Patrick Woods

THE INQUEST TOUCHING THE DEATH OF PATRICK NEIL WOODS

Ref: 39895-2016

RESPONSE TO REGULATION 28

REPORTS TO PREVENT FUTURE DEATHS

1. This document is filed on behalf of Draeger Medical UK Limited
(“Draeger’), pursuant to regulation 29 of the Coroners (Investigations)
Regulations 2013, in response to the reports dated 19 June 2017 served
by Acting H.M. Senior Coroner for Bedfordshire and Luton following the
inquest touching the death of Patrick Neil Woods,

2. The concerns expressed by the HM Coroner are:

a. The evidence of some clinicians at the Inquest would suggest that
the training was not effective;
b. There is a risk that busy clinicians:
i. Do not identify that the Tiro is a machine that they have not
been trained on;
ii. Do not identify that the Tiro is any different to other machines
that they have been trained on;

ii. Forget the relevance of the COSY switch;

v. Are not alert, in the absence of sufficient emphasis on the
same, to the risk of delivering a hypoxic mix;

v. Are not aware, in the absence of a reminder/alert, that the
Tiro is not functioning how the clinicians think it should be
functioning.

3. Whilst the concerns are expressed in two separate documents, they are

inter-related, since the desired result of addressing the concerns is that, in

the future, all clinicians using a workstation such as the Tiro will know how

to select the correct fresh gas path for the intended ventilation mode.

Draeger therefore responds to both PFD reports within this one document.

4. Draeger recognises as a crucial priority the importance of optimising

patient safety through optimising clinician competence regards the

functionality of the machine. With those objectives in mind, Draeger has

decided to take the following steps:

a. The updating of its training documentation, which has already taken

place, including:

i. The Basic Skills Checklist, which is and has been used in

iii.

basic user training, and which the trainer and user must both
specifically sign when completed. In addition to listing the skill
for the selection of the external ACGO outlet, the Checklist
now includes the demonstration of the correct/incorrect
procedure for switching between external ACGO and
manual/controlled ventilation, paying attention to monitored
parameters and gas flow direction.

i. The Workbook, which is and has been provided for self-

guided use to be completed by the user, although a Draeger
trainer can be on hand to offer advice. Pages 30-32 test the
awareness of how the machine can operate and include
several boxes with yellow triangle warnings, which refer to the
selection of the correct circuit and appropriate routing of the
fresh gas, as well as the context for measurement of O2,
pressure and volume.

The Quick Guide, which is and has been given to users who

have training on the devices. Page 8 shows the operation of

the ACGO switch and now includes a box with a yellow
triangle warning, which refers to the risk of a hypoxic gas
mixture;

iv. The Practical Exercises, which have been intended for the
user to do as part of the training package, now include five
questions (out of a total of 23) intended to concentrate on the
functionality of COSY and ACGO ventilation modes.

v. The powerpoint presentation which had been intended for use
by trainers now includes four slides devoted to the use of the
COSY switch and the relevant ventilation modes.

vi. The Training Needs Analysis includes reference specifically to
“Ventilation Modes” and “Operation of Auxiliary Common Gas
Outlet.”

b. The circulation worldwide of a Field Safety Notice (“FSN’) to
hospitals for circulation amongst their anaesthetic departments
drawing attention to the principles applicable to re-breathing circuit
systems. Draeger will also send a copy of the FSN to electrical and
biomedical engineering (EBME) bodies within each hospital within
the UK to whom the FSN is sent. Draeger anticipates that the
distribution of the FSN will begin from October 2017. Draeger will
follow up the circulation of its FSN within the UK by seeking
confirmation of receipt.

c. Having identified from its database all customers within the UK to
whom a Fabius machine has been supplied, Draeger will take steps
to contact all such customers for the purposes of arranging a site
visit from Draeger representatives within a 16 week period after the
FSN to address any concerns raised and discuss any further
training needs.

5. In further pursuit of achieving the objectives identified above, Draeger

intends also to take the following steps:
a. Making a training video specifically to address use of the ACGO
switch, for use in both introductory basic training and in refresher

training sessions.

b. Continuous review of performance data and of all feedback from

hospital and individual user information;

c. Regular review at Competence Board level of such information; and

6. Draeger would respectfully ask HM Coroner and HM Chief Coroner not to
publish paragraph 5(d) above and / or to redact paragraph 5(d) above
when publishing this document. The particular design, technical and

commercial considerations are, it is submitted, confidential.

