The following is based on publicly available Regulation 28 reports and the responses to these reports.
During June 2017 the Acting Senior Coroner, for the Coroner area of Bedfordshire & Luton concluded an investigation into the death of Patrick Neil Woods aged 45 with an inquest.
An inquest is different from other types of court hearing because there is no prosecution or defence. The purpose of the inquest is to discover the facts of the death. This means that the coroner cannot find a person or organisation criminally responsible for the death. More information about the Coroners Service can be found here; guide-to-coroner-service .
Patrick died at the Luton and Dunstable University Hospital NHS Foundation Trust in Lewsey Road on the 15thFebruary 2016. The primary medical cause of Patrick’s death was Hypoxic brain injury which results from a lack of oxygen. Oxygen is needed for the brain to make use of glucose, its major energy source. If the brain is deprived of oxygen for approximately four minutes Hypoxic brain injury occurs. As the brain controls the functions of a body’s major organs for example, the heart and liver, brain injury will cause these organs to fail. Hence the secondary medical cause of Patrick’s death was multiple organ failure.
The conclusion of the inquest was while being treated for pneumonia, Patrick required treatment with an anaesthetic machine. The hospital provided a machine which could falsely appear to be delivering fresh oxygen. The hospital failed to ensure that the machine could only be used by those clinicians that had been trained on it and failed to ensure that clinicians had been trained on all the machines they were likely to come into contact with. The clinicians attending to Patrick’s needs did not notice the deteriorating readings of FiO2. FiO2 is a measure of the fraction of Oxygen in the total volume of inspired clinical gases. Essentially, the lower the FiO2 reading the smaller the fraction of the total volume of inspired clinical gases is Oxygen. In the Coroner’s opinion Patrick’s death could have been avoided if the machine had been identified as one that the clinicians had not been trained on.
After the investigation and inquest concluded the Coroner produced two reports (Report A & Report B). These reports were produced to fulfil the obligations placed on all Coroners by Schedule 5 of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (investigations) Regulations 2013. The purpose of these regulation 28 reports is to prevent future deaths and as such they contain the outcomes of the investigation and inquest. These outcomes are summarised in one report (Report A) as a list of matters of concern. These matters of concern are as follows:
- The extent of the equipment portfolio held by the hospital seemed to be unknown
- Without knowledge of the equipment held, no potentially dangerous equipment can be identified
- Without knowledge that there is equipment that could potentially kill a patient, no risk assessment can be undertaken
- Without a risk assessment, no action can be taken to prevent further injury to patients or fatalities.
The other report (Report B) although identical in content to Report A differed in that it included a new matter of concern as follows:
- The evidence of 4 Clinicians at the inquest would suggest that the training by Draeger Medical UK limited the manufacturers and distributors of anaesthetic machines, was not effective.
The Coroner then sent these Reports (A&B) containing these matters of concern to the Chief Executive of the Luton & Dunstable University Hospital NHS Trust, Draeger, the Chief Coroner and other interested parties for example, Patrick’s relatives and, the legal representatives of the hospital and the anaesthetic machine manufacturer and distributor. The reason for sending the report to the hospital and the manufacturer and distributor of the anaesthetic machine used by clinicians to treat Patrick was because Coroners have a statutory duty to inform those parties who in their opinion have the power to take action to remediate matters of concern about the circumstances of a death a particular coroner may have in order to prevent future deaths.
The hospital produced two responses to the Coroner’s reports one response to Report A and another to Report B. Both responses were dated 18thAugust 2017. The response to report A directly addresses the Coroner’s reported matters of concern set out above. The hospital states in this response ‘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.’ The hospital goes on to explain the detail of information in this electronic register about each piece of equipment it holds. This detail consists the service, repair and maintenance history, and the equipment’s risk category on a scale of 1 to 5 based on the requirements of the uses the equipment is put to. Also, the hospital states; ‘There is a Training Need analysis (TNA) record for each location/ward held by the Trust in a non-electronic database managed by the Clinical Devices Trainer’. The hospital goes onto explain the details of information in the TNA database. This detail consists a list of equipment held at each location/ward and the devices each Clinician has been trained upon and alerts the expiry of clinicians’ competency. This TNA is distributed every other month to Ward managers and Matrons for them to check its accuracy and to follow up on any discrepancy if necessary. The Clinical Devices trainer along with the Clinical Educator offer a regular training session for Health Care Assistants, Registered Nurses, Assistant Practitioners, Student Nurses and doctors on their request. The hospital goes on to explain what additional actions should be undertaken to develop the TNA database and the operation of these systems; i.e., the electronic equipment register and the TNA database.
The Luton & Dunstable University Hospital NHS Trust responded to Report B by claiming that it should be impossible for an anaesthetic machine to deliver a lethal level of NiO2, i.e. below15% of the total volume of inspired clinical gases. Although the machine issues an alarm and an”0xgen Sensor Failure” message on the machine’s alerts screen when this level of NiO2is reached busy clinicians felt they were justified in ignoring the alarm because although the machine reported the sensor that activates the alarm was faulty clinicians falsely believed it would be impossible for the machine to deliver a lethal level NiO2 in this circumstance. Also, the hospital responded to Report B by Setting out a process whereby any piece of equipment entering the hospital would have its default alarm settings reviewed by the hospital’s Clinical Director who would ensure the equipment’s default alarm settings were set to safe levels during the process of the machine’s commissioning.
Draeger Medical UK Limited responded to Report B with this statement; ‘Draeger recognises as a crucial priority the importance of optomising patient safety through optomising clinician competence regards the functionality of the machine’. Draeger goes on to list actions it has and will take to prevent future deaths from the use of its machinery by clinicians whose training had not been effective. The most significant of these actions being:
- A Workbook, which is and has been provided and will continue to be provided to trainees for self-guided use to be completed by the trainee with the help of a Draeger trainer. This workbook covers specifically what to do in response to machine alarms and messages.
- A basic skills check list, which is and has been used in user training and will continue to be used in user training which the trainer and the trainee must both sign when training is completed.