Medical Robotics Magazine

The first and only commercial feature medical robotics news magazine, founded February 2007 by John J. Otrompke, JD, consultant and publisher


Medical Robotics Magazine is the world's first and only commercial feature news magazine devoted to all aspect of the medical robotics industry- including robotic surgery, physical therapy robots, hospital orderlies, and other topics related to robotic medicine. As a feature magazine, Medical Robotics features interviews, business news, conference coverage and editorials, as well as a generous portion of articles written by noteworthy robotics surgeons as well as clinical trials reports. MR has been on-line since 2007, and first appeared in print in January of 2008 at the annual meeting of MIRA (the Minimally Invasive Robotics Association) in Rome, Italy. Medical Robotics Magazine is copyrighted, features a nascent Board of Editorial Advisors, and is indexed by the U.S. Library of Congress. All contents (c) 2011 John J. Otrompke, JD Contact: John J. Otrompke, JD 646-730-0179

Friday, March 12, 2010

New Code of Ethics Adopted

The Medical Robotics Code of Ethics

Medical Robotics magazine and web-site hereby promises, voluntarily, that it will continue to offer high-grade journalism of this emerging industry. Medical Robotics may sometimes consider accepting paid advertising, or paid supplements. However, Medical Robotics will never allow its editorial policy or the quality of its journalism to be affected by commercial concerns. If questions of impartiality are ever caused in this regard, the matter may be submitted for comment to the Board of Editorial Advisors, which may be expanded.

March 12, 2010

New Standards to Define Quality and Safety in Medical Robots

Meanwhile, the Quest for a Definition Goes on

By John Otrompke

A workshop convened by the FDA in Maryland last month may have heralded the creation of quality and safety standards unique to the robotics industry. The meeting, which was only a first step in what might be an on-going process, was intended to coordinate efforts already going on in standards-setting organizations, which would supplement pre-existing generally-applicable standards at the FDA.

“There are existing standards that may not say ‘robotics’ on them but a robotics manufacturer would be able to use them in the design and development of robotics,” said Carol Herman, director of the standards management staff at the Center for Devices and Radiological Health of the FDA. “Our role is to help identify where standards could help us get products to market,” she added.

Standards are voluntary, but may make the FDA certification process more efficient, Herman said. “When there are standards in place with which the FDA is comfortable because we helped develop them, it allows the reviewer to spend time on other matters,” she explained.

The meeting, which was convened by the FDA with support from Medtronic and the Association for the Advancement of Medical Instrumentation (AAMI), was called to coordinate efforts going on in multiple voluntary standards-setting organizations.

“We started this process rolling because the subcommittee of the International Standards Organization, ISO TC 184, which deals with robots and robotic devices, now has a work program to develop standards for medical robotic and personal care robots,” said Chuck Sidebottom, PE, secretary of subcommittee 62A of the International ElectroTechnical Commission.

The sort of standards under discussion are for the devices themselves, not for the manufacturing process, clarified Sidebottom, who spoke in his role with the IEC, although he is also the director of corporate standards at Medtronic. “What are the gaps a medical robot might bring which are not already covered by existing standards?” he asked.

Where do Gaps Exist?

Part of the group’s work will consist of identifying gaps in existing standards posed by the emergence of medical robotics technology. One example might be where the computer of a surgical robotics system freezes up in the midst of a surgery.

“My impression is that there are some areas of medical robotics which are ready for standards, though some areas are not developed enough. Surgical robots would probably be the most advanced, since there is already a product on the market. An example of the yet-to-be-developed would be more autonomous robots. Standards would normally not be developed at that point because innovation is still happening,” said Mary Logan, JD, CAE, president of AAMI, who attended the meeting.

Standards created for medical robotics may help solve problems in other areas of health care technology. “These would be useful not only for robotics, but for systems at a higher level of complexity which put together multiple components tied together with communications networks,” said Joel Myklebust, PhD, deputy director in the office of science and engineering laboratories at the FDA.

“Take an operating room or an emergency room, for example, and think of all the multiple devices in that room. Wouldn’t it be great if somehow all the devices were appropriately networked, if they didn’t have cables running all over the floors, and you could actually rely on the devices to all work very well together,” Herman explained.

Just as hospital room devices should be interoperable, perhaps there should be a high degree of coordination among standards-setting organizations as well. “AAMI’s standards philosophy is one standard world wide. We try not to have duplicate standards, so we participate very actively with the ISO and the IEC,” said Logan.

The Search for a Definition

Part of the group’s first meeting was spent trying to define the area to be standardized. “What are characteristics of a thing which makes it a robot?” Sidebottom asked. “We came up with motion, multiple degrees of freedom, a degree of autonomy from human control. Then you have the question, ‘What is a medical robot, as opposed to a personal care robot, for example?’” he mused.

Some attendees were bemused by the inquiry into definitions. “I’m not entirely sure what the point of the meeting was,” said Howie Choset, PhD, associate professor of robotics at Carnegie Mellon University in Pittsburgh. “We spent a lot of time on definition of what a robot is, but we never got anywhere specific. We should not come up with a classification of medical robots, but should look at the question on a task-by-task basis,” he added.

Other organizations like AdvaMed and Intuitive Surgical also participated in the meeting. Another meeting could take place this year, but probably not before the fall, according to the FDA’s Carol Herman.

Monday, March 8, 2010

Are Robotics a Good Idea for Cardiac Surgeons?

