FDA Warning: Infection Risk Linked to Heater-Cooler DevicesNovember 10, 2015 — Philly.com reports that another hospital in Pennsylvania had reported an outbreak of infections linked to heater-cooler devices commonly used during open heart surgery.

Penn State Hershey Medical Center is ordering the immediate replacement of all heater-coolers with new devices, according to a news release.

At least three patients were infected with nontuberculosis mycobacteria in the last four years. Two patients died, but it is not clear whether the infection caused their deaths. The hospital said it is contacting 2,300 more patients who had open heart surgery during that time.

Last month, WellSpan York Hospital reported that eight patients contracted infections, including four who died, since October 2011. The hospital notified 1,300 patients who were exposed.

Dr. Carol Freer, chief medical officer for Penn State Hershey Medical Center, said:

“In the interest of patient safety, based on our own experience over the past several months as well as mounting clinical evidence, we recommend other hospitals carefully review their heater-cooler devices. We remain concerned that our recent experience may not be unique to our hospital.”

The FDA issued a Safety Communication after receiving dozens of reports of infections or bacterial contamination of the devices. Click here to read more.

Heater-cooler devices use temperature-controlled water, external heaters, and special blankets to warm or cool a patient. Water in the system does not directly contact a patient, but it can potentially “aerosolize” through the exhaust vent. If the system is contaminated with Nontuberculosis mycobacteria, a bacteria commonly found in tap water, it can spray onto the patient and cause a surgical-site infection.

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