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Infections found at York Hospital becoming global concern
Numerous hospitals across the country and around the world are beginning to take note of infections linked to surgical equipment that were discovered more than a year ago in several York Hospital patients.
The rare bacterial infection has been identified in at least eight patients around the world since a mid-October alert from the Centers for Disease Control and Prevention detailed a potential risk for infection related to a specific manufacturer's heater-cooler device.
The CDC and U.S. Food and Drug Administration had first issued alerts on the risk in late 2015, when WellSpan identified multiple open-heart surgery patients with nontuberculous mycobacteria, or NTM, infections likely related to the devices.
WellSpan has found a total of 12 patients affected by the issue, six of whom have died, while other hospitals in Pennsylvania, Iowa and Michigan found similar infections before the latest CDC alert.
At the time, health officials said York Hospital was the first U.S. health care facility found to have infections related to the device, but similar problems found in 2014 at a hospital in Greenville, South Carolina, have led to lawsuits implicating the device.
York Hospital was the first to begin notifying its cardiac surgery patients to look out for symptoms — which include fever, night sweats and weight loss — that might indicate the infection is present.
Alerting patients: An FDA panel last year discussed alerting patients and determined that alerting primary care physicians was more important and alerting patients was only recommended if more than one cardiac patient was found with the infection.
The CDC's latest alert, however, recommends all hospitals using the LivaNova (formerly Sorin) heater-cooler devices alert patients because they might have been contaminated during the manufacturing process in Germany. The alert notes that about 60 percent of cardiac surgeries performed in the U.S. utilize this device.
York Hospital used to use LivaNova's device — and replaced its contaminated devices with more LivaNova devices after it first identified the issue — but it has since replaced those with heater-cooler devices from another manufacturer, according to a WellSpan spokesman.
Since the latest CDC alert, health care providers in North Carolina, South Carolina, California, Indiana, New York, Minnesota, Massachusetts, Florida, Canada and Australia have sent letters to cardiac patients regarding the risk. Most note that no such infections have been identified among their patient bases.
Infections have been identified in Los Angeles (three, with a fourth being investigated, according to the Los Angeles Times), Minnesota (one, according to Consumer Reports), Canada (two, according to CTV News) and Australia (three, according to the country's Department of Health).
A probable case also was identified in a deceased patient in New York, according to WSYR 9 in Syracuse. The bacteria can't be detected postmortem, but looking at patients' records can help indicate a probable case. Two such probable cases also have been identified at York Hospital.
Health care response: Lawrence Muscarella, a hospital-safety consultant in Montgomery County, has been critical of the FDA and CDC responses to the heater-cooler device risk, but he said he was mostly happy with the CDC's latest alert urging notification of patients.
Muscarella's one critique is he wishes the alert didn't focus solely on the LivaNova device, because he doesn't believe there is sufficient proof to ensure all other heater-cooler devices are safe.
He has been closely following news reports surrounding the devices, and he has counted 55 health care providers in the U.S. and Canada that have notified their patients about the risk.
Muscarella estimated that was less than half of the facilities that currently use or have used LivaNova's device.
No news reports available online show that any hospitals in Georgia, Texas, Washington or Kentucky have alerted patients, despite a York Dispatch investigation that found facilities from each state had filed reports to the FDA indicating devices tested positive for the bacteria.