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The manufacturer of a device connected to York Hospital's recent bacterial infection outbreak requested confirmation that its customers received a letter warning about the possibility of infection and understood the risk.

The "Important Information" letter, sent to all customers of the manufacturer's heater-cooler device in July 2014, according to Sorin Group, begins:

"Dear Valued Customer, We would like to bring to the attention of our customers a newly identified risk for cardiac surgery patients. Some cardiac surgery patients have been infected with a slow growing Mycobacterium chimaera."

The Mycobacterium chimaera, a nontuberculous mycobacteria (NTM), has been identified in eight infected open-heart surgery patients — four of whom died — who were operated on at York Hospital.

Last week, WellSpan sent letters to 1,300 patients who were deemed at risk after an investigation that began this July identified a probable link between the infections and the heater-cooler devices.

No receipt: WellSpan spokesman Brett Marcy, in a media statement, wrote that the company has been unable to confirm receipt of Sorin's letter, but that WellSpan will be "open and transparent regarding that information" if they are able to eventually confirm receiving it.

Marcy added that WellSpan has learned that the hospital received a bulletin containing information about possible issues with the machine in August 2014 via a third-party notification system, but the bulletin was not fully shared throughout the WellSpan organization.

"We are investigating that communication breakdown to learn how and when it occurred and to ensure that it will not happen again anywhere in our organization," Marcy wrote.

Sorin's letter includes three attachments: one explaining the risk of the bacteria and difficulty in identifying it due to its slow-growing nature, one reinforcing the importance of following the company's cleaning instructions — which WellSpan admittedly didn't completely follow — and another that requests its customers check off whether they do or do not understand the information provided and return that attachment to Sorin.

When asked whether it had received this attachment back from York Hospital or WellSpan, Sorin said its correspondence with customers is confidential.

Lawrence Muscarella, who independently advises and audits hospitals on infection-control practices at his Montgomery County business, wrote that it's common for medical device manufacturers to request confirmation of such letters to reduce liability.

Legal perspective: Questions of liability may soon be answered by the court system, as numerous patients who received WellSpan's letter have sought legal counsel.

Donald Reihart, a medical malpractice attorney in Springettsbury Township, has advertised his services to those potentially affected by the infection. He said he's received a significant number of calls from potential clients.

Reihart has been involved in litigation with physicians at hospitals for many years, he said, including numerous cases dealing with York Hospital.

"Everybody who received that letter potentially has a case," he said.

WellSpan's legal obligation to properly clean its devices is not necessarily contingent on when it received notification of a potential problem, Reihart said.

Marcy wrote that WellSpan "profoundly" regrets any distress this news has caused the potentially affected patients and their families.

"We are deeply committed to ensuring these friends and neighbors have all the information, care and treatment they need regarding this issue," he wrote. "This has included adding a full-time nurse navigator to help these patients with their care needs related to this issue."

— Reach David Weissman at dweissman@yorkdispatch.com.

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