Deadly Infections Linked to Heart Surgery Device at WellSpan York Hospital

November 02, 2015 – – Ostroff Law is now preparing to bring suit in a case that left four patients dead, four others infected and at least 1,300 more at risk for a deadly infection contracted during open-heart surgery procedures performed at WellSpan York Hospital in York, PA.

The alleged source of the deadly infections was a device used to heat and cool a patient’s blood during the procedure. Hospital staff admitted to failing to follow proper cleaning procedures, and a company charged with evaluating medical device safety failed to detect any danger.

‍“We weren’t following [cleaning instructions for the device] to the letter,” admitted Dr. Hal Baker who oversees infection control at WellSpan York hospital, according to the New York Times. The units were sometimes not cleaned with bleach, added WellSpan spokesperson Brett Marcy in an article at philly.com.

The medical device evaluation company ECRI never warned hospitals about the heater-coolers. “It just hasn’t come up,” said Executive Director for Accident and Forensics Investigation’ Bruce C. Hansel.

Thousands of patients are left to wonder whether their infections were caused by the machine, or if they may develop one in the near future. The bacteria tied to the deaths, known as nontuberculous mycobateria or NTM, grows very slowly and symptoms may take months to appear. York hospital issued notifications to patients they believe to be at risk.

‍“We’re urging the recipients of the notifications from York Hospital to contact our office immediately,” said Jon Ostroff. ‍“The circumstances of these many incidents make it absolutely imperative that patients safeguard their legal rights.”

Concern about infections from similar bacteria was raised as early as last year when four patients died in South Carolina. Those deaths were linked to microbes in tap water. The sources of the bacteria in the tap water were identified as being either heater-cooler devices or ice machines in the operating room by Montgomeryville, PA biomedical engineer Lawrence Muscarella in June 2014.

“Why are they retrospectively looking back to identify an outbreak?” Muscarella asked in the Philly.com article.

Two patients died after Muscarella’s written warning – one in August 2014 and the other in March 2015. The heater-cooler units are made by the Italian medical device manufacturer Sorin Group that recently merged with LivaNova. U.S. Food and Drug Administration say patients can be exposed to bacteria when contaminated water gets into a part of the machine where it can be aerosolized through the device’s exhaust vent.

Jon Ostroff contends that WellSpan York Hospital had an obligation to take all reasonable steps to keep the operating room infection free. “Non-compliance with the device’s cleaning instructions further implicates Wellspan Hospital and ECRI as contributing to these patient’s deaths and injuring possibly thousands more.”

‍“The results of these cases are serious as this has already killed four patients,” Ostroff said, adding, “Not only did Wellspan York Hospital fail to keep its operating room safe, but this hospital’s disregard for the safety of it’s patients played a role in causing this infection. Our firm is particularly well positioned to pursue justice for these innocent victims.”

###

Contact Ostroff Injury Law:

Jon Ostroff
(484) 351-0350
info@ostrofflaw.com
527 Plymouth Road, Suite 413
Plymouth Meeting, Pennsylvania

ReleaseID: 60004987