Heater-Cooler Machine Spreads Germs in Sterile Areas

The medical device sounds well-intended enough: a heater-cooler machine used during heart surgery to control a patient’s body temperature. Doctors employ them in the hundreds of thousands of cardiac procedures they conduct every year in hospitals across the country. Turns out, the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler machine has a design flaw.

The design flaw causes the water in the device, which provides warmth or cooling via temperature exchangers such as blankets, to become contaminated with bacteria. The bacteria then spreads to other parts of the machine and is vented into the air during operations. More than 45 infections and at least nine deaths are linked to the European product, according to Consumer Reports.

“A wet machine with a big fan can result in these organisms,” Dr. Michael Bell, of the Centers for Disease Control and Prevention, told the magazine in an article titled “An Essential Heart-Surgery Device Poses a Rare but Deadly Risk.” “We need a better way of managing machines like this or a better design that doesn’t have that problem.”

Specific Bacteria at Issue

The bacteria is identified as M. chimaera, a type of nontuberculous mycobacterium that grows slowly but steadily. Nontuberculous mycobacterium breeds in water, as well as in soil, and sickens healthy patients during the course of several months. Symptoms include fatigue, fever, muscle aches, night sweats and weight loss. While there is no test to detect M. chimaera, laboratory cultures can be taken to determine whether someone has it.

“We know there are infections out there that are going undiagnosed,” University of Iowa Hospitals & Clinics Dr. Michael Edmond told Consumer Reports.

Heater-Cooler Machine - Operating Room - Courtesy of Wikimedia user PFree2014
Heater-cooler devices are used in operating rooms similar to what is pictured.

Edmond’s facility, as well as others in Michigan and Pennsylvania, have been contaminated by heater-cooler machines, and lawsuits have followed. The problem has become so bad that the ECRI Institute, a federal patient-safety organization, declared the machines No. 5 on the “Top 10 Health Technology Hazards for 2017” list.

“The likelihood of infection during surgery is not fully understood,” according to the list. “However, these infections can be life-threatening and have resulted in patient deaths.”

Healthcare Advisories Issued by US Health Agencies over Heater-Cooler Machine

Both the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have issued advisories to healthcare providers requesting that patients be warned of the risk of M. chimaera. The advisories are aimed at consumers and suggest that, prior to any open-chest surgery, a physician be consulted to weigh the dangers with the benefits.

“Patients with concerns about infection risks should consult with their doctor,” the FDA advisory states. “However, life-saving surgical procedures should not be delayed. Patients should ask their doctor what to expect following their procedure and when to seek medical attention.”

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