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THE FUNDAMENTALS OF ...
Robotic Surgery Systems Robert Dondelinger
For many people, the term “robotic surgery” likely evokes one of two images. One is Asimo, the Honda robot, performing a complex heart-valve replacement with the precision and finesse of the most skilled surgeon. The other is more along the lines of an industrial robot found welding on an automotive assembly line—performing surgery by rote programming on scores of patients in a row, just like in a factory. Neither is the case. Robotic surgery is, by some accounts, the next level of minimally invasive surgery. Conventional invasive surgery involves a large incision in the body to gain access to the area and organ of interest. For example, in a conventional gallbladder removal, the surgeon first performs a laparotomy, which is an incision, usually a large one, through the abdominal wall to gain access to the interior of the torso. The problem with a laparotomy is that it is very stressful physiologically and exposes large portions of the patient’s abdominal cavity to infection. Additionally, because the incision is so large, and the surgeon needs access to a large part of the patient’s interior, the surgery is characterized by a relatively large amount of trauma to the surrounding tissue, blood loss, and postoperative pain and discomfort coupled with a prolonged healing period. To overcome the problems and side effects of the laparotomy, minimally invasive surgery was developed. Minimally invasive surgery accesses the
chest or abdomen through several smaller incisions, each one typically half an inch long. Each smaller incision has a port, or a combination trocar/port is used to make the incision, to protect the surrounding tissue while a particular device is inserted through the hole. The most common items inserted are an endoscope connected to a camera, a light source (which may be part of the other devices), an insufflator, and an instrument with one or more operating channels. In the case of minimally invasive gallbladder removal, now called a laparoscopic cholecystectomy, all the associated steps (draining the gall bladder, severing it from the ducts, and removing the empty bladder) are performed through the operating channel using specially adapted instruments. In minimally invasive surgery, as few as three or four small incisions can take the place of the much larger laparotomy incision. Some surgeons also perform this procedure as “scarless surgery” by accessing the abdomen through the navel and using a specialized operating endoscope with integral illumination and operating channels. Although there technically is a scar, observers might be hard pressed to find it as it is hidden in the folds of the navel. As one would expect, the smaller incisions mean less trauma to the body as a whole, reduced blood loss, and minimal discomfort, all of which equate to a shorter healing period. Minimally invasive surgery techniques are
About the Author Robert Dondelinger, CBET-E, MS, is the senior medical logistician at the U.S. Military Entrance Processing Command in North Chicago, IL. E-mail: robert. [email protected]
Biomedical Instrumentation & Technology January/February 2014
55
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
primarily responsible for the increase in “same day surgery” procedures. Cases employing laparatomies frequently required a one to two week hospital stay for observation (in the event of complications like hemorrhage) and recuperation. Now that time is reduced to a few hours of post-recovery room rest, and patients are discharged later that same day to finish their recuperation at home. As good as minimally invasive surgery is, it also has some drawbacks. Because the space inside the torso is very limited, and the operation is performed with a minimum of disturbance to the surrounding tissue, it can be difficult for the surgeon to visualize the surgical field and manipulate the instruments. In such a small space, minute but precise movements of the instruments are required to ensure the operation remains trouble free. Poor visibility in the surgical field has led to problems ranging from accidentally nicking adjacent tissue to more serious matters, such as cutting a liver duct
To date, robotic surgery systems are viewed warily in many healthcare facilities, partially due to their high cost—$1.25 million and up—and to the limited types of procedures they may perform. Despite these obstacles, facilities in 2012 performed approximately 450,000 robotic surgical procedures in more than 2,000 facilities worldwide. in addition to the bile duct or accidentally severing an artery beyond the surgeon’s field of view. Robotic surgery systems are designed to overcome these challenges and provide yet another major advancement in surgery. To date, robotic surgery systems are viewed warily in many healthcare facilities, partially due to their high cost—$1.25 million and up—and to the limited types of procedures they may perform. Despite these obstacles, facilities in 2012 performed approximately 450,000 robotic surgical procedures in more than 2,000 facilities worldwide.
