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Devices used during open-heart surgeries in York Hospital might have caused infections in at least eight patients, four of whom died, according to a WellSpan press release.

The hospital replaced its three or four heater-cooler devices in July 2015, according to the release, and the issue is limited to York Hospital among WellSpan facilities. The devices are used during cardiopulmonary bypass to warm and cool a patient's blood, according to a Department of Health press release.

Cleaning the device: An internal review identified that the hospital's cleaning protocols for the devices did not align with the original guidelines provided by the manufacturer, Sorin Group.

Dr. Hal Baker, WellSpan's senior vice president for clinical improvement, said the device is used in the room during surgery, but doesn't directly make contact with the patient or blood.

"It doesn't connect to the patient, so people really didn't see it as a source of infection," Baker said.

According to the U.S. Food and Drug Administration, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air through the device's exhaust vent into the environment and to the patient.

Sorin recently added a step to the device's cleaning process, which Baker said helped trigger the initial investigation, but the hospital did not periodically run bleach water through the device after it was drained, a step that was initially included.

"I'm not sure that step alone would've provided safety," Baker said. "I don't think the manufacturer thought the device was a risk for infection."

Sorin Group did not immediately respond to requests for comment.

No staff members were reprimanded or terminated in relation to the issue, Baker said.

"Our staff were performing and delivering the best care they could provide," he said. "Our program here is safe; our operating room is safe."

Alerting patients: The hospital sent letters to approximately 1,300 open-heart surgery patients of possible exposure to the bacteria during open-heart surgery procedures performed between Oct. 1, 2011 and July 24, 2015.

Baker said the UPS-delivered letters should arrive at patients' homes Monday. The hospital expects a vast majority of those receiving the letter will not have a problem.

The bacterium — a nontuberculous mycobacterium, or NTM — is typically not harmful, but can cause infections in invasive healthcare procedures. The bacteria, commonly found in water, is not contagious and can usually be treated successfully once identified, according to hospital officials.

The bacteria is slow-growing and can take several months to develop and years before it is correctly diagnosed. Baker said the hospital, as a precaution, is notifying patients who've had surgery as long as 48 months ago.

Affected patients: A joint investigation by the hospital and Centers for Disease Control identified eight probable cases of open-heart surgery patients infected by NTM, and four of those patients are now dead.

All eight were males, ranging from 62-84 years old. The CDC has not directly linked the deaths to the infection, but "it's likely a contributing factor," according to WellSpan's release.

Baker said he believed most, if not all, now-deceased patients were identified as having the infection before dying.

Symptoms of the disease include fever; pain, redness, heat, or pus around a surgical incision, weight loss, night sweats, joint pain, muscle pain, and loss of energy, according to the Department of Health.

WellSpan has created a website, www.wellspan.org/yorkopenheart, that contains information and resources as well as a toll-free nurse call center (866) 217-2970, which is dedicated to answering questions from patients and the community 24 hours a day.

Baker said there is currently no test in the state for those who have been exposed but are not infected. He hopes WellSpan's efforts to alert potentially affected patients will lead to primary care physicians locating the infection earlier, he said.

If identified, antibiotics are used to remove the infection. If a patient has an infection related to open-heart surgery, WellSpan will pay any associated costs, he said.

National issue: Federal health officials believe the issue may be widespread, and the FDA on Oct. 15 issued an alert explaining that it has received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination, but York Hospital is the first to report an issue in the U.S.

"We want to get this information out to other hospitals because the general thought is 'that (device) doesn't touch the patient, how can it cause an infection from 10 feet away?'" Baker said. "Unfortunately, I think we're going to find other hospitals using similar cleaning processes."

— Reach David Weissman at dweissman@yorkdispatch.com.

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