The Los Angeles County Department of Public Health (Public Health) has identified three confirmed cases and one suspected case of a non-tuberculous mycobacterial infection, Mycobacterium chimaera, all of which occurred in persons with a history of open-chest cardiac surgery. M. chimaera are slow-growing mycobacteria which can cause infections that occur most often at the surgical site but may not become apparent until months or years after surgery.
Published findings have linked post-surgical M. chimaera infection with exposure to a specific brand of heater- cooler device, LivaNova (formerly Sorin Stockert) 3T, used during surgery. As of October 2016, more than 70 cases have been identified worldwide. More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year and approximately 60% used the devices that have been associated with these infections. The risk that patients will develop an infection following exposure to a contaminated device is very low, including at hospitals where a previous infection has been identified.
In October 2016, the Centers for Disease Control and Prevention (CDC) issued a health alert, which Public Health forwarded to all LA County facilities, describing the risk of M. chimaera infections associated with the use of these heater-cooler devices during open-chest cardiac surgery and making recommendations for surveillance, patient notification, and prevention. In November 2016, the CDC, the U.S. Food and Drug Administration, and the California Department of Public Health provided additional information to health facilities.
Public Health has been working with the hospitals that have identified cases to increase surveillance and implement control measures. Public Health also has been communicating with all hospitals in Los Angeles County that have used these devices to assess compliance with CDC recommendations.
I thought you had this figured out. More than 4 cleaning processes for each unit. 6 cleaning processes to be safer. Do your job hospitals. Get rid of the penny pinchers when it comes to sterilization.
It is appalling to think how this happened, my daughter Has this awful disease and nearly died 3 times, I cannot stress how upset I am about it all.
Hey Ane, our firm is currently representing those who have been impacted by these Sorin devices. We’d love to speak with you about your mother’s situation. Give us a call at (215) 885-1655.
I’ve been told there are no formal education programs in the US for staff working in Medical Device reprocessing (MDR) departments. Maybe its time there be some formal training in this area.
my mother in law has just been confirmed with this. No one could figure out what was happening and when she brought the letter from the hospital about symptoms of the Mycobacterium chimeara, to her cardiologist he said “no no this can’t be it” . so another 3 months went by before they finally figured it out and she could have gotten treatments months before. she is so weak. it’s scary
We are representing clients across the country with similar stories. If you’re still pursuing the possibility of Sorin playing a role, give us a call. We would love to try and help – (215) 885-1655.