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Aerobiology Laboratory Supports Testing After the CDC Warns Healthcare Providers & Patients That LivaNova PLC Stockert 3T Heater-Cooler Devices May Have Been Contaminated



Aerobiology Laboratory Supports Testing After the CDC Warns Healthcare Providers & Patients That LivaNova PLC Stockert 3T Heater-Cooler Devices May Have Been Contaminated
October 24, 2016
Center for Disease Control (CDC)
Thursday October 13th, 1:00 PM
The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential risk of infection from certain devices used during open heart (open-chest) surgery.
Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever. This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.
Between 2010 and 2015, more than 41 hospitals worldwide, most of them in the U.S., reported bacterial infections linked to the scopes, affecting 300 to 350 patients, according to a memo released by U.S. Rep. Ted Lieu, D-Calif. The lawmaker stressed that those figures likely underestimate the problem since hospitals don’t always test patients for the antibiotic-resistant “superbugs” that cause such infections.
The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) often found in soil and water. In the environment, M. chimaera rarely makes healthy people sick. There is no test to determine whether a person has been exposed to the bacteria. Infections can be diagnosed by detecting the bacteria by laboratory culture. “Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”
U.S. Food & Drug Administration (FDA)
Heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care. They are especially important tools for surgeries involving the heart, lungs, esophagus, and other chest organs (cardiothoracic surgeries). Heater-cooler devices, include tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits.
Aerobiology Laboratory Associates, Inc. was established in 1997 to meet the laboratory testing needs of indoor air quality specialists and industrial hygienists. Aerobiology prides itself in providing high quality, responsive, and cost effective environmental microbiology laboratory services.  Aerobiology Laboratory Associates, Inc. is woman owned full service AIHA-LAP, LLC EMLAP, NVLAP accredited and CDC ELITE certified microbiology lab with six locations in Washington, D.C., Atlanta, GA, Denver, CO, Phoenix, AZ, Pennsauken, NJ, and Los Angeles, CA.
We specialize in the analyses of pathogens for the following:  Healthcare Associated Infections (HAIs), Legionella, USP 797 compliance samples, allergens, asbestos, yeast, mold, pollen, and soot from wildfires.  Aerobiology also offers product validation and research assistance.  At Aerobiology Laboratory Associates, Inc. our success is measured by the success of our customers. We are dedicated to quality service, fast and accurate delivery of test results, and consultative support by experienced experts. For more information regarding our services please visit our website at  Feel free to contact the Laboratory Director, Suzanne Blevins, at (877) 648-9150 or
Press contact: Cole Mackelprang   650-302-2223


 LivaNova PLC Stockert 3T
 open heart surgery
 hospital bacteria

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