One dozen children contracted the rare bacterial infection mycobacterium abscessus following pediatric-heart surgery at Children’s Hospital in New Orleans. The rash of heater-cooler infection cases prompted swift action from the hospital.

The culprit is a heater-cooler machine, specifically the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T. The machine is used to control patients’ body temperatures. It cools the patient when their heart is stopped and warms them when it is started again.

Both the Centers for Disease Control and Prevention (CDC) in Atlanta and the U.S. Food & Drug Administration (FDA) in Silver Spring, Md., have warned the public about the problem associated with heater-cooler devices.

CDC Issues Health Alert for Heater-Cooler Infection

The CDC issued a health alert, and the FDA is conducting an investigating. “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,” the CDC states on its Web site. “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.”

stockert 3t heater cooler lawsuit“Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming / cooling blankets through closed circuits,” the FDA states on its Web site. “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.”

The 12 tiny patients at Children’s Hospital are not experiencing life-threatening infections, their doctor said.

“Our patients are responding to treatment,” Dr. John Heaton, chief medical officer, told WWL-TV in a story titled “12 children treated for serious infection after heart surgery at Children’s Hospital.”  He stated that “No one is in imminent danger at this point that we can tell.”

The children contracted the infection just as the FDA described. A design flaw in the Stöckert 3T causes the water in its tanks to develop a common bacteria. This bacteria is naturally found in dirt and dust and also in municipal water systems. The bacteria then is vented into the air and inhaled.

“It’s a bug that’s a normal contaminant…but it’s not harmful if you drink it in low quantities,” Dr. Heaton said.

Patient Surveillance Prime Heater-Cooler Infection Prevention Tactic for Hospitals

Children’s Hospital initially noticed four patients with redness and wetness around their chest incisions,  prompting emergency rounds to find out whether other patients’ incisions were infected.

“We were able to jump on this pretty quickly,” Dr. Heaton told The New Orleans Advocate in a story titled “Children’s Hospital in New Orleans says 12 patients contracted rare infection after recent heart surgeries.” “We surveil our patients pretty intensely, and when we had several patients present (symptoms) within a 72-hour period, that set off a red flag right away.”

The surgeries took place this summer. In August, the hospital sent out a letter to the families of 55 patients. Those contacted were potentially at risk of a heater-cooler infection.

“We regret that any of our patients could possibly be affected by this infection,” Dr. Heaton wrote in the letter. “Our thoughts are with those involved, and we apologize for any anxiety caused by this communication. Our response team has also consulted other hospitals that have dealt with the same issue in the past for guidance and information regarding lessons learned and best practices for treatment.”

Heater-Cooler Infection Cited as Huge Problem in Surgical Suites

Infection in surgical suites is a huge problem. Once started, it very often requires the closure of hospitals or portions of hospitals to eradicate the problem. Most hospitals have a high vigilance level for infection control because the cost to a hospital, both short-term and long-term, is astronomical.

Surgical-site infections, or SSIs, are responsible for between 14 and 17 percent of all infections acquired in hospitals, according to the Journal of Preventative Medicine and Hygiene. SSIs are divided into three categories: superficial infections, deep incisional infections and infections involving organs or body spaces. The latter two account for an approximate 50 percent of all SSIs in the United States.

“Factors causing surgical site infection are multifarious,” the Journal states. “The rate of surgical wound infections is strongly influenced by operating theatre quality, too. A safe and salubrious operating theatre is an environment in which all sources of pollution and any micro-environmental alterations are kept strictly under control. This can be achieved only through careful planning, maintenance and periodic checks, as well as proper ongoing training for staff.”

Children’s Hospital has set up an around-the-clock hotline at (504) 896-2920 and took the Stöckert 3T out of service.

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