Both the CDC and the FDA have recently issued warnings to all U.S healthcare providers certain heater-cooler devices – used in more than 250,000 open heart surgeries each year – had been contaminated and could put patients at risk of a life-threatening infection. While CDC's estimates patient’s risk of acquiring an infection from the devices in the 1 in 100 and 1 in 1,000 range, at least 28 infections have been reported across the U.S. so far and some deaths have already occurred, including two at Wellspan York Hospital. At this time, the CDC is unable to determine whether the infections were a direct cause of the devices due to the health complications patients who underwent these procedures already had.
While medical devices sometimes have unintended consequences, such as transmitting infections, many of them are essential for performing the surgical procedures patients need. Heater-coolers are necessary to regulate patients' blood temperature during open heart surgery. Roughly 699,000 open heart surgeries were performed in 2005, according to the American Heart Association. "One of the things that’s very clear about this particular incident is that heater-cooler units make it possible to do life-saving surgery," Michael Bell, deputy director of the CDC’s Division of Healthcare Quality Promotion told Healthcare Dive.
The LivaNova PLC Stöckert 3T heater-cooler, manufactured in its Munich, Germany and Arvada, Colorado facilities, were contaminated with Mycobacterium chimaera, a bacteria which can affect people with compromised defenses and lead to airborne infections. The first reported case of infection came from clinicians in Pennsylvania, Bell said. "Clinicians there were seeing infections after surgeries," Bell said. The clinicians then consulted the agency to get a better grip on the situation.
After the CDC assessed the environment of care, studied the protocols, analyzed the bacteria to make sure that it had been evaluated correctly and conducted a background check, it found related evidence in Europe.
The agency requested healthcare facilities look at their laboratory records to see if anyone had had infections like those caused by the bacteria and cross-check their surgery records to identify possible patients. The agency provided the breakdown of the infection cases that have been reported:
- Wellspan York Hospital – notified 1,300 patients who underwent open heart surgery and reported 12 infection cases from October 1, 2011 to July 24, 2015
- Penn State Hershey Hospital – notified 2,300 and reported five cases from November 5, 2011 to November 5, 2015
- Penn Presbyterian – notified 1,100 and reported four cases from October 1, 2013 to December 17, 2015
- University of Iowa – notified 1,500 and reported three cases from January 1, 2012 to January 22, 2016
- Mercy Medical Center in Iowa – notified 2,600 and reported two cases from July 1, 2012 to July 1, 2016
- Spectrum Health Medical Center in MI – notified 4,500 and reported two cases from January 1, 2012 to November 10, 2015.
Since hospitals and health systems that used these heater-coolers were made aware of the risk of potential infections, several lawsuits have been filed against LivaNova, which was first notified of "certain violations of FDA regulations" in December 2015, claiming they had not been informed about the contamination,
LivaNova said in a prepared statement it is aware of the CDC's warning and the FDA's safety communication. "We are working with regulators to develop a solution that addresses their concerns and ensures continued clinician access to this important device, which enables lifesaving cardiac surgery," LivaNova Corporate Communications Manager Laurie Ferguson said. "LivaNova and its representatives are proactively and voluntarily contacting 3T heater-cooler users to inform them of the new information in the CDC and FDA communications, and to help facilitate implementation of the agency recommendations outlined in those publications."
The company declined to comment further for this story.
Some providers, including the Cleveland Clinic, University of Michigan Health System, and University of Colorado Health, have taken measures to inform patients they may have been exposed to a potential risk of infection and some have discontinued use of the devices.
Hospital-acquired infections have earned the spotlight as reports show a lack of infection control protocols and procedures. The CDC has made addressing these infections a priority, partly because of the industry’s growing concerns over antibiotic resistance.
Here is what providers that have used the LivaNova device need to know to mitigate risks of infection:
- Ensure the exhaust fan from the machine is not pointing directly to the surgical team or to the tray table that carries their equipment about to be implanted;
- The machine can be moved out into the hallway so the potentially infectious exhausts from the machine are not in the operating room and the tubes can be passed through a hole in the wall into the patients' bedside;
- Heater-coolers can be contained in a steel jacket with an exhaust pipe carrying the contaminated air away from the patient and outside of the operating room;
- If someone has had an operation that used a bypass machine and has had no symptoms, no treatments or testing is required;
- If symptoms have appeared, especially if they are vague and doctors have tried to find a cause and have been unable to treat them with antibiotics, this could be a sign of a non-tuberculosis mycobacteria infection;
- Symptoms must not be ignored even if months since the operation because these bacteria grow very slowly; and
- The FDA is pushing toward a safer product that is designed in a way that does not create the same risk of infection.
Bell also recommended health systems remember "when they’re talking about patient safety, it’s not just about doctors and nurses, but also the individuals who are in charge of purchasing." The people who manage materials, the operating room or the ICU need to be involved with making decisions on which device to buy or how to best maintain the equipment before purchasing it.
"It’s a great opportunity for the decision makers of healthcare systems to bring those partners to the table for some of these discussions," Bell said.