PFD report

Ben Christopher Harrison · Prevention of Future Deaths report

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Issued 10 May 2024•North Wales (East and Central)

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
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
8

Described in responses

Recipients and published 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 raised1

  1. Lack of overtly clear operating instructions on CD oxygen cylinders in heightened situations
    Part of recurring concern: Failure to ensure clear and followed instructions for safe equipment use
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.5

  1. Action

    Develop a single-operation medical gas VIPR with two manufacturers and test the valves for compliance with the relevant ISO standard.

    Stated by Boc LimitedStated plannedThe respondent said that this action was planned when they made their response on 14 May 2024.
  2. Action

    Continue product-evaluation and improvement projects addressing valve operation and patient safety.

    Stated by Boc LimitedStated in progressThe respondent said that this action was in progress when they made their response on 14 May 2024.
  3. Action

    Provide illustrated online instructions covering safe VIPR operation, cylinder handling and oxygen administration.

    Stated by Boc LimitedStated completedThe respondent said that this action was complete when they made their response on 14 May 2024.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    Nurse awareness training was not provided because the hospital declined the offered training session.

    Stated by Boc LimitedUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

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 overtly clear operating instructions on CD oxygen cylinders in heightened situations

Wider context from the report

“Evidence was heard during the Inquest that a CD Oxygen cylinder manufactured by BOC was used during the resuscitation of Ben. I was shown during the Inquest how the oxygen cylinder is operated. In order for the cylinder to release oxygen the valve on the side must have its tab removed and then the valve itself rotated until it is open with the valve at the top also needing to be opened. In Ben’s resuscitation, this did not occur. The side valve had not been opened meaning that for 5-10 minutes Ben was ventilated on room air only. Once it was noted, it was immediately corrected. The evidence at Inquest was that having two valves was confusing for users and at times of high intensity and highly charged situations, even with training, those operating the cylinder may not necessarily recall that there are two valves to open. It is understood that more pronounced wording has been included on the side valve to attempt to alert users though this is not particularly pronounced. There have been 22 incidents with oxygen cylinders at the Health Board since 2014, including 2 since January 2024. There has been additional training for staff over recent years as part of their ALS / ILS training including specific focus on these cylinders and yet issues with the two valves on the cylinder remains. It is understood that BCUHB have referred numerous concerns to BOC over recent years and some minor amendments have been made to the cylinders. BCUHB also reported to the Medicines and Healthcare products Regulatory Agency (MHRA) on 6 October 2022 under The Yellow Card Scheme. No response was formally received. I remain concerned that the CD Oxygen cylinders manufactured by BOC which, it is understood, supply most if not all Health Boards in Wales (under procurement processes) are unsafe for use in heightened / pressurised situations in that it is not overtly clear how the cylinders are to be operated with the confusion of the two valves. This is evidenced by very similar ongoing issues identified by BCUHB even with adequate training of staff. ”

Is this part of a recurring concern?

Yes — Failure to ensure clear and followed instructions for safe equipment use.

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Develop a single-operation medical gas VIPR with two manufacturers and test the valves for compliance with the relevant ISO standard.

Verbatim wording from the response

“I can also confirm that BOC is currently in the process of working with two medical gas valve manufacturers who are developing a single operation Medical Gas VIPR, where the cylinder valve handwheel and flow selector functionality is incorporated into the same knob/valve. This work is in its final stages, with BOC due to conduct testing on the valves to ensure they operate in compliance with the relevant ISO standard. However, it should be noted that from a usability point of view, the introduction of this valve will need to be carefully controlled as it will require the user to follow ‘different’ procedures compared to those for the existing valve design.”

Source location

Response from BOC
Page 6 · response
Published 14 May 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue product-evaluation and improvement projects addressing valve operation and patient safety.

Verbatim wording from the response

“As you can see from the information I have provided, BOC attaches great importance to constant product evaluation as part of our continuous improvement programme. In this regard, BOC has a number of projects currently under way to improve both the safe operation of the valve, as well as reviewing and improving patient safety. One issue we have with many users is that incidents with valves are not always reported to BOC, and with the MHRA’s Yellow Card procedure, it is not always possible to understand the full circumstances related to each incident. The 22 incidents at Glan Clwyd Hospital were only reported to BOC verbally, long after the event, and we have received no indications of the two cases that you have referenced in your Report has having occurred this year.”

Source location

Response from BOC
Page 6 · response
Published 14 May 2024

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 illustrated online instructions covering safe VIPR operation, cylinder handling and oxygen administration.

Verbatim wording from the response

“In addition to the safety information that we are obliged to provide on the cylinder label, in the SmPC and in the PIL, BOC took the decision to prepare an illustrated ‘Instructions for Use’ (IFU) to provide additional information to make sure that sufficient information is made available to the end user to operate the valve both correctly and safely. The IFU (copy attached) is provided ‘on-line’ as a suitable training document for both Healthcare Professionals and Homecare patients to access and”

Source location

Response from BOC
Page 2 · response
Published 14 May 2024

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

Modify the cylinder valve handwheel tamper-evident cover with black raised-letter printing to clarify removal before use.

