Robot assisted surgery is blamed for heart patient’s death

An overhaul of the guidance related to the use of new or modified procedures and technologies in the NHS has been recommended in the wake of the death of a 69-year old patient who underwent an innovative robotic heart-valve surgery at the Freeman Hospital, Newcastle in 20151.

The procedure, which had never been performed with robotic assistance before in the UK, was considered by the Coroner to be directly responsible for the patient’s death; had the patient undergone conventional open-heart surgery the mortality risk would have been 1-2%. Included in the Coroner’s conclusions were recommendations for national guidelines relating to the introduction of new procedures and technologies. This was echoed by the Royal College of Surgeons of England (RCS), who issued a statement in response to the inquest highlighting the “need for much clearer national guidelines”2. The RCS stated that “surgeons are also subject to the governance structures that are in place where they work. A majority of NHS trusts have guidelines for introducing and performing innovative surgical techniques”2. Although the Department of Health made recommendations in 2003 to ensure all new procedures are approved by trusts Clinical Governance Committee prior to clinical use3, little is known about the prevalence, function, content or use of these guidelines in practice.

The Surgical Innovation theme within the Bristol Biomedical Research Centre, funded by the National Institute for Health Research, is working to directly address this issue. A major step towards improving guidance is currently underway in the form of an in-depth analysis of local policies for the introduction of new procedures in place across England and Wales. By also engaging with key stakeholders, this work will provide a comprehensive overview of local regulations for implementing new procedures and will highlight required areas for improvement (such as how to record and report outcomes).

The RCS noted in their statement a major factor in this case was that the surgeon undertaking the procedure had not received adequate training in the use of the robotic surgical equipment2. Training of clinicians is one of several key issues being explored in the work of the NIHR Bristol BRC Surgical Innovation theme. The Coroner’s recommendations also included ensuring patients are fully informed of the risks associated with new procedures, which is another aspect we will examine. This is key, and part of our work is reviewing what guidance trusts have in place for patient information provision. A further focus of our work is to examine how trusts decide whether procedures should be considered innovative and therefore require evaluation within a research study (and HRA research governance).

The need for standardised, fit-for-purpose national guidelines has never been more evident. We need to ensure new procedures and technologies are introduced in a way that encourages positive innovations whilst maintaining patient safety by reducing unnecessary risks.

References:
1 Dyer, C. Robot assisted surgery is blamed for heart patient’s death. BMJ 2018;363:k4791 doi: 10.1136/bmj.k4791

2 Royal College of Surgeons, RCS statement on need for national guidelines on the introduction of new procedures and technologies. [cited 2018 Nov 9]. Available from: https://www.rcseng.ac.uk/news-and-events/media-centre/press-releases/rob...

3 Department of Health. Health Service Circular (HSC2003/011). 2003. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.g...@en/documents/digitalasset/dh_4064925.pdf