Computer Science and Information Technology - Robotic Surgery - Essay Example

Robotic surgery al affiliation) Introduction Robotic surgery is a technique of performing surgery by utilizing very tinytools that have been attached to a robotic hand. The robotic arm is often controlled by the doctor by use of a computer. Small surgical tools are often attached to the arms of the robot with the doctor directing the movement through a computer. Robotic surgery is often compared to laparoscopic surgery and can be done through smaller cuts. The surgeon often makes tiny, precise movements which are possible with the type of surgery. Robotic surgery has been approved by the food and drug administration for use in both pediatric and adult robotic surgery procedures in areas such as thoracoscopically-assited cardiotomy procedures, general non-cardiovuscular thoracosopic surgeries, general laparoscopic surgeries and urological surgeries (Lowes, 2014). Political and legal issues involved FDAs stance on robotic surgery History of FDAs approval of the use of new technologies used in surgery The 1st federally approved robotic surgery was performed at a Virginia hospital, a day after the food and drug administration regulators approved the procedure. The approval of the 1st robotic surgery enabled the doctors to get rid of the gall bladder and conduct some other procedures through utilization of a laparoscope, which is a tube that in introduced into the abdomen through very tiny incisions. At the end of the tubes are miniature cameras and surgical instruments that permit surgeons to perform procedures after peering into the body. The AESOP system was approved in 1990 followed by the approval of da Vinci Surgery System in 2000. The approval of da Vinci surgical systems, a robotic system, by the Food and drug administration enabled doctors to use foot pedals on a console and hand grips to control three robotic arms that actually performs the laparoscopic surgery through utilization of a variety of tools. The approval was based on a review of clinical studies of effectiveness and safety submitted by the manufacturers and on the recommendation of the plastic and general surgical devices panel of the Food and drug administration’s medical devices advisory committee. Obstacles faced by robotic surgery in obtaining FDA approval The food and drugs administration focused on various issues before approving the utilization of the robotic technology in surgery. Some of the obstacles faced by the robotic surgery in obtaining the approval of the FDAs included showing that the technology had more advantages than as compared to other forms of surgery. Other obstacles entailed ensuring that enough training was conducted to some of the physicians. Before approving the technology, the company that produced the da Vinci system had to sponsor sufficient testing to determine whether it was safe and more effective as compared to the laparoscopic methods (Lowes, 2013) Concerning evidence that challenges the FDAs approval The modern and biggest thing that is discussed in operation rooms these days is the multi armed technology called da Vinci that has been utilized to conduct over four hundred thousand surgeries nationwide in the United States of America. The technology is currently utilized in operations such as removal of wombs, gall bladders and prostrates, shrinking stomachs, repairing heart valves as well as transplanting organs. The system is most popular in the United States of America even though it has grown worldwide. The major concerns however is that patients and doctors often embrace new treatment modes before their weaknesses and merits are fully understood. Several experiences with the robotic technology have questioned the approval of the technology that is currently being utilized in various hospitals in the United States of America. The technologies have been associated with increase in risks and costs that are associated with it. Additionally, there are minimal or less literature targeting its experiences, uses, outcomes and the number of people treated by it (Food And Drug Administration, 2000). The most recent food and drug administration’s Maude database has raised various challenges and questions about the cost effectiveness and safety of the technology leading to a review of the system by the same body and making some of the experts to get worried as to whether the benefits of robotic assisted surgeries was overstated. As per the food and drug administration’s database reports, there are existing incidences where a robotic hand failed to let go of the tissues grasped during surgery while other cases recorded have involved the robotic hand hitting the patients face during the procedures. The experience has generated various problems that are associated with medical malpractices, where there is ambiguity of liabilities between the manufacturer, the robot and the surgeon (Food And Drug Administration, 2000). Informed consent and robotic surgery The definition of informed consent and its application to robotic surgery Informed consent is the process by which is led to understand and learn about the benefits, the purpose and potential risks of a clinical trial, surgical or a medical intervention and agrees to participate in the trial to receive the treatment. An