Becker's Clinical Quality & Infection Control

24 INFECTION CONTROL & PATIENT SAFETY Specific Type of Heater-Cooler Linked to Life-Threatening Infections, CDC Warns: 9 Things to Know By Heather Punke T he CDC issued a warning in October that one type of heat- er-cooler device — used in about 60 percent of bypass pro- cedures in the U.S. each year — could be spreading a serious bacterial infection and urged hospitals to take immediate action. Here are nine things to know about the devices, the infections and CDC's suggested action plan. 1. In 2015, news broke of open-heart surgery patients in the U.S. and Switzerland coming down with nontuberculous mycobacterium, or NTM, infections. Investigations linked the infections to heater-cooler devices used during the surgeries, and thousands of patients were notified of infection risk. In response to the infections, the CDC and the Food and Drug Administration issued separate guidance on the heater-cooler machines in 2015. 2. Aer an investigation, the CDC said Oct. 13 the infections are linked to a specific brand of heater-coolers — the Stöckert 3T heater-cooler devices, made by LivaNova (formerly Sorin Group Deutschland). 3. Officials believe the devices were contaminated with Mycobacteri- um chimaera, a species of NTM bacteria, during manufacturing, since the bacteria were found at the manufacturing site in Germany. 4. Mycobacterium chimaera are oen found in soil and water, and when in the environment, rarely make people ill. However, when contracted during an open-heart procedure, the bacteria can cause difficult-to-diagnose infections, as they are slow growing. e infec- tions can be life-threatening. 5. It is believed the bacteria are aerosolized from the device, which then can result in a serious infection. 6. Stöckert 3T heater-cooler devices are used in roughly 60 percent of open-heart bypass procedures in the U.S., according to the CDC. Since more than 250,000 heart bypass procedures use heater-coolers annually in the U.S., hundreds of thousands of patients could be at risk of an NTM infection from the Stöckert 3T heater-coolers. e CDC estimates the risk of a patient getting an infection is between 1 in 100 and 1 in 1,000. 7. Michael Bell, MD, director of the CDC's Division of Healthcare Quality Promotion, urged hospitals to take action based on this news. "Hospitals should check to see which type of heater-coolers are in use, ensure that they're maintained according to the latest manufac- turer instructions, and alert affected patients and the clinicians who care for them," he said. 8. e FDA also issued a safety communication in October on the devices, recommending hospitals "strictly adhere" to manufacturer instructions, establish regular cleaning for the devices and direct the heater-cooler's vent away from the patient "to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and expos- ing the patient." 9. e CDC also issued a Health Advisory on its Health Alert Net- work regarding the devices. According to that alert, hospitals should tell patients who are experiencing NTM infection symptoms to seek medical care and put a plan in place to communicate risks to poten- tially exposed patients. n Should Patients Fear Friday Surgeries? By Heather Punke T hough previous studies sug- gested patients may be more likely to die if they had surgery on Friday as opposed to Monday, a Canadian study published in CMAJ in October could assuage some of those fears. For instance, one 2013 study in the BMJ suggested the risk of death after elective procedures on Fridays was 44 percent higher than if the surgery had been performed on a Monday. But the more recent Canadian study did not find the same problem. Re- searchers examined roughly 403,000 elective surgeries performed by 1,619 surgeons at Ontario hospitals from 2002 to 2012. While they did find surgeon experi- ence varied substantially day to day, with those working Fridays having less experience than those working Tues- days or Wednesdays, they did not find an increased risk of death for patients going under the knife on Fridays. "Our data suggest that despite dif- ferences in surgeon experience, the risk of 30-day mortality after elective surgery was similar, regardless of which day of the week the procedure took place," said Luc Dubois, MD, the study's lead author. n

• Cover