The first in a series of online events was held on 3 November exploring safety and transparency in surgical innovation. The aim of these events is to enable collaboration across the sector in order to design more consistent policies in relation to introducing innovative procedures in surgery.
Around 140 people attended the event including surgeons, medical directors, governance leads, patients, researchers, regulators, innovators and industry representatives.
The AHSN Network is working with the National Institute for Health Research (NIHR) Bristol Biomedical Research Centre (BRC), the National Institute for Health and Care Excellence (NICE), the NIHR Surgical MedTech Co-operative and the Royal College of Surgeons of England to understand the challenges and how to address them when it comes to the introduction of innovation in surgery.
The event began with an introduction from Deborah Cohen, Health Correspondent for BBC Newsnight, and former Investigations Editor for the British Medical Journal, who presented a historical case study looking at the introduction of spinal rods in children with scoliosis that aimed to reduce the need for repeat surgery. There were significant problems with this device and Deborah illustrated some of the issues identified during her investigation in terms of regulation and access to data, to help event attendees with later discussion.
Professor Jane Blazeby, Professor of Surgery, University of Bristol, presented the results of the INTRODUCE study which is the first detailed analysis of written hospital policies for the introduction of new invasive procedures. The study showed the lack of standard processes and the need to develop fit-for-purpose policies surrounding surgical innovation, and echoed the conclusions from the 2020 Cumberlege report which highlighted the need for change.
Professor Jane Blazeby said:
“Many surgeons are brilliant innovators and innovation is critical to improving healthcare. Our research has shown that we need to make essential policy improvements to how we introduce new surgical techniques and invasive procedures to increase safety, consistency and transparency.
This is about enabling change to support surgical innovation. We are bringing together clinicians, academia and regulators to consider the issues and co-develop solutions to improve how novel invasive procedures are introduced and evaluated.”
Presentations followed from NICE, RCS England, and the NIHR MedTech Co-operative to explain how the sector could enable change.
A fictitious case study was presented to help participants debate the issues around when a new procedure could be approved for introduction by the local organisation and when it should be referred to an external ethics committee for approval.
Following this event, there are plans for two more events focusing on patient consent, and evaluation following the introduction of new surgical procedures.
There are also plans to create a working group with representatives from across this clinical area to help agree the way forward in terms of standardising policies in trusts, and when applying to a research ethics committee is recommended.