HTML Preview Contaminated Devices Used During Cardiac Bypass page number 1.
October 13, 2016
To: All North Carolina Health Care Providers
From: Zack Moore, MD, MPH, Acting State Epidemiologist
Re: Contaminated heater-cooler devices used during cardiac bypass procedures
The Centers for Disease Control and Prevention (CDC) issued a health advisory today
regarding non-tuberculous mycobacteria (NTM) infections following exposure to
contaminated heater-cooler devices used to warm and cool a patient’s blood during
cardiac bypass procedures.
Hospitals or providers caring for patients with confirmed or suspected NTM infections
following heart bypass procedures are asked to contact the North Carolina Division of
Public Health (NC DPH) at 919-733-3419. All identified cases should also be reported to
the U.S. Food and Drug Administration (FDA) via MedWatch at
www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm. NC DPH is
available to assist facilities should further investigation be necessary.
NC DPH recommends that hospitals performing heart bypass procedures follow CDC
and FDA heater-cooler guidance in the attached CDC Health Advisory. NC DPH will
work with facilities that perform cardiac bypass procedures using the implicated devices
to encourage notification of potentially exposed patients and adherence to CDC and
FDA recommendations.
Recommendations may change as new information becomes available. Additional
information is available from CDC and FDA at the following sites:
https://www.cdc.gov/HAI/outbreaks/heater-cooler.html
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Cardiovascu
larDevices/Heater-CoolerDevices/ucm20082725.htm