New study shows widespread contamination of open-heart devices
- Study: more than one-third of heater-cooler devices contaminated with infection-causing bacteria.
- The device has been linked to 17 patient infections at York Hospital.
- WellSpan facing 12 lawsuits related to infections linked to heater-cooler devices.
Since York Hospital became the first in the nation to report infections related to a device used during open-heart surgery, more hospitals around the country have started alerting their patients about the potential issue.
A study released this week found that more than one-third of these devices — used in a majority of hospitals performing open-heart surgeries — were contaminated with the same bacteria that infected York Hospital patients. And that wasn't the only potentially harmful bacteria found during tests.
Jack Rihs, vice president of lab services for Pittsburgh-based Special Pathogens Laboratory, tested water samples from 89 heater-cooler devices at 23 hospitals in 14 states, Washington D.C. and Canada.
He found that 45 of the devices (50.5 percent) tested positive for some type of nontuberculous mycobacteria, or NTM, while 33 (37 percent) tested positive for M. chimaera, the specific strain of NTM found in York Hospital patients.
Meanwhile, about 15 percent of the water samples were ruled uninterpretable, Rihs explained, because they were so heavily colonized by other bacteria that researchers couldn't determine whether NTM existed.
"We were surprised at how high the rate of positive tests was," Rihs said. "Either (the manufacturer's) disinfection protocols were inadequate or these devices were just never being disinfected."
Infections: WellSpan announced in October 2014 that it had identified eight York Hospital patients with NTM infections likely related to the heater-cooler device, manufactured by Sorin Group, which is now owned by LivaNova.
WellSpan admitted that it hadn't completely followed the manufacturer's cleaning guidelines, though Sorin's instructions had changed multiple times and the U.S. Food and Drug Administration has cited the manufacturer for its inadequate testing procedures.
York Hospital has since replaced its devices with similar devices from a different manufacturer.
The device was a previously unknown risk because it doesn't come into direct contact with patients, but studies eventually found potential for the device to transmit airborne bacteria through the device's exhaust vent into the environment and to the patient.
According to WellSpan's most recent update, York Hospital has identified 14 "probable" patient infections and three "suspect" patient infections. Of the probable cases, six have died and one is no longer experiencing symptoms or in active treatment.
Patient notification: The FDA and Centers for Disease Control and Prevention have issued numerous alerts during the past few years advising hospitals on how to address the threat, while also holding meetings with stakeholders to determine best practices.
During an FDA conference in June 2016, the panel concluded that patient notification wasn't necessarily a priority, citing cost concerns and unintended panic.
Medical experts and patient advocates expressed concerns with this position because the infection can take years to show symptoms, which are nonspecific, including fatigue, weight loss and night sweats.
A York Dispatch investigation in September 2016 revealed that numerous hospitals submitting reports to the FDA of contaminated heater-cooler devices were not alerting patients.
During an FDA conference call with medical professionals held in November, officials advised hospitals to follow CDC guidelines, which prioritize patient notification and recommend informing patients undergoing open-heart surgery about the potential issue.
An FDA official revealed during that conference call that the administration was aware of at least 55 patient infections in the U.S., according to reports it had received.
Rihs said he suspects a lot of these infections probably go undiagnosed because NTM is such an unusual pathogen that requires very specific testing. He didn't know whether the hospitals with contaminated devices he had tested had alerted their patients.
WellSpan alerted about 1,300 patients when it discovered its devices were contaminated.
Lawsuits: WellSpan officials have said patient notification was critical to identifying additional patients. But the notification also has helped make WellSpan a target for lawsuits.
To date, 12 lawsuits have been filed in the York County prothonotary's office against the nonprofit in relation to the infections. The majority of those suits — all of which remain open — also name LivaNova as a defendant.
One affected patient who has yet to file a lawsuit is Dwight Blake, the 68-year-old Delta man who spoke to The York Dispatch in October about his struggles dealing with the NTM infection.
"One day, I came home from work, told my wife and son I just didn't have any push left and flopped down in my chair," he had said. "I was shutting down."
At the time of the interview, Blake said his health had been vastly improving since being placed on NTM-fighting antibiotics, but Thursday he said his health has deteriorated further as the infection and antibiotics have contributed to vision and hearing impairments in addition to liver and kidney issues.
"This NTM is ravaging my entire body," he said.
Frustrated by his treatment with WellSpan, Blake said he's started seeing doctors in Maryland in an attempt to "salvage what I have left of my liver and kidneys."
Multiple other NTM patients have reached out to him since The York Dispatch story ran, and Blake requested that his email (firstname.lastname@example.org) be provided for others in similar situations seeking to discuss their treatment.
"My only regret is not getting away from WellSpan sooner," he said.
Blake said he believes he's not being counted as one of the confirmed cases of NTM because his blood tests have come back negative, though a biopsy confirmed he had the infection and he's been getting treated at the NTM clinic.
WellSpan spokesman Brett Marcy said each patient is treated based on individual needs, but he couldn't comment on individual treatment plans or patients.
Blake had been discussing a lawsuit against WellSpan with a lawyer in Philadelphia, but he decided to switch attorneys recently, which he said has delayed the process.