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Heater-Cooler Systems Used During Heart Surgery Linked to Patient Infections

Dec 3, 2015

Heater-Cooler Machine

Patients May Have Been At Risk For A Type of Infection During Heart Surgery

WellSpan York Hospital in Pennsylvania notified 1,300 patients that they may have been at risk for a type of bacterial infection during heart surgery performed between October 1, 2011 and July 24, 2015. The potential infection stems from heater-cooler systems, a device that is used to regulate a patient's blood temperature during cardiothoracic surgery. Eight patients at York Hospital were infected, and four have died. The hospital said the deaths were linked to the infections, but also noted that other health issues may have also played a role.

York Hospital is working with the Pennsylvania Department of Health and the CDC to handle questions from healthcare professionals and affected patients. A website has also been created for more information.

The U.S. Food and Drug Administration (FDA) warned of the issue in an October 15th safety communication, stating that it knew of 32 reports of infections associated with heater-cooler systems thus far. "We are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedure," the notification read. "NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems."

Potential Bacteria Contamination with Heat-Cooler Systems

Researchers raised concerns about the potential for bacterial contamination with heater-cooler systems in a report published in the July issue of Clinical Infectious Diseases. The FDA also designated a heater-cooler system recall as Class 2 that same month. The device was recalled because of "[p]otential colonization of organisms, including Mycobacteria [...] if proper disinfection and maintenance is not performed per Instructions for Use."

Hal Baker, MD, lead of infection control at York Hospital, said staff had not been following cleaning instructions "to the letter" in an interview with the New York Times. The rate of infection among patients undergoing heart surgery was less than one percent, according to the hospital. Detecting the problem to begin with was difficult because the bacterial strain grows slowly and symptoms may not appear for months.

This is second widely publicized medical device infection case this year, the first being duodenoscopes linked to superbug infections in several US hospitals.

Need Legal Help Regarding Heart Surgery Infections

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

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