Legal and Ethical Considerations of Robotic-Assisted Surgeries

Illustrated by Sue Lee

“Minimally invasive robotic-assisted” surgeries entered the limelight of the medical field in the mid-2000s, when they were first used in the fields of gynecology and urology as innovations driven by the desire of patients to have new, minimally invasive procedures [2]. Although it has been a steadily growing field for the past few years, the da Vinci robot is currently the only FDA approved surgical robot. Despite how the name “robotic-assisted surgery,” sounds, the da Vinci robot is not an automated system. As the manufacturer website describes it, “The da Vinci system translates your surgeon’s hand movements at the console in real time, bending and rotating the instruments while performing the procedure. The instrument size makes it possible for surgeons to operate through one or a few small incisions” [3].  Essentially, the only robotic assisted surgeries approved for use today are those directly controlled by surgeons; automated surgeries have not been approved and all robotic systems are directly manned by qualified technicians, so why is there any reason for concern? It seems as if the invention of the da Vinci machines can only grow and advance the medical field. However, as important as innovation is, it is equally important to consider its potential drawbacks.

The da Vinci robot has several benefits, including increased precision and the ability to use smaller incisions for procedures. The surgeon ends up more focused and less stressed throughout the surgery [3]. Despite these benefits, there are several ethical and legal concerns when it comes to the qualifications needed for a surgeon to perform robotic-assisted surgery. Currently, there is no widely agreed upon training programs or certifications that need to be completed before a surgeon can perform the robotic-assisted surgery. Typically, the surgeon will observe a given procedure only five times before acting as the first operator on that procedure, with supervision [3]. However, this is not a standardized practice, and the lack of formal training could lead to legal issues in the case of malpractice.

Informed consent, or the lack thereof, is another major ethical concern with robotic-assisted surgery. Informed consent, as defined by the Code of Medical Ethics Opinion 2.1.1 by the American Medical Association, is the process by which “communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention” [1]. The physician must evaluate if the patient has enough information and/or the decision-making capacity to make an informed decision by both presenting accurately all relevant medical information and then considering the patient’s ability to understand said information. The issue with robotic-assisted surgery relates to what information the patient needs to be informed of.

With this novel and still rapidly changing field of biotechnology, can the patient really be aware of all the associated risks and moreover, does this lack of clarity hinder their ability to make an informed decision? Although these uncertainties with robotic-assisted procedures are likely to endure through the next decades, physicians should try to mitigate the deficiencies with informed consent by ensuring that they are having a productive, two-sided conversation with their patients [2]. These conversations should include the 4 hallmarks of informed consent by answering these questions:

  1. How does the use of the robotic system benefit the patient?
  2. Is there any added harm of using the robotic system?
  3. Does the patient have a preference for which procedure they would like?
  4. Is there equitable access to the robotic system? [2].

It is up to the surgeon to ensure that the patient has enough information and discredit any myths and misconceptions they may have had about robotic-assisted surgery to maintain a strong legal and ethical basis for the procedure.

The patient-physician relationship could also become degraded if robotic-assisted surgery becomes more commonplace in the medical field, and the implications of this degradation could change medical outcomes in the long run. Currently, the da Vinci robot has been installed in just over 1,700 medical facilities globally and has served around 775,000 patients [8]. Considering the machine’s high price tag of 2 million US dollars that puts it out of budget for most medical facilities, da Vinci procedures have been done on a very large number of people with only a 0.179% patient injury rate between 2000 and 2013 [7] and an 80-88% overall patient satisfaction rating [6]. Statistically speaking, robotic-assisted surgery seems to be a favorable procedure for patients in the short term. Nevertheless, these data do not speak for the long-term social implications of these procedures. One study done to assess gender differences in the acceptance of robotic-assisted surgery, it was found that many female subjects were concerned about the “doctor–patient relationship” aspect and considered it “an essential aspect of patient care prior to undergoing an operation” [5].  Many of the male subjects were not concerned with the lack of direct doctor-patient interaction during robotic-assisted surgery, but that is not to say this is not an important facet of patient care for everyone [5]. These interpersonal relationships are very important to consider, especially since the Duke Center for Personalized Care has found that “Effective physician-patient communication…positively influence health outcomes” through “better adherence to treatment plans” and building overall trust and communication [4]. So, while da Vinci procedures have shown to be safe and effective surgical techniques, if they become the industry standard, there may be decline in the efficacy of general medical care.

            Robotic surgery has made strides for medical research and advancement, and there is still a long way to go before these procedures become commonplace in healthcare facilities. Still, as progress is being made toward that goal, it is important to stop and consider the side effects of rapid innovation. While technology can mitigate risks of certain medical procedures and shorten recovery time, these benefits should always be considered alongside the disadvantages and drawbacks. In the case of robotic-assisted surgery, there are already legal and ethical concerns regarding training and informed consent. As innovation drives robotic surgery to automation, how will these concerns grow and how will the patient-physician relationship further deteriorate? Innovation often obscures its flaws, but if care is taken to fully consider all these factors together, medicine can move forward into the future in a safe and positive manner.

Edited by: Alexandra Dram
Illustrated by: Sue Lee

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