A Pittsburgh researcher released a study in June that found a shockingly high rate of mycobacterium chimaera contaminating heater-cooler devices used across the United States, according to the Pittsburgh Post-Gazette.
Heater-cooler systems are used to warm or cool patients’ bodies during open chest surgery. Mycobacterium chimaera is a rare, but deadly, form of bacteria causing dangerous infections in patients that have undergone such surgery.
The FDA previously estimated that up to 500,000 patients may be at risk for this infection.
Jack Rihs found in his new study that 33 of 89 heater-cooler systems from 23 states, as well as Washington D.C. and Canada, tested positive for mycobacterium chimaera, suggesting a much higher rate of contamination than the FDA estimated.
Rihs told the Post-Gazette he was surprised that so many were positive.
“[M. chimaera] is such a rare pathogen and to find so many in these devices all over the U.S. is unusual,” Rihs told the Post-Gazette.
The risk associated with heater-cooler devices has been known since early 2015, when research first linked infections to contamination in the Stockert 3T, a type of heater-cooler system made by LivaNova.
The problem with the device that leads to infection is that cooling fans aerosolize leaking water. This malfunction is prevalent in brands other than the Stockert 3T, although almost all reported cases of infection have come from the Stockert 3T, and it once made up 60 percent of the market in the U.S.
The study conducted by Rihs tested samples of water from devices that were all Stockert 3Ts.
Rihs’ research has already prompted some hospital systems to notify patients who were involved in open chest surgery with heater-cooler devices, most being Stockert 3Ts. In Pittsburgh, Allegheny Health Network has begun to notify about 3,000 patients who underwent open chest surgeries since 2012.
AHN used six Stockert 3Ts between its hospitals.
Sam Reynolds, AHN’s chief quality officer, told the Post-Gazette that he was shocked by the results of the study.
“It really stepped up our urgency,” Reynolds said to the Post-Gazette. “It showed us [the risk of contamination] is affecting a lot of [heater-cooler] units, not a few.”
Even after AHN’s Stockert 3Ts underwent more rigorous cleaning last fall and none were found to be contaminated, by earlier this year the bacteria was found on one.
As a result, AHN stopped using the Stockert 3Ts and ordered six new heater-cooler units from a different manufacturer.
Of the 3,000 patients who AHN plans to notify, none appear to have been infected as a result of the contamination, according to a review of the patient records.
However, it is extremely difficult to detect M. chimaera infections, as the symptoms are often vague, like fatigue, fever, pain, and weight loss.
Moreover, in some cases, signs of infection do not appear for months or even years. By that time, doctors and patients may not think to trace the infection back to the initial surgery.
The FDA has stated that it believes many cases of M. chimaera infections go unreported. Those that can be identified and reported have been found to be potentially fatal.
In an FDA study last year, it received 91 reports of possible contamination. Of those reports, at least 79 infections were confirmed, and at least 12 resulted in death.
The manufacturer LivaNova said to the Post-Gazette that it stopped selling the Stockert 3T last fall, although it continues to loan units out to hospitals that request them.
LivaNova also said in a statement that they are committed to continuing to work with regulators and clinicians to “resolve this important industry-wide issue and ensure 3T Heater-Cooler users have continued access to this important device that enables lifesaving cardiac surgery.”
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