Heart bypass infection risk even higher than thought
The type of machine that's been connected to 12 bacterial infections in York County was likely contaminated when they were manufactured, according to the Centers for Disease Control and Prevention.
- About 60 percent of heart bypass surgeries in the United States use the Sorin 3T Heater-Cooler System.
- The machine was previously used at York Hospital, and it has been tied to at least 12 bacterial infections. It's no longer in use.
- The Centers for Disease Control and Prevention said these devices were likely contaminated when they were manufactured.
Thousands of people, more than previously thought in the United States, could be at risk of developing a bacterial infection from a type of machine that had been in use at York Hospital because the devices were likely contaminated when they were manufactured, the federal government has announced.
In a report released on Thursday, the Centers for Disease Control and Prevention said the machine — the Sorin 3T Heater-Cooler System — is used in about 60 percent of the more than 250,000 heart bypass surgeries that are done each year. The study provides insight into how large of an issue these devices could pose across the country.
Previously, the U.S. Food and Drug Administration said bacteria had been discovered at the plant of the manufacturer, LivaNova, in Germany. But the recent report states that test results “strongly suggest” that’s how the devices were contaminated, thus increasing the number of people who could have been exposed.
“We knew that local contamination was possible, and could cause a problem,” said Melissa Brower, a spokeswoman for the CDC. “But now we also know some of these machines may have been contaminated during manufacturing.”
Exclusive: VA shuffles managers, declares 'new leadership'
On Oct. 26, 2015, York Hospital reported that it was notifying about 1,300 patients who had open-heart surgery between Oct. 1, 2011, and July 24, 2015, that they could have been exposed to nontuberculous mycobacteria, or NTM. It’s commonly found in nature, but can cause infections in those who are sick or have weakened immune systems.
Not long after, Penn State Hershey Medical Center said it was alerting about 2,300 people about the same issue.
Heater-cooler devices regulate the temperature of the blood and are critical during surgery. York Hospital no longer uses the Sorin 3T Heater-Cooler System, and has replaced them with machines from a different manufacturer.
The CDC placed the risk at between 1-in-100 and 1-in-1,000 in hospitals where the issue were discovered, which is lower relative to other complications, Brower said. If someone needs surgery, he or she should have a heater-cooler device.
“These machines are essential to perform these live-saving surgeries,” she said. “It’s just a risk to be aware of.”
Effort to aid flood victims underway at church
So far, Brower said, no other devices have been linked to infections.
On its website, WellSpan Health said the infection has been found in 12 patients at York Hospital, six of whom later died. Two people who died before the issue was discovered were “likely infected,” too.
Today, York Hospital is "adhering to the highest standards of disinfection, maintenance and testing for these devices," according to the website.
In a statement, LivaNova, the manufacturer of the Sorin 3T Heater-Cooler System, said it is aware of the recent announcements and that it’s “working with regulators, clinicians, and all relevant parties to resolve this important industry-wide issue.”
Four lawsuits have been filed against LivaNova and York Hospital in the York County Court of Common Pleas. A case that names subsidiaries of the manufacturer as defendants is also pending in U.S. District Court in Harrisburg.
When asked if the announcement will have an effect on these lawsuits, Brett Marcy, a spokesman for WellSpan Health, said the company does not comment on active litigation.
Contact Dylan Segelbaum at 771-2102.