Jacqueline Scott

From the Lord Prior of Brampton Parliamentary Under Secretary of State for NHS Productivity (Lords) Department of Health Richmond House 79 Whitehall Ms Angela Hodes, Assistant Coroner London SWIA ZNS Westminster Coroner' s Court 65 Horseferry Road London SWIP 2ED 0 4 MAY 2016 M, /.1, Thank you for your letter of 17 March 2016,following the inquest into the death of Jacqueline Scott. I was sorry to hear ofher death and wish to extend my condolences to her family: You raise four main concerns in this case regarding: the BIPAP Trilogy 202 machine and it'$ visual display symbols and alert alarms; staff training on use of the BIPAP machine; the provision of electrical power to the ward; and notification to and response from the hospital'$ estates management concerning a failed emergency call bell Many of these issues need to be addressed by Phillips Healthcare and the NHS Foundation Trust: However; I do acknowledge your concerns about the design of the BiPAP machine and the safe provision of power supply which I will address. My officials contacted colleagues at NHS England who have advised that the design of some non-invasive ventilation (NIV) systems and other critical devices could be improved by having safety features which warn staff of delivery problems, such as disconnection and power failure. NHS England has a close working relationship with the Medicines and Healthcare Regulatory Agency (MHRA) and is able to share such concerns with them: Their collective power to improve the design of medical devices is often limited however; as manufacturers are not required to make changes to a product ifit

meets the relevant regulatory requirements (the Trilogy 202 ventilator is CE marked to show compliance with the Medical Devices Directive). In order to impose manufacturers to make such improvements would require a change to the UK and EU requirements NHS England has been able to raise awareness of unintentional interruption of this type of therapy however, and on 13 February 2015,it issued a Patient Safety Alert concerning the risk of severe harm and death from unintentional interruption of non-invasive ventilation. This publication was a joint effort with the Medicines and Healthcare Regulatory Agency (MHRA) and served as a reminder of the correct procedures and the importance of familiarity with the ventilators and disposables used. copy of the alert can be found at: https ILwww england nhs uk/201 5/02/psa-nivlpsa-nivl MHRA was made aware of the events outlined in your letter in April 2015 and submitted a report to the coroner which confirmed the manufacturer had examined the device and found no faults. The Phillips model of ventilator has features to alert users to the status of the power supply. There is an LED that lights up on the unit when on mains power; and icons on the display to show whether the device is currently drawing from mains or battery power: There are also multiple visual and audible alarms to alert users to the depletion of battery power. On inspection by the manufacturer; the alarms were seen and heard to function correctly. The device showed that on the day of the event; the ventilator had alarmed as expected to alert users to the depleting battery MHRA has conducted a search ofits adverse incident database which has not revealed any similar reported incidents (involving the ventilator being used on battery power until it fully depleted) for this model of ventilator: Philips has reported that it is aware of one similar event reported to them in 2011, which occurred in the USA This involved a device which "was being used on DC and an AC source was unavailable when the batteries depleted" , but MHRA is not aware of the detailed circumstances MHRA has confirmed that this model of ventilator was first placed on the UK market in July 2010. At the time of its report to the coroner; the manufacturer had advised that a total of S01 Trilogy 202 ventilators have been sold in the UK, with a further 1 sold in the log power: power ,582

Department of Health rest of Europe and 5,799 in the rest of the world. Given the number of ventilators of this model that have been sold, the available evidence indicates that battery power depletion with no corrective action taken by the user is not currently a widespread problem with this model of ventilator: Iam aware that Phillips Electronics has already provided you with a detailed response to your Regulation 28 letter and has concluded that no changes to the design of the Device; including the alarm system; visual and audible alerts, and the instructions for use are required to prevent future deaths. However; MHRA is planning to ask Philips Electronics to consider the visibility of alarms and battery icons in terms of usability in the next design review as part of their ongoing market surveillance: With regard to issues around the provision of power to the ward, you quote from our Department' s Hospital Technical Memoranda (HTM) 06-0 land consider that there is a conflict of advice in Part A between clauses 4.22 and 6.62. HTM 06-01 Electrical services supply and distribution Part A: design considerations, provides best practice guidance and should be read in conjunction with the Institution of Engineering and Technology (IET) Wiring Regulations, British Standard 7671. The HTM sets out the application ofBS7671 in the specific, unique context of healthcare: Moreover; the text at paragraph
4.22 relating to Category Patients in special medical locations should be read in holistic manner in conjunction with the guidance provided within other sections of the HTM and BS7671. If this task is undertaken, there is no conflict of advice between 4.22 and 6.62 of the HTM By way of illustration, the HTM contains the following guidance which it is imperative to follow:
2.6 It is recommended that designers and stakeholders review Chapter 4 as well as Chapter 6 for all projects. post

