Dear 15th and yet

To summarise the training plan, the company's Clinical Application Specialist (CAS) will be on- site for a total of 4 weeks to provide on-site training and support: The training will commence on the department approximately 2 weeks before the roll out, to allow a high percentage of staff to be trained prior to the go live date: There will be a further 2 weeks support the implementation and post go live stage: The training programme will incorporate the alarm classifications and the importance of maintenance of the lead attachments to ensure optimal performance of the monitors_ The company will also deliver 'Train the Trainer" with individuals to ensure future new starters can be trained following this initial period. The CAS will then return to the Trust 3-4 weeks post go live to discuss and amend any requested configuration changes on the monitors_ Following further visits and training may be requested if required:. trust this provides you with the assurance regarding the provision of refresher training to our staff. With respect to additional learning arising from the evidence heard at Inquest; can assure you that the cardiology team are vigilant in reviewing both "advisory" 'warning" and "crisis" alarms and attending to the patient immediately to check for any artefactllead detachment; to ensure optimal monitoring conditions to detect arrhythmias_ This will be reinforced in the training for the new monitoring system. There was additional learning arising from the evidence provided byl GE Healthcare and medical expert_ The cardiac monitor in question has multi lead ECG analysis, meaning that it collects data from all four leads to analyse the rhythm utilising the automated inbuilt detection algorithms. When malfunction of Mr: Collings' cardiac monitor was suspected by the clinical team, our electronics department isolated the monitor for inspection and testing and retrieved the electrocardiogram (ECG) waveform data from the device log file. However, in this instance, the data was only printed off from one of the four monitoring leads, which was insufficient for full review by the manufacturer. In future, our Hospital Biomedical Engineering Manager will clarify with manufacturers exactly what data needs to be obtained from the device log file to allow a full and thorough inspection. As you will note, the Trust is addressing the shortfalls highlighted during our investigation and the Inquest;, in order to prevent future deaths in similar circumstances Progress of the actions detailed in this letter will be overseen by our Executive Director of Nursing, Midwifery and Allied Health Professionals, who will also keep me briefed and report to the Trust's Clinical Governance Steering Group. trust this information provides assurance to you that the Trust has taken appropriate action to mitigate any future patient safety issues with regard to the monitoring and observation of patients within cardiology: would also like to take this opportunity to offer my sincere condolences to Mr Collings' family on behalf of myself and the Trust:

Dear Mr. Winter

RE: Regulation 28 Report to Prevent Future Deaths – Mr. Thomas Smith Collings

GE Healthcare writes further to your correspondence dated April 15, 2019 regarding your concerns identified during the Inquest into Mr. Thomas Smith Collings’ death.

As a medical device manufacturer, GE Healthcare takes patient safety and patient death reports very seriously. All death and serious injury reports received are thoroughly reviewed by GE Healthcare Medical Directors, product specialists and clinicians to determine whether the relevant patient monitoring system performed within specifications or if any further root cause investigation is required.

In the case involving Mr. Thomas Collings, following an investigation, GE Healthcare concluded that the automated ECG arrhythmia detection algorithm (EK-Pro), being used to monitor Mr Collings performed within specifications and ECG monitoring industry standards based on the available information and Full Disclosure data captured. The signal acquisition conditions combined with the extremely rare “Torsades de Pointes” ECG rhythm Mr. Collings presented with on the morning of August 2, 2018 prevented the algorithm from asserting a Ventricular Fibrillation (“VF”) or Ventricular Tachycardia (“VT”) arrhythmia alarm. Unfortunately, ECG tracings for leads I, II and V were not available for review to further the assessment.

The TRAM and Solar 8000M patient monitoring system used in the Sunderland Coronary Care Unit was state-of-the-art technology in 2004 when it was manufactured. If used in accordance with the operator’s manual, the TRAM and Solar 8000M patient monitoring system is still an effective physiological patient monitoring device today.

Nevertheless, during the period since this equipment’s manufacture date, there have been technology advances in digital signal processing hardware and software and medical industry standards, such as IEC 60601-1-81, which have improved the performance of patient monitoring equipment. In addition, GE Healthcare has a dedicated team of hardware and software engineers whose focus is improving the

1 General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. GE Healthcare

sensitivity and specificity of the EK-Pro automated ECG arrhythmia algorithm based on clinical performance, customer feedback and ECG Full Disclosure data.

GE Healthcare has implemented ECG Technical Alarm notification improvements when the automated ECG algorithm detects noise and/or artifact. The current GE Healthcare CARESCAPE B850/B650/B450 Patient Monitoring platform provides escalating ECG Technical Alarms for “Arrhythmia Paused” and “Leads Off” states. These improvements allow clinicians to configure “Arrhythmia Paused” and “Leads Off“ Technical Alarms to escalate to a high “red” alarm rather than a warning or advisory alarm. This functionality was introduced in the CARESCAPE product line in 2009. In Mr. Collings’ case, based on the ECG tracings and log file information, the “Arrhythmia Paused” Technical Alarm would have escalated to a high “red” alarm at approximately 01:21:53, alerting caregivers to the loss of ECG monitoring and arrhythmia alarm detection capability.

GE Healthcare has also implemented improvements in the signal processing specific to the detection of Ventricular Fibrillation. The current GE Healthcare CARESCAPE B850/B650/B450 Patient Monitoring platform uses a spectral analysis technique within the EK-Pro algorithm that was not possible in the previous generation platforms due to the computational demands. The primary performance benefits of the newer technology include a shorter average time to alarm and the capability to utilize the data in all available leads (e.g., I, II, III, V) when the analysis is updated each second. Testing of the algorithm improvements via the requirements of AAMI/ANSI EC-57 confirm the reduced alarm delay relative to the older technology. Furthermore, while the available EC-57 databases do not directly address Torsades de Pointes arrhythmias, the use of spectral analysis techniques would be expected to mitigate the primary challenge of the rapidly changing amplitude characteristics associated with these events. GE Healthcare expects to continue to invest in improvements in its algorithm detection capabilities in future versions of its software.

Following the incident involving Mr Collings where it became apparent that data for all leads had not been captured by the Trust at the time, GE Healthcare has also re-iterated to its complaint handling team to request data from all available monitoring leads when initiating an investigation, in an effort to ensure that as much data as possible is provided when reviewing a complaint or report requiring investigation.

Please be assured that maintaining a high level of safety and quality in our patient monitoring systems is GE Healthcare’s highest priority.

We would like to take this opportunity to again offer our condolences to Mr Collings’ family.

Sincerely,

GE Healthcare