The idea of a robot autonomously diagnosing, caring for or operating on a human being is a fascinating (and possibly frightening) one. As with our previous article on autonomous vehicles (see Auto-Automaton: Liability and the Driverless Car), this article will explore some of the legal issues that will arise as the operational use and development of surgical robots increases.
While fully autonomous surgical robots are not yet a reality, there are a number of examples in which robotic systems are today assisting surgeons and helping to overcome the inherent limitations of traditional surgical techniques. One such robotic system, the ‘Da Vinci’ surgical system, is designed to facilitate complex surgery using a minimally invasive approach, and is controlled by a surgeon from a console. According to the manufacturer, the Da Vinci System is called "Da Vinci" in part because Leonardo Da Vinci's "study of human anatomy eventually led to the design of the first known robot in history”.
Da Vinci robots operate in hospitals worldwide, with the latest version, the ‘Da Vinci XI’, carring out its first operation in England earlier this year in the Royal Marsden Hospital to remove a cancerous tumour. Medical professionals are hailing this technology as pushing the boundaries in surgery, particularly in cancer care. It is set to increase the use of minimally invasive surgery which reduces pain, blood loss and risk for patients, and minimises the time they spend in hospitals recovering, potentially benefiting patients and saving the NHS money.
Some of the advantages of the Da Vinci system – which typically consists of a surgical unit that has four slave arm manipulators, three of which are surgical tools and the fourth an endoscopic camera, and a console which allows the surgeon to operate the surgical unit – compared to traditional keyhole surgery include:
- a 3D display providing depth perception from the endoscopic feed as opposed to the traditional 2D feed;
- in-built software which reduces hand tremor and corrects the inverted control of instruments associated with keyhole surgery;
- enabling more accurate surgery to be performed by magnifying and scaling down the surgeon’s movements; and
- a larger number of degrees of freedom for the instrument tip, mimicking more closely that of a human hand.
As with other robotic systems, such as autonomous vehicles and softbots, the potential for surgical robots to improve the lives of many people is clear. Just as with those other robotic systems, we must ask whether the regulation of surgical robots under the existing legal landscape is adequate to protect people when things go wrong, without unduly affecting innovation or time-to-market. In Europe, the Medical Devices Directive (Directive 93/42/EEC) classifies all medical devices on a scale of ‘I’ to ‘III’ based on the potential risk associated with the use of that device. The classification process factors in whether a device is invasive, implantable and how long it will be used for. Currently the Da Vinci robot is classified as a ‘Class IIb’ medical device – the same class as a stent or pin used in surgery. In order to obtain the Class IIb status, a medical device must first have satisfied certain regulatory requirements, and must meet certain ongoing vigilance requirements while available for use. If the device is shown to be potentially harmful to the patients, a regulator (in the UK, the Medicines & Healthcare Products Regulatory Agency) can decide to recall all of the devices currently on the market and generally prohibit its use.
It is worth noting that the Directive would not require a surgeon to undergo any initial or ongoing training to use a Da Vinci robot over and above the normal training a surgeon is required to undertake. This is despite there being a clear need for a surgeon to have adequate experience prior to operating what is essentially a complex piece of technological equipment. In light of the significant differences in the complexity in the operation of the various medical devices under Class IIb – the Da Vinci presumably being more difficult and complex to use than a stent or pin – a debate is currently taking place about the need to establish a requirement for surgeons to undertake a certain level of training, achieve a certain accreditation or meet a specified standard in order to conduct robot-assisted surgery. A parallel can be drawn with the requirement for pilots to prove themselves on a flight simulator and subsequently maintain their licence by clocking a certain number of flight hours. It is noteworthy that the Royal Marsden – the hospital that has recently started using Da Vinci XI – is launching a fellowship to train up to 30 future surgeons over the next 10 years to be able to use the technology to operate on multiple tumour types. If hospitals themselves are recognising the need for their surgeons to be up-to-speed on using the latest robotic systems and are arranging training and ongoing support voluntarily, then it seems the law in this area must catch up with the reality and inherent risks in the use of these systems.
While the evidence for the value added to patient life by robotic systems like Da Vinci is clear, such systems are not without risk. A number of liability claims, mostly in the US, have been brought against hospitals, surgeons and manufacturers arising from injuries allegedly caused during robot-assisted surgery (common complaints include internal burns and infections). Like much of the discussions relating to the use of robots, issues around the allocation and scope of liability will be central to how surgical robots can be used safely and with legal certainty.
Continuing with the example of Da Vinci, there are a number of factors to be considered if the robot malfunctions. The parties involved in the end-to-end operation of Da Vinci include (among others) the manufacturer, the surgical team, the hospital in which the surgery takes place, the maintenance provider, the software developer, and the networks and power providers. Which is liable if surgery goes wrong?
One way the industry is adapting to deal with this is the use of ‘black box’ type devices in the surgery theatre to record all movements, commands and executions involved in the robot-assisted operation. If something goes wrong, forensic analysis can be conducted on the recording to identify the cause (or causes). From this we should know which of the above-mentioned parties is potentially liable for the error. As with autonomous vehicles, where the insurance industry is beginning to respond to potential industry need, we can expect the key players in the robot-assisted surgery industry to use insurance as a means to manage their risk, either through conventional means (e.g. product liability insurance for manufacturers who will usually be strictly liable for defective systems, medical negligence insurance for surgical professionals) or through new, tailored insurance products developed specifically for the surgical robot market.
One of the driving forces behind the development of the Da Vinci robot was the ability to conduct operations remotely, known as “telesurgery”. If current trends continue, the possibility of a surgeon in one country operating a surgical robot on a patient in another country will become more likely (if it is not happening already). This could open up cross-border liability and conflicts of laws issues. If a surgeon was to make an error while operating remotely from a different jurisdiction to the location of patient and robot, in which jurisdiction would a claim be brought? What if, as is the case today outside the EU, the laws and regulations in those two jurisdictions are not harmonious and come into conflict? This invites the possibility for “forum-shopping” for patients and doctors, who may wish to respectively receive or conduct robot-assisted surgery from or in a state whose legal regime most accords with their particular interests. This example underlines the need for a consistent approach to regulating the use of surgical (and other) robots at a global level.
As is apparent from developments in this area, the stage is set for a full transition to the use of robotics and related applications in ever-more fundamental areas of medicine and patient care. It is equally clear that the legal, ethical and technological questions surrounding this rapidly developing area are yet to be fully settled, and the potential implications of the use of these systems have not been entirely thought-through by lawmakers.