A 2019 JAMA viewpoint article, Is It Time for Safeguards in the Adoption of Robotic Surgery?, explores the risks associated with the increasing, uncontrolled, and indiscriminate use of robotic-assisted surgery. We could not agree more.
For more than two decades, ECRI Institute has been emphasizing these risks based on our evidence assessments and patient safety work. We do not dispute the many potential benefits of minimally invasive robotic surgery procedures. However, we are solidly grounded in the “show me the evidence” camp. Our concerns fall squarely in three areas: patient safety and surgeon experience, evidence, and cost.
Patient safety and surgeon experience
Our work as the largest Patient Safety Organization nationwide, and our forensic work investigating robotic-surgery-related accidents, alerted us to the potential harms of robotic-assisted surgery with both experienced and less experienced surgeons. For robotic-assisted surgery, the learning curve is long. The number of procedures needed to attain and maintain skill and proficiency are not well established. The clinical literature shows significant variation in practice and recommendations for training and credentialing. Even surgeons who are well experienced in robotic surgery can have serious patient-safety events. Two recent analyses of adverse event data (10 years of FDA MAUDE data) found that surgeons need more coaching, and the complex mechanical aspects of operating the robot result in a “non-negligible number of technical difficulties and complications [that] are still being experienced during procedures” (14 years of FDA MAUDE data).
Through our work with the Pennsylvania Patient Safety Authority, a mandatory adverse event reporting program, we carried out primary research and analysis of robotic surgery adverse events reported by Pennsylvania hospitals over a 10-year period. Of 545 reported robotic surgery incidents, 177 (24.5%) were classified as “Serious Events” resulting in patient injury; 10 were patient deaths. The majority of Serious Events (75.1%) involved unintended lacerations/punctures, bleeding/hemorrhage, complications from patient positioning, retained foreign bodies, and infections.
Since 1996, we have published dozens of evidence reports assessing various robotic-assisted surgical procedures. Repeatedly, these reports concluded that the quality of most published robotic surgery studies is low to very low. The evidence is inconclusive about effectiveness compared to open and laparoscopic approaches for most procedures. The fact that more than 15,000 peer-reviewed publications have been published on robotic-assisted surgeries, increasing at a rate of about 150/month, has not bolstered the strength or quality of evidence.
Our concerns about the problems with the published clinical literature were heightened by a 2018 systematic review about conflict of interest disclosures in published robotic surgery studies and review of the Open Payments database. The researchers noted a link between payments received by authors associated with the manufacturer, Intuitive Surgical, Inc., and positive conclusion statements, particularly when payments exceeded $10,000. The study found “a potential bias…[that] demonstrates low quality and highly positive conclusions towards approval of the robot. This substantiates the need for a large, systematic review of the potential influence of sponsoring surgeons on medical literature.”
Unbridled expansion and escalating costs
Despite the state of the evidence, the number of robotic surgery procedures increased by 18% from 2017 to 2018, numbering 753,000 in the U.S. last year, according to the most recent Form 10-K submitted by Intuitive Surgical Inc. to the Securities and Exchange Commission. The manufacturer states that general surgical procedures (particularly hernia repair, colorectal, cholecystectomy, and bariatric procedures) now account for the largest and fastest growth in volume, and that “[w]e believe hernia repair procedures represent a significant opportunity with the potential to drive growth in future periods.” Prostatectomy and hysterectomy had been the mainstay procedures until now.
ECRI Institute is concerned about healthcare costs in a system already at the brink of financial collapse. Two years ago, we estimated the total cost of ownership for a general-purpose surgical robot at approximately $4,060,000. This estimate is based on the da Vinci four-arm robot and includes capital costs, accessories and consumables, and required service contract costs for a 7-year product life. Many health systems have several robots. U.S. health systems currently spend more than $3 billion annually on the intensive resources needed for robotic surgery. Could some of these resources be better allocated to other important unmet healthcare needs? We think so.
We urge health system leaders to pursue evidence-based standards for performing these surgeries, and to monitor when these surgeries should be performed, on whom, and by whom. We urge surgical societies to promote the conduct of higher quality studies, and establish evidence-based standards for credentialing. We call upon payers and hospital administrators to scrutinize every robotic-assisted surgery to protect patients from unnecessary harm.
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