If you or a loved one are among the more than 250,000 people who undergo heart surgery each year, chances are doctors used a device called a surgical heater-cooler to maintain blood temperature at a constant bodily level during the procedure.
Recently, the FDA and CDC warned that the surgical heater brand used in most heart surgeries each year, the Stockert 3T Heater-Cooler, could subject patients to deadly internal infections.
Unfortunately, new reports suggest the rate of patient infections is even worse than originally estimated, and the risks could carry over to five other brands of surgical heaters as well.
Slow Developing Infection Risk
The infection at issue is M. chimaera, a strain of non-tuberculous mycobacterium (NTM) that can develop in as few as 2 weeks or as slowly as 4 years after surgery. Although it can be treated with antibiotics, it is deadly if not discovered in time. Therefore, those at risk must regularly monitor for symptoms.
In 2013, scientists first noticed that heart patients were developing the infection years after surgery. But it wasn’t until 2015 that LivaNova/Sorin, the maker of the 3T Heater Cooler used in most of these surgeries, discovered their devices were contaminated with bacteria.
Failure to Recall Dangerous Devices
LivaNova/Sorin instructed hospitals on how to try to fix the bacterial contaminations back in 2015, but didn’t actually recall them; meaning most remained in use.
Then, in late 2015, after receiving over 30 reports of patient infection, the FDA issued a warning to consumers that the heart surgery heaters may be linked to NTM infections. However, there was no recall and the machines continued to be used.
It wasn’t until last October that the FDA and Centers for Disease Control issued strong alerts to the public over the infection dangers tied to blood heater coolers used in heart surgeries. However, the manufacturer still hasn’t issued a public recall.
Patients in 16 States Affected So Far
Since then, hospitals in 16 states have discovered contaminated machines, reported NTM infections, or sent letters to patients notifying them they may be at risk and need to monitor for symptoms.
These states include California, Connecticut, Georgia, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Pennsylvania, South Dakota, South Carolina, Tennessee, Texas and Washington.
Doctors: Problem Could be Worse Than Expected
This January, at the annual Society of Thoracic Surgeons meeting, doctors dropped more bad news: field reports show as many as 90% of 3T Heater Coolers may be contaminated, which is a higher percentage than anticipated.
And, according to St. Luke’s Hospital’s Dr. Keith Allen, contaminations have been reported across the five other brands of surgical heater coolers, not just the Stockert 3T models. Among these, infections have been linked to four of the other brands and patient deaths have been linked to three.
"We've only begun to scratch the surface, (since) the incidence is likely underreported," said doctors from the STS conference. Some experts predict as many as 1 million heart surgery patients may be at risk of serious infection.
Among the five other brands of surgical blood heaters used in U.S. operating rooms are the CardioQuip MCH-1000, the Hemotherm 400CE Heater-Cooler from Cincinnati Sub Zero Products Inc., the HCU 40 Heater-Cooler from Maquet Cardiovascular, Medtronic’s Bio-Cal 370 Blood Temperature Control Module, and the Terumo HX2 Temperature Management System from Terumo Cardiovascular Systems Corp.
Stay tuned to DrugNews for more updates on the infection risks related to heart surgery blood heaters. For those who’ve suffered infection or received notice that they may be at risk. Contact us today to speak with a lawyer about your legal options before it’s too late.
Phend, C. Heater-Cooler Infections: Incidence Most Likely Underreported. MedPage Today. (January 23, 2017). Retrieved from http://www.medpagetoday.com/meetingcoverage/sts/62676
Muscarella, L. Infections Are Not Limited to the LivaNova’s Sorin 3T Heater-Cooler Device or to Mycobacteria chimaera. LFM Healthcare Solutions. (January 18, 2017). Retrieved from https://www.lfm-hcs.com/2017/01/infections-are-not-limited-to-the-livanovas-sorin-3t-heater-cooler-device-or-to-mycobacteria-chimaera/
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