4.17 While it is not intended to be absolute, this section should be sufficient to prompt the necessary discussion at all stages of the design process: The categories given are intended to demonstrate a range f patient risk from an electrical fault or loss of electrical
4.18 Consideration of the categories in Figure 6 should establish a minimum acceptable risk at the point of treatment or care the purpose of this guidance, the patient levels described are not intended to be exhaustive, but rather an aid to consider the issues. The definition relating to Medical Location (Chapter 1) (location intended for the purpose of diagnostic treatment (including cosmetic) or monitoring a patient under medical supervision), identifies those locations where discontinuity of the electrical supply can cause danger to life. Group 0 Medical locations where no applied parts are intended to be used: Group Medical locations where discontinuity of the electrical supply is not a risk to human life (unless the location is part of a Group 2 location). Group 2 Medical locations where discontinuity of the electrical supply can cause danger to life. Should patient' life be endangered by a discontinuity of supply, then Group 2 definition may be required to be applied to the Category 4 patient clinical risk The HTM contains the following guidance with respect to 2 areas:
16.37 IEC 60364-7-710 and BS 7671 require Group 2 areas to have at least two separate socket-outlet sub circuits at each patient treatment location (for example bedhead or theatre pendant). This to Group 1 areas also. This can be achieved from a single IPS unit with an integral single-phase distribution board: The resilience would be further enhanced if the IPS had dual 100%-rated isolation transformers serving different integral distribution boards Such arrangements would provide an N+l resilient IPS isolation transformer aS defined in paragraphs 6.8-6.14. The HTM also provides guidance o the provision of audible and visual alarms in relation to interruptions to power supply failures and the need to provide indication at the nurse'$ station for the relevant medical area. supply option For Group applies

Department of Health For the reasons set out above, the Department does not consider that there is a conflict of advice in the HTM. However; the concerns you raise are noted and the relevant sections of the HTM will be considered and reviewed, as part of the wider technical guidance programme, to determine if there is need for greater Similarly, the issue of alerts will be considered, although the HTM is considered to provide adequate guidance on this issue. 1 hope that this reply is helpful and I am grateful to you for bringing the circumstances of Mrs Scott's death to my attention: u) 5 DAVID PRIOR clarity.

Dear Ms Hodes am writing in response to the Regulation 28 report that you issued to St. George's University Hospitals NHS Foundation Trust on 17/03/2016 regarding the death of Mrs_ Jacqueline Scott: In relation to the matters of concern you raised the following points:
1) The Philips Respironics Trilogy 202 (BIPAP) The BIPAP Trilogy 202 machine had subtle visual display symbol which denoted when the machine was running on battery power. That symbol is not visible if there are many alert alarms as the alarm messages fill up the screen as they come in pushing the earlier alerts (low battery) off the screen: The BIPAP Trilogy 202 Machine has the same alarm sound for battery depletion as for circuit disconnect (where for example the face mask slipped) which was the more usual and expected reason for an alarm and these twO factors separately and together did not have any feature of urgent warning to alert staff to battery depletion:
2) Staff Training iii) Staff who were experienced and trained on the BIPAP machine did not appear to be trained to be alert to the situation or to the significance of battery symbol showing on the machine when the machine was plugged in to the mains or to any particular alarm which denoted battery depletion rather than mask slippage.
3) The provision of power to the ward iv) Richmond ward ADU beds was designated as a category 4 area which in this case meant there was no isolated power supply (IPS) provided to the ward not withstanding life-saving equipment was routinely used. Hospital Technical Memoranda (HTM) 06-01 Part A provides advice and guidance and benchmarking standards for electrical installation, maintenance and safety etc in healthcare premises. It is a matter of concern that there is a Chairman: Sir David Henshaw Chief Executive: Prof Simon MacKenzie

