(The Philadelphia Inquirer: Published 10/26/2015, Avril, Tom, Web)
Eight open-heart surgery patients at WellSpan York Hospital apparently were infected with bacteria that grew in the heating-cooling devices used with bypass machines, hospital officials said Monday. Four of the patients at the central Pennsylvania hospital later died, with the infections “likely a contributing factor,” hospital officials said, citing a joint investigation with the federal Centers for Disease Control and Prevention. The U.S. Food and Drug Administration issued a safety communication about the devices earlier this month, saying it had received 32 reports of contaminated units worldwide since January 2010, most of which were in Europe. The problem was largely unknown in the field of medicine until this year. The FDA said the number of contaminated devices could be larger, in part because patients can develop symptoms months after their procedure and so the connection may not be apparent. The agency said patients became ill from contaminated devices in half of the 32 instances. The actual number of people who got sick was not immediately clear.
The eight infections at York Hospital, a half-hour’s drive south of Harrisburg, were deemed to be the “probable” result of infection from contaminated water in the heating-cooling devices. Such devices modulate temperature by circulating water through closed circuits, so ordinarily the water does not come into contact with patients, the FDA said in its Oct. 15 notice. But if the water contains bacteria, the microbes can become aerosolized when emitted from the device’s exhaust vent, the agency said. WellSpan officials said they had sent letters about the infections to 1,300 patients who received open-heart surgery over the past four years. The hospital said an internal review found that its cleaning protocols “did not align perfectly” with the manufacturer’s guidelines. The hospital said it replaced its heating-cooling units in July, and “is advising current patients that there is no longer a risk of this bacterial exposure,” according to a hospital statement.
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From the desk of Michael W. McGuckin, Esquire.