The claims sound terrifying:
Just breathing the air in an operating room where hot surgical tools are being used to slice and cauterize tissue — emitting puffs of caustic smoke in the process — is said to be the equivalent of smoking up to 30 unfiltered cigarettes a day. The smoke contains an array of carcinogenic toxins. And nurses regularly exposed to it report they are are twice as likely as the general public to suffer congestion, coughing, and asthma.
Citing such data, health care workers have launched national campaigns to push hospitals to require the use of devices that suction up surgical smoke as it’s produced. Laws to mandate such devices in operating rooms are already making their way through state Legislatures in California and Rhode Island, with vocal backing from nurses. But the warnings of health risks are based on scant evidence — and, at least in some cases, propelled by profit motives.
A STAT analysis of scientific literature has found that the most frightening claims about the dangers of surgical smoke are mostly drawn from small studies of dubious quality and scattered anecdotal reports. Activists generally fail to highlight more reputable studies that find little danger in exposure to plumes.
What’s more, the public campaigns warning about risks are largely funded by companies that sell devices to capture surgical smoke. A global nonprofit working on the issue, for instance, is sponsored by several companies in the field — and run by a former sales and marketing executive for a leading manufacturer of smoke evacuation devices.
Those devices, with names like “Smoke Shark II,” “PlumeSafe Turbo,” and “StrykeVac,” can cost anywhere from a few hundred to a few thousand dollars, depending on size and complexity. They used to be bulky, noisy, and hard to operate, but newer models are considerably more nimble and much cheaper. Global sales are projected to hit $180 million a year by 2020.
And manufacturers are doing their best to grow the market: They’re putting out white papers on the risks of surgical plume, sponsoring awards for hospitals that improve operating room air quality, and hosting “continuing education” workshops for health care professionals to raise concerns about surgical smoke.
“Do you know the hidden dangers of surgical smoke?” a trade group for surgical nurses asks on its website, in a campaign sponsored by medical device maker Medtronic (MDT).
Perhaps the most dramatic promotional pitch about the perils of smoke comes from Dr. Tony Hedley, an orthopedic surgeon in Phoenix. In 2014, Hedley received a double transplant to replace lungs so scarred by pulmonary fibrosis he could scarcely breathe. He hadn’t smoked for 40 years. But he had spent more than 30,000 hours in the operating room.
While he does have a family history of weak lungs, he’s convinced his problems stem from the voluminous smoke he inhaled while performing thousands of joint replacements over his decades-long career.
Hedley, 72, has been working with public relations professionals to promote his story in media interviews and with a video. Those efforts are being paid for by Stryker (SYK), a global medical device company that makes several smoke evacuation products, including a lightweight surgical tool that can evacuate smoke as it cauterizes tissue.
Stryker has also paid Hedley nearly $3 million in recent years, largely to license innovations he developed for hip and knee surgeries. But Hedley said he does not stand to profit personally from Stryker’s sales of smoke evacuating devices. “They contacted me because I’m on the team, so to speak,” he said, adding that his push for stronger smoke protections in the OR comes out of concern for his colleagues’ health.
Stryker’s director of marketing, Nate Miersma, said his company’s interest in the area — it helps sponsor the interest group highlighting the issue of surgical smoke — is partly about boosting its share of the market. But he said Stryker also wants to protect OR doctors and nurses. “Obviously we benefit from sales, but we want to be seen as partners and leaders in health care safety,” Miersma said.
That’s a compelling pitch. But it appears to be based on very weak data. The health risks of surgical plumes have been little studied — other than by those worried about those risks.
“Obviously we benefit from sales, but we want to be seen as partners and leaders in health care safety.”
Nate Miersma, director of marketing at Stryker
Those who are less worried — including many surgeons, who are often closest to the smoke as they operate — said they are hesitant to publicly question the health risk research for fear of coming across as uncaring to hospital staff. But the handful of experts with no ties to industry who have looked deeply into the matter in recent years are not convinced that health risks truly exist.
A group of surgeons and researchers who examined 20 of the strongest papers in their 2013 review “Is Surgical Smoke Harmful to Theater Staff?” found that while toxins were present in smoke, “the risk presented to the theater staff remains unproven.” They concluded that “no existing literature establishes a direct link between the components of smoke and the transmission of disease.”
An in-depth review of 30 years of literature on surgical smoke conducted by the British government’s workplace safety arm in 2012 found most published research studies on the issue were either biased, filled with confounding factors, or poorly designed — so much so that the authors could not conclude that smoke causes any short- or long-term health risk.
