Expert says he warned of machine used in Children's Hospital heart surgeries

An expert says he warned about a machine that is believed to be at the center of infections acquired by some children who had open heart surgeries at Children's Hospital.

Twelve children are currently fighting an infection in Children's Hospital. It is believed it came from a medical device used in open heart surgery that can trap bacteria, then release it in the air during surgery.

After WWL-TV's story ran Monday night, an expert on device safety, contacted Eyewitness News to explain why he's been warning the government for years that this could happen.

He's been concerned that reusable open heart surgery heater-cooler machines potentially could not be adequately decontaminated after cleaning.

"In 2014, I suggested and published that this would turn out to be probably a national concern, and possibly a national calamity if proper mitigations were not developed and immediately implemented," said Bioengineer Dr. Lawrence F. Muscarella,  President and Owner of LFM Healthcare Solutions, LLC in Montgomeryville, Pennsylvania.

Dr. Muscarella says it took the CDC a couple of years to confirm the suspicions that he was raising, that the heater-cooler machines could be a source of spreading different types of infections, even when cleaned following the manufacturers recommendations.

"I think I've identified as many as 60 instances, 60 different medical facilities in North America, three quarters of that in the United States that have suspected a heater-cooler device could have either exposed or infected patients." 

In the past, he says oversight was backwards. The FDA relied on the manufacturer to tell them that the disinfecting procedures worked. Now after people across the U.S. have died from two types of infections, the manufacturers have to demonstrate to the FDA that the devices can be cleaned before it goes on the market. Now he is asking for more proof of safety.

"So I'd like that the FDA come out and distinguish those devises it thinks are safe, and those that it think are not," he explained.

The doctor says that the devise made by one manufacturer, the Stockert 3T, appears to responsible for most of the infections.

He says sterile water should be used in it, and that ice used in heart surgery should also be made from sterile water, not tap water.

The FDA did not respond to Eyewitness News by air time.

 

The CDC's response on the matter is below:

Manufacturer and FDA guidance for cleaning and disinfection of heater-cooler devices should be followed. FDA and the manufacturer will be best suited to answer questions regarding testing and cleaning/disinfection for NTM of medical devices such as the Stockert 3T heater-cooler device.

CDC had issued case-finding guidance in 2015 and 2016 for healthcare facilities to help identify patients with NTM infections potentially related to heater-cooler exposure and included all NTM infections. For more information click here

© 2017 WWL-TV


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