Current Technology Robotic surgery systems are expensive, and they are approved by the U.S. Food and Drug Administration (FDA) for only a handful of procedures in cardiac, gynecology, 56
otolaryngology, pediatric, and urology specialties. Second, as of this writing, there are only three models of systems approved for sale and use in the United States, and all of them are made by a single company. Their high price and relatively limited number of approved applications makes them impractical for many small rural medical facilities. They are found more often at tertiary referral facilities, where the necessary specialists and case workload supports their utilization. Because there is only a single manufacturer, much of the information on the three models is considered proprietary. However, some interesting information about them is available if one digs deep enough. All three robotic surgery systems employ a physician’s console with computerized controls and a patient side cart containing up to four instrument arms, including an endoscope connected to a fiber optic camera. The surgeon’s console is located within several yards of the operating table and patient side cart. Unlike traditional endoscopic viewing, with robotic systems, the surgeon sits and looks into a large hooded viewing area. The hood blocks outside light and facilitates concentration. The high-resolution video monitors inside the hood provide the surgeon a stereo image magnified tenfold of the operating site from the endoscope mounted on the patient side cart. This video system places the surgeon inside the patient looking at the surgical site from only a few millimeters away, with the instruments and images directly in front of the surgeon, between his or her arms. Even current minimally invasive surgery requires the surgeon to look up and away from the patient and his instruments to view the surgical site on a monitor mounted near the operating table. Some surgeons believe that this view is superior to that provided by even conventional surgery. At the surgeon’s left and right hands are joystick-like controls with additional controls mounted at his feet. A “bumper” device in the hand controls provides tactile feedback when using certain tissue grasping instruments. Armrests help to minimize fatigue during the operation. The hand and foot controls manipulate the operating instruments attached to the patient side cart. Additionally, the surgeon is capable
Biomedical Instrumentation & Technology January/February 2014
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
of zooming in to obtain a better view of details at the surgical site. The computer forms the interface for the surgeon’s hand and foot movements and translates those into movements of the instruments attached to the patient side cart. Two important characteristics of the software is that it controls the zoom of the video and reduces the surgeon’s movements to compensate for the magnified view of the surgical field. Lastly, the computer buffers the surgeon’s movements to compensate for any minor tremors and provides positive feedback to the bumpers when grasping something. The patient side cart replaces the table-side surgeon and looks like a cross between a praying mantis and the multiarmed Hindu goddess Kali. The cart contains as many as four arms, folded like the forelegs of a praying mantis when retracted to the parked position,
arrayed across its top to allow full movement of each arm in all planes. Each arm is capable of holding one of the specially designed or adapted operating instruments—a miniaturized surgical camera, wristed scissors, scalpels, forceps—all designed to help with delicate dissection and reconstruction deep inside the body. As the operation progresses, the instruments are changed by the secondary surgeon or by a trained operating room nurse or technician as required.
