Despite concerns around both cost and safety, robotic surgical systems are becoming increasingly popular in hospitals nationwide. Here’s what HTM professionals need to know
As the chief of urology at the VA Greater Los Angeles Healthcare System (VAGLAHS), Carol Bennett, MD, never passes up an opportunity to improve patient care. So in 2013, when VAGLAHS took delivery on its first robotic surgical system—a da Vinci unit from Intuitive Surgical—Bennett was among the first at the facility to receive formal training on its use. As part of that preparation, she took a course in California offered by Intuitive, but she also spent time under the watchful eye of another surgeon who already had extensive experience with the system. “That doctor came in and taught us and proctored us here for probably the first 20 or so procedures,” she recalls. “It is ‘intuitive,’ but it does take practice.”
According to Bennett, who now directs the facility’s robotics committee and shares the machine with many other physicians, the da Vinci has helped her and her colleagues become better surgeons. “In some cases,” thanks to magnification, “it allows you to see areas that you couldn’t see easily before.” And because you sit, she says, “you can work ergonomically—it obviates the fatigue that you would feel bending and standing and twisting your arm to get the right angle” during a normal procedure.
Still, Bennett says, sometimes issues do come up, “so you always have to be prepared.” One potential complication is uncontrolled bleeding, which would typically require hands-on attention. But there can also be problems with the robot itself, in which case “you have to know how to troubleshoot the machine.” Depending on the situation—and whether it occurs before, during, or after a procedure—that troubleshooting might involve online consultation with a representative from Intuitive, or it might entail calling in Biomed.
“We have an excellent biomedical attaché to the operating room,” Bennett explains. “And one of our guys in particular”—biomedical engineering support specialist Nat Klungmontri—“is very responsive to a page or phone call and will come in right away if anything isn’t working properly.” Intuitive, Bennett notes, provides “excellent support, and they should considering how expensive their systems are.” But that support becomes far more valuable when you have someone on staff who can help as well.
The Robotics Debate
Chances are you’re familiar with the debate around surgical robotics—how despite tightening budgets, and perhaps to boost their marketing, an increasing number of hospitals are purchasing robotic systems that can cost $1.5 million or more apiece. That the robots are used for a range of procedures, including ovarian, gallbladder, and colorectal surgery, yet a 2014 study by researchers at Columbia University Medical Center found that for some conditions robotic surgery may result in more complications and more expense. And that for those on the HTM front, providing anything beyond basic in-house support for the systems can be exceedingly difficult, since the robot-maker’s service contracts often limit biomeds to rudimentary repair work. Even so, sales are on the rise after a rocky 2014: Intuitive reported 110 da Vinci systems shipped in the first quarter of 2016, compared to 99 during the same period in 2015. The company declined to be interviewed for this article.
The safety issues associated with surgical robotics are of particular concern for Scott Lucas, PhD, PE, associate director of ECRI Institute’s Accident and Forensic Investigation program. “A lot of the reported problems involve instrument failure,” he says, “but problems also occur during the set-up phase, prior to rolling the patient into the operating room.” For example, a fiber optic cable might be left unconnected, which in turn might lead to delays that impact patient care. Such downtime might affect little more than throughput, but “if there is a delay while the patient is under anesthesia, that could be a different story,” he says.
The biggest risks around robotic procedures are “essentially the same you see with any kind of surgery,” Lucas notes. They include infections, bleeding, and the dangers of anesthesia. What sets robotic surgery apart, he says, are the “additional risks that are unique to these machines.” Among them are human factors issues associated with bringing a highly technical device into what is already a complex operating room environment. There is also the potential for software and electromechanical failures, which could lead to delays in surgery—or, less often, unanticipated instrument motion causing unintended lacerations. And issues can occur around what Lucas describes as “extreme patient positioning” for extended periods of time, such as a steep headfirst angle. “The patient has to be positioned in such a way that they can be accessed” by the surgeons controlling the robot, he explains. “When a surgeon is still early on the learning curve, they may need more time to complete the surgery, [and] that can lead to things like nerve palsies,” where the nerve ceases to function.
A Training Shortfall
Many facilities are addressing these issues through in-house training programs, says Christopher Schabowsky, PhD, program manager of ECRI’s Applied Solutions Group. But often these programs are less than adequate considering the complexity of the technology involved. (Sunnyvale, Calif-based Intuitive, which Schabowsky says “has a lock on this industry” as the only player approved by the FDA, provides initial training in the operation of its system, but the company does not offer procedure-specific training or credentialing.) “It’s particularly challenging because there are no national standards for surgical robotics training. There are only recommendations from certain professional societies, but nothing is mandated.”
While all of that may change in the future as other companies start to compete with Intuitive (and in theory, at least, offer procedure-specific training as a way to make them more attractive to buyers), Schabowsky doubts that will happen any time soon. “There are other companies out there that are getting some buzz,” including TransEnterix and Titan Medical, but it’s “unlikely they’ll roll out anything for another 2 or 3 years.”
Schabowsky, ECRI’s lead consultant for hospitals that want to establish surgical robotics programs, notes healthcare organizations are “chomping at the bit” for a company like TransEnterix to enter the market, and not just because it could lead to improvements in patient safety. “There’s not a lot of room for negotiations when you just have one vendor, and that’s been a pain point for a lot of facilities.” His recommendation to biomeds when that day arrives? “Make sure you have a seat on the committee” at your facility responsible for robotics purchasing and planning. “Big decisions will have to be made, so it’s important that technicians and engineers be involved.”
