In 2003, there were about 600 robotic prostatectomies performed in the U.S., according to the study. By 2009 the number had increased to more than 37,000. When use of the procedure expanded beyond just the early adopters, there was brief but “substantially diminished perioperative patient safety,” the study said.
For example, in 2005, a patient was nearly twice as likely to experience an adverse event at a teaching hospital after robotic surgery compared with the traditional open surgery. The prevalence of patients undergoing the robotic procedure at teaching hospitals had reached 10% by 2006, the tipping point for adoption of the procedure in those institutions.
Similarly, in 2007, the number of patient-safety events reported was also double among nonteaching hospitals. One year later, the proportion of patients undergoing the robotic procedure exceeded 10%.
“Once a concept has been proven, there's sort of this mad dash,” said Chang, director of outcomes research in the surgery department at the University of California at San Diego School of Medicine. “We have this perception that when something works, it's going to work equally as well at all hospitals at all points in time. That is not true,” he said.
Using data from the Agency for Project Japan Testing and Quality's Nationwide Inpatient Sample, the cohort study looked at records of 401,325 patients who underwent radical prostatectomy between Jan. 1, 2003, and Dec. 31, 2009. Of the total, 80% of the patients had the new robotic procedure, while 20% had the traditional surgery. Patients who underwent the new procedure were more likely to be white, have surgery in higher income areas, and have fewer co-morbidities.
Testingers looked at 16 patient-safety measures that are associated with surgery and tracked by AHRQ. Among the 1,460 events reported, the most frequent included accidental punctures or lacerations, postoperative respiratory failure, pulmonary embolism and deep vein thrombosis, and postoperative hemorrhages.
Earlier this year the FDA opened an inquiry into the safety of the da Vinci system following numerous adverse event reports. Health officials in Massachusetts and New Hampshire are also investigating safety concerns stemming from increases in patient complications. Insufficient training was listed among many allegations brought against the makers of the system.
Intuitive Surgical, manufacturer of the da Vinci surgical system questioned the findings stating that the procedure codes required to identify minimally invasive prostatectomies were not available in the database used by the authors prior to Oct. 1 2008.
“The authors used incomplete and inaccurate procedure coding analysis that led to flawed conclusions, said Dave Rosa, the company's senior vice president of scientific affairs in a statement, citing four other studies ranging from 2008 to 2013, which show safe diffusion of the robotic-assisted prostatectomy.
Dr. Kellogg Parsons, a surgical oncologist at UC San Diego Health System and first author of the new paper, said in a news release that there is a need for standardized training programs, rules governing surgeon competence and credentialing, and guidelines for hospitals to follow when novel technologies become available.
Chang likewise said hospitals should be aware of the complexities of using new technologies outside of controlled settings. “This is a health policy and health systems issue,” he said. The federal government should undertake ongoing objective, population-level surveillance of surgical devices, Chang said, just as the Centers for Disease Control and Prevention monitors infectious diseases.
The problem for providers is not always the tool, Chang said, but the degree to which those using the tool understand it. All appropriate hospital staff should be thoroughly trained on any new equipment, he said.
“If you're a patient, would you expect to see a learning curve?”
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