How to Manage Robotic Surgery Systems Maintenance services should be scheduled and tracked uniquely for each system with equal consideration given to liability, the initial cost, and the proprietary nature of the hardware and software. Each system should have a detailed maintenance history. Owing
ORIGIN AND EVOLUTION As horrendous as war can be, it historically has led to many advances in medical and surgical practices. The Civil War, for example, taught us the importance of good field sanitation and preventive medicine, and it resulted in increased respect for the role of women in medicine. World War I saw the introduction of both blood banking and X-rays into field surgical hospitals. World War II proved the value of training medical corpsmen in advanced skills to treat the wounded as far forward as possible. Additionally, the use of more effective painkillers in a medic’s aid bag and the widespread application of penicillin decreased the combat mortality rate. The Korean War gave us mobile army surgical hospital (MASH) facilities located minutes by air from the front and discovery of “the golden hour”—the window of time during which a patient is most likely to survive if taken to a hospital. The Vietnam conflict confirmed the theory behind the golden hour and proved that stateside-quality surgery could be provided and supported halfway around the world. Later conflicts, such as Operation Desert Storm and the Iraq and Afghanistan wars, were no exception, providing major advancements in the fields of orthotics and neurology, particularly with the discovery of mild traumatic brain injury (MTBI). This discovery and determining its diagnosis, effects, and treatment, has had wide-ranging impacts in such diverse areas as sports
injuries and traffic accidents. In the late 1980s, the U.S. Amy contracted with the former Stanford Research Institute to develop a system to allow stateside surgeons to operate remotely on wounded military personnel. The system’s goal was to allow a single surgeon working from a major medical center (Walter Reed, for example) to perform delicate procedures in battlefield operating rooms. Using ground-based mobile uplinks and existing communications satellites, the resultant system employed helmetmounted cameras with audio to perform triage and enabled the remote surgeon to literally “look over the shoulder” of the local surgeon or medic and advise during a procedure. However, the goal of developing true remote operating capability was stymied by the five to ten seconds it took to communicate signals from the near-combat zone hospital operating room to the stateside surgeon’s video display and back to the remote unit. During surgery, such a delay could compromise patient safety, so the best use of this prototype system was in a consultative capacity only, with very limited use during an actual operation. However, the basic idea prompted many innovators to explore a new way of performing surgery. That result is robotic surgery, where the robot performs the surgery and the surgeon operates the robot, not from a half-world away, but only a few yards away, eliminating the delay.
Biomedical Instrumentation & Technology January/February 2014
57
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
to both the uniqueness and proprietary components of robotic surgery systems, a maintenance contract with the manufacturer is recommended. As competitive products enter the field of robotic surgery, options other than full-service contracts may be viable in the future. With manufacturer training, a first-call contract would be the best mix of in-house and contractor maintenance capabilities.
Regulations There are no specific regulations covering robotic surgery systems. As always, it is crucial to follow regulations promulgated by the FDA.
Risk Management Issues There have been reported equipment malfunctions in robotic surgery systems that impact the risk manager. Malfunctions of the arms, console, the optics, the computer, or any of the instruments during an operation can result in disaster for the patient. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database contains a number of incident Owing to both the uniqueness reports and complaints about and proprietary components these systems. In 2012, there were of robotic surgery systems, a 282 adverse event reports associmaintenance contract with the ated with these systems at more than 2,000 hospitals. Before manufacturer is recommended. allowing surgeons to use robotic surgery systems, hospitals typically require many hours of simulator training, akin to requiring flight simulator and actual flying hours prior to awarding a pilot’s rating. Aside from the few computerrelated hardware problems, most of the risk management issues associated with these systems are totally in the surgeon’s hands. Although tremor-like movements are filtered out, gross unintended hand movements are replicated by the system, which could result in a surgical error. Postoperative infection is always a concern with any invasive procedure, and robotic surgery is no exception. Although the surgery site or sites are smaller, infection either at the point of intrusion or deep within the torso is still a possibility.
Troubleshooting The most common problems reported with 58
these systems are blown fuses, damaged cannulae, system “lockups,” and operational failure due to software issues. The first two can be can be resolved by in-house biomeds and nursing staff. Rebooting the system can resolve a software lockup, but this can be problematic if a computer lockup occurs repeatedly, especially during a case. Since contract maintenance is recommended, in-house biomeds will rarely if ever be called in to troubleshoot a problem.
