Important Cardiac Surgery Information
The mission of HaysMed is “To help people be healthy.” As part of this commitment, we feel that it is important to share information with our patients about a device-related issue that is impacting many hospitals throughout the United States and Europe. Please see resources and publications below for further information.
The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have notified hospitals about a risk of infection that has been linked to certain heater-cooler devices that are used with cardiopulmonary bypass machines during cardiac surgeries. The bacteria linked to these heater cooler devices is known as Nontuberculous Mycobacterium (NTM). These bacteria grow slowly and are commonly found in water and soil.
These infections are very rare. The CDC estimates that the risk is less than 1%. However, we feel that it is important to notify individuals who may be at risk for developing one of these infections. We want to explain what occurred and assure you that we are committed to answering any questions you may have and to addressing your concerns. This web page is intended to provide information regarding this issue.
If you received a letter from HaysMed about a possible exposure to NTM and have any questions, please call the HaysMed Hotline at (785)639-6126 and we would be pleased to answer any questions.
For Patients
- CDC Questions and Answers for Patients
https://www.cdc.gov/HAI/outbreaks/heater-cooler.html#quest
- CDC Press Release 10/13/2016
https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html
- FDA Safety Alert 10/13/2016
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM520191.htm
For Providers and Hospitals
https://www.cdc.gov/HAI/outbreaks/heater-cooler.html#questh
- CDC Press Release 10/13/2016
https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html
- CDC Health Advisory 10/13/2016
https://emergency.cdc.gov/han/han00397.asp
- Morbidity and Mortality Weekly Report (MMWR)
https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a6.htm?s_cid=mm6540a6_w
- FDA Safety Alert 10/13/2016
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM520191.htm