“High quality papers,” the authors wrote, “were in short supply.”
Behind dire warnings, flimsy science
There’s no doubt that smoke from surgical tools is highly unpleasant and irritating. It smells terrible, often stings the eyes and throats of those in the operating theater, and can lead to headaches and chest tightening.
More worrisome, the smoke has been shown — conclusively — to contain numerous toxins, carcinogens, and particles small enough to slip through regular surgical masks and embed in alveoli, the tiny air sacs in the lungs. The smoke can even carry viruses and bacteria that are dislodged when surgical tools tear through tissue. Some think the smoke might harm patients by slowing healing if it collects in large amounts in abdominal cavities during laparoscopic surgeries.
“OR smoke is not ordinary smoke,” Hedley said, reading off dozens of chemicals found in surgical smoke — formaldehyde, benzene, and hydrogen cyanide among them — from a list he carries. “It’s scary.”
That’s why the California Nurses Association is pushing a bill that would require the state to adopt stricter smoke evacuation regulations. The Legislature is expected to vote later this month. (A similar bill was passed last year, but Governor Jerry Brown vetoed it, saying the issue should be up to the state occupational safety board. This year’s version will allow that board to set the specific regulations.)
“Our members wanted to know, why aren’t hospitals doing something to mitigate this harm?” said Stephanie Roberson, a legislative advocate for the association. Roberson said her group had accepted no funding from manufacturers. “We are strictly doing this to protect our nurses and our patients,” she said.
STAT’s close look at the research, however, raised doubts about the level of threats. Consider the claim that breathing surgical plumes for a day is equivalent to smoking more than two dozen unfiltered cigarettes. It’s become something of a rallying cry for advocates.
But it does not appear to be grounded in solid science.
That statistic was extrapolated from a single obscure paper — which involved analyzing fumes emitted when the researchers used surgical tools to burn 1 gram of dog tongue in a small box. A direct comparison doesn’t take into account that when you smoke cigarettes, you inhale the chemicals directly into your lungs. The paper’s authors even stated in their conclusion that based on experience at their hospital, they felt exposure to smoke in an OR was “rather limited” compared to cigarette smoke.
A separate, three-month study of operating room air found that while surgical tools did indeed create airborne particles, OR air was actually cleaner than air outside the hospital: It contained fewer small and potentially irritating particles, likely because of routine HEPA filtering. (The study also noted that OR air was much drier than outdoor air, a factor which could contribute to airway irritation.)
And while mutagenic compounds have been detected in trace amounts in surgical smoke, exposure to the smoke has never been proven to cause cancer. A 2007 analysis of health records of more than 86,000 nurses found no increase in lung cancer risk for those who had spent their careers in operating rooms.
As for the statistic that OR nurses are twice as likely to have respiratory ailments, that comes from a web survey of nearly 800 nurses but does not account for other reasons — like drier air or more exposure to disease — that OR nurses could become sick. Nor does it account for the fact that people with respiratory issues might be more interested in taking the survey.
‘No clear signal of disease’
One of the most frightening claims about surgical plume is that it may transmit genital warts, or human papillomavirus, to medical staff who are working to ablate a patient’s warts.
Those pushing for smoke restrictions repeatedly cite two decades-old published case reports, one involving a surgeon from Norway, another a nurse from Germany; both were diagnosed with genital warts in their throats after taking part in laser surgeries. There are other anecdotal case reports involving surgeons with warts in uncommon areas: their eyes and at the edges of their noses, and one 2013 study reporting that two laser surgeons suffered HPV-positive tonsillar cancer despite having few risk factors.
“OR smoke is not ordinary smoke. It’s scary.”
Dr. Tony Hedley, orthopedic surgeon
But an analysis of laser surgeons showed that those who treated warts — even those with long careers — were no more likely to suffer warts than the general public. What’s more, those who took precautions in the OR, including using laser masks and smoke evacuators, suffered warts as commonly as those who did not.
The one lab study often cited by advocates as proof that surgical smoke can cause viral disease is not all that relevant to real-life conditions in a hospital. Researchers captured smoke emitted while using lasers on cow tissue infected with bovine papilloma — and then injected bits of viral DNA from the smoke directly into calves. They got sick. But it is not typical of OR nurses to inject themselves with particulates found in surgical smoke.
In 2013, a panel that advises the Centers for Disease Control and Prevention on infection control said there was no evidence of disease transmission during laser surgery on patients with HPV. “We’ve had 20 years of these exposures happening and no clear signal of disease,” Dr. David Kumar, a CDC medical officer, said at the time.
