Robotic Surgery - Political and Legal Influences - Research Paper Example

Robotic Surgery: Legal and Political Elements Introduction The fields of Robotic surgery has many supporters and an equal number of opposition, for a multitude of ethical, logistic, economic, legal, and political reasoning. The debates concerning this issue are not, likely, to conclude anytime soon. At this point, there are several issues that cannot go un-addressed. Robotic surgery does offer advantages in precision, accuracy, less invasive procedures for patients, and can contribute to a lessening of overall recovery times. However, the technology is most certainly current, but that does not guarantee that its surgeries will be any more or less successful that previous procedures, that the margin of error equates to less risk, and whether it is, in fact, the best surgical intervention for a particular ailment. Although, having successes it has, also, had failures that have contributed to injury and, in one particular case, death. For this reason, it can and will, inevitably, lead hospitals into having malpractice, liability, and negligence claims being leveled against them. These suits could extend, not only, to the physicians but, also, hospital management, marketing campaigns, and manufacturers will be entirely likely. Background Most industrialized nations, like the United States, have only been defined as “industrialized” for a less than 200 years, yet look how far technology, engineering, and the world of science as a whole. We interact and depend upon technology today so much that we hardly even notice that it is there anymore.(Schwartz Cohen, 2012) Robotics are one of those ever-advancing and ever-innovating scientific and technological fields. Amongst the robotics fields, robotic surgery is still young, but is not exactly new. Robotic surgeries have been practiced for several decades. In 1985 a robotic surgical system was used to perform a neurosurgical biopsy and in 1987 it was used to perform a cholecystectomy. In 1990 it was granted approval by the Food and Drug Administration, or FDA, which allowed robotic surgical systems to be used to perform endoscopic procedures.(Wolinsky, 2013) There are a few companies who have developed, or are presently developing, robotic surgery systems, but it is the da Vinci Surgical System that appears to be standing out among all of the competing concepts. The da Vinci is a considered a breakthrough in its field. It features four remote controlled arms that the operating surgeon uses a combination of hand and foot controls. The system, as seen in the photographs below, also, features an, extremely, sophisticated camera, offering a 3-Dimensional field of view, and the promises the greatest possible precision and visibility. (Carreyrou, 2010) Today the da Vinci surgical system can be found in a multiple hospitals all over the world. They are highlighted as the primary option for gynecological, prostatic, and certain cardiovascular surgeries. The costs of the systems are quite high, with an initial cost of $1 million to $2 million to install the equipment into the hospital for use. The same robotic surgical systems can cost, approximately, $140,000 just for basic monthly maintenance and an additional $1500-$2000 necessary for the replacement of needed parts. Although, robotic surgery has been involved a number of instances where patients have been injured or have died after having had a robotic surgical procedure. Two strong examples focus on an elderly gentleman, in 2007, who suffered internal damage while being operated upon. He survived the surgery, but died shortly after. Another involved a patient whose surgeon began the procedure using the robotic system, but the surgeon opted to abandon the system and switch to traditional surgery in middle of the procedure, because an artery was nicked. Unfortunately this patient could not be saved.(Carreyrou, 2010) Discussion Although robotic surgery was involved, in the above mentioned examples, no legal admonishments or lawsuits have, as of yet, been brought against them. This is, likely, a temporary reprieve. There are a number of ethics based considerations that could very easily become questions of legality and result in a great deal of potential litigation. Legality, ethics, moralities, ideologies, and politics are, often, intertwined. That never seems more true that when it relates to medicine, specifically. Perhaps, that is because it involves human lives and no perspectives can go unattended to. The real question in the field of medicine is when mistakes are made who is responsible? Is it the surgeon himself who misused or negligently handled the equipment and was he or she qualified to perform the surgery in the first place? Is it the fault of the manufacturer who provided the equipment, or is it the hospital and healthcare facilities that market the technology? Unfortunately these questions cannot, as yet, be answered. Until legal and regulatory precedent is made then the realm of robotic surgical technologies will remain in a sort of ethical and legal limbo. Legal The first of three relevant legal concerns involves the nature of how robotic surgery systems are presented and marketed to patients through hospital websites and other “ direct to consumer,” or DTC, advertising. Presently, hospitals allow robotics manufacturers to market their product as they see fit. Unfortunately, much that information may be exaggerated, misleading, or, in some, cases, completely untrue. For example, about 33% of all hospitals practicing robotic surgeries have websites claiming that the robotic approach guarantees “better cancer outcomes.”