The Growing Concerns Over Robotic Surgery (Part II)

In Part I of this blog  we discussed how the use of robotic-assisted surgery systems has grown steadily in the U.S. over the past twenty years. This growth has been fueled by two major drivers. First, hospitals want to keep up with competition from other hospitals that have already acquired a system and second, to keep their own surgeons happy by providing them with the ‘latest and greatest’ technology, regardless of the cost.

As noted in Part I of this blog, a recently published JAMA article addressed some of the problems and concerns associated with robotic-assisted surgery systems. The JAMA article referenced the February 28, 2019 FDA safety communication that cautioned patients, surgeons, and health care organizations about the use of robotic-assisted surgical systems.1

Recently the not-for-profit ECRI Institute published their extensive research and documented concerns over robotic-assisted surgical systems.2  As a service to our readers, we posted the first half of ECRI’s very important and informative report in Part I of this blog. Here is Part II of ECRI’s excellent, fact-filled report:

“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.”3

Another recent study on the problems of robotic-assisted surgery that was published by The National Institutes of Health (NIH) documented the fact that:

“During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant (mean = 83.4, 95% confidence interval (CI), 74.2–92.7 per 100,000 procedures) over the years. Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. In 1,104 (10.4%) of all the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it (2.5%).”4

Given the FDA’s warning letter, the NIH study, the JAMA article on the need for additional safeguards, the tremendous cost of the systems combined with ECRI’s lengthy and well-researched concerns, it really is time to take a hard look at robotic-assisted surgery systems. The data cited is conclusive that conventional laparoscopic surgery has equal or better outcomes than robotic-assisted surgery at a dramatically lower cost. Please share these articles and the ECRI report with administration in your facility to ensure that they are aware of these vitally important issues and concerns.

 

1 “Is It Time for Safeguards in the Adoption of Robotic Surgery? JAMA. 2019;321(20):1971-1972. doi:10.1001/jama.2019.3736

2 “Reining in Unbridled Uses of Robotic-Assisted Surgery” ECRI Institute, August 12, 2019

3 Op. Cite.

4 “Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data” Homa Alemzadeh, Jaishankar Raman, Nancy Leveson, Zbigniew Kalbarczyk, and Ravishankar K. Lyer, Published online 2016 Apr 20. Doi: 10.1371/journal.pone.0151470, National Institutes of Health, PLoS One. 2016; 11(4): e0151470.