Alaska Injury Law Blog
The FDA and the CDC have recently warned the public about the risk of contracting nontuberculous mycobacterium (NTM) infections associated with the use of the Sorin surgical blankets during cardiac and thoracic surgery. These surgical blankets help maintain a patient’s body temperature during surgery. NTM are bacteria commonly found in water and in the environment. Water is used in the temperature control process and, although it does not come in contact with the patient, it is suspected that it may enter the surgical theater during venting. Typically not harmful, NTM can create significant infections for patients when exposed to NTM during this type of surgery, or when a patient is suffering from a compromised immune system.
The FDA first noted this problem in a safety recall involving the Sorin 3T system, and then issued a safety communication on October, 2015, following it with a second safety communication in June, 2016. The CDC similarly issued a warning in October, 2015.
A significant concern for patients is that the latency period can be as long as 5 years as NTM infections are slow growing. Also, NTM infections have many manifestations that are often nonspecific and make it difficult for a patient or a physician to readily identify that an infection is at work, or even that an infection was associated with this type of exposure. Without knowing to look for the particular bacterium, it is often missed in a typical patient workup, but can be identified if specific testing is done. This type of infection is also new enough that medical literature does not yet exist to provide clear recommendations for treatment.
The stakes are high for patients, however, as NTM infections can be associated with cardiac complications, organ compromise, bone infections, and immunological effects. Patients should be alert to these concern if they begin to suffer: fever, pain, redness, heat, or pus around a surgical incision,; night sweats; joint pain; muscle pain; weight loss; or fatigue.
Sources:
FDA, Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication, October, 2015.
CDC, Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices, October 2015.