Source · Prevention of Future Deaths

Kay Sheard

Date: 21 Dec 2015 Coroner: John Gittins Area: North Wales (East and Central) Responses identified: 1 / 1 View PDF

Pulse oximeter alarm settings are fixed at a routine level rather than being adjusted to individual patient baselines, risking unnoticed significant oxygen desaturation.

Date 21 Dec 2015
56-day deadline 15 Feb 2016
Responses identified 1 of 1
Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary
Pulse oximeter alarm settings are fixed at a routine level rather than being adjusted to individual patient baselines, risking unnoticed significant oxygen desaturation.
View full coroner's concerns
During the procedure the Deceased's oxygen saturations were being monitored by a pulse oximeter for which was advised that the alarm settings are routinely set at 85% However all evidence indicated that it was not the actual level of reading which would be significant for a patient but rather the amount by which saturations had dropped from the patients normal base level. Notwithstanding this, the evidence indicated that this would not be taken into account when fixing an alarm setting level and am therefore concerned that there exists a potential risk to patients which could be reduced or eliminated by ensuring that the alarm level correctly reflects the individual patient's condition. Kay

Responses

1 respondent
Kay Sheard
10 Feb 2016 PDF
Action Planned

Betsi Cadwaladr University Health Board acknowledges the complex issue of pulse oximeter alarm settings and is developing a comprehensive action plan. They have initiated work to review device holdings and settings, and plan to establish expert consensus on alarm levels, address equipment issues, and ensure staff awareness. They will also raise these concerns with manufacturers and at national levels. (AI summary)

View full response
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.

Report sections

Investigation and inquest
On the 8th of January 2015 commenced an investigation into the death of Michelle Sheard (DOB 6.1.73,DOD 6.1.15). The investigation concluded at the end of the inquest on the 16th of December 2015. The cause of death was 1(a) Unascertained and recorded an Open Conclusion
Circumstances of the death
The Circumstances of the death are that on the 6th of January 2015 the Deceased underwent an outpatient procedure under sedation at Glan Clwyd HGospital for the removal of gall stones form the bile duct: Upon completion of the procedure she went into cardiorespiratory failure for reasons which could not be established at a Post Mortem nor from evidence at the inquest,
Action should be taken
In my opinion action should be taken to prevent future deaths and believe your organisations have the power to take such action.

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Report details

Date of report
21 December 2015
Coroner
John Gittins
Coroner area
North Wales (East and Central)

Responses identified

Responses identified 1 of 1
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 15 Feb 2016.

Sent to

BCUHB, Ysbyty Gwynedd

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