OSU hospital getting false heart monitor alerts
run afoul of the First Amendment.” Reynolds was one of five tobacco companies that challenged the FDA’s original warning labels.
The nation’s largest tobacco company, Altria, said it will “carefully review the proposed rule.” The company, which makes Marlboro, was not part of the industry lawsuit.
Nearly 120 countries around the world have adopted the larger, graphic warning labels. Studies from those countries suggest the image-based labels publicize smoking risks and encourage smokers to quit.
Current U.S. cigarette labels don’t reflect the enormous toll of smoking, said Geoff Fong, who heads the International Tobacco Control Project.
“This is a deadly product,” said Fong, who studies anti-to- bacco policies at Canada’s University of Waterloo. “We have more prominent warn- ings on many other products that don’t pose even a fraction of the risk that cigarettes do.”
Canada became the first country to put graphic warn- ings on cigarettes in 2000.
Smoking causes more than 480,000 deaths each year in the U.S., even though smok- ing rates have been declining for decades. Approximately 14% of U.S. adults smoke, according to government figures. That’s down from the more than 40% of adults who smoked in the mid-1960s.
Under the 2009 law that first gave the FDA over- sight of the tobacco indus- try, Congress ordered the agency to develop graphic warning labels that would cover the top half of cigarette packs. The FDA proposed nine graphic labels, including images of rotting teeth and a smoker wearing an oxygen mask.
But a three-judge panel ruled that the FDA’s plan vio- lated companies’ right to free speech. The judges said the images were unconstitutional because they were “crafted to evoke a strong emotional response,” rather than to educate or warn consumers.
The FDA said it would develop a new batch of labels, but when new ones didn’t appear, eight health groups sued the agency in 2016 for the “unreasonable delay.”
Under a court order this year, the FDA was required to propose new labels by August.
The Ohio State Univer- sity Wexner Medical Center employs eight nurses whose only job is to read the elec- tronic transmissions flowing from thousands of implanted heart devices living in their patients’ chests.
Like health-data workers across the U.S., the nurses at the Columbus medical center scan the transmissions every day for signs of prob- lems like atrial fibrillation. Lately, though, the team was drowning in bad data thrown off by a popular implantable heart monitor, Medtronic’s industry-leading Reveal Linq implantable loop recorder.
According to study results published online last month in the peer-reviewed Heart Rhythm journal, the team analyzed data on 559 consecutive Ohio State patients and found that between 46% and 86% of the health alerts sent by their implantable Medtronic heart monitors were false. “The average time to review one transmission and adjudication after consultation with electrophys- iologist requires 30 to 45 minutes at our center,” the study said. But Medtronic said it may only require one to two minutes to adjudicate a false positive.
Dr. Muhammad Afzal, cor- responding author of the Heart Rhythm p aper, said the number of false positives using devices with factory settings was “significant.” Medtronic stressed that the minimally invasive Linq device can be programmed by a doctor to tone down the detection of certain heart signals that may not be relevant to a particular patient, reducing time spent on false-positive transmissions.
Smaller than a AAA battery, the Linq retails for slightly less than $5,000 to hospitals, analysts said, which can double that price or more in its bills to insurers.
Kentucky cardiologist Dr. John Mandrola, a frequent industry commentator who did not take part in the Ohio State study, said the false-positive rates reported in the recent Heart Rhythm article appeared to be “super high,” especially for a device bearing a medical-grade price tag.
“False positives are a problem because not only do they give you a misdiagnosis, they can lead people to ... doing things they wouldn’t otherwise do, like further testing and anti-coagulation,” Mandrola said.In the Ohio State study, 93% of the 46 reports of cardiac pause in patients with CS were found to be false positives.
Overall, 86% of all 78 transmissions in CS patients were found to be false positives, while 71% of the syncope patients’ and 46% of the atrial fibrillation patients’ were false positives.