IOWA CITY — One University of Iowa Hospitals and Clinics patient has been diagnosed with a potentially-fatal bacterial infection connected with a type of bypass machine, and university officials say there could be more, which is why they’ve sent letters to about 1,500 patients who could be at risk.
So far, just one UIHC patient has been identified with an infection believed to have stemmed from use of a heater-cooler device employed during certain major heart, lung, and liver surgeries. And, having replaced their four old devices with new equipment while also heightening maintenance and disinfecting procedures, UI officials said they’re confident “the risk of this bacterial exposure has been eliminated.”
“We regret that any patient within our care could be affected by this situation and apologize for any concern it causes,” according to a UI news release. “We are absolutely committed to making sure our patients have the information and care they need.”
The U.S. Food and Drug Administration in October issued a warning that heater-cooler devices commonly used in surgery to warm and cool patient blood have been linked to Nontuberculous Mycobacterium infections. The bacteria are slow growing and found in surface water, tap water, and soil, and researchers discovered fans used in the heater-coolers can spread the bacteria to patients.
In addition to warning health care providers about the possible link, the FDA has updated instructions for maintaining, cleaning, disinfecting and monitoring the devices. The Centers for Disease Control and Prevention has provided guidance on identifying patients and infections.
“Patients who might have been exposed to (the bacteria) during a surgical procedure should continue to look for signs of potential infection,” according to a CDC notice. “Due to the potentially long delay between exposure to (the bacteria) and manifestation of clinical infection (up to several years), identifying infections related to the use of heater-cooler devices can be challenging.”
UI officials said the hospitals were exceeding manufacturer guidelines for disinfecting and maintaining the devices before the warning, and they’ve updated those procedures based on the new recommendations.
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Due to privacy concerns, the university is providing few details on the patient diagnosed with the related bacterial infection, including whether he or she is or has been treated and what type of procedure the patient originally underwent that led to the infection.
Theresa Brennan, cardiologist and chief medical officer for the UIHC, said the hospital learned of the patient diagnosis Jan. 19 and made the connection to the heater-cooler Jan. 20. By Jan. 23, the old equipment had been replaced, Brennan said.
The hospitals and clinics on Monday began sending letters to about 1,500 of its patients potentially subjected to the heater-cooler-related infections in the last four years — between Jan. 1, 2012 and Jan. 22 of this year.
For those who underwent operations before that, officials said, the increased risk has passed.
And even patients who fit the at-risk criteria have a low chance at being infected — less than 1 percent, according to the CDC. But any UI patients who receive the letter and need an appointment will not be charged for the visit.
Brennan said some of the patients who were sent letters already have called the hospital to, at a minimum, report having received the letter. Patients diagnosed with the infection can be treated with a cocktail of antibiotics, Brennan said, although some hospitals nationally have reported deaths connected with the infection.
The New York Times in October, for example, reported at least eight patients at a Pennsylvania hospital had developed the bacterial infection from the heater-cooler devices. And at least four of those patients died — although officials said it wasn’t clear whether the infection was the primary cause.
Symptoms of the infection include fever lasting longer than a week; pain, redness, heat, or pus around the surgery site; night sweats; joint pain; muscle pain; loss of energy; and failure to gain weight or grow in infant cases.
The bacteria can’t be spread by contact, officials said. And patients who had other types of procedures — like those involving stents, pacemakers, defibrillators, ablations, biopsies, and other surgeries — are not at risk.
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Brennan acknowledged the concern some patients might have and stressed the “safety and well-being of our patients is our first concern.”
“We are focused on helping them understand the risk and to seek the correct medical evaluation and treatment if they develop symptoms,” Brennan said in a news release.
Michael Edmond, chief quality officer and UIHC epidemiologist, said the university remains “confident that we are doing everything possible to safeguard the health and safety of our patients.”
UnityPoint Health – St. Luke’s Hospital in Cedar Rapids also uses the devices in question, and officials on Thursday told The Gazette they received notice from the manufacturer in June to change the cleaning process along with new recommendations and testing guidelines.
Those were immediately put into practice, and officials said the hospital has no reported cases.