informed consent often requires a responsible party o the patient to sign a statement confirming that they understand the benefits, risks and procedures of the treatment (Ryan et al, 2009). As it is often included under the same heading of medical malpractice, the informed consent issue arises parallel with or apart from issues of due care. Lack of informed consent is often associated with the failure of medical practitioners to provide their patients with adequate information regarding their treatment to enable them make informed decisions. Battery, a claim for more aggravated misconduct, may arise when there was no consent to a particular treatment or procedure targeting a certain portion of the body. The issue of informed consent has been associated with robotic surgery in various ways. A medical practitioner is considered legally liable, if a patient does not consent to a medical procedure that may eventually lead to harm even if it is conducted in professional manner. For instance, if a medical practitioner fails to inform the patient that the procedure being conducted can result can result to deformities and the patient ends up with deformities after the procedure, then the medical practitioner will be legally liable for the outcome. Lack of informed consent is one of the major challenges that affect robot assisted surgery. Robot assisted surgery is still evolving. With the new utilization of the technology and the resultant complex procedures that is associated with it, the standard of disclosure of the benefits and the risks that hospitals must offer the patient is still evolving and not tangible (Ryan et al, 2009). The medical staffs responsibility with regards to informed consent It is important for medical practitioners to keep the patients informed about the outcome of the robot assisted surgery as well as the relevant information that is in existence. The family and the patient should be informed that the procedure may have some unknown risks. The robot may break up leading to the conversion of the surgery into an open surgery. In addition, the changing from robotic surgery to an open surgery might take a very long time hence the patient may need more anesthesia to prolong the surgery. The approach might be risky to the patient. With the various cases associated with robotic surgery such as the case when a patient was hit by a robotic arm in the face during a hysterectomy operation, a New York man whose colon was allegedly perforated during prostrate surgery, a Chicago man who died after spleen surgery in 2007 and a female patient who died during the 2012 hysterectomy surgery after the robot controlled by the doctor unintentionally nicked a blood vessel offers evidence that the technology may not be fully efficient and calls on the medical practitioners to ensure patients are informed about the procedure and the risks that may be associated with the outcome (Ryan et al, 2009). From the legal point of view, complete informed consent often requires a complete discussion of the patients’ diagnosis as well as the nature and purpose of the proposed procedure and treatment, the benefits and risks of the proposed procedure or treatment, the associated risks, alternatives and benefits, the benefits of not receiving or undergoing procedure or treatment, the precautions that are needed postoperatively as well as the recommendations of the doctor. The medical practitioner is often required to explain such information in a language that can be understood well by the patients. Omission of any information may make the patients’ consent invalid. It is therefore the responsibility of the patient to a medical practitioner to ensure the patients undergoing a robot assisted surgery to understand all the information that is associated with the procedure (Ryan et al, 2009). Consequences of failing to meet informed consent requirements The patient may have a ground to sue a medical practitioner for medical malpractices in the event where they are not fully informed about the procedures that are involved in conduction of certain medical procedure. It is therefore a requirement for all medical practitioners to keep the patient informed about the risk of robotic surgery before they are allowed in the surgical room. Basically, doctors require patients to consent to certain medical procedures before they are conducted. However, signing the form alone does not indicate that the patient consented to the robotic surgery. Doctors are supposed to discuss the test, procedures, and treatment regimen as well as the risk involved with the patient. The patient has to understand as much as possible the potential risks that may be associated with the practice. Whether or not the patient consented to a certain procedure conducted in the hospital is crucial to the law of medical malpractice. If the patient is not informed that the procedure which is being conducted by robotic-assisted surgery may lead to a certain deformity or injury and then after the procedure they end up with a deformity, the patient or family may sue the doctor or any other medical practitioner involved with informed consent. In the process the medical practitioners may end losing their licenses as they await investigation (King & Moulton, 2006). Robotic surgery impact on issue of malpractice