A recent study by a Pennsylvania scientific researcher has found that more than a third of heater-cooler devices used in open-heart surgeries could be contaminated with dangerous bacteria.
Study Finds That Heater-Cooler Devices Used in Surgery Could Be ContaminatedHeater-cooler devices such as the Stockert 3T heater-cooler system, which helps regulate a patient’s body temperature during surgery, have previously been linked to infection during certain surgeries.
According to the FDA, signs and symptoms of NTM infection include:
Redness, heat or pus at the surgical site
While the water used in heater-cooler systems does not come in direct contact with the patient, contaminated water could potentially enter other parts of the system or transmit harmful bacteria through the air via the device’s exhaust vent into the operating room and to the patient.
The Food and Drug Administration (FDA) and The Centers for Disease Control (CDC) have both issued Stockert 3T infection reports specifically involving M. chimaera, a bacterial infection.
The study, Microbial Contamination of Heater/Cooler Units: M. Chimaera and Beyond, published in June 2017 in the American Journal of Infection Control, analyzed 505 water samples from 103 heater/cooler units to assess for the presence of non-tuberculous myobacterial (NTM), primarily M. chimaera, before and after decontamination.
“33 of 89 (37 percent) heater-cooler units assessed between July 2015 and December 2016 tested positive for Mycobacterium chimaera (M. chimaera), a bacterium associated with fatal infections in open-heart surgery patients,” Science Daily reported on the study. Plaintiffs have filed numerous lawsuits related to the Stockert 3T heater-cooler devices, alleging that they were exposed to Mycobacterium Chimera (M. chimaera) or Mycobacterium abscessus (M. abscessus) from the Sorin 3T Heater-Cooler System.
In January 2017, plaintiffs filed a motion In RE: Sorin 3T Heater-Cooler System Products Liability Litigation, MDL No. 2772 to transfer 15 Stockert 3T heater-cooler lawsuits pending in five districts to US District Judge Bruce H. Hendricks, US District Court for the District of South Carolina, Greenville Division for multidistrict litigation that would centralize the lawsuits under one judge.
However, the US Judicial Panel on Multidistrict Litigation denied the motion.
M. chimaera is frequently found in soil and water but not generally associated with infections. Still, patients exposed to the bacteria through open-heart surgery can develop symptoms that may take months to emerge. Infections may not show up for years, which makes the infections difficult to treat.
“Our results showed M. chimera in 37 percent of units tested and is consistent with previous findings. The extent of contamination from such a rare organism in multiple units from all over the country was surprising,” said the study’s lead researcher John Rihs, according to Science Daily:
“Some devices remained positive for M. chimera for months, indicating that disinfection can be difficult and routine testing is advisable. Beyond M. chimera, we found other NTM species, Legionella, and fungi, indicating these units are capable of supporting a diverse microbial population.”