Affected hospitals left in dark on device maker violations

David Weissman
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 -

The FDA identified multiple issues with the new cleaning process of a device linked to deadly infections in local heart surgery patients, but the area hospitals involved weren't notified of the violations for more than four months.

On Dec. 29, the U.S. Food and Drug Administration sent a warning letter to LivaNova, formerly Sorin Group, the manufacturer of heater-cooler devices that have been linked to infections in open-heart surgery patients at WellSpan's York Hospital and Penn State Milton S. Hershey Medical Center. The two hospitals have identified a total of 11 infected patients, seven of whom are dead.

The letter, which is available on the FDA's website, indicates that the administration inspected Sorin's facilities in Munchen, Germany, and Arvada, Colorado, in late August and immediately informed representatives at the Munchen facility of multiple violations.

FDA: Big issues with maker of device linked to infections

When contacted by The York Dispatch on Tuesday, WellSpan spokesman Brett Marcy said no one in his organization was aware of those violations or had seen the Dec. 29 letter until it was brought to their attention. Hershey Med spokesman Scott Gilbert wrote in an email that his organization was made aware of the letter by a LivaNova representative on Tuesday.

FDA spokeswoman Deborah Kotz wrote in an email that the warning letter is only intended to inform the firm about violations. The FDA is continuing to refer users of the device to the administration's Oct. 15 safety communication, which recommends strictly adhering to the manufacturer's updated cleaning and disinfection instructions.

Marcy said Wednesday that WellSpan officials are now reviewing the letter and continuing to work with the FDA for support.

Gilbert wrote that infectious disease specialists at Hershey Med are exploring what they and others believe is a flaw in the design of commonly used heater-cooler equipment.

"We also feel it’s important to note that for patients requiring an open-heart procedure, the risks of forgoing surgery far outweigh the risks they would have of acquiring any infection during surgery," he wrote.

According to the warning letter, the FDA is working to refuse further entry of the devices into the United States.

LivaNova representatives did not respond to multiple requests for comment, but it did post a letter on its website about the FDA's warning that it intends to send to customers.

The letter, written by Vice President of U.S. Sales and Marketing Sean McNerney, informs customers that they may continue using the device and urges them to continue following its updated cleaning and disinfection procedures.

Kotz wrote that the FDA does have some concerns about the safety of these devices, but they have not issued a recall.

"These devices do serve a critical need for improving patient outcomes from many types of surgery," she wrote.

However, those concerns might soon be enough to warrant the FDA alerting health care providers, patients and consumers.

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On Dec. 31, the FDA drafted a document intended to provide guidance on the agency's policy with regards to notifying the public about potential issues with medical devices.

Historically, the FDA has, in most cases, communicated important medical device information only after reaching a decision about "relevant recommendations for the device user community," according to the document.

Based on several factors, including the seriousness of the adverse event and potential from mitigating a risk, the document argues that it may be beneficial to alert the public prior to official recommendations being distributed.

Kotz wrote that the guidance was not written in response to any specific device or issue.

The document, which seeks comments for 60 days after its publication, would still only be a recommendation and is "not binding on the FDA or the public."

— Reach David Weissman at