WellSpan continuing work with NTM at-risk patients

David Weissman

The Centers for Disease Control presented its findings earlier this month of an investigation into a bacterial outbreak at WellSpan York Hospital — a study that revealed the first confirmed evidence in the U.S. connecting a specific medical device to Nontuberculous mycobacteria infections.

Dr. Hal Baker sits by a cooler-heater device that might have caused infections in at least 12 of York Hospital's open-heart surgery patients. Monday, Oct. 26, 2015  (Bill Kalina - bkalina@yorkdispatch.com)

Joe Perz, a CDC health care epidemiologist who supervised the investigation, said his team reviewed medical records for 10 identified cases of York Hospital open-heart surgery patients with symptoms of Nontuberculous mycobacteria, or NTM, and 48 patients who had no such symptoms.

The group found during its research that patients' chances of contracting the disease increased with longer exposure to a heater-cooler device, which was a previously unrecognized source of infection, Perz said.

The device is intended to provide temperature-controlled water to heat exchanger devices used during open-heart surgeries lasting six hours or less.

What we know: NTM bacterial infection outbreak

It has no direct contact with the patient during surgery, but further investigation has found a potential for contaminated water to enter other parts of the device or transmit airborne bacteria through the device's exhaust vent into the environment and to the patient.

WellSpan had originally identified eight NTM-infected patients, four of whom died, after York Hospital open-heart surgeries. Those numbers have since climbed to 10 infected patients, six of whom have died, according to WellSpan spokesman Brett Marcy.

One of the four patients still living is no longer experiencing symptoms of the infection and no longer receiving treatment, Marcy said.

York Hospital had originally replaced its heater-cooler devices, manufactured by German-based Sorin Group, with new versions of the same device.

Marcy said the hospital continued to have concerns with those devices and have since replaced them with similar devices manufactured by Ohio-based Cincinnati Sub-Zero.

The U.S. Food and Drug Administration sent a warning letter in late December to Sorin, now LivaNova, alleging multiple violations, including inadequate information regarding the validity of its new cleaning procedures.

FDA: Big issues with maker of device linked to infections

Aside from the patients who have been identified with the infection, York Hospital had notified approximately 1,300 patients who were deemed at-risk based on when they underwent open-heart surgery at the hospital. Marcy said. WellSpan has been able to see or speak with 1,156 of those patients.

"We're working hard to ensure we talk with all of them," he said.

After originally opening a 24-hour call center for patients with questions or concerns about the infection, WellSpan shifted to a dedicated care line, which can be reached at (866) 217-2970.

Marcy said the line deals with approximately 200 calls per week on average, including 472 calls since May 1.

The company also opened an NTM clinic, which offers patients additional monitoring and counseling from infectious disease specialists, on its Apple Hill campus in December, Marcy said. The clinic has seen 446 patients since opening, he added.

The clinic was opened in conjunction with Penn State Milton S. Hershey Medical Center, which identified three of its own patients with NTM infections believed to be related to the heater-cooler devices.

Perz, the CDC epidemiologist, said his team helped move Hershey Medical Center's internal investigation along while it was investigating the cases at York Hospital.

Marcy said WellSpan officials have had multiple conversations with hospitals and health systems across the country regarding the findings.

The only other confirmed case in the U.S. was at University of Iowa Hospitals and Clinics in Iowa City, Iowa.

— Reach David Weissman at dweissman@yorkdispatch.com or on Twitter at @DispatchDavid.