Training and Equipment At this time, no additional training or equipment is necessary to service robotic surgery systems. Because there is only one manufacturer of this product, contract maintenance is the only sensible way to service these systems. As more manufacturers enter the field of robotic surgery, it’s possible that service options could well include something other than a full-service contract. When this occurs, a first-call maintenance contract is the method of choice provided manufacturer training is available. Unlike a typical first-call maintenance agreement, such a contract also should cover software and firmware updates. Additionally, it should contain negotiated prices for system upgrades and other options when needed. Although current system designs are proprietary to the sole manufacturer of robotic surgery systems, future systems may employ, in addition to their computer and electronics components, principles of fluidic and vacuum systems to manipulate the arms, hands, and instruments. Biomeds servicing this equipment must be familiar with these systems and generally well versed in all disciplines of biomedical equipment maintenance.
Future Development While there is only one manufacturer marketing robotic surgery systems in the United States, more are sure to follow. At this time, the field is wide open for improvements. For example, one system currently under development promises to provide both visible light and ultrasound images of the surgical site. This feature will allow the surgeon to see not only the surface, but also the internal structure of the tissue. Another area needing further development is that of
Biomedical Instrumentation & Technology January/February 2014
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
tactile feedback. Current units only provide a vibrating indicator of the pressure being exerted. Future instruments may well provide real-time, pressure-proportionate tactile feedback to the surgeon. n
References • ECRI Institute. Healthcare Product Comparison for Telemanipulation Systems, Surgical. Subscription service available at at https://www. ecri.org/Products/Pages/hpcs.aspx. Accessed Sept. 1, 2013. • Evarts H. Insertable Robot Offers New Approach to Minimally Invasive Surgery. Medical Press. Available at http://medicalxpress.com/news/201205-insertable-robot-approach-minimally-invasive. html. Posted May 28, 2012. Accessed Jan. 20, 2014.
• Mayo Clinic Staff. Tests and Procedures: Minimally Invasive Surgery. Available at www. mayoclinic.org/tests-procedures/minimallyinvasive-surgery/basics/definition/PRC-20025473. Posted Jan. 10, 2010. Accessed Jan. 20, 2014. • Titan Medical Inc. Developing Next Generation Robotic Surgical Technologies. Available at www.titanmedicalinc.com/product/. Accessed Jan. 20, 2014. • USC. What is Laparoscopic Surgery? Center for Pancreatic and Biliary Diseases. University of South California, Department of Surgery. Available at www.surgery.usc.edu/divisions/ tumor/pancreasdiseases/web%20pages/ laparoscopic%20surgery/WHAT%20IS%20 LAP%20SURGERY.html. Accessed Jan. 20, 2014.
• Intuitive Surgical. Surgery Enabled by da Vinci. Available at www.davincisurgery.com/da-vincigynecology/da-vinci-surgery/. Accessed Jan. 20, 2014.
Top Selling AAMI Standards…Are You Missing Any?
1
ANSI/AAMI ST79:2010, A1, A2, A3, & A4,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated Text) Order Code: ST79 or ST79-PDF
2
ANSI/AAMI ES60601-1-1:2005, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (Includes A1) Order Code: 606011, 606011-PDF, 606011-CD, or 606011-PE
3
AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software Order Code: TIR45 or TIR45-PDF
4
ANSI/AAMI ST58:2013, Chemical sterilization and high-level disinfection in health care facilities Order Code: ST58 or ST58-PDF
5
AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices Order Code: TIR30 or TIR30-PDF
6
ANSI/AAMI EQ56:2013, Recommended practice for a medical equipment management program Order Code: EQ56 or EQ56-PDF
7
ANSI/AAMI HE75:2009, Human factors engineering—Design of medical devices Order Code: HE75 or HE75-CD
8
ANSI/AAMI/ISO 14971:2007/(R)2010, Medical devices— Application of risk management to medical devices Order Code: 14971 or 14971-PDF
9
ANSI/AAMI/ISO 15223-1:2012, Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements Order Code: 1522301 or 1522301-PDF
10
ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose Order Code: 1113702 or 1113702-PDF
SOURCE CODE: PB
Order Your Copy Today! Call 877-249-8226 or visit http://my.aami.org/store Biomedical Instrumentation & Technology January/February 2014
59
Columns and Departments
THE FUNDAMENTALS OF ...
