LINKEDINCOMMENTMORE

Infections related to a device used during open-heart surgeries have officially been found in the U.S. outside of Pennsylvania.

University of Iowa Hospitals and Clinics recently began notifying approximately 1,500 patients of possible exposure to Nontuberculous mycobacteria, or NTM, according a hospital news release.

NTM is a slow-growing organism and can take several months to develop into an infection and years before it is correctly diagnosed. The vague symptoms of an NTM infection, which include fever, weight loss and back aches, make the infection particularly difficult to diagnose, according to state Department of Health officials.

One University of Iowa Hospital open-heart surgery patient has developed the NTM infection, which is believed to be related to "the use of heart-lung bypass machines with heater-cooler systems," according to the release.

Hospital officials were unable to immediately confirm that the device being mentioned is same heater-cooler device, manufactured by German-based Sorin Group, that was first identified in the U.S. as being linked to infections at York Hospital last October.

The device was later also linked to NTM infections at Penn State Milton S. Hershey Medical Center. A total of 11 patients at the two hospitals have been identified with the infection. Seven of those patients have died.

The Centers for Disease Control and Prevention and U.S. Food and Drug Administration have each issued notices regarding the device since York Hospital first identified the risk.

Sorin Group, now owned by London-based LivaNova, updated its cleaning and disinfection protocols for the devices after they were first linked to NTM infections in Europe, but the FDA recently sent the manufacturer a Warning Letter indicating that its new protocols are insufficient.

The FDA wrote in its letter that it would take steps to prevent the device from being shipped into the U.S. until corrections are made, but it continues to allow hospitals currently using the device to continue to do so.

— Reach David Weissman at dweissman@yorkdispatch.com.

LINKEDINCOMMENTMORE
Read or Share this story: https://www.yorkdispatch.com/story/news/health/2016/02/05/iowa-hospital-reports-same-infections-york-hospital/79883610/