CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery
The Centers for Disease Control and Prevention (CDC) is advising 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.
The CDC specifically recommends the following:
For Healthcare providers:
- Internists, infectious disease specialists, cardiologists, cardiothoracic surgeons, and other clinicians should suspect NTM infections among patients who have signs of infection and a history of open-chest cardiac surgery.
- Infections can take months to cause symptoms.
- Patients with NTM infections following cardiac surgery have presented with a variety of clinical manifestations. Common examples are endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.
- Diagnosis can be difficult due to the nonspecific presentation of illness and the slow growing nature of the bacteria.
- Physicians should consider consulting with an infectious disease specialist if caring for patients who have undergone an open-chest cardiac procedure and present with signs of infection.
- Cultures for acid fact bacilli (AFB) should be obtained as part of the evaluation.
- Other specialized testing to detect M. chimaera may be needed and further laboratory testing should be discussed and arranged in consultation with an infectious disease specialist or health department.
- Hospitals performing open-chest cardiac surgery should immediately assess their use of heater-cooler devices and determine whether they are currently using – or have previously used – 3T devices. Facilities should ensure that they are implementing current FDA recommendations to minimize patient risk to infections associated with heater-cooler devices (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM520191.htm).
- Hospitals should notify cardiothoracic surgeons, cardiologists, infectious disease physicians, internists, primary care physicians, and other clinicians who evaluate patients that have had open-chest cardiac or other bypass surgery, about the risk of infection associated with 3T heater-cooler devices. CDC has sample letters available at https://www.cdc.gov/hai/outbreaks/heater-cooler.html.
- Hospitals should review their facility’s microbiology laboratory database and records of surgical procedures for any positive NTM cultures in surgery patients that might indicate a possible case. CDC has provided guidance on case-finding: http://www.cdc.gov/hai/pdfs/outbreaks/Guide-for-Case-Finding.pdf.
- Hospitals should consider institution-specific strategies for alerting patients of the risk of infection related to potentially contaminated heater-cooler devices. CDC has sample patient notification letters available at https://www.cdc.gov/hai/outbreaks/heater-cooler.html.
- Hospitals can consider prospective surveillance of patients who have undergone open-chest cardiac surgery involving a 3T heater-cooler device.
- Hospitals should consider using informed consent to educate patients of the potential NTM infection risk.
- The overall risk of M. chimaera infection is low relative to other complications following cardiac surgery; emergent cardiac procedures should not be delayed because of the use of 3T devices. Continued use of 3T devices should be done in accordance with the latest manufacturer’s recommendations, including maintenance and proper positioning of devices to minimize the risk of patient exposure.
- Hospitals that have identified contaminated 3T heater-cooler devices or patient infections associated with devices should promptly alert their local or state health department and submit a report to FDA via MedWatch athttp://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
See the complete CDC Health Advisory for additional background information and resources.
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