DAC Beachcroft LLP

Solicitors for Draeger
29 September 2017

LUTON &
BLE

Lewsey Road Luton LU4 ODZ
Yel: 01582 49 13 66 www Jdh nhs.uk

18" August 2017

PRIVATE AND CONFIDENTIAL
ADDRESSEE ONLY

HM Acting Senior Coroner Mr lan Pears

Office of HM Coroner - Bedfordshire and Luton
C/O Mrs Kerry Mcllroy (Coroner's Officer)

The Court House

Woburn Street

Ampthill

Bedfordshire MK45 2HX

Dear Mr Pears

Regulation 28 Report to Prevent Future Deaths — Court Reference 39895 - 2016

| write in my capacity as Acting Chief Executive of Luton and Dunstable University Hospital
NHS Foundation Trust (“the Trust”) to address the concerns raised in the Prevention of Future
Deaths Report issued following the inquest into the death of Mr Patrick Woods.

The matters of concern raised in the Report were:

1) The alarms on the equipment and monitors seemed to play no part in managing risk for
the Anaesthetists

2) The AAGBI Guidance is quite specific, but time and again the witnesses said their
practice was in effect contrary to the guidance. It is unacceptable for such Guidance to
be wilfully ignored

3) It was revealed that the factory setting for the Tiro for FiO2 was 18%. There seems to
be agreement that this was not a safe setting, yet there were very few circumstances
(mainly paediatrics) that the settings were changed.

3
i

The Trust has now considered the above concerns in detail and reviewed the action to be
taken to prevent future deaths. On behalf of the Trust, | set out the response below and would
like to reiterate our sincere apology and condolences to the family and friends of the late Mr
Patrick Woods.

Alarms on anaesthetic equipment/factory settings

Every anaesthetic machine and monitor is configured with default alarms by the manufacturer
prior to delivery of the machine to the Trust. As part of the commissioning of the machine, the
settings of these default alarms are reviewed on behalf of the Trust by the Clinical Director for
Anaesthetics to ensure they are fit for purpose. Since this incident, the default alarm settings
have been discussed within the anaesthetic and operating department practitioners’ forums,
and the Trust has agreed a Trust default setting for each variable, which have been applied
retrospectively to all machines currently in use from 21 July 2017, and will be applied
prospectively to all future machines before they are deployed for clinical use.

These Trust defaults will be reviewed annually by the Clinical Director for Anaesthetics to
ensure that they remain consistent with latest guidance, and provide safe alarm protection for
all parameters.

Simon Linnett Luton and Dunstable University Hospit.
cutve: Pauline Philp

MHS Foundation T

The agreed default settings are as follows:

FiO2 30% - 100%

ETCO2 3.0-7.0 kPa

Respiratory rate <8 breaths/min

Pulse 45 — 120 beats/min

Blood Pressure Systolic 80 — 150 mmHg
Mean 60 ~- 125 mmHg

Oxygen Saturations 94- 100%

The default alarm settings have been agreed by the anaesthetists and operating department
practitioners as providing acceptable safety for the majority of elective adult patients who are fit
and well. We have highlighted this fact in our communication with anaesthetists and ODP’s,
and advised of the need to review alarm limits and set appropriate alarm limit values for all
other cases.

Another point it is important to highlight is that the Tiro is manufactured and designed to
display an “Oxygen Sensor Failure” message on the alerts screen if the FiO2 falls below 15%.
This is only reasonable if it was considered impossible for a machine functioning correctly to
deliver such a low level of oxygen, and that therefore such a reading must be due to a faulty
sensor. What this case has demonstrated is that under the correct circumstances, this
machine WILL deliver such an FiO2, and that for the machine to display such a message
under these circumstances falsely leads the anaesthetist to believe that they should disregard
the Low FiO2 alarm, because the machine is telling them that the sensor is not working.

Although the Trust is not able to take action in respect of manufacturing issues, the Trust
considers that this is something which Drager should review and we would invite the coroner to
consider the same when reviewing Drager’s PFD responses. For example, had that message
not been displayed in this case, it is quite possible that there would have been earlier
investigation of the low FiO2 because the low FiO2 alarm would not have been disregarded, or
the decision to switch to an alternative oxygen source and mechanism of ventilation might
have been made earlier.

impiementation of AAGBI (Association of Anaesthetists of Great Britain and Ireland) Guidance

The AAGBI guidelines “Recommendations for Standards of Monitoring During Anaesthesia
and Recovery December 2015"”, with the relevant sections highlighted, have been circulated
to all anaesthetists and Operating Department Practitioner's by the Medical Director with an
email’ outlining the outcome of the inquest, and the concerns the Coroner raised.

Notices have been placed in each anaesthetic room to remind anaesthetists of the importance
of ensuring they have received training on all pieces of equipment they are going to use, that
they have checked the anaesthetic machine, and that they have reviewed the alarm settings.
This TCA (Trained / Checked Machine / Alarms) methodology will become part of the routine
practice of anaesthesia at the Luton & Dunstable Hospital, and will become part of the pre-
operative huddle that occurs before the start of every list, including emergencies.

