Jacqueline Scott

From the Lord Prior of Brampton
Ps Parliamentary Under Secretary of State for NHS Productivity (Lords)

Department
of Health

Richmond House
79 Whitehall
Ms Angela Hodes, Assistant Coroner London
Westminster Coroner’s Court SW1A 2NS
65 Horseferry Road P|
London

~ . SWIP 2ED

\ 04 MAY 2016
{ M, [ote

Thank you for your letter of 17 March 2016, following the inquest
into the death of Jacqueline Scott. I was sorry to hear of her death
and wish to extend my condolences to her family.

You raise four main concerns in this case regarding:

e the BIPAP Trilogy 202 machine and it’s visual display
symbols and alert alarms;

e staff training on use of the BIPAP machine;
e the provision of electrical power to the ward; and

e notification to and response from the hospital’s estates
management concerning a failed emergency call bell

Many of these issues need to be addressed by Phillips Healthcare and
the NHS Foundation Trust. However, I do acknowledge your
concerns about the design of the BiPAP machine and the safe
provision of power supply which I will address.

My officials contacted colleagues at NHS England who have advised
that the design of some non-invasive ventilation (NIV) systems and
other critical devices could be improved by having safety features
which warn staff of delivery problems, such as disconnection and
power failure. NHS England has a close working relationship with
the Medicines and Healthcare Regulatory Agency (MHRA) and is
able to share such concerns with them. Their collective power to
improve the design of medical devices is often limited however, as
manufacturers are not required to make changes to a product if it

meets the relevant regulatory requirements (the Trilogy 202
ventilator is CE marked to show compliance with the Medical
Devices Directive). In order to impose manufacturers to make such
improvements would require a change to the UK and EU
requirements.

NHS England has been able to raise awareness of unintentional
interruption of this type of therapy however, and on 13 February
2015, it issued a Patient Safety Alert concerning the risk of severe
harm and death from unintentional interruption of non-invasive
ventilation. This publication was a joint effort with the Medicines
and Healthcare Regulatory Agency (MHRA) and served as a
reminder of the correct procedures and the importance of familiarity
with the ventilators and disposables used.

A copy of the alert can be found at:

https://www.england.nhs.uk/2015/02/psa-niv/psa-niv/

MHRA was made aware of the events outlined in your letter in April
2015 and submitted a report to the coroner which confirmed the
manufacturer had examined the device and found no faults.

The Phillips model of ventilator has features to alert users to the
status of the power supply. There is an LED that lights up on the unit
when on mains power, and icons on the display to show whether the
device is currently drawing from mains or battery power. There are
also multiple visual and audible alarms to alert users to the depletion
of battery power. On inspection by the manufacturer, the alarms
were seen and heard to function correctly. The device log showed
that on the day of the event, the ventilator had alarmed as expected to
alert users to the depleting battery power.

MHRA has conducted a search of its adverse incident database
which has not revealed any similar reported incidents (involving the
ventilator being used on battery power until it fully depleted) for this
model of ventilator. Philips has reported that it is aware of one
similar event reported to them in 2011, which occurred in the USA.
This involved a device which “was being used on DC power and an
AC source was unavailable when the batteries depleted”, but MHRA
is not aware of the detailed circumstances.

MHRA has confirmed that this model of ventilator was first placed
on the UK market in July 2010. At the time of its report to the
coroner, the manufacturer had advised that a total of 501 Trilogy 202
ventilators have been sold in the UK, with a further 1,582 sold in the

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Department
of Health

rest of Europe and 5,799 in the rest of the world. Given the number
of ventilators of this model that have been sold, the available
evidence indicates that battery power depletion with no corrective
action taken by the user is not currently a widespread problem with
this model of ventilator.

I am aware that Phillips Electronics has already provided you with a
detailed response to your Regulation 28 letter and has concluded that
no changes to the design of the Device, including the alarm system,
visual and audible alerts, and the instructions for use are required to
prevent future deaths. However, MHRA is planning to ask Philips
Electronics to consider the visibility of alarms and battery icons in
terms of usability in the next design review as part of their ongoing
post market surveillance.

With regard to issues around the provision of power to the ward, you
quote from our Department’s Hospital Technical Memoranda (HTM)
06-01and consider that there is a conflict of advice in Part A between
clauses 4.22 and 6.62.

HTM 06-01 Electrical services supply and distribution - Part A:
design considerations, provides best practice guidance and should be
read in conjunction with the Institution of Engineering and
Technology (IET) Wiring Regulations, British Standard 7671. The
HTM sets out the application of BS7671 in the specific, unique
context of healthcare.

