- Prioritise competency/proficiency/minimum requirements of robotic skills training of surgeons
- Classify the roles of surgeons, robotic companies & hospitals in performing/facilitating same
As robotic surgery is an emerging field of surgery in the context of Sri Lanka, it necessitates a guideline to address the legal and ethical concerns on the handling of surgical robots by prioritising the competency, proficiency, and minimum requirements of robotic skills training of the surgeons, and the clear classification of the roles of surgeons, robotic companies and hospitals in performing and facilitating the relevant surgical procedures.
These recommendations were made in an article on the contentious issue of the ‘Legal and ethical facets of robotic surgery: A suggestion for a guideline’ which was authored by A.P. Rathnayake (attached to the General John Kotelawala Defence University's Law Faculty) and published in the Sri Lanka Journal of Forensic Medicine, Science and Law's 15th Volume's First Issue, last month.
‘Robotic surgery’ or ‘robotic assisted surgery’ is an innovation in the field of medicine that has its pros and cons. The significance of such a surgical procedure is, according to N. Sharkey and A. Sharkey's ‘Robotic surgery: On the cutting edge of ethics’, the minimisation of pain and the less time it takes for recovery. It includes two categories: controlled systems and automatic systems. The significance of controlled systems is that such a procedure is controlled by the surgeon or dependent on the actions of the surgeon whereas the automatic systems operate after being programmed by the surgeon or the relevant operators. The efficiency of robotic assisted surgery is a revolutionary transformational technology. The interference of robots in surgical ventures transformed the era of traditional surgery into a new era of technological advancement. Even though the procedure has earned the epithet of opening avenues, it is considered in A. Mavroforou, E. Michalodimitrakis, C. Hatzitheo-Filou and A. Giannoukas's 'Legal and ethical issues in robotic surgery’, as one of the more complicated scientific innovations which deal with both legal and ethical aspects.
The relevance of this discussion is of utmost importance to Sri Lanka as the technology is now being used in hospitals under different disciplines: urology, gynaecology, cardiology, and oncology. The handling of surgical robots necessitates special training and experience and the professional liability of the surgeon who operates the robot remains unchanged. However, there is a simultaneous concern about the ethical aspects as robotic surgery collides with patient rights.
Medical & product liability under law
A surgical robot, per A.W. Garrison's ‘Robotic surgery: Applications, limitations, and impact on surgical education’, is considered a ‘self-powered and computer controlled’ device. This helps in positioning and manipulating surgical instruments and supports the surgeon in carrying out complicated tasks. However, surgical robots still have no independence to work out of the supervision of surgeons or to replace them. This implies the fact that handling robots is the sole responsibility on the part of the surgeon who embarks on the particular act of surgery.
This further signifies that misconduct in the process of performing the surgery will create a liability of medical negligence. In the present context, different categories of surgical robots exist: internal, external, and mixed robots. Internal robots have the potential to perform surgery inside the human body (e.g.: endoscopic capsules) whereas external robots such as Acrobot, and Cyberknife are used to perform surgery on the surface of the patient’s body while mixed robots operate both inside and outside of the patient’s body (e.g.: neuromate, and da Vinci), as explained in F. Graur, E. Radu, N.A. Hajjar, C. Vaida and D. Pisla's ‘Surgical robotics – Past, present and future’.
The intervention of robots in a surgical practice has both positive and negative aspects. The positivity is highlighted when analysing the potential benefits, which are, according to H. Crouch's ‘Legal considerations when it comes to robotics in surgery’, the standard of clinical care, the faster performance of the surgery, the lesser number of incisions on the human body, the lesser amount of bleeding, and the comparatively lower possibility of infections. However, seeking the assistance of robots to perform surgery has its risks as well. The risk is extended to several parties and it is not singlehandedly borne by the surgeon in a negligence-related claim. The risk is borne by the surgeon, the manufacturer of the surgical robot, the supplier, the clinicians, and the hospital staff while the main victims will be the patients.
The manufacturer’s liability in the context of a malfunctioning surgical robot is discussed in the United States Court of Appeals for the Third Circuit case of Roland C. Mracek vs. Bryn Mawr Hospital, Intuitive Surgical Inc. (2010) where the plaintiff instituted an action in the Court and the litigation was based on a malfunctioning ‘robotic assisted surgery device’ and the basis of the complaint was that there was a defect in the device which was not visible or known to a surgeon in the course of the operation.
Robots & patients
The right to health entitled to by people ensures, as emphasised in M. Daher's ‘Patient rights’, the fact that all human beings receive the highest attainable standard of health to preserve fundamental dignities. Patient rights are based on the fundamental right to health. Patient rights are considered as the ‘basic rules of conduct between the patients and the medical caregivers and the purview of it includes access to care, informed consent, confidentiality, the right to information, and the protection of the patient's dignity’. Patients' rights have a significant ethical dimension. The positive aspects of robotic surgery include the convenience and timeliness of the procedure. Robotic surgery is lauded as a novel technological form of surgery that operates on patients through, per J. Fajardo's ‘Ethics of robotic surgery’, miniature surgical instruments. However, there are risks involved in the process. The risks as elaborated in Narayana Health's "The ethical implications of robotic surgery" include the fear of complications, technical malfunctions, costs, training, inexperience, liability, and brand reliability.
