingdom Homecare Association _ Wr
The professional association for homecare providers q

UNITED KINGDOM
HOME CARE ASSOCIATION
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The City Courts
Bradford
BD1 1LA

7 August 2018

Pauline Taylor, deceased, Repor' revent further dea

Thank you for your contact with this office regarding the above.

This organisation is aware of the circumstances of Pauline Taylor’s death and
would like to extend our condolences to members of her family.

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

1. A fact sheet, “UKHCA Guidance: Emollient Products - Guidance for
homecare providers”, was prepared for UKHCA by London Fire Brigade and
published in January 2018. It can be downloaded from
http://www.ukhea.co.uk/downloads,aspx?ID=565. A copy is enclosed.

2.  Anarticle, “Fire Chiefs issue warning on dangers of emollient creams”, was
published in the November 2017 issue of our bi-monthly magazine,
“Homecarer”. The magazine has a print circulation of around 3,000 copies
and a further 4,000 copies are send in PDF format. A copy is enclosed
(please see pages 8 and 9).

3. An e-mail briefing was sent to around 2,000 of our member organisations

entitled “Fatality highlights fire risks of using paraffin-based emollient” in
June 2016. The text of this briefing is reproduced at the end of this letter.

Page 1

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Sutton Business Centre,

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Surrey Ne Lee 3 * 020 8669 7100 Gi) membership@ukhca.co.uk @® www.ukhce.co.uk

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United Kingdom Homecare Association Limited
Registered in England under number: 03083104 i: i ANG ont
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Text of e-maii aiert sent to UKHCA members, June 2016

Fatality highlights fire risks of using paraffin-based emollient

A coroner's accidental death review has highlighted the dangers of using E45
emollient, which is highly flammable (although this is not displayed on the
packaging). In the case in question, the deceased was smoking in bed and the
Fire Officer considered that, as the bedding and clothing were covered in E45
residue, the emollient acted as an accelerant, increasing the intensity and speed
with which the fire took hold. NHS England's helpful note on the coroner's review
includes key points for action and learning for professional staff involved in
patient or client care. (Thank you to Westminster Homecare for drawing this to
our attention.)

We suggest that homecare providers caring for service users who use E45 or
another paraffin-based emollient (prescribed or not) risk assess and discuss
switching to a non-inflammable alternative with their community pharmacist,
where appropriate. More about emollients:
http://www.nhs.uk/conditions/emollients/Pages/Introduction.aspx

Page 3