For its part, the National Institute for Occupational Safety and Health has been recommending the use of smoke evacuators within 2 inches of a surgical site since 1996, but has shown little urgency in mandating action. The Occupational Safety and Health Administration’s website estimates some 500,000 hospital workers are exposed to surgical smoke annually and says “employers should be aware of this emerging problem” — but states there have been no documented cases of disease transmission.
One surgeon who’s long been skeptical about the hype over surgical smoke is popular medical blogger and tweeter @skepticscalpel. He’s inhaled his share of smoke in the OR over decades of general surgery — “It’s not pleasant,” he said — but said he’s searched in vain for concrete evidence that it’s dangerous. (He requested anonymity for this article so he can continue to speak freely on controversial medical issues.)
The blogger estimated that equipping every OR and outpatient clinic in the country, even as prices of the devices decline, could cost tens of millions of dollars.
“Is this really worth spending all this money on?” he asked. “I just can’t see how it’s a real problem when there are so many real problems out there.”
Nurses rally for stricter controls on smoke
Those pushing for new rules say they are critical to protect worker health — and complain that stingy hospital administrators won’t invest in smoke evacuators unless they are forced to by law.
The push is being made largely by OR nurses, who, like scrub technicians and anesthesiologists, are considered to be at higher risk than surgeons because of the longer hours they often spend in operating rooms. Many feel this issue has been overlooked because it has not been important to surgeons.
Last year, the Association of periOperative Registered Nurses launched a three-year campaign, called “Go Clear,” to encourage hospitals to reduce their surgical smoke. The program is supported by Medtronic, which sells a number of smoke evacuation devices and systems.
The International Council on Surgical Plume Inc. launched two years ago to support education and expert consulting on surgical smoke and to generate funding for new studies. The council’s sponsors, prominently displayed on its website, include by Stryker, Buffalo Filter, Megadyne and Medtronic — all sellers of smoke evacuation devices.
Among the council’s recommendations: Nurses should consider refusing to work with any surgeon who doesn’t use smoke evacuation equipment. “That would take some guts, but it would send a powerful message,” said an article in the council’s most recent newsletter. It also recommended that nurses demand safety audits of their operating theaters: “Doing nothing is not an option.”
The council was created and is led by Daniel Palmerton, who spent 20 years working in sales and marketing for Buffalo Filter, a New York company that’s widely considered the world leader in smoke evacuation devices.
Palmerton said his group’s connections with the corporations are not a conflict of interest, noting that many nonprofit medical organizations rely on funding from related industries. His corporate sponsors, he said, have no vote or say in council matters.
Palmerton said he started the council because in his decades in the field he heard from countless nurses who were upset and worried about surgical smoke and couldn’t find anyone to listen. “These people have been beating their heads against the wall for years,” he said. “Nurses would plead with me, ‘We can’t get our facility to do anything about this.’”
“Nurses would plead with me, ‘We can’t get our facility to do anything about this.’”
Daniel Palmerton, International Council on Surgical Plume
Despite the lack of gold-standard studies showing harm, Palmerton said it’s a threat worth taking seriously: “We’re not saying the sky is falling,” he said. “We are just saying there are people in the OR every day that don’t want to be breathing ablated human tissue.”
The campaigns, however, can have a sky-is-falling feel to them.
In its official guidelines, available to members, the Association of periOperative Registered Nurses offers an exhaustive review of the scientific literature and is careful to caution that many potential health risks have not been conclusively proved.
But its public website leaves out any ambiguity: It states point-blank that smoke does pose a health risk and asserts that a day in the OR is as hazardous as 27 to 30 unfiltered cigarettes.
Dr. Mark Talamonti, a general surgeon at NorthShore University HealthSystem in Chicago, acknowledges the lack of gold-standard studies to back up such claims. Yet he says he knows from personal experience how bad plumes can be: He attributes the sarcoidosis in his lungs to years of inhaling smoke from oncology surgery. He said he’s had far fewer symptoms and discomfort since he’s started using smoke eliminating devices.
Another side benefit: happier colleagues. Nurses tell him they love working in the clearer air of his OR, said Talamonti, who is a board member with the International Council on Surgical Plumes.
As for Hedley, the orthopedic surgeon in Arizona, he’s now back to full health and a full operating schedule. But he will no longer replace a hip or a knee without a small suction device attached to his surgical tool to evacuate the smoke.
He estimated the disposable tool might add, at most, a few hundred dollars to a surgery — a fraction of the cost of most of his procedures.
“They are routine in my OR,” he said. “And definitely worth it.”