Where liability lies in robotic surgery Despite the various advantages of robotic surgeries, cases of malpractices have being reported as a result of negligence by the medical practitioner involved due to lack of enough skills to use the technology. Patients have ended up with injuries that were never anticipated after undergoing surgical procedures such as hysterectomies, urological procedures, gynecological procedures as well as prostrate surgeries. Surgical procedures that entail the utilization of robotic procedures are often known as robotic assisted surgeries, indicating the surgeon is conducting the procedure with the help of the machine or the robot. The patients’ perspective is however different. The software and the machinery conduct the actual work in the body, if any robotic surgery complications take place in the process, then someone should be held accountable, either the manufacturer or the medical practitioner involved (Moylan, 2014). Complication that is related to the negligence of the medical practitioners is called medical malpractice while the one levied against the manufacturer of the robot or machine is known as the product liability. As a result of carelessness in the machine operations, surgeons may cut organs such as ureters, blood vessels and a section of the intestines. Some of these complications may be due to insufficient training in the operation of such a new technology. Complications that result from the mistakes of the doctor are considered as a malpractice and can be taken to court. Injuries that arise from the flaws of the machine are known as medical product liability and the manufacturer are liable for the occurrence (Granade, 2010). Samples of recent lawsuits involving mishaps from robotic surgery Many lawsuits have been reported against utilization of robotic assisted surgery in the country. In the Intuitive surgical Inc versus Taylor, the manufacturers of the surgery robots have been accused of putting the patient at risk through marketing of the technology to the doctors without conducting adequate training. The suit was recorded in Washington in 2012. Another lawsuit involves Bryn Mawr Hosp. versus Mracek. In the case, the plaintiff alleged that malfunctioning of the robot during the surgery resulted to major injuries to the patient. The district court however held that Mracek failed to offer any conclusive evidence to eliminate secondary causes of the robot’s malfunctioning as well as to associate the malfunction with the injury that took place (Goldberg, 2012). The incident was reported in Pennsylvania in 2009. The other case involved Dulski versus intuitive surgical, Inc. the case was reported in Illinois in 2011, the plaintiff underwent a radical prostectomy with the company’s product, a Da Vinci robotic surgical device. The robot created a hole in the colon of the patient during the operation. The defendant Ryan Smith was accused of professional malpractice during the procedure. The plaintiff however learned during the course of discovery of the medical malpractice that over twenty one service calls were made on the device prior the Thomas Dulski’s surgery and that the defendant had worked on the device eighteen times and as recently as 6 days prior the surgery. As a result, Dulski commenced the 2nd action in New York accusing the manufacturer and Ryan Smith of carelessly, recklessly and negligence in the manufacture and utilization of the equipment. The second case was dismissed as a result of inadequate evidence while the 1st case was never made public. Ryan smith was found not to be negligent and that he had performed under the scope of employment (Rosenblatt, 2013). A comparison between malpractice in manual surgery and robotic surgery Manual Surgical malpractice is the act of negligence targeting a patient by a surgeon, surgical nurse, anesthesiologist and other medical practitioners involved in a surgical procedure. It takes place when a medical practitioner acts in a manner that is different from the standard of care accepted in a medical community. A legitimate malpractice case or action must have evidence that the actions of the surgeon harmed the patient. Many surgical malpractices come in various forms. The fact that doctors are the only medical practitioners that are often involved in negligence is highly publicized by cases involving sponges or surgical devices left behind in the bodies of patients or the surgeon removing the wrong organ or amputating the wrong limb. However, there exist some differences between malpractices in normal surgery and robotic assisted surgery (Van & Gastmans, 2008). Most of the robotic surgery often has less number of medical practitioners surrounding the patient and on various occasions, the surgeon is the one who is liable for any complication on the operation table. Unlike, manual surgery, malpractices in robotic surgery can be associated with the malfunctioning of the machine or the negligence of the surgeon. Complications that may arise at the end of surgery may be linked to either the negligence of the doctor of malfunction of the device. In some extend both the manufacturer and the doctor may be held accountable. Conclusion Robotic assisted surgery has become a standard surgical procedure in numerous hospitals around the world and more