A machine commonly used during open heart surgery has been linked to some bacterial infections across the country, according to the Centers for Disease Control.
The agency has advised hospitals to notify certain patients who are feeling ill that they may have been exposed to mycobacterium chimaera, a species of nontuberculous mycobacterium often found in soil and water.
In Syracuse, letters are being sent to about 5,000 patients who were treated at St. Joseph’s Hospital between January 2012 and November 2016.
Following up on the CDC’s alert, the hospital did discover the bacteria in a couple of machines they use to regulate body temperature during open heart surgery.
The CDC reports that evidence suggests the machines, described as LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, are believed to have been contaminated during manufacturing.
The device is reportedly used in about 60-percent of heart bypass procedures in the United States, including those procedures performed at St. Joseph’s Hospital.
John Kratz, who says he had a quadruple bypass last year, recently received a notification from St. Joseph’s Hospital, listing the symptoms of exposure to the bacteria – ranging from night sweats, muscle aches, weight loss, fatigue and an unexplained fever.
“It’s a very slow acting infection and it could show up years down the road after surgery,” Kratz says. “So, who knows. I may be fine now. But, tomorrow I may not, two years I may not. Who knows?”
While a representative of St. Joseph’s Hospital calls the infection extraordinarily rare, workers who reviewed four years of records did find a case that they believe is linked to the heating and cooling device in question.
“Ultimately the patient passed unfortunately, not necessarily a result of this infection, but certainly it was a potential contributing factor,” says Christopher Jordan, the Director of Quality Resources at St. Joseph’s Hospital.
Jordan says the bacteria could be sent into the air via a fan in back of the machine, so the hospital has moved them toward vents to avoid exposing the surgical room.
He says steps were also taken to disinfect the devices they own and all four units are expected to be replaced in the next couple of weeks.
“Nobody has found a way to be able to decontaminate these machines to an extent that it would actually be able to rid the machines 100% of all bacteria. Really all that can be done is to really decrease the amount of bacteria in the machines so that they are safe to use,” Jordan adds.
Despite that hurdle, Jordan says patients would face a higher risk of complications if the machine was not used to keep body temperatures regulated during surgery…versus the risk of an infection.
For Kratz, knowledge is power. He’ll make sure his doctor keeps the letter on file…just in case.
“My primary care physician, he wants to see me because of that note that I told him about. I have most of the symptoms on that list.”
The CDC puts the risk of Mycobacterium chimaera infection anywhere between 1 in 100 to 1 in 1,000 in hospitals that have seen at least one infection.
Click here to see more information being reported by the agency.
Scan the pictures in this story to see part of the letter sent to Kratz from St. Joseph’s Hospital.
Here is the full statement released by St. Joseph’s Hospital regarding the CDC alert and patient notifications, attributed to Jordan:
In October 2016, the Centers for Disease Control & Prevention (CDC) and the Food & Drug Administration (FDA) issued safety alerts about Sorin 3T heater-cooler devices used during open heart surgeries that may have been contaminated during the manufacturing process.
This is not a product recall, but we take these kinds of advisories, and all patient safety events, very seriously and have since initiated a rigorous disinfection process associated with these devices. In addition, we relocated these devices in the operating room suite so as to ensure they are being vented away from the patient and directly towards the room exhaust, thereby decreasing risk of infection even further. We are also working with a Trinity Health task force to identify viable alternatives since these units represent about 60 percent of all heater-cooler devices currently in use in the U.S. It is important to note that the risk of acquiring an infection as a result of being exposed to this device is far less than 1 percent.
Prior to surgery, St. Joseph’s Health proactively and fully discloses the known risks and benefits for all patients who need a procedure requiring the use of this equipment. We are currently working to alert patients who underwent an open heart procedure during the past several years about their very small risk of infection. Additionally, we have ensured our clinical teams are fully aware of the risks and the symptoms that could indicate the need for treatment or assessment for possible infection.
Open heart surgery patients who are concerned or curious about the public warning or their personal risks can visit the CDC website for more information or call their provider to schedule an evaluation and discuss their concerns. Those who have had an open heart surgical procedure at St. Joseph’s Health between January 2012 and November 2016 received a letter with further instructions.
Patient safety is our top priority, and we will continue to monitor reports from the CDC and the FDA detailing concerns about this and any other type of medical device used at St. Joseph’s.