Mid-2000s observed the introduction of "minimally invasive robotic-assisted" surgeries, which were advances in the medical world brought on by patient who were looking for more improved and extra efficient, novel, minimally invasive procedures exclusively demanded in the departments of gynaecology and urology, these being the two fields relatively engaging the most patients. But pursuing and pragmatically using robotic surgery in the real world invites certain complexities in many areas, that include medical difficulty, legal obligations and duties, and various ethical issues that could need immediate attention. Such problems have the potential to expand dramatically with the quick adoption of breakthrough technologies in surgical practice, such as computer-enhanced robotic surgery.
The only surgical robot currently recognised by the FDA is the da Vinci. The da Vinci robot is not an automated system, despite the way the term "robotic-assisted surgery" sounds. The da Vinci technology "translates the surgeon's hand movements performing the surgery at the console in real time. It will feed in movements such as bending and rotating the instruments while conducting the treatment,". All these basic facts about the robot have been put forward for everyone to read by the manufacturers on their website. Inn fulfilling this process accurating the capability of the surgical robotic system need to be programmed in such a manner that it can react to a range of sensory data in a highly advance fashion merely as good as human being could, this will be incumbent if the manufacturers and the medical world desire to increase the levels of autonomy practiced by the robot. It can only be made possible with the development of a technology that can mimic the sensorimotor abilities of a skilled surgeon making it a crucial step toward achieving full autonomy.
ETHICS INVOLVED IN ROBOTIC SURGERIES
Though the likelihood of a malfunction that could hurt a patient will rise as human oversight declines and robotic perception, judgement, and action (the conventional "sense-think-act paradigm") will be made to grow for the purpose of increasing autonomy.
Harm to the life of a patient would remain the gravest concern but apart from this severe issue there are multiple other difficulties that could arise out of this system, Privacy and cybersecurity are two such important factors to be taken into account.
One major procedure in this practice would be making the patient truly understand all the hazards involved with this novel and still constantly evolving field of biotechnology. This step of making the patient understand the repercussions of the practice holds great deal of significance as it is the sole basis of the patient’s decision making. For this objective Physicians should make sure they are having an effective, two-sided communication with their patients in order to attempt and alleviate the inadequacies with informed consent, even if these uncertainties with robotic-assisted operations are likely to persist for the foreseeable future.
Leaving aside medical mishaps that could take place it is necessary to note that - Regulatory, moral, and legal frameworks might not be able to keep up with such immense technological advancement. Risk in management will always be an essential concern during implementation to prevent backlash that would obstruct development. Along with changing technology, autonomous robot risk tolerance is also anticipated to alter. It has been predicted by experts that as autonomous technologies, like self-driving cars, become more prevalent, so will the acceptance of risk from autonomous robots used in medical application, making people more accustomed and perhaps if found to be reliable then they will become more rusting of the technology as well. In parallel, pattern recognition and self-learning algorithms will advance, giving medical robotics a greater role in more autonomous levels of operation, this would further encourage people to opt and rely on robotic surgery.
If robotic-assisted surgery becomes more prevalent in the medical community, the patient-physician relationship may also deteriorate, with long-term repercussions for altered medical outcomes. Currently, the da Vinci robot has been used by about 775,000 patients and has been placed in slightly over 1,700 medical facilities worldwide. According to statistics, robotic-assisted surgery appears to be a successful therapy for patients in the near future. Many females were interested in volunteering for the purpose of one such study that looked into ‘how differently men and women accepted robotic surgery. It was noted that a majority of these women expressed concern about the "doctor-patient relationship" and they were of the opinion that this relationship will be "a crucial part of patient care before having surgery", further calling it a notable drawback of robotic surgery.
Contrary to this the study reported that the loss of direct doctor-patient interaction during robotically assisted surgery didn't seem to bother many of the male subjects, but that doesn't mean it's not a crucial aspect of patient care for everyone. Given that the Duke Center for Personalized Care has discovered that "Effective physician-patient communication...positively influences health outcomes" through "better adherence to treatment plans" and "building overall trust and communication," these interpersonal relationships are crucial to take into account. Therefore, even if da Vinci procedures have proven to be safe and successful surgical techniques, there could be a deterioration in the effectiveness of general medical treatment if they become the industry standard.
