Kay Sheard
Action Planned
AI-generated response summary
• The Health Board reviewed device holdings and checked device settings. • The Health Board scoped an Action Plan for an inventory of approximately 1200 devices. • The Health Board will raise issues concerning manufacturer default alarm levels and user adjustability at Wales level and with the MHRA.
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Dear Mr Gittins
Re: Regulation 28: report to prevent future deaths
BCU Health Board is grateful to the Coroner for his report, and is taking the findings extremely seriously in order to prevent deaths or serious harm in the future.
The Matters of Concern relate to the use of pulse oximeters to measure oxygen saturation (SpO2 %), and in particular to the setting of an alarm level ie the value of oxygen saturation below which the device would give an alarm to indicate the need for remedial action. The expectation set out is that the alarm level should be adjusted to reflect the individual patient's condition to reduce the risk of an adverse incident.
A number of national and international bodies have produced guidelines on pulse oximetry. The Health Board has a significant amount of work to do on this issue, noting that pulse oximetry is used so widely, by so many different staff, in different clinical situations. However, our inquiries indicate that this issue also extends beyond the Health Board to the manufacturers, who install default alarm levels in their products, and the extent to which they support and facilitate user adjustment of alarm levels. Accordingly there are likely to be issues to be considered beyond BCU Health Board, and we will raise these both at Wales level, and at UK level through the MHRA (Medicines and Healthcare products Regulatory Agency).
Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.
A number of inter-related key factors are involved in establishing an effective Action Plan:
1. Expert consensus on appropriate alarm levels (adult, paediatric, patients with Chronic Obstructive Pulmonary Disease [COPD], absolute levels [eg 90%], relative levels [eg 3% drop in baseline] etc)
Cyfeiriad Gohebiaeth ar gyfer y Cadeirydd a'r Prif Weithredwr / Correspondence address for Chairman and Chief Executive: Swyddfa'r Gweithredwyr / Executives' Office, Ysbyty Gwynedd, Penrhosgarnedd Bangor, Gwynedd LL57 2PW Gwefan: www.bcu.cymru.nhs.uk / Web: www.bcu.wales.nhs.uk
2. Equipment issues –
a. reviewing equipment holdings across North Wales, clarifying manufacturer default settings, and adjustability by the user.
b. Planning and costing any equipment changes required
3. Achieving adequate staff awareness and compliance with the agreed alarm levels and equipment.
Please find enclosed the action plan relating to this regulation 28 report.
Re: Regulation 28: report to prevent future deaths
BCU Health Board is grateful to the Coroner for his report, and is taking the findings extremely seriously in order to prevent deaths or serious harm in the future.
The Matters of Concern relate to the use of pulse oximeters to measure oxygen saturation (SpO2 %), and in particular to the setting of an alarm level ie the value of oxygen saturation below which the device would give an alarm to indicate the need for remedial action. The expectation set out is that the alarm level should be adjusted to reflect the individual patient's condition to reduce the risk of an adverse incident.
A number of national and international bodies have produced guidelines on pulse oximetry. The Health Board has a significant amount of work to do on this issue, noting that pulse oximetry is used so widely, by so many different staff, in different clinical situations. However, our inquiries indicate that this issue also extends beyond the Health Board to the manufacturers, who install default alarm levels in their products, and the extent to which they support and facilitate user adjustment of alarm levels. Accordingly there are likely to be issues to be considered beyond BCU Health Board, and we will raise these both at Wales level, and at UK level through the MHRA (Medicines and Healthcare products Regulatory Agency).
Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.
A number of inter-related key factors are involved in establishing an effective Action Plan:
1. Expert consensus on appropriate alarm levels (adult, paediatric, patients with Chronic Obstructive Pulmonary Disease [COPD], absolute levels [eg 90%], relative levels [eg 3% drop in baseline] etc)
Cyfeiriad Gohebiaeth ar gyfer y Cadeirydd a'r Prif Weithredwr / Correspondence address for Chairman and Chief Executive: Swyddfa'r Gweithredwyr / Executives' Office, Ysbyty Gwynedd, Penrhosgarnedd Bangor, Gwynedd LL57 2PW Gwefan: www.bcu.cymru.nhs.uk / Web: www.bcu.wales.nhs.uk
2. Equipment issues –
a. reviewing equipment holdings across North Wales, clarifying manufacturer default settings, and adjustability by the user.
b. Planning and costing any equipment changes required
3. Achieving adequate staff awareness and compliance with the agreed alarm levels and equipment.
Please find enclosed the action plan relating to this regulation 28 report.