In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Gone are the days of tool type indications for this type of device. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.
This view was highlighted, recently, in a safety warning issued by FDA regarding surgical robots for treatment of cancer (here). In this safety communication, FDA states:
The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. ***
RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. These clearances are based on short-term (30 day) patient follow up. The FDA has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
This view of FDA’s role in regulating RAS devices is strange. The essence of RAS devices is to aid surgeons in conducting surgery. Therefore, it makes sense that FDA would review data on intra‑operative performance and perhaps acute outcomes. But these devices are not independent cancer therapeutics. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes.
As a scientific/medical matter, there are many variables beside the RAS device that are responsible for clinical outcomes. Will FDA now begin reviewing various types of manual surgical tools based on their long term clinical outcomes? The question answers itself. Although RAS devices do introduce some novelty in how the surgery is performed, they should not be treated as if they were intended to confer a specific therapeutic benefit any more than manual surgical tools would be.
FDA issued the same type of warning regarding RAS devices and mastectomy back in February 2019 suggesting that FDA believes the problem has persisted. Notably, the 2021 safety warning makes no mention of FDA actually be aware of patients having been injured or adverse health outcomes related to RAS devices being used for mastectomy or other cancer-related procedures, and the 2019 safety warning mentions only “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”
The recent safety warning also highlights that FDA expects an investigational device exemption (IDE) for studies of RAS devices for new indications for use. FDA states that such studies should include long-term patient follow-up regarding the prevent and treatment of cancer, and safeguards such as study stopping rules and periodic reporting to FDA. Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer.
For many years, Intuitive surgical had the sole FDA clearances for surgical robotic systems. The original clearances were largely for a tool-type indication, even if examples of specific procedures were provided. Subsequently, more companies have entered this space with full or partially roboticized devices. Examples include the Medrobotics Flex System and the Hominis Surgical System.
FDA has taken a hard line that each new surgical robot, as compared to Intuitive’s original robot, are not tools and each one presents new issues of safety and effectiveness due to their complex design and construction and specific indications. This approach has the perverse effect of slowing innovation in RAS devices, helping to further entrench Intuitive’s 20 year old technology.
Again, this situation raises the question of where FDA’s role ends and the surgeons’ role begins with regard to use of RAS devices in the field of medicine. The Federal Food, Drug, and Cosmetic Act states that nothing in the Act shall “limit or interfere with” the authority of a clinician to utilize any legally marketed device on a patient “for any condition or disease within a legitimate health care practitioner patient relationship.” 21 U.S.C. § 395.
With FDA’s push for more specific indications for use for RAS devices, healthcare providers cannot be limited only to those indications for use, especially if a device could be useful for an unapproved procedure/patient. Thus, this part of the Act becomes that much more important to healthcare providers innovating in the field of medicine. Healthcare providers must assess and make use of legally marketed devices in whatever way they see fit to treat their patients appropriately.
Equally, how can FDA issue a specific warning, like its recent cancer warning, regarding use of a legally marketed device if a surgeon believes it is appropriate for his/her patient, especially when, at best, FDA has cited “limited, preliminary evidence” of adverse outcomes? If limited evidence is the bar for putting patients and healthcare providers on notice that an alleged off-label use of a medical device is dangerous, it seems that FDA should be warning about all sorts of issues.
We support FDA’s general efforts to inform healthcare providers and protect patient safety. In the case of RAS devices, however, it seems to have may be going too far with policing practice of medicine and surgeons’ ability to choose which tool is right for a patient’s procedure. To further innovation, FDA should limit itself to a review of whether a novel surgical platform is safe and effective for use in performing surgery and perhaps out to 30 days’ follow up. Anything more is unwarranted mission creep. FDA’s focus on long term clinical outcomes in surgical procedures performed with RAS devices invades a space that should be left to the practice of medicine.