The Growing Concerns Over Robotic Surgery (Part I)

The use of robotic-assisted surgery systems has been growing steadily in the U.S. over the past two decades. In an effort to keep up with competition from other hospitals and to keep their own surgeons happy, many hospitals have made the huge investment in robotic-assisted surgical systems. All too frequently, hospitals have made this large purchasing decision without fully understanding all of the risks, costs and potentially negative patient outcomes associated with these systems.

A recently published JAMA article addressed some of the problems and concerns associated with robotic-assisted surgery systems. The 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 for the management of breast cancer and other cancers. The FDA’s safety communication cited concerns that evidence to support the use of robotic-assisted surgery for the management of these cancers was limited and may even be associated with shorter long-term survival compared with other surgical approaches.1

Recently the not-for-profit ECRI Institute shared their concerns over robotic-assisted surgical systems as well. If you’re not familiar with the ECRI Institute, you should know that “Since its founding in 1968, the mission of the ECRI Institute has been to protect patients from unsafe and ineffective medical technologies and practices. More than 5,000 healthcare institutions and systems worldwide—including four out of every five U.S. hospitals—rely on the ECRI Institute to guide their operational and strategic decisions. ECRI’s conflict-of-interest rules are the strictest in the healthcare industry.2

If your facility already has, or is thinking about acquiring a robotic-assisted surgical system, you need to read and study ECRI’s comments and observations on these systems. Here is Part I of ECRI’s very important report:

“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.

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.”3

(We will share Part II of ECRI’s excellent report in next week’s blog.)

Given the recent JAMA article on the need for additional safeguards, the FDA’s warning letter, the tremendous cost of the systems and ECRI’s lengthy and well-researched concerns, it really is time to take a second look at robotic-assisted surgery systems. The data cited is conclusive that conventional laparoscopic surgery has equal or better outcomes than robotic-assisted surgery and at a dramatically lower cost.

 

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 ECRI website https://www.ecri.org/about/

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