* Recommendations for Standards of Monitoring during Anaesthesia and Recovery AAGBI December 2015
Available at http://www.aagbi.org/sites/default/files/Standards_of_monitoring_2015. 0.pdf
* Email from Dr Robin White, Medical Director to all anaesthetists and ODP’s sent 01/09/2017

It is important that | point out that to individually adjust all of the alarm settings on the patient
monitor and the anaesthetic machine/ventilator takes approximately 10 minutes. For the
majority of elective operating lists, it would be feasible to set appropriate defaults for the whole
list at the start of the session, and this can be done alongside the operational checks that are
carried out on each machine by the anaesthetist before use. However, the majority of
machines will re-set to the default settings at the end of each case, requiring them to be re-set
before each case in a list.

in an emergency setting, such as was the case of Mr Woods, the anaesthetist may be actively
involved in treating the patient while transporting them to the theatre. As such, there will be
scenarios where it may not be possible for an Operating Department Practitioner to be able to
predict what alarm settings might be appropriate for such cases. Under such circumstances,
the case may have to commence with the default alarm settings, and fine tuning of the alarm
limits may need to take place during the case.

The Trust has written to AAGBI about this separately, to ensure that there is no conflict
between the guidance and emergency situations, and if necessary to seek their assistance on
ensuring there is a working practice within the Trust that adheres to the guidance.

Summary

The Trust believes that it has done all that it can reasonably be expected to do in addressing
and raising awareness of the issues contained within the Prevention of Future Deaths Order,
distributing and highlighting the current guidance available from the profession with respect to
monitoring, and having put in place appropriate default alarm limits which enhance patient
safety. The Trust will also take forward with AAGBI the application of the guidance in
emergency situations.

The Trust would like to again re-iterate our sincere apologies and best wishes to the family and
friends of the late Mr Patrick Woods, and to thank the Coroner for his careful and detailed
examination of the facts.

if any further information is required by the Coroner, of if he would like to discuss the letter,

please do not hesitate to contact my office on or via email at

Yours sincerely

a

David Carter
Acting Chief Executive Officer

LUTON 8
DU

18" August 2017

PRIVATE AND CONFIDENTIAL
ADDRESSEE ONLY

HM Acting Senior Coroner Mr lan Pears

Office of HM Coroner — Bedfordshire and Luton
C/O Mrs Kerry Mcliroy (Coroner's Officer)

The Court House

Woburn Street

Ampthill

Bedfordshire MK45 2HX

Dear Mr Pears

Regulation 28 Report to Prevent Future Deaths — Court Reference 39895 - 2016

| write in my capacity as Acting Chief Executive at Luton and Dunstable University Hospital
NHS Foundation Trust (“the Trust’) to address the concerns raised in the Prevention of Future
Deaths Report issued following the inquest into the death of Mr Patrick Woods.

The matters of concern raised in the Report were:

1) The extent of the equipment portfolio held by the Hospital seemed to be unknown

2) Without the knowledge of the equipment held, no potentially dangerous equipment can
be identified

3) Without the knowledge of that there is equipment that could potentially kill a patient, no
risk assessment can be undertaken

4) Without a risk assessment, no action can be taken to prevent further injury to patients
or fatalities

The Trust has now considered the above concerns in detail and reviewed the action to be
taken to prevent future deaths. As acknowledged by the Coroner during the inquest itself,
completing the actions in respect of these concerns is a time consuming task which requires
substantial resources. However, on behalf of the Trust | set out below those measures which
are already in place, and the action which will be taken by the Trust and the timescales for the
same.

On behalf of the Trust | would like to reiterate our sincere apology and condolences to the
family and friends of the late Mr Patrick Woods.

Action already taken

It is unfortunate that it was not made clear at the time of the inquest that the Trust does hold a
register of all equipment and its location within the Trust.

A comprehensive log of equipment i.e. Manufacturer, model, serial no, device location
(ward/department name), commissioning date & service requirement is already held by the
Trust on an electronic database managed by the Clinical Engineering department. The
database also keeps a record of the device history i.e. service, repair, and maintenance
contract and field safety notice. In addition equipment is risk categorised into priority 1 to 5
based on the service requirement of devices. There is also a procedure in place for
commissioning/disposing of devices on the database and a formal approval process is in place

Simon Linnett Luton and Dunstable Universi
tye Pauline Philp MN

ty Hospita

&
2
8

for any device not already on the database and new to the trust. The department also keep a
copy of agreed configuration related to specific devices and ward/department and ensure the
device has the right dataset once it is serviced/ repaired

There is a Training need analysis (TNA) record for each location/ward held by the Trust on a
database managed by the Clinical Devices Trainer.

