Robotic surgery - legal considerations
05/03/18With the ever rapid development of robotics and technology it is not surprising that its use in healthcare is increasing. Many hospitals already have surgeons trained to use robots to perform complex and difficult surgery. The advantages are obvious - complex and intricate procedures which previously might have required open surgery with longer recovery can now be done more easily through a robot rather than a surgeon actually making the incision and the surgeon can be in a different room, hospital or even country.
However robotics does also present a number of issues that any hospital undertaking surgery this way must consider. This includes but is not limited to:
- Checking training, experience and assessment of those using robotics in surgery is appropriate and having training records which are kept up to date
- Ensuring that manufacturers guidelines on use of robots is followed and maintenance records are stored safely
- The contractual indemnity position with the supplier or manufacturer needs to be clear and adequately covered in the contract documents
- Regulatory compliance with the Medical Devices Directive must be considered
- Where the surgeon is controlling the robot from another country issues around which law would apply if something went wrong and the adequacy of the insurance cover must be clearly understood and managed as of course should the cyber security threat
Looking ahead robots will no doubt continue to reach the parts of the human body that others cannot reach quite as easily. The expansion in the use of robotics in our hospitals should be good news for patients and their surgeons. However legal considerations such as those listed above and ethical implications, such as the demographic of the population benefitting from the use of healthcare robotics, cannot be ignored.
As more robots become available to NHS surgeons, their growth will be exponential as the number of medical professionals trained to use them will also proliferate.
The NHS has earmarked £300 million for robotics in UK hospitals, and launched a public tender for companies that work with the technology at the end of last month