Ethics & rights
‘Patient autonomy’ is a basic right and a fundamental ethical aspect in the field of medical practice. Autonomy, as pointed out in M. Lbugami and U.E. Alem's ‘Patient autonomy’, simply connotes an instance where a patient is entitled to make decisions concerning medical care without being influenced by the physician. Thus, it is evident that there is a positive link between autonomy and informed consent. However, the question is on the ‘informed consent’ of a patient undergoing a surgical practice intervened by a robot which is an innovative procedure and in some circumstances, the patients may be unaware of the fact that they are subject to a new technology.
This, per MedPro's ‘The essential role of informed consent in robotic surgery’, necessitates the disclosure of standard consent information to the patient and that includes a clear explanation of the procedure, the risks and benefits, and the alternative options which are available. It is mandatory to disclose all the foreseeable risks of the surgery to the patient. The potential risks of robotic surgery may incur as a consequence of equipment failures, malfunctions, system errors, problems with video imaging, unintended instrument movements and electrical problems. Further, the patient should be informed of the potential risks that would arise as a result of the physical condition of the patient.
The disclosure of risks to the patient is of importance due to the possible harms. Robotic surgery is an innovation that will affect the increasing mortality and morbidity of the patients. Patients in some circumstances may confront the tragedies of infections and harms which are financial and psychological. The non-disclosure of such risks will result in a loss of trust in the profession of medicine. Thus, it is important to ensure the patient’s safety which is a basic patient right.
In the scope of robotic surgery, the informed consent obtained from a patient is currently turning to defensive consent. ‘Informed consent’ becomes complete under three arrangements. As mentioned in A. Ferrarese, G. Pozzi, F. Borghi, L. Pellegrino, P.D. Lorenzo, B. Amato, M. Santangelo, M. Niola, V. Martino and E. Capasso's ‘Informed consent in robotic surgery: Quality of information and patient perception’, the first arrangement is the integration of the information present in the informed consent (causes of the diseases, the consequences which arise if the disease is not treated, the possible technique and the consequences if treated and the risk of re-intervention) with the surgeon’s experience of robotic surgery, the procedures and expertise. This is supplemented by the second arrangement of imparting information to the patients about the responsibilities of lawyers and preceptors and the third arrangement of stimulating surgical societies to create guidelines on robotic surgery.
The next important aspect is the evasion of a conflict of interest. As this is an innovative technology, the surgeons who embark on the venture may be affected unconsciously by the benefits and the upgraded social status originating from being a ‘surgical innovator’. This can be further accelerated by the personal preference of a surgeon to use a device in the process without considering the interests of the patient. The surgeon will prioritise a technique on which they have invested time, training, and expenses and particularly be influenced by ‘brand loyalty’. When the subjective preferences of surgeons are not based on well-grounded reasons and override the interests of the patients, a conflict of interest emerges.
Hospital-based liability for surgical misconduct is a well-known legal principle. Before undertaking ventures on robotic surgery, the hospital authorities have a foremost obligation to consider the appropriateness of the institution to handle an innovative technique. Per F.D. Moore's ‘Ethical problems special to surgery: Surgical teaching, surgical innovation, and the surgeon in managed care’, three criteria should be fulfilled to make a surgical innovation acceptable. Thus, the criteria specify that a hospital/institution inclined to robotic surgery must ensure the fact that there is sufficient laboratory experience before conducting innovative procedures, the availability of technical and intellectual expertise in the institution, and the existence of good ‘institutional stability’ filled with resources, human resources including staff and supporting systems. The staff and supporting systems include well-trained surgeons with the relevant technical expertise and knowledge.
Conclusions
Robotic surgery is hailed as one of the emerging innovative surgical procedures that support patients with minimal pain and a minimal number of incisions in the body. Such surgeries take place with the support of controlled and automated systems. However, surgical robots work under the supervision of human surgeons. This clearly shows the fact that the operation of surgical robots is primarily the responsibility of the surgeon. The use of surgical robots gives rise to two facets of liability. Medical liability is concerned with the liability of the surgeons, who are entrusted with the duty of handling surgical robots.
The intervention of a surgical robot in a specific medical procedure has pros and cons. The robot’s presence makes the process speedier, and more efficient with a lower risk of infections. However, an error caused by a surgical robot will be serious. In this instance, the malfunctioning of the robotic system may not constitute an error on the part of the surgeon who operated it. Thus, the liability shall be extended to the manufacturer as well. The manufacturer’s liability emerges when the defects exist and such defects are unknown or invisible to the surgeon.
Robotic surgery has both pros and cons. There is a substantial impact on patient rights and autonomy. The surgeon is bound to disclose possible harms and risks of the procedure to the patient. This enables the patient to give informed consent. However, the modern concept of informed consent within the scope of robotic surgery is defensive. Thus, when imparting information to the patient, the surgeon should disclose the possible risks and consequences of treatment and non-treatment. However, the basic information should be further supplemented by the disclosure of the experiences of the surgeon, the procedures and the expertise. The consent given by the patient should be free and voluntary. However, in certain circumstances, a surgeon’s personal preference over the technology and robotic device or brand loyalty may override the patient’s wellbeing.
The liability relating to robotic surgery is not solely focused on the surgeon-patient relationship. The hospital liability is of imperative concern. In addition to the individual surgeon’s liability for handling the surgical robot, the hospital is accountable for ensuring that there is a conducive technological background within their premises to work with surgical robots.