Moreover, the text at paragraph 4.22 relating to Category 4 —
Patients in special medical locations should be read in a holistic
manner in conjunction with the guidance provided within other
sections of the HTM and BS7671. If this task is undertaken, there is
no conflict of advice between 4.22 and 6.62 of the HTM.

By way of illustration, the HTM contains the following guidance
which it is imperative to follow:

2.6 It is recommended that designers and stakeholders review
Chapter 4 as well as Chapter 6 for all projects.

4.17 While it is not intended to be absolute, this section should be
sufficient to prompt the necessary discussion at all stages of the
design process. The categories given are intended to demonstrate a
range of patient risk from an electrical fault or loss of electrical
supply

4.18 Consideration of the categories in Figure 6 should establish a
minimum acceptable risk option at the point of treatment or care.
For the purpose of this guidance, the patient levels described are not
intended to be exhaustive, but rather an aid to consider the issues.

The definition relating to Medical Location (Chapter 1) (location
intended for the purpose of diagnostic treatment (including cosmetic)
or monitoring a patient under medical supervision), identifies those
locations where discontinuity of the electrical supply can cause
danger to life.

* Group 0 Medical locations where no applied parts are
intended to be used.

* Group 1 Medical locations where discontinuity of the
electrical supply is not a risk to human life (unless the location
is part of a Group 2 location).

* Group 2 Medical locations where discontinuity of the
electrical supply can cause danger to life.

Should a patient’s life be endangered by a discontinuity of supply,
then a Group 2 definition may be required to be applied to the
Category 4 patient clinical risk.

The HTM contains the following guidance with respect to Group 2
areas:

16.37 IEC 60364-7-710 and BS 7671 require Group 2 areas to have
at least two separate socket-outlet sub circuits at each patient
treatment location (for example bedhead or theatre pendant). This
applies to Group I areas also. This can be achieved from a single
IPS unit with an integral single-phase distribution board. The
resilience would be further enhanced if the IPS had dual 100%-rated
isolation transformers serving different integral distribution boards.
Such arrangements would provide an N+I resilient IPS isolation
transformer as defined in paragraphs 6.8-6. 14.

The HTM also provides guidance on the provision of audible and
visual alarms in relation to interruptions to power supply failures and
the need to provide indication at the nurse’s station for the relevant
medical area.

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Department
of Health

For the reasons set out above, the Department does not consider that
there is a conflict of advice in the HTM. However, the concerns you
raise are noted and the relevant sections of the HTM will be
considered and reviewed, as part of the wider technical guidance
programme, to determine if there is a need for greater clarity.
Similarly, the issue of alerts will be considered, although the HTM is
considered to provide adequate guidance on this issue.

I hope that this reply is helpful and I am grateful to you for bringing
the circumstances of Mrs Scott’s death to my attention.

ides be

DAVID PRIOR =

St George's University Hospitals Nh

NHS Foundation Trust

St George’s University Hospitals
NHS Foundation Trust

11th May 2016 Blackshaw Road

Ms Angela Hodes

London
SW17 0QT

Tel: 020 8725 4555

Assistant Coroner for Inner West London
Westminster Coroners Court

65 Horseferry Road

London

SW1P 2ED

Dear Ms Hodes

| am writing in response to the Regulation 28 report that you issued to St. George’s
University Hospitals NHS Foundation Trust on 17/03/2016 regarding the death of Mrs.
Jacqueline Scott.

In relation to the matters of concern you raised the following points:

1) The Philips Respironics Trilogy 202 (BIPAP)

2)

3)

i)

ii)

The BIPAP Trilogy 202 machine had a subtle visual display symbol which
denoted when the machine was running on battery power. That symbol is not
visible if there are many alert alarms as the alarm messages fill up the screen
as they come in pushing the earlier alerts (low battery) off the screen.

The BIPAP Trilogy 202 Machine has the same alarm sound for battery
depletion as for circuit disconnect (where for example the face mask slipped)
which was the more usual and expected reason for an alarm and these two
factors separately and together did not have any feature of urgent warning to
alert staff to battery depletion.

Staff Training

ii)

Staff who were experienced and trained on the BIPAP machine did not
appear to be trained to be alert to the situation or to the significance of a
battery symbol showing on the machine when the machine was plugged in to
the mains or to any particular alarm which denoted battery depletion rather
than mask slippage.

The provision of power to the ward

iv)

v)

Richmond ward ADU beds was designated as a category 4 area which in this
case meant there was no isolated power supply (IPS) provided to the ward
not withstanding life-saving equipment was routinely used.

