Political and Legal Influences in Robotic Surgery - Research Paper Example

? Political and legal influences of/in robotic surgery Political and legal influences of/in robotic surgery Introduction The advancement of technology is availing services and products that people never thought would exist. The use of robots in surgery was beyond imagination but has come to reality in recent times. Robots are highly precise and capable of doing their work without any interference. They are used for sensitive surgeries to ensure that there is enough precision as per the requirement. Even with that precision and advantage, robotic surgery is faced with a lot of controversies. There are legal, political and ethical issues associated with the procedure. Robotic surgery is the best invention there is in medicine but the controversies have raised concerns about this technology and addressing them could better automated and efficient surgeries used robots. Description Robotic surgery uses an automated system that has three systems; the console which the surgeons use to control the system, four arms that are controlled by the console and can be manipulated to do practically any task and a high definition visual system for providing real time images of the parts being operated on. Three of the arms are fitted with surgical instrument while the fourth arm is used to control the camera which guides the surgeons on the parts to be operated on. Advantages of the robotic surgery Doctors are able to operate many clients using robotic surgery. Since they are involved indirectly, they do not get as tired as compared to manual operations. Patients on the other hand benefit as the procedure does not take long using the robots for surgery. This saves time for the patient and the doctor. Time saved by the robotic surgery procedure is saving hospitals as much as thirty percent of their budget on surgery. Money saved can be directed to other projects within the hospitals. The robots are quite precise and the incisions required when using them are usually small compared to a normal surgery. This makes the healing process faster for the patients. They do not have to stay in the hospitals for long time thereby saving money as well (Beck, 2013, para. 5). Controversies Despite the advantages that come with robotic surgery, there are many issues that have been raised regarding the use of these machines. They include the safety of the use of the robots, the risks associated with their use, the functioning of the robots and the regulatory framework on the same. These issues have spurred a never ending debate and threaten the use of these systems and are categorized into several (Mavroforou, Michalodimitrakis, Hatzitheofilou, and Giannoukas, 2010, p.77). Political issues Regulation The use of robots in surgery is not regulated by any institution. Although they have been given the green light by the relevant government institutions, there needs to be a body that regulates their use, evaluates the advantages, the disadvantages, issues raised and any suggestions. Lack of regulation in this field has led to a lot of issues relating to the use of the system. One, there are many injuries and deaths that are associated with the use of robots in surgery in the last few years. In fact, the number has been increasing year after year. If there was a regulatory body, the issues leading to death would have been addressed and less injuries and deaths would be reported. This fact has made some politicians to step up and propose the regulation of the use of robots in surgical procedures. Senator Dick Moore from Massachusetts proposed that there should be a new policy and law to regulate the use of robots in surgery in Massachusetts. Moore is conversant with policies regulations and costs in the health care industry. Senatorial colleagues across the United States including the minority leader Bruce Tarr appreciate that Moore has enough knowledge on this and fully support him. Moore is credited to the enactment of the 2006 universal health care legislation which was a key part in the Obamacare health reforms in 2009. Hahesy (2013, para.4) puts the doctors, hospitals and healthcare facilities using or planning to use the robotics for surgery on notice. Moore is known to follow up something until he succeeds. It is only a matter of time before he ensures that his new goal of robot surgery regulation is achieved. Dr Martin Makary who is an associate professor at the John Hopkins University support the Robotic Surgery Bill by Senator Moore. He claims that hospitals were fast to embrace the technology without knowing the real value of that investment. To him, robotic surgery was not done right from the start. It should have started with proper evaluation to detect any flaws and loopholes followed by the introduction of a regulation policy before it could be implemented and used in hospitals. He claims that what Senator Moore is doing is of great importance, as it creates good value for the money spent and also ensures that the well being of the citizens are guaranteed (Jin, et al, 2011, p.48). Standardization Lack of standardization in the use of robots for surgery is one of the red lights for this technology. Despite the boom of the technology, there are no guidelines at all on the use of the system. The use of robots in the various hospitals has been determined to be totally different. Each hospital has its own guidelines and regulations on the use of robots for surgery. As such, patients may be operated using robots yet they were not supposed to be operated on using the technology. They can also be operated on normally yet it would have been best for them to be operated using the robots. Some medical experts believe that the increased injuries and death are as a result of lack of standardization. They propose that a regulatory body should be established for this purpose only. According to surgeons and doctors, that there should be patient criteria for selecting those that are best suited for the procedure. This can only be done to perfection by first understanding the system completely, understanding the different conditions and which conditions would be best to be treated using the robots. In