("Intuitive surgical (nasdaq:isrg)-intuitive," 2013) This could bring a great deal of legal issues in the future if their information continues to be so profoundly, often, blatantly misleading. It is playing upon the hopes of, often, terminally ill, patients that are looking for whatever hope that they can. There is also an issue involving healthcare professionals, physicians and surgeons, who may not be entirely honest about robotic surgeries, potential, risks versus benefits when promoting the new technology. In a modern era where technology is constantly changing and adapting then the honest and current details of, “…the risks and benefits that hospitals must provide each patient is fluid and evolving. (Peters, 2012) The relationship between patients and the caregivers is essential and that is completely negated when a patient is not properly informed fairly of all options, benefits, and the outcomes of specific procedures.(DeBernardo, Starks, Barker, Armstrong & Kunos, 2011) The second aspect of the potential legal issues to focuses on the lack of training requirements and credentialing for those who operate robotic surgery systems. Unfortunately, competency using the equipment is difficult to gauge what an adequate required standard should be. Every individual can have a distinctly differing learning curve... “Medical professionals have said that it could take anywhere from 200-700 surgeries to become highly proficient.” (Peters, 2012) That is an incredible level of variation and can inevitably lead to legal cases concerning mistakes that can be attributed to a surgeon’s competence and experience, to determine the presence or absence of potential malpractice. Some may be misunderstand that skilled surgeons who perform life-saving procedures with their hands may not have a gift for operating complex machinery; the greatest of all surgeons may be the worst possible of robot surgical equipment. The third and final specifically legal considerations involve the lack of proper and absolute regulations. After having been approved by the FDA for use, in 2000, little has changed in regulations to follow along with changing and, continually, developing technology.(Carreyrou, 2010) as mentioned, there are no regulations to enforce qualifications and credentials for surgeons. There are, also, no specific regulations related to safety and the overall equipment. There are no regulations enforcing greater clarity and honesty in how robotic surgeries versus advertised to the public and a world full of vulnerable patients seeking “miraculous treatments.” Most importantly, however, it is the fact that there has been no focused regulation encouraging “comparative-surgical studies.”(Joelving, 2012) This would determine the efficiency of the robotics surgical potential alongside traditional surgical approaches. Without these studies there are many unanswered questions associated with the technology that could be rectified by establishing that sort of regulation. Until these things come to pass the robotic surgery industry may be destined for many lawsuits in the future. Political The political influence and interest seems to be rather equilateral in many ways. Robotic research has, both, supporters and opposition, among conservatives and liberals, republicans and democrats. These considerations in relation to robotic surgery have many ethical, economic, and potential, legal concerns, but it seems to avoid being in the middle of direct political debate. However, this does not mean that it is not affected by politics; in fact, recent legislation is about to, and will continue, have a profound affect the future of robotic surgery and healthcare as a whole. The new healthcare act, often called Obamacare, was supported by a Supreme Court ruling. The implementation of Obamacare will change how healthcare is obtained and approved. The reason, for many individuals, that people with serious illnesses and conditions are able to find and receive the best treatments with the most “miraculous” results is because, in the United States, such individuals have the freedom to seek out the best possible physicians, surgeons, and healthcare professionals in their respective medical fields. Obamacare will, very likely, put an end to average individuals having as many options as they once had when choosing treatments.(Brodsky, 2012) After all, Obamacare will be looking for the most inexpensive ways to treat the largest numbers. Because robotic surgery equipment is quite costly to install, maintain, and put into practice, it is unlikely that it would ever be recommended to patients through Obamacare. The new healthcare act focuses less on swift diagnoses and expeditious treatments and more on multiple diagnoses, numerous second opinions, with the overall goal of finding what option they “government” is willing to offer you. The decisions and available options will be removed from the hands of patients and families and into the hands of the government agencies.