By: Chad Sumulong
(senior at Maryknoll High School in Honolulu, Hawaii)

According to the American Heart Association, Heart Disease is the leading cause of death in the United States. This issue could be caused by the growth of the fast food business, or the lack of health awareness around the country. Whatever the cause may be, something needs to be done about this problem. Through surgical technology and the development in cardiology (study of the heart) many advancements have been made that could help combat the problem of heart disease. But is too much money and thought being put into futile machines that show no or little net gain in the case of surgery?
Over the years, new technology has been created that has impacted cardiac surgery in a positive way. Equipment such as the heart-lunch machine, and the artificial heart have been essential to the success of heart surgery and the survival of many who have encountered heart problems. According to Henry Louie MD, these pieces of technology have allowed cardiac surgeons to stick to the same routine throughout the years, “Ironically, heart surgery has not really changed in approach since its inception from the late ‘70s. We still use needle and thread to construct bypass grafts, sew in or fix defective valves or close holes within the heart. Materials and imaging techniques to fix or see into the heart have dramatically improved however” (Louie MD). But there are new machines that many say will change the face of the cardiac practice.
In 2000, the FDA approved a revolutionary machine called the DaVinci Robot. This machine specializes in surgical processes, and uses its tiny mechanical arms to create a more accurate but less painful procedure. It also decreases the patient’s stay in the hospital by a couple of days. One would think that the DaVinci Robot is a very prestigious tool that would serve well in the field of cardiovascular surgery. Many people want to see the rise of robotic technology in their every day life because technology has made life easier for many others. Robotic technology can help create confidence in many of those undergoing the procedure. But what is the difference between a necessity and an option?
According to the educators and doctors at Brown University, there is none to little difference when comparing heart surgery with the conventional method and the robotic method. Robotic surgery, however, is slightly on the expensive side. Each machine needs an investment of about $1 million. “Cardiac surgery for the patient is about the same with or without robot assistance… However, overall the cost is slightly greater for robotic assisted surgery than for conventional surgery” (Brown University). Also, the size of these machines does not fit the right criteria needed for cardiology. When dealing with the heart, the surgeon needs space to properly conduct the operation. The fact that these machines could take up half a room denies the surgeon the legroom and breathing space that would be comfortable. “The sheer size of robots in this technology presents a problem for cardiac surgery, especially in the area of pediatrics. Surgeons look toward smaller instruments with tactile feedback as well as a reduced cost of equipment” (Brown University). Brown University also interviewed Dr. del Nido, who does cardiac surgery in children. When asked about the major drawbacks of robotic surgery, his response was that, “The biggest drawback is that you don’t have any sense of feel. You have no sensation. The robots have no sensors on it. So if you’re putting your hands into a box, and you know that there are things inside, you can feel around with your hands and get a pretty good sense of what’s going on and what’s in there. The robot gives you no tactile feedback. You’re basically going by visual to what you’re doing to the tissue and that’s the biggest drawback.”
Robotics and technology are becoming growing resources in America, and the thought of robotics in surgery appeals to every American. Robotics in surgery would fulfill many dreams of having a technology ruled society; however, there are things that robotics cannot rule over (just yet), and that is cardiac surgery.
When speaking with Dr. Mark Grattan, a thoracic surgeon at Straub Medical Center, his views of robotic surgery are clear. In a recent Q&A session, Dr. Mark Grattan shares his opinion:

Q: So how do you feel about the use of robotic surgery? Would you rather use that in the future?
A: Not now, I don’t think robotics has gotten to a point yet where it’s safe to use on a lot of patients. To do robotics means that you have to do certain other things in order to protect the heart because you have to stop the heart. (Mark Grattan M.D)

Q: So when medical magazines say robotics can make surgery safer, technically it’s not true?
A: No, it’s not true, that is not true. They can make nice small incisions, and when you talk about robotics what you’re talking about is you want to make a smaller incision. So we make a smaller incision, but we don’t use the robot, there’s a minimally invasive surgery that does not necessarily need the robot. (Mark Grattan M.D)
Also, by speaking to Henry Louie, another thoracic surgeon in Hawaii, the views of robotic surgery become much clearer.
Q: How do you feel about the use of robots in heart surgery?
A: Robotic innovations have revolutionized many surgical procedures, but for heart surgery it has not really made an impact. For some technical reasons, robotics may not be suited for cardiac surgery because of the need for the heart lung machine use during the procedure. The heart lung machine is used to maintain blood flow to the patient while the heart contractions are arrested so the surgeon is able to work on a still heart without blood flow. (Henry Louie M.D)
The use of robots is definitely an intriguing and interesting idea for surgery. Robotics may be used in many different aspects of the medical community, but in the views of different scientists and surgeons, robotics does not currently fit the criteria of cardiac surgery. So in conclusion, is robotics a good idea for cardiac surgery? In the future there may be some exceptions to include robotic arms in the operating room, but currently, the size, cost, and complexity of robotics is too overwhelming for those in the operating room.

Works Cited
Grattan, M.D, Mark. "Interview with Dr. Mark Grattan." Personal interview. 9 Nov. 2009.

Louie, M.D, Henry. “Interview with Henry Louie MD.” Personal interview. 18 January. 2010.

"Robot-Assisted Surgery: Da Vinci." Division of Biology and Medicine. Web. 05 Mar. 2010. .
"Robot-Assisted Surgery: Glossary." Division of Biology and Medicine. Web. 05 Mar. 2010. .
"Robot-Assisted Surgery: Interview." Division of Biology and Medicine. Web. 05 Mar. 2010. .

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