WellSpan York (Pa.) Hospital is notifying about 1,300 patients who underwent open-heart surgery at its facility in the past four years that they may have been exposed to harmful bacteria from a medical device used during the procedure.
A joint investigation by the CDC, the state Department of Health and WellSpan identified eight open-heart patients at WellSpan York Hospital who developed bacterial infections, and four of those patients have died. Less than 1 percent of patients who received open-heart surgery at the hospital in the last four years have presented signs of the infection, according to WellSpan.
The bacteria in question, a nontuberculous mycobacterium, is commonly found in nature and typically is not harmful. However, in people with weakened immune systems, it can be a more serious concern.
The devices in question — heater-cooler machines — are used during open-heart surgery to regulate temperature. There is potential for the water used in the machine to become contaminated with the bacteria. The bacteria can become airborne through a vent on the device and then transmit to patients, according to the Food and Drug Administration.
The device manufacturers issued a safety notice in June that updated guidelines for proper maintenance. However, Hal Baker, MD, an infection preventionist at York Hospital, told the New York Times that hospital workers had been using cleaning guidelines first published in 2010 and were not following them precisely.
In response to these infections, the hospital replaced its heater-cooler devices with new equipment in July 2015. "The new equipment is being meticulously maintained according to the enhanced cleaning procedures," said Keith Noll, senior vice president of WellSpan Health and president of WellSpan York Hospital.
In the letter sent to the open-heart surgery patients, WellSpan York Hospital encourages patients to see their primary care physician and monitor their health for possible NTM infections for four years after their open-heart surgery. NTM infections can be treated successfully once identified, according to hospital officials.
Other healthcare facilities in the U.S. and in Europe may have the same problem with the heater-cooler devices, and the CDC and the FDA have issued safety advisories about the link between NTM bacteria, heater-cooler devices sand infections in open-heart surgery patients.
"While it is still unknown whether other U.S. Hospitals using similar equipment during open-heart surgery may also have patients with bacterial infection, our work with the DoH and the CDC provides a template for other hospitals to follow in identifying and addressing this possible potential risk to patients," said Noll.
WellSpan has established a dedicated website, found here, that contains resources and information for concerned patients and medical providers.