Heart patients at risk from infection and battery malfunction
Patients with heater-cooler devices used for heart bypass procedures are at potential risk of infection, warns the CDC; some of the patients involved in CDC's investigation have died due to these infections and around 250,000 heart bypass procedures in the US use these heater-cooler devices. At the same time, St. Jude Medical has warned that a battery malfunction in its implanted heart defibrillators could cause 350,000 of its devices to quickly lose power and stop working. The malfunction was found in 2014, and St. Jude said it had resolved the issue by 2015. Two patients have already died after their defibrillators malfunctioned, according to the Food and Drug Administration.

Dive Brief:

The CDC issued a warning Thursday to all healthcare providers and patients about a potential risk of infection from certain devices used for heart bypass procedures.

The warning comes in the heels of information that indicated some LivaNova PLC Stöckert 3T heater-cooler devices could have been contaminated while being manufactured and cause life-threatening infections.

About 60% of all heart bypass procedures in the U.S. use the devices linked to these infections, the agency said.

Dive Insight:

The CDC says upwards of 250,000 heart bypass procedures in the U.S. each year​ use the heater-cooler devices. Some patients in the CDC's investigation of these devices have died due to infections though the agency is uncertain whether the infections were directly related to their deaths. ​

In the CDC’s investigation, where there was at least one infection, the patient’s risk of acquiring an infection was in the 1 in 100 and 1 in 1,000 range. Patients who received valve or prosthetic implantations may more likely to acquire the infections.Guidance for hospitals and healthcare providers was also issued Thursday in an effort to help them identify which patients might have been exposed to an infection.

Antibiotic resistance has increased the pressure to address hospital-acquired infections. Certain pathogens have already been deemed urgent threats, such as C. difficile. One-third of 3,100 hospitals in a recent Consumer Reports review received poor scores for being unable to properly control C. difficile.

"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,”said Michael Bell, deputy director of CDC’s Division of Healthcare Quality Promotion.