so in the United States of America. Due to the various benefits associated with it, the technology is here to stay. It is therefore important for the manufacturers of the devices to ensure that their product is of high quality to prevent medical product liability. The hospitals should also ensure that the health practitioners especially the surgeons are well trained on how to utilize the device with an intention of reducing malpractices that are associated with it. Like any technology, robot-assisted surgery has its own demerits but that does not mean that the same cannot be quarantined or cured (Lowes, 2014). References Food And Drug Administration. (2000, July 17). FDA Approves New Robotic Surgery Device. ScienceDaily. Retrieved March 17, 2015 from www.sciencedaily.com/releases/2000/07/000717072719.htm This article is from the FDA. It shows the first time the FDA cleared robotic surgery which was in the year 2000. At the time it was only approved for laparoscopic gall bladder and reflux disease surgery. Goldberg, M. (2012). Robotic Arm Went Crazy-The Problem of Establishing Liability in a Monopolized Field, The. Rutgers Computer & Tech. LJ, 38, 225. http://heinonline.org/HOL/LandingPage?handle=hein.journals/rutcomt38&div=15&id=&page= This online journal gives discusses samples of lawsuits that have targeted the utilization of robotic-assisted surgery in the United States of America. An example of the lawsuit that has been discussed involves Mracek versus Bryn Mawr hosp. Granade, P. F. (2010). Medical malpractice issues related to the use of telemedicine-An analysis of the ways in which telecommunications affects the principles of medical malpractice. NDL Rev., 73, 65. http://heinonline.org/HOL/LandingPage?handle=hein.journals/nordak73&div=11&id=&page= This journal source outlines the issue of malpractices associated with telemedicine or the utilization of the robotic-assisted surgery. The emergence and use of robotic technology in surgical rooms have raised various legal issues. King, J. S., & Moulton, B. (2006). Rethinking informed consent: the case for shared medical decision-making. American Journal of Law and Medicine, 32, 429-501. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1284511 This source is a journal an American journal of medicine and law which discusses the various aspects of informed consent. The source outlines the various weaknesses associated with informed consent and the information that should be contained. Lowes, R. (2013, April 30). FDA Investigates Robotic Surgery System After Adverse Event Spike. Retrieved March 7, 2015, from http://www.medscape.com/viewarticle/803339 This article shows the FDA launching an investigation. There was a recent spike of events, injuries linked to robotic surgery. Lowes, R. (2014, May 2). FDA Clears da Vinci Robotic Surgery Firm on Warning Letter. Retrieved March 7, 2015, from http://www.medscape.com/viewarticle/824507 This article states that the FDA has cleared a robotic surgery firm after sending them a warning. The firm made improvements to their current model for safety. The warning was issued due to the high number of reports of events linked to robotic surgery. Moylan, T. (2014, April 9). Da Vinci Surgical Robot Maker Reserves $67M To Settle Product Liability Claims. Retrieved March 17, 2015, from http://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2014/04/09/da-vinci-surgical-robot-maker-reserves-67m-to-settle-product-liability-claims.aspx This article states that Intuitive Surgical Inc. reserved $67 million dollars to settle liability claims. This is the company that makes one of the major robotic units called da Vinci. There were 3,000 claims submitted from October 2012. Rosenblatt, J. (2013, April 29). Intuitive Trial Witness Says Robotic Surgery Hastened Death. Retrieved March 17, 2015, from http://www.bloomberg.com/news/articles/2013-04-29/intuitive-robot-patient-s-death-hastened-by-surgery-doctor-says This article shows an example of a case against robotic surgery. The accuser said that the training for the robotic unit was simplified to sell more units. This resulted in errors during her husbands surgery. Ryan, S., Chirumamilla, V., Bello, R., D’Alessandro, D., Michler, R., Rabin, J., ...Derose, J. (2009). How Informed is “Informed Consent” for Robotic Cardiothoracic Surgery? Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery,4(6), 307-310. Retrieved March 17, 2015, from http://journals.lww.com/innovjournal/Fulltext/2009/11000/How_Informed_is__Informed_Consent__for_Robotic.3.aspx This online scholarly journal explains the informed consent to patients. It also shows how much patients know before they get their procedure done by robotic surgery. It also states that they are trying to come up with a questionnaire to see how much each patient knows and how they can educate themselves of all the risk that comes with robotic procedure. Van Wynsberghe, A., & Gastmans, C. (2008). Telesurgery: an ethical appraisal. Journal of Medical Ethics, 34(10), e22-e22. http://jme.bmj.com/content/34/10/e22.short This journal of medical ethics and provide a preliminary evaluation of effect of robotic surgery on patient care. The source outlines the significance of patient-physician relationship in dealing with the issue malpractices in telemedicine approach. Read More