addition to that, surgeons should be provided with the number of surgeries they can perform per day, month of year depending on what the regulatory body finds fit. Though there is less energy used by surgeons, the procedures can have a toll on them especially if they do a lot of them within a short time. In this case, the regulatory body established, would have to evaluate the performance of surgeons using the technology to determine when their productivity starts to decrease. The number of surgeries at that point would be regulatory number (Sherman, 2009, p.1). At the same time, there should be a process of using the system. For example, the first thing would be for a surgeon to learn how to use the system. Once they have completed that, they should be tested and then put to task of using the system in a real case scenario using test subjects for example pigs. Confirmation that a surgeon can use the robots for surgery well should be followed by assigning them low risk human surgeries. Competence in that should be followed by medium risk and high risk human surgeries in that order. A few case scenarios should be used in each case to prove that in deed the surgeons are competent (Schneider, 2013, para.4). Standardization of any process or procedure cannot be complete without determining the consequences of not meeting the conditions. In this case, there should be policy stating clearly what happens when surgeons do not meet the required standards. In most case, there are fines or a lawsuit is filed against the person on the wrong. Regulatory framework should be used to ensure that the surgeons follow the practices and standards made. Registry Like any other computer system, the robots are not expected to be perfect. There may be errors and injuries or death as a result. Most governments have institutions that are follow up on such reports. In this case, any injury or damage or complication to the patient should be reported accordingly. The case of the use of robots for surgery is however different. The number of complications, injuries and death as a result of the use of robots are underreported, reported inaccurately or reported late. A study by Martin Makary of the John Hopkins University found out that indeed some of the cases are in these categories. Determined to unearth this problem, Makary found out that five cases were not reported, three cases had problems, and one case was reported close to three years later while another was reported almost two years after the surgery (Berko, n.d, para.3). The study by Makary was a sample of two hundred and forty five cases. Basing on the fact that the robots have been used to perform more than a million surgeries, then the number of unreported, reported late or with errors is quite big. Robots are used to perform an average of three hundred thousand surgeries in the United States alone. Basing on the sample Makary did, the number of cases that would fall in this category would be more than twelve thousand in the United States. The findings of the team led by Makary proved correct when the Food and Drug Administration confirmed that would start evaluating the strengths and the weakness of the robot surgeries. There was a spike of more than thirty percent increase in the number of reports for complications and injuries related to robotic surgery (Lowes, 2013, para.4). Legal Issues Injuries Lawsuits This is one of the greatest concerns of using robots for surgery. There are many cases which have been reported on this subject matter. Take for example Erin Izumi from Tacoma, Washington State. She was admitted in a hospital and doctors were convinced that a surgery was good. Surgeons used robotic surgery for the endometriosis. A few days later, she got sick and was rushed to the hospital. Doctors noted that she had been operated on ten days earlier using robots and followed up on the previous surgery. They realized that her colon and rectum had been injured by the robot during the surgery. She was hospitalized for the following five weeks in the quest to repair the damaged organs. It was worrying to note that Izumi’s case was never reported to the Food and Drug Administration within the required timeline of thirty days. In fact, it was never reported (Rabin, 2013, para.9). There are many more surgeries that have gone this way and they are never reported. Injuries elated to robotic surgery are not well taken by most people. They go ahead to file lawsuits against the hospitals, the surgeons and the manufacturer depending on their reasoning. There are views that surgeons only use the machine and therefore the problem can be from the manufacturer. People who have such view points usually sue the manufacturer of the robot. Michele Zarick, who suffered injuries five weeks after her surgery claimed that the hospital she was operated in, did not inform her of the potential risks of robotic surgery. She went ahead to claim that the design of the robot used, Da Vinci in this case was faulty and was prone to cause injuries to those being operated on, in her lawsuit (Gilleon Law Firm, 2013, para.2). Another case filed by Gilmore through the Rheingold Valet law firm was also against the manufacturer. Gilmore claimed that the robot used to perform surgery on her daughter caused severe burns to her intestines and arteries leading to her death ten days later. He was convinced that the robot was faulty in its arms and was also emitting a lot of heat which easily burned the sensitive organs’ tissues. The argument was that the robots were using electricity to perform which means they had to generate heat. Gilmore felt that the heat released by these machines is not regulated properly causing the damage (Robotics and Machine learning, 2012, p.9). Other people feel that the surgeons performing the surgery are fully liable in the case of an injury or death of a patient. They are of the view that the machines are operated by the surgeons who are capable of making mistakes or being careless. Surgeons are sued in case there are direct injuries in such a case. Many surgeons and their hospitals have been sued. Attorney William Audet from San Francisco for example claims that his company is representing several plaintiffs