Robotic Surgery Systems Robert Dondelinger
For many people, the term “robotic surgery” likely evokes one of two images. One is Asimo, the Honda robot, performing a complex heart-valve replacement with the precision and finesse of the most skilled surgeon. The other is more along the lines of an industrial robot found welding on an automotive assembly line—performing surgery by rote programming on scores of patients in a row, just like in a factory. Neither is the case. Robotic surgery is, by some accounts, the next level of minimally invasive surgery. Conventional invasive surgery involves a large incision in the body to gain access to the area and organ of interest. For example, in a conventional gallbladder removal, the surgeon first performs a laparotomy, which is an incision, usually a large one, through the abdominal wall to gain access to the interior of the torso. The problem with a laparotomy is that it is very stressful physiologically and exposes large portions of the patient’s abdominal cavity to infection. Additionally, because the incision is so large, and the surgeon needs access to a large part of the patient’s interior, the surgery is characterized by a relatively large amount of trauma to the surrounding tissue, blood loss, and postoperative pain and discomfort coupled with a prolonged healing period. To overcome the problems and side effects of the laparotomy, minimally invasive surgery was developed. Minimally invasive surgery accesses the
chest or abdomen through several smaller incisions, each one typically half an inch long. Each smaller incision has a port, or a combination trocar/port is used to make the incision, to protect the surrounding tissue while a particular device is inserted through the hole. The most common items inserted are an endoscope connected to a camera, a light source (which may be part of the other devices), an insufflator, and an instrument with one or more operating channels. In the case of minimally invasive gallbladder removal, now called a laparoscopic cholecystectomy, all the associated steps (draining the gall bladder, severing it from the ducts, and removing the empty bladder) are performed through the operating channel using specially adapted instruments. In minimally invasive surgery, as few as three or four small incisions can take the place of the much larger laparotomy incision. Some surgeons also perform this procedure as “scarless surgery” by accessing the abdomen through the navel and using a specialized operating endoscope with integral illumination and operating channels. Although there technically is a scar, observers might be hard pressed to find it as it is hidden in the folds of the navel. As one would expect, the smaller incisions mean less trauma to the body as a whole, reduced blood loss, and minimal discomfort, all of which equate to a shorter healing period. Minimally invasive surgery techniques are
About the Author Robert Dondelinger, CBET-E, MS, is the senior medical logistician at the U.S. Military Entrance Processing Command in North Chicago, IL. E-mail: robert. [email protected]
Biomedical Instrumentation & Technology January/February 2014
55
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
primarily responsible for the increase in “same day surgery” procedures. Cases employing laparatomies frequently required a one to two week hospital stay for observation (in the event of complications like hemorrhage) and recuperation. Now that time is reduced to a few hours of post-recovery room rest, and patients are discharged later that same day to finish their recuperation at home. As good as minimally invasive surgery is, it also has some drawbacks. Because the space inside the torso is very limited, and the operation is performed with a minimum of disturbance to the surrounding tissue, it can be difficult for the surgeon to visualize the surgical field and manipulate the instruments. In such a small space, minute but precise movements of the instruments are required to ensure the operation remains trouble free. Poor visibility in the surgical field has led to problems ranging from accidentally nicking adjacent tissue to more serious matters, such as cutting a liver duct
To date, robotic surgery systems are viewed warily in many healthcare facilities, partially due to their high cost—$1.25 million and up—and to the limited types of procedures they may perform. Despite these obstacles, facilities in 2012 performed approximately 450,000 robotic surgical procedures in more than 2,000 facilities worldwide. in addition to the bile duct or accidentally severing an artery beyond the surgeon’s field of view. Robotic surgery systems are designed to overcome these challenges and provide yet another major advancement in surgery. To date, robotic surgery systems are viewed warily in many healthcare facilities, partially due to their high cost—$1.25 million and up—and to the limited types of procedures they may perform. Despite these obstacles, facilities in 2012 performed approximately 450,000 robotic surgical procedures in more than 2,000 facilities worldwide.
