Concerns raised 1 Lack of overtly clear operating instructions on CD oxygen cylinders in heightened situations View source
Actions described in response An action is something this recipient says it has done, is doing, or plans to do in response to the concern raised. 5
Action
Develop a single-operation medical gas VIPR with two manufacturers and test the valves for compliance with the relevant ISO standard.
View source
Action
Continue product-evaluation and improvement projects addressing valve operation and patient safety.
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Action
Provide illustrated online instructions covering safe VIPR operation, cylinder handling and oxygen administration.
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Action
Modify the cylinder valve handwheel tamper-evident cover with black raised-letter printing to clarify removal before use.
View source
Action
Make IOD medical oxygen cylinders with electronic setup and flow alarms available to healthcare facilities.
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AI-generated summary
Ben Christopher Harrison · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Ben Christopher Harrison, aged 37, died on 18 December 2020 after being found in cardiac arrest with a ligature around his neck while a voluntary inpatient. During resuscitation, an oxygen cylinder's side valve was not opened, so he was ventilated on room air for approximately 5–10 minutes. The principal concern was that the cylinder's two-valve design was confusing and potentially unsafe in heightened situations, despite staff training and repeated similar incidents.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Boc Limited; that does 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.
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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
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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 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
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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 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
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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
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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
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3 Dec 2014 Sandra Danks · Prevention of Future Deaths report Teesside
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Concerns raised 1 Lack of backup oxygen provision during interruption of the main oxygen apparatus View source
Actions described in response An action is something this recipient says it has done, is doing, or plans to do in response to the concern raised. 1
Action
Supply backup oxygen cylinders and train home oxygen patients in equipment use and emergency procedures.
View source
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AI-generated summary
Sandra Danks · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Sandra Danks required continuous home oxygen supplied by an electrically powered apparatus. An electricity interruption stopped the apparatus, and she was unable to use the nearby spare oxygen bottle before she died. The principal concern was that the main oxygen apparatus had no backup to maintain oxygen provision during a power interruption.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Boc Limited; that does not assign responsibility.
PFD Monitor interpretation Lack of backup oxygen provision during interruption of the main oxygen apparatus
Wider context from the report “(1) An interruption in the electricity supply to the main oxygen apparatus stopped the oxygen provision and there was no back up on the main oxygen apparatus to continue to provide oxygen , thus leaving Mrs Danks in a very vulnerable position.
” Open source report
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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 Supply backup oxygen cylinders and train home oxygen patients in equipment use and emergency procedures.
Verbatim wording from the response “BOC delivers oxygen to home patients as part of its North East NHS contract. BOC has held the contract since 2011 following a public procurement tender process. BOC follows to the letter the requirements of such contract in terms of the specification given by North East NHS for the equipment and services provided and which are determined by the primary caregivers. As part of an oxygen concentrator installation - for long term oxygen therapy - the contract stipulates that BOC will deliver and train the patient on the use of a back-up oxygen cylinder in case of equipment malfunction or power failure. The back-up oxygen cylinder lasts 8 hours at the patient's prescribed flow rate and BOC will attend to the equipment reported fault within that period of time.”
Source location 2014-0525-Response-by-BOC-Healthcare Page 1 · response Published 3 December 2014
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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 Removed oxygen equipment was found in working order, and BOC was not contacted during the power failure.
Verbatim wording from the response “In dealing with this patient, BOC has followed its robust processes and procedures, and is in compliance with the terms of its contract with North East NHS. The oxygen equipment was checked at the required regular intervals and all necessary risk assessments were carried out in line with BOC's contractual obligations. In the particular instance of this patient and the power failure, BOC was not contacted by the patient or a family member at the time of the power failure - had BOC been contacted, the advice given would have been for this patient to use the back-up oxygen cylinder supplied by BOC until power was reconnected. BOC would then have made a visit to replenish the back-up oxygen cylinder.”
Source location 2014-0525-Response-by-BOC-Healthcare Page 3 · response Published 3 December 2014
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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 Following its comprehensive review, BOC saw no reason at present to take further action, while continuing to monitor procedures.
Verbatim wording from the response “Following BOC’s comprehensive review of its policies and procedures in respect of the supply of oxygen concentrators and BOC’s actions in respect of the current incident, BOC sees no reason at present to take any further action. BOC shall however continue to monitor its current procedures and make any adjustments and improvements as necessary.”
Source location 2014-0525-Response-by-BOC-Healthcare Page 3 · response Published 3 December 2014
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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 Existing policies, contractual requirements, backup oxygen provision, training, servicing and risk assessments were considered sufficient for patient safety.
Verbatim wording from the response “BOC takes patient safety very seriously and has in place robust policies and procedures to ensure the safety of patients using BOC’s Oxygen Concentrators. BOC has conducted a full review of both its general policies and procedures in respect of the supply of oxygen concentrators and also a full review of BOC’s actions in respect of this specific patient since the initial supply of oxygen in July 2013.”
Source location 2014-0525-Response-by-BOC-Healthcare Page 1 · response Published 3 December 2014
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