The medical device liability attorneys at The Law Offices of Peter Angelos discuss recent occurrences of dangerous infections associated with the use of heater-cooler devices.
Many hospitals use heater-cooler systems to maintain internal body temperature and consistent blood circulation during invasive surgical procedures. Although the devices are used in thousands of surgeries each year, recent reports suggest that heater-cooler systems can become contaminated, and thus have the potential to cause dangerous infections in vulnerable and unsuspecting patients.
What is a Heater-Cooler Device?
Heater-cooler devices (HCD) circulate temperature-controlled water to external machines, which in turn work to warm or cool patients during cardiothoracic procedures and other invasive surgeries. This process helps physicians to maintain the internal body temperature and blood circulation of a patient throughout a procedure, which may assist the patient with recovery. According to the Center for Disease Control, the devices are used in more than 250,000 procedures and in nearly sixty percent of the hospitals across the United States each year.
How Do HCDs Cause Infections?
HCDs are designed to store water in a tank to be used during surgeries. While patients typically do not come into direct contact with the water, it is possible that the water can contaminate other components of the device or spray through small openings in the device and onto a surgical opening. Further, bacteria in the water can aerosolize, and expel through the HCD ventilation system, causing the air surrounding the surgical site to become contaminated.
Many incidences of HCD-related infection involve the presence of Mycobacterium chimaera, a strain of nontuberculous mycobacteria which is commonly found in tap water. Though the bacteria is generally harmless when consumed by healthy individuals, it presents severe infection risks to surgical patients whose immune systems may be vulnerable. M. chimaera-related infections can be particularly difficult to treat in cardiothoracic patients because successful eradication often requires additional surgeries or intensive antibiotic regimens.
Have Reports Been Filed that Connect HCDs with Infection?
Since 2010, more than 30 cases of infection have been reported to the FDA. This includes more than 10 cases specifically identified in hospitals throughout Pennsylvania. Regulators have suggested it is possible that many cases of infection may not have been reported, and indicate that some patients developed infections several months or even years after their surgical procedures—a factor which could make proper reporting of such incidents more difficult for patients and physicians. It should also be noted that the FDA has released numerous safety communications related to HCD-related infections.
Patients’ attorneys have filed claims alleging that they suffered unnecessarily due to defects in HCD devices. Victims and their families continue to inquire as to why the FDA and device manufacturers did not make the public aware of the risks associated with the devices sooner, despite the fact that such evidence was available as early as 2002.
What are your legal options?
If you or a loved one has suffered severe infection, and had previously undergone cardiothoracic surgery that may have required the use of a heater-cooler device, you may be eligible to seek compensation for your suffering. Contact the medical device liability attorneys at The Law Offices of Peter Angelos for additional information, or to schedule a free consultation.