Current Technology Robotic surgery systems are expensive, and they are approved by the U.S. Food and Drug Administration (FDA) for only a handful of procedures in cardiac, gynecology, 56
otolaryngology, pediatric, and urology specialties. Second, as of this writing, there are only three models of systems approved for sale and use in the United States, and all of them are made by a single company. Their high price and relatively limited number of approved applications makes them impractical for many small rural medical facilities. They are found more often at tertiary referral facilities, where the necessary specialists and case workload supports their utilization. Because there is only a single manufacturer, much of the information on the three models is considered proprietary. However, some interesting information about them is available if one digs deep enough. All three robotic surgery systems employ a physician’s console with computerized controls and a patient side cart containing up to four instrument arms, including an endoscope connected to a fiber optic camera. The surgeon’s console is located within several yards of the operating table and patient side cart. Unlike traditional endoscopic viewing, with robotic systems, the surgeon sits and looks into a large hooded viewing area. The hood blocks outside light and facilitates concentration. The high-resolution video monitors inside the hood provide the surgeon a stereo image magnified tenfold of the operating site from the endoscope mounted on the patient side cart. This video system places the surgeon inside the patient looking at the surgical site from only a few millimeters away, with the instruments and images directly in front of the surgeon, between his or her arms. Even current minimally invasive surgery requires the surgeon to look up and away from the patient and his instruments to view the surgical site on a monitor mounted near the operating table. Some surgeons believe that this view is superior to that provided by even conventional surgery. At the surgeon’s left and right hands are joystick-like controls with additional controls mounted at his feet. A “bumper” device in the hand controls provides tactile feedback when using certain tissue grasping instruments. Armrests help to minimize fatigue during the operation. The hand and foot controls manipulate the operating instruments attached to the patient side cart. Additionally, the surgeon is capable
Biomedical Instrumentation & Technology January/February 2014
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
of zooming in to obtain a better view of details at the surgical site. The computer forms the interface for the surgeon’s hand and foot movements and translates those into movements of the instruments attached to the patient side cart. Two important characteristics of the software is that it controls the zoom of the video and reduces the surgeon’s movements to compensate for the magnified view of the surgical field. Lastly, the computer buffers the surgeon’s movements to compensate for any minor tremors and provides positive feedback to the bumpers when grasping something. The patient side cart replaces the table-side surgeon and looks like a cross between a praying mantis and the multiarmed Hindu goddess Kali. The cart contains as many as four arms, folded like the forelegs of a praying mantis when retracted to the parked position,
arrayed across its top to allow full movement of each arm in all planes. Each arm is capable of holding one of the specially designed or adapted operating instruments—a miniaturized surgical camera, wristed scissors, scalpels, forceps—all designed to help with delicate dissection and reconstruction deep inside the body. As the operation progresses, the instruments are changed by the secondary surgeon or by a trained operating room nurse or technician as required.
