Making robotic surgery safe: why training is key to avoiding tragedy
An inquest into the death of a patient who underwent a robot-assisted heart operation in the UK concluded that the patient’s death was directly caused by the operation and the robotic assistance, and noted a lack of benchmarks for training on new technologies. Robotic systems are already revolutionising surgery in many ways, but what training and support needs to be in place to make sure it’s safe? Abi Millar finds out.
n 2015, Stephen Pettitt, a retired music teacher, underwent a pioneering operation – the UK’s first robot-assisted heart valve surgery. While Da Vinci robots have been operating in the UK since 2001, this was the first time the system had been used for a mitral valve repair.
Unfortunately – as an inquest was later to find out – the procedure went badly wrong. Pettitt died a few days after the surgery as a result of multiple organ failure. According to an expert at the inquest, he would have had a 99% chance of survival had the operation been performed conventionally.
“Mr Pettitt died due to complications of an operation to treat mitral valve disease and, in part, because the operation was undertaken with robotic assistance,” said the coroner, Karen Dilks, as the inquest concluded in November 2018.
The case involved a catalogue of errors, not least poor communication between the surgeons, and clinicians leaving the theatre halfway through. Most gallingly, the lead surgeon (who was later dismissed) had turned down opportunities to train on the Da Vinci machine.
The Royal College of Surgeons (RCS), responding to the case, said in a statement: “Like the coroner, the RCS recognises the need for much clearer national guidelines on the introduction of new procedures and technologies… It is wholly unacceptable for any surgeon to perform an operation they have not fully trained for.”
Why robots are on the rise
The risks of robotic surgery, then, are plain to see. Or rather, what this tragic case makes clear is the risk of complacency. By and large, we know that robotic surgery is safe, with these devices used successfully across a wide range of applications, including urological, gynaecological and some types of general surgery, with cardiothoracic surgery being a relatively new use.
In one 2016 review, which looked at 14 years' worth of US Food and Drug Administration data, researchers found 10,624 adverse events across 1,745,000 robotic procedures. This equates to a 0.6% chance that something would go wrong in any given procedure (usually an equipment failure). Deaths associated with robotic surgery were extremely rare.
On top of that, using a robot brings certain advantages to the operating table. In this type of surgery, the surgeon sits at a console, which controls the movement of one or more robotic arms. Since the robotic arms are more flexible than a human arm, they can access parts of the body that would otherwise be hard to reach.
“Robot-assisted surgery offers improved accuracy, improved precision and of course eliminates any risk of a surgeon’s hand shaking,” says Richard Kerr, chair of the RCS Commission on the Future of Surgery. “Combined with 3D screens and image magnification, the risks involved in surgery will significantly reduce, with faster recovery times and less reported postoperative pain.”
However, since the associated technologies are still so new, no surgeon can afford to be blasé.
“It can take a long time, and significant cost, to train a surgeon to use surgical robots. Commentators quantify the learning curve as up to 200 robot-assisted procedures before achieving the best outcomes,” says Kerr.
How robotic surgery training works
Matt Beane, an assistant professor at the University of California Santa Barbara, studied robotic surgery for two years to find out how surgeons are adapting. After witnessing hundreds of procedures in the US, he concluded that there was a problem: rather than learning by doing, trainees are forced to learn predominantly by observing.
In other words, rather than placing their hands into a real human, as per traditional surgery, they simply watch another surgeon use the console. In some procedures, they might only get five or ten minutes on the controls themselves. Beane thinks this leads to significant variations in how well each trainee is prepared.
“Those who manage to learn despite current obstacles offer valuable clues to how training could be improved,” he says. “They started to familiarise themselves with this technique years before they were supposed to, they spent many extra hours learning through digital rehearsal, and they found ways to struggle meaningfully in actual procedures.”
One thing is for sure – adequate training takes patience. As Kerr explains, it is always a graduated process.
“To begin with, surgeons will observe experienced colleagues carrying out such procedures,” he says. “Training on robotics in particular makes use of simulation, as well as other training platforms. Once they have completed an appropriate period of observation and simulation, they will move to proctorship where an expert guide will direct them during surgical procedures. They will likely also undertake a fellowship to further develop their skills.”
For any given operation, they need to demonstrate sufficient proficiency and safety before they are allowed to carry it out themselves. Even then, the results should be subject to regular audit and peer review.
New guidelines needed
The tragic case of Stephen Pettitt – in which the surgeon hadn’t trained at all – is definitely something of an anomaly. Currently in the UK, National Health Service (NHS) trusts have guidelines for using new technologies, and surgeons are expected to follow these guidelines as they expand their area of practice.
However, the RCS believes there should be protocols introduced on a national level, with a view to further ensuring patient safety. They are looking to draft these guidelines in partnership with the Department of Health and Social Care and the General Medical Council.
“There should also be a nationally coordinated, new intervention and implant database, with mandatory follow-up and submission of patients’ outcome data,” says Kerr.
Guidance of this kind will become even more important as robotic surgery becomes more prevalent. Over the years ahead, the nature of surgery is expected to change dramatically, which will pose many new questions about the best modes of training and support.
The future of robot-assisted surgery
Over the short term, surgical robots are likely to become cheaper, lighter and more versatile. We will see this soon with the rollout of the Versius robot, coming to the NHS this year. Unlike its predecessor, it can be moved between hospitals and theatres, helping make robot-assisted surgery more widely available.
Over the longer-term, there will be greater robotic autonomy and machine learning – although the disruption may be lower in surgery than it is in some other industries. Kerr doesn’t think there will be fully autonomous robots, at least not in the next 20 years.
“The wider use of robotics is likely to reduce variation in surgical performance and the invasiveness of interventions,” he says. “This may raise also the possibility that skilled surgical technicians could undertake some procedures under the supervision of a surgeon.”
He thinks that surgical robots could also be used for data collection, which could be used to drive improvements in surgical training. What’s more, the ergonomics of robotic systems could make surgery less onerous for the surgeon, thus lengthening careers.
However, he concedes that people in general are still wary about entrusting their surgery to a robot. Rare cases of medical malpractice aside, it is natural to have reservations about what is new.
“Research shows that patients want to maintain the ‘human touch’ and that this ‘touch’ is a vital basis of healthcare interaction,” he says. “Therefore, building up trust in robot-assisted surgery will take time.”
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