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The state Department of Health and U.S. Food and Drug Administration have assured York Hospital and other health facilities that a device recently linked to bacterial infections is safe for use with new cleaning procedures, but questions regarding the process to ensure safe use — past and present — remain unanswered.

During a Thursday afternoon conference call, state Secretary of Health Dr. Karen Murphy said she has no reason to believe York Hospital and Penn State Milton S. Hershey Medical Center are unique in their use of the heater-cooler devices, which are widely used nationwide during open-heart surgeries. The two facilities have thus far identified 11 patients infected with a nontuberculous microbacteria, or NTM, believed to be related to the device. Seven of them have died.

Murphy said the department is directing all Pennsylvania hospitals using the device to follow the new guidelines and review their records to try to identify NTM-infected patients who underwent open-heart surgery.

The department forced York Hospital and Hershey Med to replace their devices once infections were identified, and the department has ensured their safety under the new guidelines, according to WellSpan spokesman Brett Marcy.

The department did not respond to questions about the process it used to ensure the new guidelines made the device safe for use, whether it has instructed other hospitals to test its devices for the bacteria or how it plans to monitor hospitals' compliance with the new guidelines.

Concerns: Lawrence Muscarella, who independently advises and audits hospitals on infection-control practices at his Montgomery County business, said his thorough review of the infection outbreaks at these two hospitals has raised concerns of far-reaching implications.

"It is possible that state and federal health officials, particularly the FDA, did not previously review the manufacturer's validation test data to ensure that, when hospital staffers strictly adhere to the manufacturer's decontamination instructions ... patients are not infected," Muscarella said. "If I am right, then these most critical devices being used in operating rooms on the sickest and most vulnerable of patients were not properly scrutinized and vetted by health authorities prior to their being marketed to hospitals to confirm they work properly and safely."

Protocols: The FDA, which has the authority to ban the use of medical devices in the U.S., labels heater-cooler devices as Class 2 medical devices and reviews manufacturer applications to clear devices for marketing, according to spokeswoman Deborah Kotz.

Class 2 medical devices are considered medium risk, with class 1 being lower risk and class 3 being high risk, according to the FDA website. The FDA also considers condoms to be class 2 medical devices.

Kotz wrote in an email that the FDA reviews elements, including proposed labeling for cleaning and disinfection instructions, but she did not directly respond to questions regarding whether the FDA, or any governing body, ensures that the proposed cleaning and disinfection instructions are adequate for safe use.

The FDA issued an alert on Oct. 15, urging users of the devices to "strictly adhere to the cleaning and disinfection instructions provided in the manufacturer's device labeling," and the administration is continuing to allow hospitals to use the device, according to Kotz.

But when asked whether the FDA has ensured that these new guidelines are completely effective, Kotz wrote that the administration is working with manufacturers to review their recommended protocols.

Instructions: Sorin Group, the German-based manufacturer of the devices used by both York Hospital and Hershey Med, wrote that it has been "collaborating proactively with the FDA ... since 2014 on this issue."

Muscarella wrote that if the new instructions haven't been properly vetted by the FDA or Department of Health, "this oversight would have significant implications to the public and hospitals, not just in York, but all across U.S."

"Replacement of the old heater-coolers with new ones may only temporarily prevent infections, until biofilms of the bacteria grow again," he wrote. "If anything, the manufacturer's new instructions are lengthy, taxing and cumbersome to perform, and, for some hospitals, they will likely prove to be too infeasible to execute."

Part of the FDA's current review is to ensure the new procedures can be understood and followed by medical staff, Kotz wrote.

Sorin details its new procedures in 56 steps on a video posted to its website recently. Marcy said the initial cleaning procedure — which WellSpan has admitted it didn't follow — was only about six steps.

While Marcy did not know the average length of time to complete the new process, he said all WellSpan staff who clean and operate the device have received "ample" and documented training, and staff members are required to check off each step as it's completed to ensure uniform compliance.

In addition to following the new guidelines, WellSpan has been regularly testing its new devices for bacteria and hasn't seen any positive cultures, Marcy said.

York: When WellSpan discovered, through investigation with the Department of Health and Centers for Disease Control, the potential connection between the devices and infections, it sent letters to 1,300 patients who had open-heart surgery at York Hospital during a four-year period.

In addition to the eight infections, which "likely contributed" to five deaths, WellSpan found that 264 patients who had open-heart surgery during that time frame have died, according to Marcy. Marcy said he's been told there's no way to determine if any of those patients were exposed to the bacteria.

This lack of knowledge further concerns Muscarella.

"The possibility cannot be ruled out that, at the time of their deaths, thousands of patients across the U.S. had been exposed to and carriers of NTM due to contaminated heater-cooler devices, and no one would know," he wrote. "This might cause the manufacturers and regulators to become (relaxed), because only rare NTM infections can be identified, not exposures."

Moving forward, Muscarella recommends that all open-heart patients are monitored for the infections, and those who die should be tested for the infection, to better assess the risk of these devices.

— Reach David Weissman at dweissman@yorkdispatch.com.

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