How to Manage Robotic Surgery Systems Maintenance services should be scheduled and tracked uniquely for each system with equal consideration given to liability, the initial cost, and the proprietary nature of the hardware and software. Each system should have a detailed maintenance history. Owing
ORIGIN AND EVOLUTION As horrendous as war can be, it historically has led to many advances in medical and surgical practices. The Civil War, for example, taught us the importance of good field sanitation and preventive medicine, and it resulted in increased respect for the role of women in medicine. World War I saw the introduction of both blood banking and X-rays into field surgical hospitals. World War II proved the value of training medical corpsmen in advanced skills to treat the wounded as far forward as possible. Additionally, the use of more effective painkillers in a medic’s aid bag and the widespread application of penicillin decreased the combat mortality rate. The Korean War gave us mobile army surgical hospital (MASH) facilities located minutes by air from the front and discovery of “the golden hour”—the window of time during which a patient is most likely to survive if taken to a hospital. The Vietnam conflict confirmed the theory behind the golden hour and proved that stateside-quality surgery could be provided and supported halfway around the world. Later conflicts, such as Operation Desert Storm and the Iraq and Afghanistan wars, were no exception, providing major advancements in the fields of orthotics and neurology, particularly with the discovery of mild traumatic brain injury (MTBI). This discovery and determining its diagnosis, effects, and treatment, has had wide-ranging impacts in such diverse areas as sports
injuries and traffic accidents. In the late 1980s, the U.S. Amy contracted with the former Stanford Research Institute to develop a system to allow stateside surgeons to operate remotely on wounded military personnel. The system’s goal was to allow a single surgeon working from a major medical center (Walter Reed, for example) to perform delicate procedures in battlefield operating rooms. Using ground-based mobile uplinks and existing communications satellites, the resultant system employed helmetmounted cameras with audio to perform triage and enabled the remote surgeon to literally “look over the shoulder” of the local surgeon or medic and advise during a procedure. However, the goal of developing true remote operating capability was stymied by the five to ten seconds it took to communicate signals from the near-combat zone hospital operating room to the stateside surgeon’s video display and back to the remote unit. During surgery, such a delay could compromise patient safety, so the best use of this prototype system was in a consultative capacity only, with very limited use during an actual operation. However, the basic idea prompted many innovators to explore a new way of performing surgery. That result is robotic surgery, where the robot performs the surgery and the surgeon operates the robot, not from a half-world away, but only a few yards away, eliminating the delay.
Biomedical Instrumentation & Technology January/February 2014
57
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
to both the uniqueness and proprietary components of robotic surgery systems, a maintenance contract with the manufacturer is recommended. As competitive products enter the field of robotic surgery, options other than full-service contracts may be viable in the future. With manufacturer training, a first-call contract would be the best mix of in-house and contractor maintenance capabilities.
Regulations There are no specific regulations covering robotic surgery systems. As always, it is crucial to follow regulations promulgated by the FDA.
Risk Management Issues There have been reported equipment malfunctions in robotic surgery systems that impact the risk manager. Malfunctions of the arms, console, the optics, the computer, or any of the instruments during an operation can result in disaster for the patient. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database contains a number of incident Owing to both the uniqueness reports and complaints about and proprietary components these systems. In 2012, there were of robotic surgery systems, a 282 adverse event reports associmaintenance contract with the ated with these systems at more than 2,000 hospitals. Before manufacturer is recommended. allowing surgeons to use robotic surgery systems, hospitals typically require many hours of simulator training, akin to requiring flight simulator and actual flying hours prior to awarding a pilot’s rating. Aside from the few computerrelated hardware problems, most of the risk management issues associated with these systems are totally in the surgeon’s hands. Although tremor-like movements are filtered out, gross unintended hand movements are replicated by the system, which could result in a surgical error. Postoperative infection is always a concern with any invasive procedure, and robotic surgery is no exception. Although the surgery site or sites are smaller, infection either at the point of intrusion or deep within the torso is still a possibility.
Troubleshooting The most common problems reported with 58
these systems are blown fuses, damaged cannulae, system “lockups,” and operational failure due to software issues. The first two can be can be resolved by in-house biomeds and nursing staff. Rebooting the system can resolve a software lockup, but this can be problematic if a computer lockup occurs repeatedly, especially during a case. Since contract maintenance is recommended, in-house biomeds will rarely if ever be called in to troubleshoot a problem.