conflict of advice between clause 4.22 and Clause 6.62. Clause 4.22 states: clinical treatment and patient safety may be compromised (but not endangered) by any interruption of electrical supply" whereas clause 6.62 states: "In clinical risk Category 4 and 5 areas the patient environment should have at least two IPS circuits at the bedhead" vi) There was no system or check that would alert ward staff to the failure of mains power in any particular area.
4) Notification to estates management vii) The crash bell for bed 5 did not work when the emergency arose. However estates management had been notified some days earlier of the broken patient call in the same This was of concern as both emergency bells were on the same circuit and not fixed until 2 April 2014 when by chance the failure of electricity was identified_ In response to these concerns for ease will address each of these points individually: Point 1 The Philips Respironics Trilogy 202 (BIPAP) Ms Louise Best has provided a written response on behalf of Phillips on the 12th April 2016_ Point 2 Staff Training During the Serious Incident investigation, the panel reviewed the training for nursing staff provided for non-invasive ventilation (NIV) and the particular medical device (Trilogy ventilator): found that training was overseen by a nurse consultant and a clinical nurse specialist in respiratory medicine. There were appropriate clinical competencies developed as part of the Trust's NIV policy. The nurses had undergone either formal (e.g. classroom based) training or informal on the job training by the specialist nurses, practice educators and senior staff on the respective ward and in ED. The panel was satisfied during the investigation that all nursing staff involved in the care of Mrs Scott were appropriately trained on the particular machine and NIV therapy. There was also access to senior help and practice educator was available on the when the incident happened: The nurse directly involved in the incident was a trained ITU nurse of six years, who had additional training on the NIV and the Trilogy machine_ The panel found, however; that there was no consistent documentary evidence of the training that staff had received, The panel therefore concluded that staff training was appropriate in this case, but recommended an action in the Sl report to complete training needs analysis to establish the exact number of other staff that had been trained and to improve documentation of this training: Following this incident staff working in this area have undergone period of retraining by Phillips which includes the points raised in These aspects of training have further been incorporated into the training delivered by the practice educator and specialist nurses. The unit has further employed a dedicated practice educator to work with staff in ADU: All staff other than two new starts have now received training on NIV and this device and competencies are held within the department Point 3 The provision of power to the ward The Trust engaged an external expert to advise the organisation on the areas where the electrical infrastructure requires upgrading to comply with HTM 06-01. This advice has Chairman: Sir David Henshaw Chief Executive: Prof Simon MacKenzie bay: They day point key

formed the basis of the design of a UPSI IPS back up system in the Richmond ADU area_ The work has now been put to a tender process with the summer 2016 set as the date for completion of this work due to the co-ordination that is required with clinical areas for this work to be completed. The Trust has set aside sufficient funds for this work to be completed and once installed the designed UPSIIPS back up system will alert staff of any failure in the electricity supply to the mains sockets. would be happy to update you on the progress of this work following the tendering process and on completion of the installation: Point 4 Notification to estates management Call bell repairs are part of the top priority (Priority 1) schedule Calls rated at Top priority are attended within 3 hours of the call being logged Timely Response to Priority1 calls forms part of the Performance Indicators for the Estates department: The electrical circuits in the Richmond ADU area are to be upgraded in line with the response under section 5 part 3 of the section 28 notice. Therefore the installation of the UPSIIPS system following the tendering process will ensure that this requirement is met. Additionally following this incident the nursing staff within this area undertake checks of emergency call bell systems twice weekly to ensure are operational. This is recorded on department checking sheets which are held locally and any faults reported to estates that the above actions address your concerns and provide reassurance that the Trust is fully committed to providing our patients with the highest level of care and to this end we are continually seeking to improve patient safety: If you require clarification on any of the above actions, would be very happy to respond further, Yours -sincerely, Jennie Hall Chief Nurse and Director of Infection Prevention and Control Chairman: Sir David Henshaw Chief Executive: Prof Simon MacKenzie Key they hope