Denmark Hospitals Temporarily Suspended Da Vinci Surgery Robot Procedures Over Sterility Worries
Earlier this year, as a number of plaintiffs in the U.S. were filing Da Vinci Surgery Robot lawsuits, some hospitals in Denmark temporarily suspended Da Vinci robot surgical procedures over sterility concerns. According to a report from MassDevice.com the hiatus lasted about two weeks, while investigators worked to confirm whether or not Da Vinci Surgery Robot instruments could be safely cleaned and sterilized.
According to the Danish Health & Medicines Authority (DMHA), concerns about the sterility of Da Vinci Surgery Robots were first raised by Denmark’s largest hospital, Odense University Hospital. In late June, the hospital informed the DMHA that it was suspending surgeries with the Da Vinci Robot after it “had identified potential problems with the quality of the associated surgical instruments.” No injuries were reported in connection with those concerns, but Danish investigators did note “surface irregularities, which raised doubt as to whether the instruments could be sterilized,” MassDevice said. Other hospitals in Denmark were made aware of the concerns, and as a precautionary measure, they temporarily discontinued their Da Vinci Robot procedures and offered patients traditional surgery instead.
Hospitals resumed their Da Vinci Robot surgeries on July 10, after Intuitive Surgical, the manufacturer of the device, guaranteed that Da Vinci procedures could be conducted safely for patients. All of the impacted hospitals also updated their action plans with consistent instructions on how to use and clean Da Vinci instruments in accordance with Danish regulatory guidelines, MassDevice said.
Intuitive Surgical touts the Da Vinci Robot as a revolution in minimally invasive surgery that allows surgeons a range of movement greater than the human hand. The company promises that Da Vinci Robot procedures will result in less blood loss, much smaller scars and a faster recovery. Those marketing claims have paid off – as of today, the da Vinci Robot is used at thousands of hospitals in procedures ranging from prostate removals, to hysterectomies and heart surgeries.
However, some critics contend that the Da Vinci Surgery Robot is being overused without any evidence that it provides patients with additional benefits over traditional laparoscopy. Among other things, they point out that studies assessing the safety and effectiveness of the robot lag.
“What disturbs me is that we haven’t done the thing we always say we should do — which is look at a detailed, randomized trial across institutions to assess whether what we’re offering patients is better,” Dr. John Luber, a Tacoma heart surgeon, recently told the Seattle Times.
The sterilization concerns in Denmark were just the latest safety concerns to spring up involving the Da Vinci robot. In the U.S., a number of Da Vinci Surgery Robot lawsuits have alleged that use of the device led to organ damage, surgical burns, torn blood vessels and other serious injuries. Among other things, the complaints charge that Intuitive Surgical induced hospitals to purchase Da Vinci robots by creating a fear in their minds that if they did not offer the technology they would lose business to competitors.
Some Da Vinci Surgery Robot lawsuits also claim that doctors aren’t receiving adequate training on the machine. The Seattle Times report pointed out that more than 12 years after the Da Vinci robot hit the market, there is still no industry standard for training and credentialing of doctors to use the robot. If a surgeon isn’t adequately trained, critics say the Da Vinci robot poses unique risks to patients, including burns and lacerations.