How was the Bacteria at York Hospital Found?
December 8, 2015
York Daily Record – The Centers for Disease Control and Prevention spent three weeks at York Hospital, looked at thousands of lab records and analyzed samples from the heatercooler devices.
When staff members from the Centers for Disease Control and Prevention arrived at York Hospital in July to investigate several cases of rare, bacterial infections they already had a theory of how people had gotten them: Devices used during openheart surgery to heat and cool the blood.
Recently, these heatercooler devices have been linked to infections in patients, including in an article in the medical journal Clinical Infectious Diseases. And on July 20, the hospital notified the Pennsylvania Department of Health about a “cluster” of patients with these illnesses.
The CDC spent almost three weeks doing research at York Hospital, reviewing thousands of lab records and analyzing samples taken from the devices. As a result, York Hospital then sent out about 1,300 letters to people who had openheart surgery, telling them they might have been exposed.
“This isn’t an outbreak where we have 50 patients in the last month,” said Joseph Perz, an epidemiologist at the CDC who was in contact each day with the team in York. “This takes a lot more, careful analysis to tease it apart.”
On Oct. 26, the hospital announced that it was notifying patients who had openheart surgery between Oct. 1, 2011, and July 24 that they could have been exposed to nontuberculous mycobacteria. These bacteria are commonly found in nature, but they can cause infections in people who have weak immune systems — or are very sick.
The CDC found that eight people — including four who died — had likely had been infected. Though those deaths have not been definitively linked to the infections, York Hospital said they likely were a “contributing factor.”
Perz said that staff members from the CDC, at least five, got to York Hospital on July 26, and stayed until Aug. 14.
By the time they arrived, the hospital had already removed its three machines, called the Sorin 3T HeaterCooler System. These bacteria are not “run of the mill,” he said, so samples were sent to the centers’ lab in Atlanta to be examined.
The bacteria are “notoriously slow growing,” he said, in both people and in the lab. Three of the eight people who had been infected had the same species of bacterium that was found in the equipment: Mycobacterium chimaera. That’s also the same kind that’s been linked to cases in Switzerland, Perz said.
But the investigation took more steps.
“If we’re trying to prove an association,” he said, “we have to take a step back.”
So the team also reviewed “thousands” of lab records at the hospital, covering an approximately fiveyear period. After comparing them with surgical records, Perz said, the team found that the odds of having these kinds of infections were “significantly higher” if a patient had openheart surgery while a heatercooler device was running.
The CDC is continuing to look into the case, seeing if, for example, the strain of bacteria found in the devices is “indistinguishable” from what was discovered in patients. But the centers, he said, have a “clear sense” that its preliminary findings are reliable.
Meanwhile, during the last several weeks, the federal government has issued two separate alerts about bacterial infections related to heatercooler devices.
Between January 2010 and August, the U.S. Food and Drug Administration said, it received 32 reports about machines that had been contaminated with bacteria, or people with infections linked to them. Most — 24 — were from outside the United States.
Medical device companies and places such as hospitals are required to report cases to the administration in which equipment might have caused or contributed to someone’s death.
Deborah Kotz, a press officer with the FDA, said that the administration does not know how often these devices cause infections, but the problem is considered to be rare. Part of the difficulty, she said, is how long it takes for the bacteria to grow.
“I think that’s presented a real challenge, in terms of trying to get hospitals to report these infections,” she said. “Now, we’re trying to increase awareness.”
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To learn more about your legal rights and options as a victim of an infection caused by a Heater-Cooler device used during open heart surgery, please contact Atlee Hall, LLP today for a free consultation. We have offices in Lancaster, Pennsylvania, but help victims across the state.