Clipboard: State health officials urge caution in putting patients under the robotic knife
Robot-assisted surgeries are being linked increasingly to complications for patients, according to an advisory letter sent by state health officials to hospitals in Massachusetts last week.
Liz Kowalczyk of the Globe staff reports in today’s Globe that the Quality and Patient Safety Division of the agency the regulates Massachusetts doctors asked hospitals to make sure surgeons were proficient in the technology before using the robots on patients and to closely monitor results. She writes:
In some cases, it appears that doctors have used the aggressively marketed robots to perform hysterectomies and colorectal operations that were too complex for the technology, or for the surgeons’ skill level in directing the robots’ actions.
During one hysterectomy, two surgeons failed to coordinate their movement of the remote-controlled robotic arms, damaging the patient’s bowel and causing excessive bleeding, according to the letter from the Quality and Patient Safety Division, part of the agency that licenses Massachusetts doctors.
In another hysterectomy, a woman was anesthetized and placed for nearly four hours in a steep head-down angle — a position often used during robotic operations. She suffered shoulder injuries. The advisory described a number of mishaps but did not identify the doctors or hospitals involved
Robotic surgery — in which doctors sit at a video console and remotely move robotic arms holding surgical instruments and a tiny camera — has surged in popularity for prostate operations and other procedures. That’s partly because the manufacturer and hospitals heavily advertise the technology as reducing complications and speeding recovery.
Earlier this month, the American College of Obstetricians and Gynecologists warned women that robotic surgery may not be the best option for them, despite what they are told by marketers.
The statement cited a study published in the Journal of the American Medical Association in February that found the use of robotic hysterectomies rose dramatically over three years, to account for nearly 1 in 10 hysterectomies performed in 2010.
Some outcomes were similar to what was seen in laparoscopic hysterectomies, the researchers found, but the cost of robotic surgery was $2,189 higher.
“Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient,” Dr. James T. Breeden, president of the OB-GYN group, wrote on the college’s website. “It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.”
Kowalczyk points out just how much hospitals that buy in to robotic surgery have to lose:
Given the high cost of the robot equipment — $1.5 million to $1.75 million, not including annual service fees and the expense of buying disposable instruments — hospitals must attract many patients to reap a return on their investment. [The ECRI Institute] said procedures nationwide rose from 25,000 in 2005 to 360,000 in 2011.
“Hospitals have this equipment and they have to use it,’’ said Diane Robertson, ECRI’s director of Health Technology Assessment Information Service. “Hospitals generally speaking in their advertising and marketing have made some claims not necessarily supported by the evidence.’’
The company that makes the only surgical robot on the market, called the da Vinci, has said that studies have shown good outcomes for patients. But some patient lawsuits have alleged that doctors were too inexperienced with the system and caused injuries.
Roni Caryn Rabin reports in today’s New York Times about a lawsuit filed against the company, Intuitive, by the widow of a man who suffered various severe complications after a prostatectomy performed with the robot. The story cited company e-mails in which representatives sometimes pushed for doctors to use the robots even with little experience:
In December 2009, a sales representative urged a hospital in Billings, Mont., to ease up on its credentialing requirement, saying in an e-mail that requiring surgeons to do five supervised operations using the robot before going solo was “on the high side” and could have “unintended consequences.” Hospital officials replied, saying, “We will review and most likely will decrease the 5 down to 3.”Chelsea Conaboy can be reached at email@example.com. Follow her on Twitter @cconaboy.
Ms. [Angela] Wonson, the Intuitive spokeswoman, said the company does not get involved in determining who is qualified to operate its robotic equipment, which is the responsibility of the hospitals. “We do not make recommendations,” she said in an e-mail.