Heater Cooler Devices: What the Studies Suggest
According to new research presented at the 44th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC), 37 percent of heater-cooler units assessed between July 2015 and December 2016 tested positive for Mycobacterium chimaera, a bacterium associated with fatal infections in open-heart surgery patients.
The research presented by John Rihs, VP of Laboratory Services at Special Pathogens Laboratory suggested the possibility of colonization by the M. chimaera in the HCU units. Rihs and his associates tested the HCU’s for the bacterium in devices already in use both before and after decontamination.
They collected a total of 653 water samples from 89 units. Samples were received from 23 hospitals in 14 states, the District of Columbia, and Canada. Thirty-three of the units tested positive for M. chimaera, while four units were colonized with Legionella. One major concern for researchers were how contaminated the units were. Ninety-seven of the cultures were deemed uninterpretable due to high levels of bacterial and fungal contamination. “The extent of contamination from such a rare organism in multiple units from all over the country was surprising,” said Rihs, “some devices remained positive for M. chimera for months, indicating that disinfection can be difficult and routine testing is advisable.”
FDA & CDC Warnings
Both the Food and Drug Administration, and the Center for Disease Control and Prevention have previously issued safety warnings about a widely used brand of HCUs that may be contaminated during manufacturing, putting patients at risk for life-threatening infections. According to the FDA and CDC approximately 60 percent of heart bypass procedures performed in the U.S. use the brand of device associated with these infections.
The m. Chimaera bacteria are often found in soil and water but is rarely associated with infections. However, patients exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that can often take months to emerge. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat.
Hospitals have been instructed by the FDA and CDC to notify any person who has had an open-heart surgery within the last 5 years as they may be at risk for infection.
What Are Your Legal Options?
Product and medical device liability claims often are tied to large corporations with vast resources and sophisticated legal teams. Having to navigate through such a complex process alone can be challenging. If you or a loved one have had a cardiothoracic surgery procedure that required the use of HCU and suspect you might suffer from an infection, you may be eligible to seek compensation for your suffering. call the medical device liability attorneys at The Law offices of Peter Angelos.