At VAGLAHS, Bennett and her team use their da Vinci primarily to do prostatectomies and partial nephrectomies. In addition, CT surgery, General Surgery, and ENT all use the system. Her take on the robot: “It isn’t flawless, but we’ve always been able to resolve the issues we’ve had, and it’s never malfunctioned in a dangerous manner” during a case. Sometimes, she says, “you might notice that an arm isn’t moving completely, and that it needs to be readjusted or maybe replaced. Or maybe certain instruments don’t open and close cleanly when you deploy them. But those are the only problems that we’ve seen here.”
Of course, one of the reasons the facility has had relatively few issues is the fact that Klungmontri is there to help as needed. His robotics responsibilities, Klungmontri says, range from teaching clinicians “first-line troubleshooting” to knowing when it’s time to call an Intuitive engineer. “The company didn’t provide any training for me, so I basically read the manual and learned it on my own,” he says. In the early days, every time Intuitive sent a field engineer to do preventive maintenance, Klungmontri would “sit by their side and watch what they did.” Now he knows the system well enough to solve basic problems by himself, but “as a biomed you’re kind of limited if anything really breaks down.”
Fortunately, Klungmontri says, when problems do occur, they’re often a result of user error and so can generally be resolved quickly and easily. “For example, if the image is blurry, the first thing you need to do is check the scope and see if it’s dirty. And if it’s not, then you need to check the camera head that connects to the scope.” Or, he says, if the surgeon doesn’t see the image in 3D, “you need to figure out which part of the system is faulty—whether it’s the console where the surgeon’s sitting or it’s the tower that houses the computer.” (Hint: If there are two surgeon consoles and the image is fine in one, it’s a console issue.)
He knows biomeds at other facilities that will “call Intuitive right away if they get any kind of error or problem” with their machine. “So their surgeons end up having to cancel their cases if they haven’t started, or if they have, to open up their patients and do things manually instead.” His approach, he says, is decidedly different: Before he gets on the phone with the robot’s maker, “I’ll give things a look and do what I can.”
It’s a similar story at Thomas Jefferson University Hospital in Philadelphia, where Ed Snyder, CBET, is a clinical engineer and manager in the Department of Biomedical Instrumentation. When it comes to their four da Vinci robots, he says, he and his team tackle “typical stuff” like problems with video cables and other attachments that can become disconnected or broken during normal use. They also devote much of their time to what Snyder describes as the “specific handling and cleaning requirements” of those attachments. “When you’re dealing with endoscopes, for example, after they’re cleaned with fluid they have to be either sprayed out or hung to dry. If you don’t do that, you don’t have a clean scope”—and that, he notes, is a major patient safety issue. “In my opinion, the big headache with the robots is not necessarily the consoles themselves, because we have a service contract with Intuitive that covers them, but the cleaning of the tools and instruments used with it.”
The other major issue, as Snyder sees it, involves the record keeping associated with their Intuitive robots. “In our situation, keeping records on service and preventive maintenance is Biomed’s responsibility.” The problem is that Intuitive handles the servicing and maintenance (not to mention other things like product upgrades and recalls), “and it’s very difficult to get documentation from them.” In the last 5 years, Snyder says, Intuitive has “done a much better job of service and support than they did over the previous 5 years, and that’s been great to see.” But in terms of providing his department with the paperwork they need to meet the requirements of agencies like The Joint Commission, “that has been an ongoing challenge.”
The Future of Robotic Surgical Systems
Lucas agrees that Intuitive needs to improve the structure of its service contracts to stop excluding biomeds. He envisions a future where biomeds will have a bigger role. “There’s going to come a time when there will be more options out there, so the more you’re involved now, the better you’ll do then.” Toward that end, Lucas says, it’s important to be vigilant when it comes to hazard management, and to stay abreast of the latest recalls that might affect robotic systems. And when problems do occur, “get in there and observe, if that’s all you can do, so you can better understand how these systems work.”
Bennett, for her part, says she took a similar hands-on approach as she learned how to use her facility’s new robot. “You have to understand how it works, and what it can do, and what its relative strengths and weaknesses are.” Overall, she adds, the advantages that come with having a robotic system in their case have “outweighed the disadvantages.” Their surgical patients are experiencing less blood loss intraoperatively, they seem to be feeling better faster post-operatively, and they’re leaving the hospital sooner than they would have otherwise if they had undergone traditional procedures. “And then for those patients who are concerned about their appearance, the incisions are magnitudes smaller than an open surgical incision would be,” Bennett says. “I’m not trying to plug Intuitive necessarily, but robotic surgery’s day is here.”
Chris Hayhurst is a contributing writer for 24×7.
Photo credit: The da Vinci Xi with splayed arms. ©2016 Intuitive Surgical Inc
One issue with taking care of these surgical micro manipulators or “waldoes” as Heinlein called them, is service manuals. Does the NFPA-99 chapter on manufacturers requirements exempt robot makers from the requirement for Service manuals with “comprehensive repair and maintenance procedures” or “schematics and wiring diagrams” ??? if not, Every Biomed shop that has such a “robot” should have on file, the technical service manuals for their devices. If you don’t have these manuals in your shop why? Did a CE or Biomed allow the device in for a DEMO without making the OEM cough up the manuals? So next time a salesman stands in front of you and says: “I need a sticker for this so I can DEMO it” you say, “I have to have a copy of the factory service manual, before I can start the inspection” Biomeds and CEs failing to get service manuals created this problem, and only Biomeds and CEs standing firm on requiring them, can solve it.
We recently recieved a Davinci and I was the CE who handled the install. The idea that you “Wont check in a device without a service manual” is absord. Some companies do not provide them and as long as they provide the service to support them that is acceptable. Refusing to check in equipment would cause a delay in care, and result in your department becoming a henderance and not a help. Patient safety and satisfaction is number one.
Quick poll for those that read this article: Does your hospital classify the surgical robots as critical or non-critical equipment?