Product News and Recalls

Eyes Turn to Delays at FDA Over Heater-Cooler Infection Blame

fda delayed for years on heater-cooler risksWhen it comes to keeping you and your family safe, most Americans would agree that they’d like to think that the agencies with that responsibility are ready to act on their behalf. That, when a problem arises, they will correct the issue and move to solve it quickly and decisively. Not only will they know what needs to be done, but they will do it when it matters most.

By all accounts however, it looks like the United States Food and Drug Administration may have waited for well over a year to take action after determining that a surge in hospital-acquired NTM infections was tied to the heater-cooler units present in surgical suites during cardiothoracic surgery.

‘Action,’ in this case, might be giving the agency a bit too much credit. A public safety alert was issued in the form of a Safety Communication. Real action, in the form of actual actionable advice to hospitals and patients, wouldn’t come for another two years.

Some believe that a faster response from the agency responsible for keeping our food, medicines, and healthcare equipment safe could have saved lives and limited the number of infections. Heater-coolers spread infection when the exhaust fans of contaminated units blow bacteria out and into the air of a surgical suite. And, while NTM bacteria pose no real threat to a healthy human, a compromised patient undergoing open-heart surgery is a perfect target for an infection looking for a place to take hold and grow.

It is now believed that up to 600,000 patients may have been exposed to NTM bacteria during this time. And, by its very nature, NTM is extremely slow to manifest. In some cases, a patient can show no signs of infection for months, or even years after initial infection.

The Centers for Disease Control caution that the overall risk of infection from NTM exposure is low. Estimates range from 1 in 100 to 1 in 1,000 for any hospital where an NTM infection has occurred. Still, any infection for an immunocompromised patient can be deadly, and patients who have undergone open-heart surgery prior to 2014 are advised to familiarize themselves with the symptoms of NTM infection. Those that exhibit these symptoms should contact their medical team if any symptoms present themselves. Symptoms of NTM infection include night sweats, aches and pains, unexplained weight loss, fatigue, and fever.