Scientists investigating heart surgery infection causes have found a likely link between certain medical devices and infection.
When undergoing open heart surgery, patients must have their blood and organs maintained at a certain temperature to ensure adequate blood flow during the operation.
A heater cooler device uses water to control temperature. Even though the water never touches the patient, the machine may emit water through its exhaust system, water that once airborne can settle inside the open chest cavity or upon the cardiac implants before they are inserted.
Heart Surgery Infection Causes Include Specific Bacteria
Scientists have found evidence that heater cooler units made at the LivaNova PLC manufacturing facility in Munich, Germany may have been contaminated with Mycobacterium chimaera bacteria during production.
These cardiac heater-cooler units have been linked to patient deaths related to infections worldwide since 2013.
Tests have concluded that the strain of bacteria found in the machines is the same as that found in environmental samples from the production and servicing facility in Germany. The bacteria can be found naturally in soil and water.
Scientists published their study in The Lancet Infectious Diseases journal. They looked at 250 DNA samples of Mycobacterium chimaera and compared it with samples from 33 infected patients. In addition to the LivaNova brand, scientists looked at samples from another German brand, Maquet.
Samples from patients were very similar to the samples from the LivaNova heater-cooler units and from the LivaNova factory.
Scientists also warned that they found some hospital water systems and Maquet units to be contaminated as well, though, leading to the possibility of local contamination.
If local contamination is to blame as one of the heart surgery infection causes, hospitals need to take greater precautions in maintaining and sterilizing the heater cooler devices. The water placed in the machine also is a factor.
The FDA recommends using new accessories, tubing and connectors each time the device is used. The FDA also recommends directing the exhaust fan away from the patient.
The University of Iowa Hospitals and Clinics has gone a step further by placing the heater cooler unit in a room separate from the operating room. The rooms are connected, but the mist is nowhere near the patient.
Dr. Michael Edmond told Kaiser Health News, “I don’t think we can safely say the machines can be decontaminated. The only safe mitigation strategy is you have to separate the air that comes out of that machine from the air in the operating room.”
The hospital reports no new infections have been reported since the heater coolers have been in a separate room, a practice they began in January 2016.
Mycobacterium chimaera is a slow growing bacteria that can take months or years before it becomes an apparent heart surgery infection cause.
If you or someone you know has contracted an infection after heart surgery, you could be eligible for compensation through legal representation.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The cardiac heater-cooler attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, cardiac heater-cooler lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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