Rachel Klein, Consultant
April 19, 2013
Robotic surgery has seen its fair share of controversy in the past few months—several high-profile papers have dismissed its clinical benefit, a lawsuit points to the robot as the cause of a patient's death, and a series of emails has exposed the pressure Intuitive places on surgeons to increase use.
And that's not all—the FDA has widely publicized its current investigation into the safety of the robot. After seeing an increase in the number of complaints about the robot—more than 500 since January—the FDA is doing its due diligence to determine the root cause of these problems.
Intuitive asserts that the increase in the number of complaints is due to a change in their reporting methodology, and not an actual increase in the number of problems caused by the robot. However, Intuitive has seen a steady increase in the number of procedures performed with the robot, so it's not uncommon to expect a higher number of reported incidents.
Use of the robot must be justified
While this may likely blow over in the next few months, it does call into question the extremely high number of procedures performed using the robot in ORs today.
Hospitals often use the robot as a defensive strategy to guard against competition rather than as a clinical tool. Intuitive will need to justify the role of the robot in the OR as complications arise and the blame is placed on the technology, in addition to the surgeon.
It is not yet clear how the FDA will determine whether complications are due to the robot or to the surgeon—or if it's even possible to separate the two. It is ultimately up to robotics committees to determine which surgeons should use the robot when operating and which patients will benefit.
Having clear guidelines for making these determinations may help prevent complications in robot-assisted surgery.
- Need help establishing clear guidelines for making decisions about robotic surgery at your organization? Contact us for a unique assessment of your surgical program.
More on Robotic Surgery
A recent article questions the credentialing processes advocated by Intuitive Surgical for its da Vinci surgical platforms, calling on hospitals to ensure adequate training for and appropriate use of the robotic systems.
FDA is investigating a spike in reported problems involving da Vinci surgical robots, which were used in nearly 400,000 surgeries across the country last year.
We discuss a new technology used to perform robotic-assisted percutaneous coronary interventions that was approved by the FDA in July 2012—and some considerations for those looking to invest.
We outline the clinical and financial differences between two popular minimally-invasive techniques—laparoscopy and robotic surgery—and why surgical investment priorities may soon be changing.
In a recent custom research project focusing on robotics technology, we helped one medium-sized hospital determine whether they should invest in a second surgical robot. Read our case study to learn more.