The TNA analysis contains the list of equipment specific to the ward/department and the
devices each clinician has been trained upon and alerts the expiry of competency. The TNA is
distributed every other month to Ward Managers and Matrons for accuracy and follow up. The
recording process is currently under review and the Trust is looking into an electronic database
solution. The Clinical Devices Trainer along with the Clinical Educator offer a regular training
session to Health Care Assistants (HCA), Registered Nurses (RN), Assistant Practitioners, and
Student Nurses. The Clinical Devices Trainer arranges training for doctors as and when
requested

In addition, at present, all incidents reported on the Trust’s incident reporting system (Datix)
involving faulty or any failure of equipment, are reviewed at each Medical Equipment Group
meeting. The Medical Equipment Group meets every two months, and all events which have
been reported through Datix pertaining to medical equipment are reviewed, regardless of what
local action has already been taken. A decision is then made as to whether the event occurred
as a result of user error, equipment malfunction or improper use. The results of this are then
actioned by either our Clinical Devices Trainer (in the case of user error or improper use) or
Clinical Engineering Manager (in the case of equipment malfunction). Because all events
related to equipment are discussed at this one meeting, an overview is maintained in order to
identify any themes or patterns which emerge. The group has the power to remove an item or
type of equipment if necessary, and would communicate with the Medicines and Healthcare
products Regulatory Agency (“MHRA”) if necessary.

The Medical Equipment Group also review and act upon all “Medical Device Alerts” reported to
the Trust by external agencies.

Action to be undertaken

The Trust has considered carefully what further action needs to be undertaken, and this is set
out in the below table, with the timescales for completion of the same.

Further action Timescale

There is to be a review of each clinical area where an
item of equipment is used, to ensure that the Trust
has a complete and up to date “master” log of the
equipment held.

The current "sub-list" of equipment for each area
(taken from the master log) will be distributed to the
Clinical Director and Matron of each respective area,
for them to review and cross-check with all equipment
in that area. Any items in the clinical area which are
not on the “sub-list” must be added.

The Trust's Head of Clinical Risk and Governance,
supported by the Clinical Engineering Manager has

The “sub-lists” to be sent to each
area by the end of September 2017

The Clinical Director / Matron of
each area will be required to return
the cross-checked and updated
“sub-list” within two weeks of receipt
of the “sub list” to the Chair of the
Medical Equipment Group, with a
copy also sent to the Head of
Clinical Risk and Governance.

been tasked to create and distribute the “sub-lists” to
each clinical area

Once the updated “sub-lists” have been received by
Chair of the Medical Equipment Group and the Head
of Clinical Risk and Governance from each clinical
area, Chair of the Medical Equipment Group must
assimilate the information into the “master” log held
by the Trust.

The “sub-lists” will also be kept for each clinical area.

The “master” log to be confirmed as
updated and complete by the end of
October 2017.

Each “sub-list” to be stored safely
immediately upon completion and
receipt.

From October 2017 the Trust will implement a new
procedure whereby:

a) Any new equipment entered into the Trust will
be reviewed and entered onto both the
“master log” and the appropriate “sub-list” for
the clinical area for where that item will be
kept. The “master” and “sub-lists” will be
maintained by the Medical Equipment Group,
and the procurement team will cross-check the
lists and provide an exception report to the
Medical Equipment Group if any equipment
has been bought and is not on the logs.

b) At regular intervals (every four months, i.e. at
every other Medical Equipment Group
meeting) both the “master” log and the “sub-
lists” will be reviewed to ensure that they are
accurate and up to date. The Clinical Director
and Matron of each area which has a “sub-list”
will be asked to confirm that the same is
accurate in advance of the Medical Equipment
Group meeting.

The Medical Equipment Group Committee will have
overall responsibility for the “master” log and “sub
lists”.

Once the “master” log and “sub-
lists” are completed as above, this
new procedure will be in place.

At every Medical Equipment Group
meeting (i.e. every two months)
both the “master” log and “sub-lists”
will be reviewed to ensure
accuracy.

By the end of October 2017, a request will be sent to
the Clinical Director and Matron of each clinical area
which has a “sub list”, who will then be responsible for
undertaking a risk assessment of the identified
equipment in their area and to review the unused
functionality of said equipment / device.

The risk assessments must take
place by the end of January 2018.

Risk assessments will thereafter be performed
annually and reviewed at a_ specific Medical
Equipment Group meeting for that purpose. The
findings of the review will be reported to COB/COSQ

Ongoing from February 2018

Summary

The Trust believes that it has done all that it can reasonably be expected to do in addressing
the issues contained within the Prevention of Future Deaths Order, to ensure that a complete
and accurate portfolio of equipment is held at ail times, and that appropriate risk assessments
are undertaken.

If any further information is required by the Coroner, of i i discuss the letter,
please do not hesitate to contact my office on or via email at

The Trust would like to again re-iterate our sincere apologies and best wishes to the family and
friends of the late Mr Patrick Woods, and to thank the Coroner for his careful and detailed
examination of the facts.

Yours sincerely

David Carter
Acting Chief Executive Officer