The medical device liability attorneys at The Law Offices of Peter Angelos provide important health-risk information related to heater-cooler devices.
Nearly sixty percent of hospitals in the United States use heater-cooler systems to maintain internal body temperature and consistent blood circulation during invasive surgical procedures-approximately 250,000 procedures each year. However, recent reports suggest that the devices can become contaminated and thus have the potential to cause dangerous infections in vulnerable patients.
Heater-cooler devices (HCD) are used primarily during cardiothoracic procedures, and other invasive surgeries, in conjunction with external machines that warm or cool patient’s bodies throughout surgery. 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. The devices are designed to store water in a tank, which is then funneled through closed water circuits to external heat exchangers or to warming/cooling blankets during the heating or cooling process.
While patients typically do not come into direct contact with the water in the HCD, 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.
Several incidences of reported HCD-related infection involve the presence of Mycobacterium chimaera, a strain of nontuberculous mycobacteria which is commonly found in tap water. Though the bacteria are typically harmless when consumed by healthy individuals, it presents severe infection risks to surgical patients, as their immune systems are in a vulnerable state post-operation. When infection is detected in such patients, treatment often requires additional surgery and intensive antibiotic regimen, for which a surgical patient’s body may not be fit.
FDA Informs of Risk Related to Heater-Cooler Infection
The FDA has released numerous safety communications related to HCD-related infection. As of January, 2017, more than 30 cases of infection have been reported, including 10 that specifically linked to hospitals in 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.
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.