Infections from a heater-cooler device that had been used for several years in hospitals to control a patient’s temperature during bypass surgery has been “probably” linked to at least 4 deaths in a York hospital. The just-released report follows an internal investigation by WellSpan York Hospital that was prompted by findings from the Centers for Disease Control and Prevention and the Pennsylvania Department of Health warning of infections from use of the device. York lies just 4 hours from Philadelphia.

WellSpan had been using the device for at least the past 5 years, which operates by aerosolizing the water in the devices, a process that sprays water into the air.

WellSpan’s investigation revealed that at least 8 of its patients could have contracted an infection from the device that is manufactured by Sorin Group, an Italian company. Heart bypass patients and others with compromised immune systems are more susceptible to surgical site infections and endocarditis, an infection of the inner lining of the heart (source). If untreated, endocarditis can damage or destroy heart valves and present life threatening complications.

The manufacturer has published guidelines on cleaning the devices, which includes periodically adding bleach to the process. Sorin group earlier this year advised that hospital technicians who were instructed to use bleach during cleaning should also fill the devices with filtered water that has hydrogen peroxide when conducting the cleaning. Brett Marcy, a spokesman for the York hospital where the infections and fatalities were reported, admitted that the hospital did not always follow the cleaning protocol.

ECRI Failed to Warn Hospitals

Medical devices used in York hospitals and elsewhere are evaluated by a non-profit group, ECRI, which is based out of Plymouth Meeting. Its spokesman commented that it had not seen any need to warn hospitals about the risk of infection from the devices until the recent released FDA and state report. However, this was not the first indication of the risk from infections from use of these devices. Similar infections were reported last year in a South Carolina hospital where officials noted that the infections could have originated from microbes in tap water. Sources of tap water include the heater-cooler device. Last July, a biomedical engineer, Lawrence Muscarella, warned that such sources could be the culprit for these infections and that federal officials should have been more proactive. He also noted that hospitals should always be looking for sources of infection and wondered why they are just now doing the investigations.

WellSpan began its internal investigation this past July but only after European health officials had reported 32 instances of contaminations worldwide. There were four known fatalities and 11 other cases of serious injuries associated with the heater-cooler device.

Health officials also pointed out that complications from infections may not manifest for some time after the bypass procedures so that there are potentially other cases yet to be reported. WellSpan York has sent out notices to some 1,300 patients who underwent bypass surgery at its facility over the past 4 years about the risks associated with the medical device.

Medical device injuries can lead to catastrophic injuries and death. Infections in heart bypass patients like the ones in this case can lead to previously noted complications such as damaged or destroyed heart valves but also:

  • Aortic valve incompetence
  • Pericarditis
  • Aneurysms
  • Embolisms
  • Cardiac valve disease
  • Splenic infarction
  • Stroke
  • Organ damage

Damages for our patients are likely to be substantial since they often suffer significant diminution in the quality of their lives along with pain and suffering and emotional trauma. The cost of care and subsequent procedures can be in the hundreds of thousands of dollars.

Legal Lookout

Posted by Legal Lookout

A Legal Blog Devoted to Legal Industry News.