Presentation
Reacting to the FDA: When are users of RAS systems special… and when aren’t they?
SessionRobotics Summit - Session 2
DescriptionRobotic-assisted surgical (RAS) systems have enabled new and ever-expanding platforms through which we can perform medical care. Manufacturers of these systems often seek to create robust platforms that can be utilized by different specialties enabling safer and more effective surgical procedures. Considering the cost, training, and implementation efforts associated with RAS systems, those that can be used by multiple specialties are more likely to be successful in the marketplace. To create and validate such a platform, manufacturers must perform clinical evaluations to justify that their system can be used by various specialties to perform the necessary procedures. These systems typically also undergo very thorough human factors (HF) validation efforts to demonstrate that the users – surgeons, tableside assists, OR nurses - can interact with them safely and effectively. Our recent experience has been that the FDA views users across surgical specialties as being unique. As a result, they have begun asking for specialty-specific HF validation efforts.
Many of us know that, for HF validation testing, FDA’s Applying Human Factors and Usability Engineering to Medical Devices (February 2016) requires at least 15 participants per user group to evaluate each critical task. As written, the FDA also allows the manufacturer to define those user groups and provides guidance in doing so. Defining these user groups can become challenging when a system might have applications across multiple surgical specialties. Historically, the FDA has seemed to agree that, for example, “surgeons” were considered a single user group when testing equipment used in the OR. For the surgeon user group, it was considered that surgeons, though they might have different clinical knowledge that facilitated performing different surgical procedures, had similar skills, capabilities, and limitations when interacting with a RAS system, regardless of the clinical specialty. The FDA’s position on this though seems to have changed recently. At Emergo, we have been involved with testing several RASs over the past year, and the FDA has clearly indicated that user groups for RAS HF validation tests must be differentiated by surgical specialty. This means, if you are testing an RAS system that will be indicated for use in cholecystectomies, hysterectomies, and prostatectomies, you need 15 general surgeons, 15 Ob/Gyns, and 15 urologists. This then would also apply to the other users that commonly comprise a robotic-assisted surgical team. The execution of such evaluations can be quite time-consuming, costly, and burdensome for a manufacturer to execute.
While clinical trials should evaluate that RASs can effectively facilitate the surgeries it claims to, how does that apply to human factors engineering efforts? In recent communications, the FDA has expressed the concern that RAS system users might follow unique workflows depending on the surgery being performed, hence why they have asked manufacturers to include 15 participants from each user group from each indicated surgical specialty. Their argument seems to be that these unique workflows could lead to unique modalities of use that could then translate to previously unforeseen findings. However, from a human factors standpoint, workflows seem quite streamlined and translate to multiple procedure types across disciplines on current platforms. This raises the question, do unique procedure workflows exist such that they affect the system’s human factors, or is that only a clinical consideration?
In this presentation we will:
• Summarize the recent history of HF validation testing for RAS systems and the FDA’s recent expectations
• Delineate the differences in scope between HF validation testing and clinical evaluation
• Identify how different surgical specialties might affect such considerations as workflow, potential use errors, and hazardous situations specifically as they apply to human factors.
• Explore the FDA’s concern by presenting HF validation testing considerations for different specialties
• Explore possible rationale for why different surgical specialties should or should not warrant additional HF validation testing, including addressing the following questions:
o Do differing surgical specialties have different impacts on RAS system workflows?
o Can surgeons who will use an RAS system be considered to have equivalent training and knowledge to be considered a single user group regardless of surgical specialty?
o What aspects of the surgical procedures (and workflows) are considered “clinical” and should not be considered as part of a human factors methodology?
Many of us know that, for HF validation testing, FDA’s Applying Human Factors and Usability Engineering to Medical Devices (February 2016) requires at least 15 participants per user group to evaluate each critical task. As written, the FDA also allows the manufacturer to define those user groups and provides guidance in doing so. Defining these user groups can become challenging when a system might have applications across multiple surgical specialties. Historically, the FDA has seemed to agree that, for example, “surgeons” were considered a single user group when testing equipment used in the OR. For the surgeon user group, it was considered that surgeons, though they might have different clinical knowledge that facilitated performing different surgical procedures, had similar skills, capabilities, and limitations when interacting with a RAS system, regardless of the clinical specialty. The FDA’s position on this though seems to have changed recently. At Emergo, we have been involved with testing several RASs over the past year, and the FDA has clearly indicated that user groups for RAS HF validation tests must be differentiated by surgical specialty. This means, if you are testing an RAS system that will be indicated for use in cholecystectomies, hysterectomies, and prostatectomies, you need 15 general surgeons, 15 Ob/Gyns, and 15 urologists. This then would also apply to the other users that commonly comprise a robotic-assisted surgical team. The execution of such evaluations can be quite time-consuming, costly, and burdensome for a manufacturer to execute.
While clinical trials should evaluate that RASs can effectively facilitate the surgeries it claims to, how does that apply to human factors engineering efforts? In recent communications, the FDA has expressed the concern that RAS system users might follow unique workflows depending on the surgery being performed, hence why they have asked manufacturers to include 15 participants from each user group from each indicated surgical specialty. Their argument seems to be that these unique workflows could lead to unique modalities of use that could then translate to previously unforeseen findings. However, from a human factors standpoint, workflows seem quite streamlined and translate to multiple procedure types across disciplines on current platforms. This raises the question, do unique procedure workflows exist such that they affect the system’s human factors, or is that only a clinical consideration?
In this presentation we will:
• Summarize the recent history of HF validation testing for RAS systems and the FDA’s recent expectations
• Delineate the differences in scope between HF validation testing and clinical evaluation
• Identify how different surgical specialties might affect such considerations as workflow, potential use errors, and hazardous situations specifically as they apply to human factors.
• Explore the FDA’s concern by presenting HF validation testing considerations for different specialties
• Explore possible rationale for why different surgical specialties should or should not warrant additional HF validation testing, including addressing the following questions:
o Do differing surgical specialties have different impacts on RAS system workflows?
o Can surgeons who will use an RAS system be considered to have equivalent training and knowledge to be considered a single user group regardless of surgical specialty?
o What aspects of the surgical procedures (and workflows) are considered “clinical” and should not be considered as part of a human factors methodology?
Authors
Event Type
TimeSunday, March 2210:00am - 10:30am EDT
LocationMurray Hill