The PROBOT was therefore developed in order to perform this procedure, a purpose-built machine. This development ushered in the era of using purpose-built machines, fine-tuned to the specifications needed for a particular procedure, in robotic surgery. The promise that early efforts like the Puma showed encouraged engineers to engage in more development of medical applications. At this time, the medical field was largely making use of existing technology, adapting it for its own needs. Integrated Surgical Supplies in Sacramento developed ROBODOC for hip replacement surgery, and this was the first robotic surgery device that was granted approval by the FDA (Lanfranco, 2004).
The ROBODOC had to go through the standard FDA approval system for medical devices. The process was instituted in the 1970s, therefore in an era where there were no robotic medical devices. A robotic surgical device would be a Class III device, the highest risk category, and therefore would have the highest level of regulatory burden. The ROBODOC's approval took much longer than it could have because the patent owners would go bankrupt before the approval process could be completed. As a result, there has been considerably debate in the medical community about the approvals process for medical devices, in that many feel the development of robotic surgery devices has been hampered by the burdensome nature of the regulatory process. The counter to this is that surgical devices should have high standards, as the cost to patients of device failure is likely to be catastrophic (Curfman & Redberg, 2011).
The ROBODOC was basically a workstation. It worked in several stages. In the first stage, the orthopaedic surgeon uses the device to examine the bone, and ROBODOC proved to excel at this. The pre-operative plan is then developed, with the assistance of the device, and the ROBODOC then is used by the orthopaedic surgeon to perform the actual surgery. The device was tested on more than 850 patients at half a dozen hospitals by the mid-1990s, when it still had not yet completed the FDA approvals process (Pransky, 1997).
The next wave of development in robotic surgery sought to resolve the issues in mechanics that were acting as a constraint on what surgical robots could do. In particular, the mechanical motion limitations and low haptic feedback sensitivity were seen as issues that needed to be addressed to develop robotic surgery for laparoscopic applications (Davies et al, 1997).
A further issue in the development of robotic surgery by the late 90s and early 2000s was training. Because so few devices had received FDA approval at this point, their use was not widespread, and thus training on the usage of these devices was not widespread. Given the need for exceptional spatial reasoning and hand-eye coordination, the learning curve for most robotic surgery applications is steep. A study in 2002 showed that just 14% of residents were receiving any training in robotic surgery, despite much larger interest among these residents in laparoscopic surgery. More encouraging, however, was that 23% of directors of medical programs indicated that they were seeking to institute robotic surgery training programs (Donias, et al, 2002). For the most part, however, the development of such training at the medical school and to a lesser extent the training hospital level remains nascent, despite the growing popularity of the field among physicians, insurance companies and patients. It should be noted that the FDA does not regulate the training or practice of medicine, and with robotic surgery systems the training is just as important as the device itself. While this has always been the case in surgery, the fact that so few physicians are learning robotic surgery in their medical school training is a cause for concern, and will stunt the adoption of the technology in the field. The absence of such standardized training can result in a dramatic difference in the skill of physicians at using robotic surgery equipment, and gives rise to the necessity for manufacturers to develop their own standardized training and certification programs to ensure that quality standards in the application of robotic surgery in the field are maintained to a high level. Such training would also serve to minimize malpractice risk, so there is definitely benefit ot the industry to have such programs.
By the early 2000s, the focus of robotic surgery was focused on laparoscopic applications. The future of robotic surgery was understood to be focused on smaller devices with greater tactile sense and more refined movements (Camarillo, Krummel & Salisbury, 2004). The past decade of development in robotic surgery has thus remained based on the arm-and-hand anthropomorphic model of robot and the use of a…
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