Hospital Technical Memoranda (HTM) 06-01 Part A provides advice and
guidance and benchmarking standards for electrical installation, maintenance
and safety etc in healthcare premises. It is a matter of concern that there is a

Chairman: Sir David Henshaw Chief Executive: Prof Simon MacKenzie

conflict of advice between clause 4.22 and Clause 6.62. Clause 4.22 states: “
clinical treatment and patient safety may be compromised (but not
endangered) by any interruption of electrical supply” whereas clause 6.62
states: “In clinical risk Category 4 and 5 areas the patient environment should
have at least two IPS circuits at the bedhead”

vi) There was no system or check that would alert ward staff to the failure of
mains power in any particular area.

4) Notification to estates management
vii) The crash bell for bed 5 did not work when the emergency arose. However
estates management had been notified some days earlier of the broken
patient call in the same bay. This was of concern as both emergency bells
were on the same circuit and not fixed until 2 April 2014 when by chance the
failure of electricity was identified.

In response to these concerns for ease | will address each of these points individually.
Point 1 - The Philips Respironics Trilogy 202 (BIPAP)

Ms Louise Best has provided a written response on behalf of Phillips on the 12" April 2016.
Point 2 — Staff Training

During the Serious Incident investigation, the panel reviewed the training for nursing staff
provided for non-invasive ventilation (NIV) and the particular medical device (Trilogy
ventilator). They found that training was overseen by a nurse consultant and a clinical nurse
specialist in respiratory medicine. There were appropriate clinical competencies developed
as part of the Trust’s NIV policy. The nurses had undergone either formal (e.g. classroom
based) training or informal on the job training by the specialist nurses, practice educators
and senior staff on the respective ward and in ED.

The panel was satisfied during the investigation that all nursing staff involved in the care of
Mrs Scott were appropriately trained on the particular machine and NIV therapy. There was
also access to senior help and a practice educator was available on the day when the
incident happened. The nurse directly involved in the incident was a trained ITU nurse of six
years, who had additional training on the NIV and the Trilogy machine. The panel found,
however, that there was no consistent documentary evidence of the training that staff had
received.

The panel therefore concluded that staff training was appropriate in this case, but
recommended an action in the SI report to complete a training needs analysis to establish
the exact number of other staff that had been trained and to improve documentation of this
training.

Following this incident staff working in this area have undergone a period of retraining by
Phillips which includes the points raised in point 1. These key aspects of training have
further been incorporated into the training delivered by the practice educator and specialist
nurses. The unit has further employed a dedicated practice educator to work with staff in
ADU. All staff other than two new starts have now received training on NIV and this device
and competencies are held within the department.

Point 3 - The provision of power to the ward

The Trust engaged an external expert to advise the organisation on the areas where the
electrical infrastructure requires upgrading to comply with HTM 06-01. This advice has

Chairman: Sir David Henshaw Chief Executive: Prof Simon MacKenzie

formed the basis of the design of a UPS/ IPS back up system in the Richmond ADU area.
The work has now been put to a tender process with the summer 2016 set as the date for
completion of this work due to the co-ordination that is required with clinical areas for this
work to be completed. The Trust has set aside sufficient funds for this work to be completed
and once installed the designed UPS/IPS back up system will alert staff of any failure in the
electricity supply to the mains sockets.

| would be happy to update you on the progress of this work following the tendering process
and on completion of the installation.

Point 4 - Notification to estates management

Call bell repairs are part of the top priority (Priority 1) schedule. Calls rated at Top priority
are attended within 3 hours of the call being logged. Timely Response to Priority1 calls forms
part of the Key Performance Indicators for the Estates department. The electrical circuits in
the Richmond ADU area are to be upgraded in line with the response under section 5 part 3
of the section 28 notice. Therefore the installation of the UPS/IPS system following the
tendering process will ensure that this requirement is met.

Additionally following this incident the nursing staff within this area undertake checks of
emergency call bell systems twice weekly to ensure they are operational. This is recorded on
department checking sheets which are held locally and any faults reported to estates.

| hope that the above actions address your concerns and provide reassurance that the Trust
is fully committed to providing our patients with the highest level of care and to this end we
are continually seeking to improve patient safety.

If you require clarification on any of the above actions, | would be very happy to respond
further.

Jennie'Hall
Chief Nurse and Director of Infection Prevention and Control

Chairman: Sir David Henshaw Chief Executive: Prof Simon MacKenzie