Date Sent: 10/14/2016 03:37 PM EDT
Sender: Michigan Health Alert Network
Subject: Contaminated Devices Putting Open-Heart Surgery Patients at Risk
On 10/13/16, the Centers for Disease Control and Prevention (CDC) released an advisory to hospitals to notify patients who underwent open-heart (open-chest) surgery involving a Stöckert 3T heater-cooler that the device was potentially contaminated, possibly putting patients at risk for a life threatening infection. New information indicates that these devices, manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), were likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing. Hospitals should advise potentially exposed patients to seek medical care if they are experiencing symptoms such as night sweats, muscle aches, unexplained weight loss, fatigue, or unexplained fever. In addition, hospitals that use or have used this device are strongly encouraged to make and execute a plan to communicate with potentially exposed patients and to increase awareness among healthcare providers.
The advisory included recommendations to healthcare providers, hospitals, health departments, and patients.
The Michigan Department of Health and Human Services (MDHHS) Surveillance for Healthcare-Associated and Resistant Pathogens (SHARP) Unit encourages health care facilities who identify possible patient exposure to NTM through contact with a heater-cooler unit to report all instances to the FDA via MedWatch at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.
Additionally, health care facilities who believe they have multiple patients exposed are asked to report to the MDHHS SHARP Unit via email to email@example.com by calling (517) 335-8165. Due to the potentially long delay between exposure to NTM and manifestation of clinical infection (up to several years), identifying infections related to the use of heater-cooler devices can be challenging. The most important action to protect patients is to remove contaminated heater-coolers from operating rooms, and ensure that those in service are correctly maintained. If you have any questions or concerns about this advisory, please contact the MDHHS SHARP Unit at (517) 335-8165.
To read the full CDC Health Advisory, please see the attached document.