Surgical Heating-Cooling Device Linked to 8 Infections and 4 Deaths at Pennsylvania Hospital

A device used to heat or cool the patient’s blood during cardiothoracic surgery is believed to have spread infections to patients at WellSpan York Hospital in York, Pennsylvania. Eight infections and four deaths have been linked to the device.

WellSpan Hospital is contacting about 1300 patients who may have been exposed to nontuberculous mycobacterium (NTM) during open-heart surgeries performed from October 1, 2011 to July 24, 2015, Qmed reports.

European health authorities noticed this problem and a report in the July 2015 issue of Clinical Infectious Diseases brought the problem to the attention of U.S. authorities, according to Qmed. The Food and Drug Administration (FDA) says it has received 32 reports of patient infections or bacterial contamination linked to the device.

According to WellSpan Hospital, less than 1 percent of patients who underwent cardiac procedures using the heater-cooler device had been identified as being affected by the bacterium, but the hospital said that the four patient deaths from 2010 to 2015 have been linked to the infection. These four patients also had underlying health conditions that could have contributed to their deaths, the hospital said.

The heater-cooler device controls the patient’s blood temperature through temperature-controlled water flowing to external heat exchangers or warming/cooling blankets through closed circuits. Though water does not come into direct contact with the patient, contaminated water could possibly enter other parts of the device or transmit bacteria through the device’s exhaust vent into the environment surrounding the patient, the FDA explains. NTM infections are hard to track because the bacterial strain reproduces slowly and symptoms can take months to appear.

WellSpan said it is working collaboratively with the Pennsylvania Department of Health and the federal Centers for Disease Control and Prevention (CDC) to address questions about the infection. The hospital has set up a web site dedicated to the situation.

The FDA issued a safety announcement about the heater-coolers on October 15, saying it is “aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.” According to the agency, NTM organisms are commonly present in soil and water, including sources of tap water. Though “typically not harmful,” in rare cases they may cause infections in seriously ill patients and/or in individuals with compromised immune systems.

The safety announcement says hospitals should carefully follow the manufacturer’s cleaning and disinfection instructions for the heater-coolers. And tap water should never be used for rinsing, filling, refilling, or or topping-off the device’s tank because this could introduce NTM organisms. Only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns should be used for heating or to make the ice needed for cooling. During a procedure, the device’s exhaust vent should be directed away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the field and possibly exposing the patient to bacteria.

from Parker Waichman http://www.yourlawyer.com/blog/surgical-heating-cooling-device-linked-to-8-infections-and-4-deaths-at-pennsylvania-hospital/