(Brodsky, 2012) More so, Obamacare calls for the establishing of “Diagnosis Related Groups” or DRGs, which would act as a medical council who would make the decisions of sorts of treatment that a given individual will be allowed to receive. That said, it is very likely, that once this happens the best quality care would only be available to those who can afford to pay for them out of their pockets, creating an inferred value of wealthy lives over poor ones. Also, the DRGs will base much of their decision to improve or save your life upon what contributions you will make in society if they allow you to live. It is not just the patients that will be boxed into corners, but researchers in the fields of robotic surgery. If such systems are deemed too costly to be offered to the general populace, then the research into those fields, all of the potential advances and innovations, will be crippled, if not, completely, abandoned for other endeavors. Healthcare will have little to do with care and everything to do with politics. These ethical considerations, apparent in this political act, are certain to encourage a great deal of lawsuits. ("Intuitive surgical (nasdaq:isrg)-intuitive," 2013) Issues/Solutions As stated before, many of the issues developing around the topic of robotic surgery are entirely rectifiable if logical or feasible steps are taken. Establish the needed regulations that will allow science to move forward with the technology, but still provide the best and practical treatments of patients. Require the hospitals to be accountable for the marketing that is targeted at patients and to the direct public. There is an immediate need to access the skills of surgeons working in the field to be properly credentialed and certified to be certain of physician competence and of a patient’s, potential safety. It is essential that they establish of studies that will truly determine the efficiency, practicality, and ratio of success of the robotic surgery potentials, but, also, free them from a future containing ethical accusations and legal proceedings.(Joelving, 2012) Conclusion In present society, and very likely well into the future, we grow more and more dependent upon technology. Robots already vacuum our homes, mow our lawns, entertain our children and elderly, assemble our vehicles, as well as thousands of other products, they fill our medication prescriptions, they deliver sensitive tissue samples and fluid specimens in medical settings, monitor our investment portfolios and financial records, and, when in the hands of the military, spy on others. (Ellis, Cavanagh & Redman, 2013) Given all of that, is it really a wonder that eventually robots found their way into operating rooms? Science-fiction has presenting the concept for generations. However, in order for technology, like robotic surgeries, to become widely accepted and a more commonly used practice then the proper further research needs to be conducted and ethical issues must be addressed. Until that time robotic surgeries will continue to be debated and be at risk for, potential, legal entanglements in the future. References Carreyrou, J. (2010). Surgical robot examined in injuries. Wall Street Journal, 1. Retrieved from http://online.wsj.com/article/SB10001424052702304703104575173952145907526.html Brodsky, I. (2012, August 23). Obamacare and the vanishing medical miracle. The Daily Caller. Retrieved from http://dailycaller.com/2012/08/23/obamacare-and-the-vanishing-medical-miracle/ DeBernardo,, R., Starks, D., Barker, N., Armstrong, A., & Kunos, C. A. (2011). Robotic surgery in gynecologic oncology. Obstetrics and Gynecology International, Retrieved from http://www.hindawi.com/journals/ogi/2011/139867/ Ellis, D., Cavanagh, S. J., & Redman, B. K. (2013). Robot ethics. Hospitals & Health Networks, 1.Retrieved from http://www.hhnmag.com/hhnmag/jsp/articledisplay.jsp?dcrpath=HHNMAG/Article/data/06JUN2009/090622HHN_Online_Ellis&domain=HHNMAG Joelving, F. (2012). Pricey surgery lacks clear benefits: study. Reuters, 1. Retrieved from http://www.reuters.com/article/2012/01/30/us-pricey-robots-idUSTRE80T1SC20120130 Peters, J. D. (2012). Robots holding the scalpel. Trial, 35-40. DOI: http://www.c2lawfirm.com/Robotic Surgery_Trial.pdf Wolinsky, H. (2013). The forward march of robotic surgery. Chicago Medicine, 116(1), 18-23. Retrieved from http://www.cmsdocs.org/news-publications/chicago-medicine-magazine/2013-issues/Jan2013issue.pdf Schwartz Cohen, R. (2012). Industry and technological systems. In M. Winston & R. Edelbach (Eds.), Society, Ethics, and Technology (updated fourth edition ed., pp. 39-54). Boston: Wadsworth Cengage Learning. (2013). Intuitive surgical (nasdaq:isrg)-intuitive surgical: Angel with broken wings, or the devil in disguise? . Citron Research, 1-30. Retrieved from http://www.citronresearch.com/wp-content/uploads/2013/01/Intuitive-Surgical-part-two-final.pdf Read More