By Andrew M. Seaman
NEW YORK (Reuters Health) - Patients may be more likely to have complications when a new surgical device is first being adopted, suggests a new study looking at prostate removal.
Based on the results, the process of how new surgical technologies are introduced to the healthcare system should be improved, researchers suggest.
“We think the current system in the U.S. by which surgical innovations are spread through the community practice is flawed,” said Dr. Kellogg Parsons, the study’s lead author.
There is currently no formal process for introducing new surgical technologies into hospitals after they are approved by the U.S. Food and Drug Administration (FDA), said Parsons, from the Moores Cancer Center at University of California, San Diego.
He and his colleagues write in JAMA Surgery, “it is possible that the informal systems by which surgical innovations diffuse into practice may expose patients to increased risk for medical error.”
For the new study, they analyzed data on complications around the time when U.S. hospitals began using a robotic device to remove the prostates of men with prostate cancer. The device, known as the da Vinci Surgical System, is manufactured by Intuitive Surgical, Inc. and was approved by the FDA in 2000.
The researchers compared the rates of complications among 321,361 men who had their prostates removed the traditional way - without a robot - and 79,964 men who had surgery using the robot between 2003 and 2009.
They had data on 1,460 complications related to those procedures, including complications with anesthesia, infection, accidentally cutting the patient and breathing problems.
Parsons and his colleagues found that the risk of complications about doubled in 2005, which was the year before the robot was rapidly adopted. By 2006, about one in 10 surgeries to remove prostates in the U.S. was done with a robot.
The researchers found similar patterns when they examined just academic hospitals and just nonteaching hospitals.
Parsons said the increased risk of complications was likely due to surgeons learning the new technology during the early years of its adoption. It’s unlikely that the complications were the result of the da Vinci system malfunctioning.
Over the entire study period, complications occurred during a similar proportion of traditional and robot-assisted surgeries - between one and two percent.
Parsons said surgeons, medical societies, policymakers, companies and patients “need to get together and agree upon a system in which surgical innovation can be safely introduced into broad community practice.”
For example, he said the surgical community could model the aviation industry, which requires pilots to undergo rigorous training before flying a new aircraft. Also, there could be an independent, national monitoring system for complications.
Complications also increased in the 1980s and 1990s after a new surgical technique to remove the gallbladder was introduced, Parsons noted.
“Without some improvement to the system, it will happen again,” he said.
In an editorial accompanying the new study, Drs. Mohamad Allaf and Alan Partin of Johns Hopkins University in Baltimore write that the question of how new surgical procedures are adopted is important.
“Patient safety should be the centerpiece of the mechanism by which diffusion occurs,” they write.
Allaf and Partin dispute whether the increased risk of complications during the early days of robotic prostate removal was large enough to make a meaningful difference, however.
A representative for Intuitive said the findings of the new study are flawed and inaccurate, because the researchers "used incomplete and inaccurate data."
"Independent, peer-reviewed studies that use appropriate methodology and databases come to conclusions similar to ours regarding both safety and diffusion of robotic-assisted prostatectomy," said the company's statement.
Parsons said the statistical limitation Intuitive highlighted in its response "does not change the fundamental conclusions of our study."
"I am aware of no other studies of robotic prostatectomy diffusion that, like ours, combined data from hundreds of thousands of prostate cancer surgeries," he added.
Intuitive offers a list of publications supporting the effectiveness of prostate removal using robots on its website (see here: http://bit.ly/1mvFEKS.)
Other studies have found that robotic and traditional surgery are equal when it comes to complaints about sexual problems and urinary leakage following the procedures (see Reuters Health article of Jan. 6, 2012 here: http://reut.rs/1nbeSYK.)
The FDA told Reuters Health in an email that once it approves or clears a device, the manufacturer may introduce the device to the market.
The FDA also largely doesn’t regulate or oversee physician training programs. “The primary responsibility for developing and implementing training programs in an effective manner lies with surgeons and health care facilities under the practice of medicine, as well as manufacturers,” the agency wrote.
The statement continued that the FDA uses several processes and activities to monitor the safety and effectiveness of medical devices once they are on the market.
SOURCE: http://bit.ly/1snGwlQ and http://bit.ly/1oBAH3a JAMA Surgery, online July 2, 2014.