THE LEGAL POINT OF VIEW
Looking into the legality of such robotic surgeries, exclusively when there has been a mishap or any other form of damage to the patient during the treatment raises several concerns.
The legal rules that govern professional liability in medicine and robotic surgery are identical. Given that the usage of an advanced medical technology is an essential component of a patient's treatment, it is challenging to determine culpability, which contributes to the litigation's complexity. Therefore, if an unfavourable result occurs, either the physician performing the surgery or the maker of the robotic system, or both, may be held accountable. As a result, even though the two areas of law are entirely distinct, robotic surgery litigation sometimes blends medical malpractice and products liability law.
The negligence standard of liability is used in cases of malpractice. Including "indications for a diagnostic or therapeutic procedure, making thorough explanations to his [or her] patients, taking decisions and proceeding to actions, [and] to up-to-date instrumentation and maintenance of the highest level of competence through continuous education and training," a doctor is responsible for all facets of his or her own practise. It is challenging to determine whether a certain procedure or technique is acceptable among the medical community and validated in clinical practice because robotic surgery is still in its infancy.
It's interesting to note that the FDA mandates that the device's producer give surgeons practical training sessions and fully inform them of the risks associated with the product. When patients assert that a surgeon's training from the manufacturer was insufficient for him or her to operate the equipment and complete the surgery effectively, litigation might grow complicated. Unfortunately, there isn't a set standard for how much education a surgeon needs to be certified to use a robotic surgery system. Instead, each institution decides how to award credentials. As a result, it is challenging to pinpoint the specific obligations and liabilities of the many parties involved.
Manufacturers are required to educate customers of the hazards associated with their products, and doctors are also required to inform their patients of these concerns. The Learned Intermediary (LI) doctrine "absolves the manufacturer from the obligation of providing further warning to the patient; and shifts the duty to warn patients about device hazards to the physician" if the manufacturer provides the doctor with sufficient educational instructions and warnings. Therefore, while the manufacturer would be exempted from accountability, a doctor may be held accountable for medical malpractice if they failed to adequately warn the patient about the risks of the device. Because the obligations of the physician and the manufacturer are intertwined, robotic surgery lawsuits are generally very complicated.
Although robotic surgery has advanced medical research, there is still a long way to go before these treatments are routinely performed in hospitals. Even so, as we move closer to that objective, it is crucial to pause and think about the negative implications of rapid innovation. While technology can reduce the dangers associated with some medical operations and speed up the healing process, these advantages should always be weighed against the limitations and drawbacks.
There are already moral and legal questions around training and informed consent in the context of robotic surgery. How will these worries escalate and how will the patient-physician connection further erode as innovation pushes robotic surgery toward automation? Innovation frequently masks faults, but if effort is made to carefully analyse each of these variables individually, medicine can advance into the future in a secure and beneficial way.
Without a doubt, robotic surgery technology has had and continues to have a substantial impact on surgical practise. Despite this, the widespread usage of it makes it difficult for the legal system to deal with novel and complicated claims within the current system of liability and regulation. On the one hand, producers shouldn't be deterred from creating cutting-edge technology, especially because the robotic surgery tool has been employed successfully in a lot of cases.
On the other hand, it is the duty of the device's creators and the medical professionals who use it to take all practical steps to reduce any hazards connected to its technology. In order to deal with this particular area of disagreement, the legal norms related with robotic surgery have blended products liability and medical malpractice law, however this is not fully straightforward. This is only one illustration of the difficulty that many various fields are currently having in adapting to how quickly society is progressing.
1. Frontiers, http://frontiersmag.wustl.edu/2021/11/28/legal-and-ethical-considerations-of-robotic-assisted-surgeries/ (last visited on 2nd June 2022)
2. PubMed, https://pubmed.ncbi.nlm.nih.gov/20224537/ (last visited on 2nd July 2022)
3. Science, https://www.science.org/doi/full/10.1126/scirobotics.aam8638 (last visited on 2nd July 2022)
4. Pulj, https://www.pulj.org/the-roundtable/litigation-robotic-surgery-product-liability-or-medical-malpractice (last visited on 2nd July 2022)
This article is written by Amanbir Minhas of Lloyd Law college, Noida.