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A too-rapid adoption of new medical technology can threaten patient safety, according to a new study in JAMA Surgery. Risk managers should work to prohibit new devices until physicians and staff have been sufficiently educated and trained on the patient safety risks, the authors suggest.
The researchers focused on the adoption of robotic surgery systems, particularly the da Vinci surgical robot by Intuitive Surgical in Sunnyvale, CA. In 2003, there were about 600 robotic prostatectomies performed in the United States, increasing to 37,000 in 2009, the researchers found. The fast rise in procedures resulted in a brief but "substantially diminished perioperative patient safety," the researchers say.
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, according to the study. The prevalence of patients undergoing the robotic procedure at teaching hospitals had reached 10% by 2006. By 2007, the number of patient-safety events doubled among nonteaching hospitals.
The authors reached their conclusions using data from the Agency for Healthcare Research and Quality’s Nationwide Inpatient Sample. They studied records of 401,325 patients who underwent radical prostatectomy between Jan. 1, 2003, and Dec. 31, 2009. Eighty percent of them had the new robotic procedure, while 20% had the traditional surgery.
Among the 1,460 patient safety events reported, the most frequent were accidental punctures or lacerations, postoperative respiratory failure, pulmonary embolism and deep vein thrombosis, and postoperative hemorrhages. (An abstract of the study is available online at http://www.ncbi.nlm.nih.gov/pubmed/24990549.)
After investigating a flurry of injury reports involving the da Vinci robot, the Food and Drug Administration investigated and issued a warning to Intuitive Surgical in July 2013 that criticized the company’s safety reporting of patient adverse events and highlighted the need for thorough training on the device. Health officials in Massachusetts and New Hampshire also are investigating safety concerns stemming from increases in patient complications.
Officials at Intuitive Surgical questioned the findings of the recent study and say the procedure codes required to identify minimally invasive prostatectomies were not available in the database used by the authors prior to Oct. 1 2008. That lack of codes would make safety events from the pre-da Vinci era seem inaccurately low, the company says.
Even if the numbers as disputed, there is no doubt that adopting new medical technology without adequate education and credentialing is a threat to patients, says Stephen G. Pereira, MD, FACS, a New Jersey surgeon who specializes in minimally invasive laparoscopic and robotic surgery. Pereira was a member of the two surgeon team to perform the first robotic surgical procedures in the Northeast United States. He has been performing robotic surgeries for more than 10 years.
To counter that threat, risk managers can work collaboratively with the chairman of the department surgery — or a similar leader — to assess and, if necessary, improve the credentialing process, Pereira says.
When Hackensack (NJ) University Medical Center acquired a surgical robot in 2001, Pereira helped develop guidelines and requirements for general surgeons who wanted to use it.
"When things really took off the radical prostatectomies and neurologists, some of oversight got a little relaxed," he explains. "There was a turf battle where the neurologists wanted to have control and do their own criteria, the general surgeons wanted the same, and so on. The result was that the requirements first put in place weren’t adhered to as much as originally intended."
The specialty surgeons created their own criteria for robotic surgery, and then compliance improved at the hospital, Pereira says. Different requirements can be appropriate if their function is to highlight the concerns unique to that specialty and if the general requirements apply across the board, he says.
Pereira notes that many hospitals now have a chief of robotics, a surgeon who is specifically tasked with developing criteria for privileging robotic surgery and enforcing the requirements.
"The goal is the same as with granting privileges for any type of surgery: to confirm that the surgeon is properly trained and experienced," he says. "When a new field comes along that is very different, like what happened with laparoscopy and robotic surgery, the medical community can stumble and require some time to catch up with the technology. We’re there now with robotics."