Verbatim wording from the response

“Around the time of the two Yellow Card reports, BOC had been in discussion with the MHRA about the actions we had already taken, to emphasise the need to open the cylinder valve handwheel prior to”

Source location

Response from BOC
Page 4 · response
Published 14 May 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Make IOD medical oxygen cylinders with electronic setup and flow alarms available to healthcare facilities.

Verbatim wording from the response

“As part of the range of cylinders BOC offers to customers, we now have available to Healthcare Facilities the IOD Medical Oxygen cylinder, based on the same lightweight cylinder, but fitted with a VIPR that has an electronic gauge. The gauge has a number of functions, including visual and audible alarms to warn the user when the cylinder has not been set up correctly. One of the alarms provides an indication as to when a flow has been selected without first opening the cylinder valve handwheel. I understand that BOC has offered this cylinder package to Glan Clwyd Hospital, but they have decided not to purchase it. I have attached for your information, a copy of the IFU for the IOD cylinder package so that you can see the functionality of the electronic gauge, but you will note that the instructions still cover the safe use and handling of Medical Oxygen cylinders.”

Source location

Response from BOC
Page 6 · response
Published 14 May 2024

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

Nurse awareness training was not provided because the hospital declined the offered training session.

Verbatim wording from the response

“From the discussions BOC has had with the staff at Glan Clwyd Hospital, I can confirm that BOC has provided them with some training, but this has been related to the management of the Medical Gas Pipeline System (MGPS). The training BOC provided was intended for ‘Training the Trainer’, aimed primarily at the engineering and portering staff responsible for operating the MGPS. Although it did cover some aspects of handling cylinders, this was related to cylinders used to supply the pipeline, rather than cylinders used at the patient’s bedside or when transferring patients between departments. BOC has offered to provide awareness training for nurses in their ‘mess room’, (avoiding any issues of taking nurses away from the wards), but this offer was declined by the hospital.”

Source location

Response from BOC
Page 5 · response
Published 14 May 2024

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

Responsibility for ensuring healthcare staff receive appropriate cylinder training and retraining rests with the healthcare facility.

Verbatim wording from the response

“However, BOC does regularly offer a variety of training programmes for different aspects of handling Medical Oxygen, as well as offering ‘free’ training for nursing staff to make sure that they are familiar with the correct procedures. With the cylinder package now having been in service for almost 25 years, the responsibility of ensuring that all staff are appropriately trained is down to the Healthcare Facility, as they are aware of the changes in the staffing levels and their need for retraining.”

Source location

Response from BOC
Page 5 · response
Published 14 May 2024

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.3

  1. 1

    Offer medical oxygen handling training programmes, including free training for nursing staff.

    Stated by Boc LimitedStated completedThe respondent said that this action was complete when they made their response on 14 May 2024.
  2. 2

    Develop and publish harmonised best-practice guidance for industry and end users with UK and European gas associations.

    Stated by Boc LimitedStated completedThe respondent said that this action was complete when they made their response on 14 May 2024.
  3. 3

    Provide online videos demonstrating safe cylinder use, correct gas delivery and oxygen-fire risk mitigation.

    Stated by Boc LimitedStated completedThe respondent said that this action was complete when they made their response on 14 May 2024.

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

Offer medical oxygen handling training programmes, including free training for nursing staff.

Verbatim wording from the response

“However, BOC does regularly offer a variety of training programmes for different aspects of handling Medical Oxygen, as well as offering ‘free’ training for nursing staff to make sure that they are familiar with the correct procedures. With the cylinder package now having been in service for almost 25 years, the responsibility of ensuring that all staff are appropriately trained is down to the Healthcare Facility, as they are aware of the changes in the staffing levels and their need for retraining.”

Source location

Response from BOC
Page 5 · response
Published 14 May 2024

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

Develop and publish harmonised best-practice guidance for industry and end users with UK and European gas associations.

Verbatim wording from the response

“It should also be noted that BOC has worked with the relevant UK and European Gas Associations (British Compressed Gases Association (BCGA) and the European Industrial Gases Association (EIGA)) to prepare ‘best practice’ guidance for both the industry and for end users (via their websites). These Guidance Notes were prepared to harmonise the information that the individual gas companies prepare to accompany their products and have been reviewed prior to publication by the relevant national Regulatory Authorities - the MHRA in the UK and the HPRA in Ireland. Although the GCE valve used in the CD cylinder package is the most common type of VIPR used by BOC in medical gas cylinder packages, it is also commonly used by other gas suppliers in the UK and across Europe.”

Source location

Response from BOC
Page 3 · response
Published 14 May 2024

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 online videos demonstrating safe cylinder use, correct gas delivery and oxygen-fire risk mitigation.

Verbatim wording from the response

“BOC also provides videos on-line to help show users how to safely use the product, both to ensure that the patient receives the correct gas for therapy and that the risks associated with delivering oxygen safely are met.”

Source location

Response from BOC
Page 3 · response
Published 14 May 2024

Open published response
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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
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Data last updated 7 September 2026