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Charla Acker was at work Monday morning when she heard on the news that York Hospital had connected a bacterial outbreak to a device used during open-heart surgeries.

Her thoughts immediately turned to her 58-year-old husband, William Acker, who had undergone an aortic valve replacement surgery at the hospital in March 2014.

"I'm appalled at how (the hospital) handled it, that I had to hear about it on the news," said Charla Acker.

When the Gettysburg woman arrived home that afternoon, she was one of about 1,300 people to receive a letter from WellSpan.

The health care system sent the letter to patients who had surgery as far back as Oct. 1, 2011, because the bacteria — Mycobacterium chimaera, a type of nontuberculous mycobacterium (NTM) — is slow-growing and can take several months to develop and years to diagnose.

"My husband is doing great, back to work, active, but this is a huge dark cloud over us," Acker said. "It's going to cause him stress, and certainly a heart patient doesn't need that."

The infection has been linked to the device in at least eight patients, four of whom died. The earliest death occurred from a 2010 surgery that was diagnosed in 2012, according to WellSpan spokesman Barry Sparks, but the investigation into the potential connection didn't begin until late July of this year.

No steps were taken to investigate the root cause of the first infection — caused by a rare bacteria — because no one could tell it was related to health care, Sparks said.

National problem?: Lawrence Muscarella, who independently advises and audits hospitals on infection control practices at his Montgomery County business, doesn't think national organizations — including the Centers for Disease Control and the U.S. Food and Drug Administration — did enough to inform York Hospital of the potential risk.

Muscarella pointed to an alert sent on April 30, 2015, by the European Centre for Disease Prevention regarding a connection between open-heart surgery patients contracting the Mycobacterium chimaera infection and a heater-cooler unit, which the CDC confirmed was the same device used by York Hospital.

Dr. Joseph Perz, a health care epidemiologist at the CDC, said his organization helped the FDA make the connection with the device but didn't necessarily have a handle on its usage in America at the time.

Timeline: York Hospital officials drew a connection and began an investigation after the European alert and an alert sent by the device's manufacturer — Sorin Group — added an extra step to the device cleaning procedures.

WellSpan contacted the state Department of Health and the CDC on July 20.

The Department of Health required the hospital to replace the devices immediately because of the potential connection between the infection and the devices, which WellSpan admitted its hospital did not clean according to original manufacturer guidelines.

The department's investigation into the incident is ongoing, according to spokeswoman Amy Worden.

Perz, who helped to oversee the investigation, said the manufacturer updating its cleaning guidance indicates the original instructions may not have been sufficient anyway.

After three weeks on site in York investigating the hospital's surgical and microbiology departments and numerous more weeks researching in Atlanta, the CDC issued an alert about the potential connection on Oct. 21, nearly a week after the FDA issued a similar alert.

Some of the results are still preliminary, Perz said, as the CDC has not directly linked the deaths to the infection. WellSpan's release indicated the infection was "likely a contributing factor."

The hospital directly contacted the eight patients known to be affected or their families last week, and Perz said WellSpan has prepared itself well.

Similar case: Muscarella said the CDC and FDA could've helped York Hospital prepare earlier.

Officially, York Hospital is the first confirmed case in the U.S. linking the infection and devices, but the announcement set off a "red flag" for Muscarella, who closely followed coverage last year of a seemingly similar case at Greenville Memorial Hospital in South Carolina.

In May 2014, Greenville Health System began investigating a surgical infection involving a different strand of NTM, also commonly found in tap water, that affected 15 patients, four of whom died, according to a company news release.

The hospital brought in the South Carolina Department of Health and Environmental Control and the CDC to assist in the investigation, which resulted in additional precautions to remove any source of tap water used in the surgical environment.

Those precautions included removing "equipment used for cardiopulmonary perfusion ... (that) used a closed system in which cooled or heated water encased in tubes is run in close proximity to patient blood," according to the release.

The hospital and health department did not respond to a request for confirmation that the device was the same one used by York Hospital.

Perz said the CDC was only used as an off-site consultant on the Greenville case and wasn't given the opportunity to investigate the heater-cooler device there before it was removed.

Hindsight: Greenville's press release was published July 21, 2014. One of the four dead in connection with the York Hospital outbreak had his surgery on Dec. 15, 2014, according to Sparks.

Perz said he's "certainly curious in hindsight" whether it possibly played a role and said he has heard comments from medical colleagues since the connection was made about other past bacterial investigations potentially resulting from this device.

Hindsight isn't enough, according to Muscarella.

"Health care needs to be more pre-emptive. York is a microcosm of what's going on in our country," said Muscarella, who added that much of his research has involved the use of tap water in hospitals. "Tap water should never be used near a surgical procedure ever."

— Reach David Weissman at dweissman@yorkdispatch.com.

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