A device used in more than 60 percent of open heart surgeries is at the center of the spread of a nationwide infection advisory.
5 On Your Side's PJ Randhawa investigates why many hospitals are not notifying patients that may be infected.
Cardiac surgery saved Rene Knott's life.
"You lay down on that table, hoping and praying you're going to get up and walk away," said Knott, who underwent Pulmonary Thromboendarterectomy surgery in July 2016.
But a month later, Knott learned the operation that saved him, might now threaten his life. The news came in a letter from his hospital.
"It's like 'Oh, so you're out of the woods, but you're not necessarily out of the woods,'" said Knott.
So what happened?
It keeps patients alive during surgery by regulating their body temperature, but it emits a aerosolized exhaust. And that, experts say, is what can cause bacteria, and the infection to enter operating rooms.
"What was discovered was these machines had an exhaust that was blowing bacteria around the operating room and settling into the open chest," said Lisa McGiffert, the director of Consumers Union's Safe Patient project.
But McGiffert says unlike Knott, many people who've had open heart surgery with this particular brand of heater cooler haven't been notified at all. That's because neither the FDA nor the CDC require hospitals to do it.
"It's very expensive to go back and find those patients, find their addresses, contact them," said McGiffert.
In the meantime, the infection, known as NTM (short for Nontuberculous mycobacteria) can take years to develop symptoms, making it's impact on the patient population hard to track. Treatment involves several strong antibiotics, to be taken over the course of several months.
"It doesn't seem that anyone knows what the risk is. I think the statistic is about 50 percent of patients identified from having this infection have died," said McGiffert.
According to the FDA, between January 2010 and January 2016, at least 79 patients became infected, with at least 12 reported patient deaths across 10 states.
Many hospitals are working on ways to fix the heater-cooler contamination issue, but consumer protection advocates say it's best to be on the look out for NTM symptoms, such as night sweats, muscle aches, persistent fever, weight loss, fatigue and shortness of breath. Symptoms can appear up to five years after surgery.
And while the CDC estimates that, if exposed, the risk of infection is small — anywhere between 1 in 100 to 1 in 1000. Mcgiffert said, "You need to act quickly if you have symptoms of infections."
"I think it's wrong not to notify people," Knott said. "The doctors, the hospitals, they're there to make you better. If they know there's something that could effect that . Take you right back to where you were. They should make you aware of that."
If you or a loved one has had open chest surgery in the past five years, there are pre-prepared letters you can print and take to your doctor. You can find them on this website, under Heater Cooler notification Tool-kit.
Consumer advocates say since neither the FDA nor the CDC can compel hospitals to take out the equipment, fix it, or even notify patients of the risk, states could take a larger role in regulating these advisories.
We asked area hospitals that perform heart and lung surgeries if they have notified patients, and whether they're still using the heater-cooler device. Here are their statements:
"SSM Health Saint Louis University Hospital used an updated version of the device not noted by the CDC and FDA, but did send letters to their patients out of an abundance of caution.
At this time, we are unaware of any SSM Health patients becoming infected because of these machines. Nonetheless, we promptly notified all of our patients, who may have been exposed during the use of these machines, and their doctors. We also provided a dedicated resource to answer questions and address any concerns they may have. In addition, we continue to follow all recommendations from the CDC, FDA and the manufacturer to ensure patient safety."
"Yes, the U.S. Centers for Disease Control and Prevention (CDC) notified U.S. hospitals in October 2016 about a risk of infection related to a device used in major open-chest surgical procedures that require heart-lung bypass. The local BJC hospitals affected by this device notice are Barnes-Jewish Hospital, Christian Hospital and Missouri Baptist Medical Center.
Although BJC has no indication at this time that any of our patients have been affected, as a precautionary measure we have notified patients who underwent such procedures at BJC hospitals to make them aware of this potential issue and to provide resources to answer questions.
For patients who had one of these procedures, the chances of getting the infection are very low. BJC has reviewed the records of patients who underwent such heart and lung procedures at BJC hospitals since January 2010. In this review, BJC found no evidence of this infection related to use of this device at BJC hospitals."
Question asked: how many patients were notified?
Answer: We respectfully decline to disclose that number, as we believe the most effective approach regarding this complex issue is through direct communication with patients, and between patients and their doctors.
I can reiterate that the risk to patients is low and that the number of cases worldwide among hundreds of thousands of procedures also remains very low. BJC followed the guidance from the CDC to proactively notify patients to help increase awareness among patients in case they need to seek care.
Additional information for patients regarding the device was posted on the BJC HealthCare website at www.bjc.org/SafetyNotice. Patients also were provided the link to the CDC website at http://www.cdc.gov/HAI/outbreaks/heater-cooler.html.
MEMORIAL REGIONAL HEALTH:
We have never used this device.
St. Luke's Hospital has not ever used the device.
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