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.
Receives logs, handles and processes various body fluids, exudates or scrapings for testing and stores specimens in acceptable manner as defined in specimen storage procedure.
Verifies patient/specimen identification and informs Supervisory personnel and/or Technical personnel of any discrepancies.
Files/scans the reports and lab test requests if necessary
Recognizes and processes all "STAT" requests according to the lab procedures.
Assists with data entry and checking the insurance eligibility as required. Transports specimens to technical areas according to Laboratory policy.
Answers telephone courteously, taking messages or transferring calls, providing information, reporting and faxing to the appropriate clinical personnel
Adheres to laboratory safety standards (OSHA) and is familiar with and utilizes procedure manuals.
Maintains work area in a neat and organized manner; keeps surrounding areas clean and orderly. Appearance and dress need to be neat and acceptable; may be required to wear uniform and special insignia and/or name tag to appropriately convey Clinic identity and to maintain proper public image.
Performs all other job-related duties as assigned.
Maintains yearly competency with phlebotomy as well as related job duties.