Training and Equipment At this time, no additional training or equipment is necessary to service robotic surgery systems. Because there is only one manufacturer of this product, contract maintenance is the only sensible way to service these systems. As more manufacturers enter the field of robotic surgery, it’s possible that service options could well include something other than a full-service contract. When this occurs, a first-call maintenance contract is the method of choice provided manufacturer training is available. Unlike a typical first-call maintenance agreement, such a contract also should cover software and firmware updates. Additionally, it should contain negotiated prices for system upgrades and other options when needed. Although current system designs are proprietary to the sole manufacturer of robotic surgery systems, future systems may employ, in addition to their computer and electronics components, principles of fluidic and vacuum systems to manipulate the arms, hands, and instruments. Biomeds servicing this equipment must be familiar with these systems and generally well versed in all disciplines of biomedical equipment maintenance.
Future Development While there is only one manufacturer marketing robotic surgery systems in the United States, more are sure to follow. At this time, the field is wide open for improvements. For example, one system currently under development promises to provide both visible light and ultrasound images of the surgical site. This feature will allow the surgeon to see not only the surface, but also the internal structure of the tissue. Another area needing further development is that of
Biomedical Instrumentation & Technology January/February 2014
© Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.
Columns and Departments
tactile feedback. Current units only provide a vibrating indicator of the pressure being exerted. Future instruments may well provide real-time, pressure-proportionate tactile feedback to the surgeon. n
References • ECRI Institute. Healthcare Product Comparison for Telemanipulation Systems, Surgical. Subscription service available at at https://www. ecri.org/Products/Pages/hpcs.aspx. Accessed Sept. 1, 2013. • Evarts H. Insertable Robot Offers New Approach to Minimally Invasive Surgery. Medical Press. Available at http://medicalxpress.com/news/201205-insertable-robot-approach-minimally-invasive. html. Posted May 28, 2012. Accessed Jan. 20, 2014.
• Mayo Clinic Staff. Tests and Procedures: Minimally Invasive Surgery. Available at www. mayoclinic.org/tests-procedures/minimallyinvasive-surgery/basics/definition/PRC-20025473. Posted Jan. 10, 2010. Accessed Jan. 20, 2014. • Titan Medical Inc. Developing Next Generation Robotic Surgical Technologies. Available at www.titanmedicalinc.com/product/. Accessed Jan. 20, 2014. • USC. What is Laparoscopic Surgery? Center for Pancreatic and Biliary Diseases. University of South California, Department of Surgery. Available at www.surgery.usc.edu/divisions/ tumor/pancreasdiseases/web%20pages/ laparoscopic%20surgery/WHAT%20IS%20 LAP%20SURGERY.html. Accessed Jan. 20, 2014.
• Intuitive Surgical. Surgery Enabled by da Vinci. Available at www.davincisurgery.com/da-vincigynecology/da-vinci-surgery/. Accessed Jan. 20, 2014.
Top Selling AAMI Standards…Are You Missing Any?
1
ANSI/AAMI ST79:2010, A1, A2, A3, & A4,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated Text) Order Code: ST79 or ST79-PDF
2
ANSI/AAMI ES60601-1-1:2005, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (Includes A1) Order Code: 606011, 606011-PDF, 606011-CD, or 606011-PE
3
AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software Order Code: TIR45 or TIR45-PDF
4
ANSI/AAMI ST58:2013, Chemical sterilization and high-level disinfection in health care facilities Order Code: ST58 or ST58-PDF
5
AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices Order Code: TIR30 or TIR30-PDF
6
ANSI/AAMI EQ56:2013, Recommended practice for a medical equipment management program Order Code: EQ56 or EQ56-PDF
7
ANSI/AAMI HE75:2009, Human factors engineering—Design of medical devices Order Code: HE75 or HE75-CD
8
ANSI/AAMI/ISO 14971:2007/(R)2010, Medical devices— Application of risk management to medical devices Order Code: 14971 or 14971-PDF
9
ANSI/AAMI/ISO 15223-1:2012, Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements Order Code: 1522301 or 1522301-PDF
10
ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose Order Code: 1113702 or 1113702-PDF
SOURCE CODE: PB
Order Your Copy Today! Call 877-249-8226 or visit http://my.aami.org/store Biomedical Instrumentation & Technology January/February 2014
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