in cases regarding injuries after undergoing robotic surgeries. William confirms that the cases could be many across the United States. If he is representing a few clients from his home town, then the number of law firms and lawyers representing the injured could be quite high. The number is already into hundreds this year basing on the fact that there were 80 lawsuits filed against the company, surgeons and hospitals as of February 2013 (Murphy, 2013, para.1). The lawsuits filed do not usually proceed in most cases. Most people across the country and the world are astonished how the manufacturers get out of this. In all the cases that have been filed, they are either dismissed or there are no people to take responsibility. It is interesting that in such cases, the company that manufactures the robots for surgery states that their machines are in order and are not to blame. The blame falls on the surgeons and the hospitals who do not take responsibility in addition to the fact that they are protected by their respective employers and boards. Blame game between the three continues and the cases end just like that. A good example would be the case in which the manufacturers of the most commonly used robot Da Vinci were exonerated by the Washington State Jury. The case was filed by a family whose member passed on after being operated on by the Da Vinci Robot. The jury claimed in their judgment that there was no enough evidence to show that in deed the machine caused death of the patient. In addition, the jury claimed that the surgeon operating the machine was adequately trained and could not make any errors (Davincilawsuit, 2013, para.7). This was despite the fact that there are claims that most of the surgeons using the machine are not well trained. Dr Cohen, who has been using the robot for surgeries for six years, confirms that lack of proper training on these robots can be disastrous (Fabregas, 2013, para. 6). Addressing the issues The issues, controversies and concerns regarding the use of robotics in surgery have been there for a while. Legislators from different parts of the world are working hard to ensure that this sector is well regulated and standards of working established. Institutions concerned with this for example the National Institutes of Health and medical boards are also working to address the challenges and improve on the sector. It may take some time but with determination the targets and objectives of making robotic surgery the ultimate solution will be achieved (Feely, 2013, Para.3). Some experts who support the use of robotics believe that increased studies on the use of these machines would be important in addressing the challenges. They propose that all surgeons who would like to use this system, to train during their free time using pigs which are good test subjects for this technology. This would ensure that there are low numbers of injuries, lawsuits and less time and money wasted (Greenberg, 2013, para.36). For the robotics surgery to work effectively, the manufacturers and surgeons have to be committed. The manufacturers have to ensure the robots are well manufactured and also tested effectively. At the same time, they should be ready to address the issues raised by the users and patients across the world. They should take responsibility for what has happened to the patients especially injuries. Although they have not taken responsibility for any of the injuries caused, it is evident that the manufacturers have a hand in the issue. Government institutions should also have a responsibility to follow up on the use of robotics for surgery. The machines used should be evaluated keenly before they can be authorized. On their part, surgeons should be committed to learn how to use the machine well. They should be committed to practice using the robots before they can start operating patients. Conclusion The use of robotics in surgery is a great milestone in the world of medicine. It comes with many advantages but there are many issues of concern as well. The issues of concern seem to outweigh the benefits and addressing them can really improve the sector. The relevant institutions are doing whatever it takes to ensure that the use of robotics in surgery is improved for the better. This can make the use of robotics common, reduce costs of surgery and also make things easier for the surgeons. References Beck, M. (2013). Study Raises Doubts Over Robotic Surgery. The Wall Street Journal, 1,1. Berko, L. (n.d). Complications from Robot Surgery Are Underreported, Johns Hopkins Found. Retrieved from http://motherboard.vice.com/blog/complications-from-robot-surgery-are-underreported-johns-hopkins-found Da Vinci Robot Lawsuits Forge ahead despite defense verdict exonerating manufacturer from negligent physician training. Retrieved from http://davinci-surgical-robot-lawsuit.com/ Fabregas, L. (2013). Robot use in surgery debate. Tribune - Review / Pittsburgh Tribune - Review. Feely, P. (2013). NH Board of Medicine to review concerns about robotic surgery complications. McClatchy - Tribune Business News. Gilleon Law Firm. (2013). Safety Concerns Over Robotic Surgery Systems. JD Supra Law News. Retrieved from http://www.jdsupra.com/legalnews/safety-concerns-over-robotic-surgery-sys-08864/ Greenberg, H. (2013). Robotic Surgery: Growing Sales, but Growing Concerns. CNBC. Retrieved from http://www.cnbc.com/id/100564517 Hahesy, J. (2013). Legislation Poses the Question: Are Surgical Robots Automatically Good? Massachusetts Politics Blog. Retrieved from http://pretiminahan.blogspot.com/2013/09/legislation-poses-question-are-surgical.html Jin, L. et al. (2011). Robotic Surgery Claims on United States Hospital Websites. Journal for Health Care Quality, 33(6), 48-52. Lowes, R. (2013). Complications of Robotic Surgery Underreported, Study Says. Medscape. Retrieved from http://www.medscape.com/viewarticle/810490 Mavroforou, A., Michalodimitrakis, E., Hatzitheofilou, C and Giannoukas, A. (2010). Legal and ethical issues in robotic surgery. International Angiology, 29(1), 75-9. Murphy, P. (2013). Report: Over 80 deaths tied to da Vinci robot surgery. Lawyers USA. Rabin, R. (2013). 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