Upstate hospitals warn of possible device infection

surgery

GREENVILLE, S.C. (WSPA) – Upstate hospitals are warning patients of a possible infection due to a device used during surgery.

An Anderson Lawyer, Stephen Welch with McGowan, Hood, & Felder law firm, says between eight and 12,000 people in South Carolina could potentially be affected.

“They may have this bacteria and may not know for 3 to 5 years,” Welch said.

The Center for Disease Control recommended hospitals notify their patients of the issue; although, they did not recommend a recall of the Stöckert 3T heater-cooler devices.

The CDC says they believe bacteria called mycobacterium chimaera contaminated the devices during manufacturing in Germany.

The device helps keep a patient’s body and organs at a certain temperature during surgery.

It is used in 60 percent of open heart surgeries in the country.

“An open chest, or in one situation an open brain, bacteria, it settles in there and starts the infection,” Welch said.

Upstate hospitals say they haven’t had any indication that any of their patients have been infected.

Bon Secours St. Francis had to notify 1500 patients. The hospital says they’ve already ordered replacement devices and are waiting on their arrival.

Greenville Memorial stopped using the device in 2014 after a bacterial infection outbreak which caused a few deaths.

Welch said it was the outbreak in Greenville that caused him to get involved this time. He filed a class action suit as well as individual lawsuits.

“Basically pay medical costs, medical monitoring, because these people will need to be seen by a physician to make sure they don’t have it,” Welch said.

He says he hopes greater awareness will come out of this situation.

“Primary care physicians will be better equipped to recognize it,” Welch said. “People come in with certain symptoms, and they’ll be able to ask if you’ve had open chest surgery as a normal part of their exam.”

Symptoms are similar to a normal infection such as fatigue, high temperature, night sweats, and weight loss which is why it’s hard to detect.

The CDC says patients who had valves or prosthetic products implanted are more at risk for getting an infection.

Read the hospital statements below:

AnMed        

(Anderson, S.C. – Oct. 13, 2016) AnMed Health has used the Stöckert 3T heater-cooler device manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) for about five years with no complications or infections caused by the Mycobacterium chimaera.

The device is used by about 60 percent of the nation’s hospitals to cool and heat the body during certain heart surgeries. The Centers for Disease Control recently found that the devices may have been contaminated by the bacterium during the manufacturing process. The bacterium, which is common in soil and water, does not generally pose a threat to healthy people. It has never been detected in an AnMed Health lab test.

Chief perfusionist Nick Davis says AnMed Health has been aggressive about making sure the devices are disinfected and maintained according to manufacturer guidelines, often going beyond recommended protocols.

AnMed Health will notify all patients who have undergone surgery with use of the Stöckert 3T, with a priority on efforts to reach those who have had surgery in the last four years. AnMed Health also is taking measures to inform current and future surgical patients of the CDC alert and the potential risk of having surgery with the device.

Although the CDC is not recommending a recall of the Stöckert 3T, AnMed Health is already looking for replacement devices.

Bon Secours St. Francis

“Bon Secours St. Francis Health System has ordered new heater/cooler devices to replace the Sorin 3T brand and is currently waiting on the replacements to arrive. In the interim, we continue to follow manufacturer’s guidelines to ensure the safe utilization of Sorin 3T devices for our patients.”

“Bon Secours St. Francis Health System is actively notifying approximately 1,500 patients who had surgeries involving the Sorin 3T device within the past five years. According to our records, no patient within that time frame who had surgery at Bon Secours St. Francis Health System has been identified with any signs of mycobacterium. We are committed to providing the highest quality health care and will replace the Sorin 3T devices as soon as the new devices become available in an effort to be proactive in ensuring the safety of our patients,” said Rose Leo, Vice President of Surgical Services and Women’s Services at Bon Secours St. Francis Health System.

Spartanburg Regional

Per Dr. Chris Lombardozzi, SRHS Chief Medical Officer of Quality

As with many other hospitals in the country, Spartanburg Regional Healthcare System is following guidance from the Federal Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to notify patients about the potential risk of infection from heater-cooler devices used during open heart (open-chest) surgery. To date, SRHS has found no evidence of any heater-cooler-related infections.

 

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