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# Panel to Discuss Cardiac Device Infections
- URL: https://www.fdaweb.com/panel-to-discuss-cardiac-device-infections/
- Published: 2016-04-15T12:00:00.000Z
- Updated: 2026-09-14T20:55:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135390

*Federal Register* Notice: FDA will hold a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee 6/2-3, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA will seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: **(1)** The effectiveness of cleaning and disinfection methods for heater-cooler devices; **(2)** the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; **(3)** appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and **(4)** appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Contact **Evella Washington**, (301) 796-5290, Evella.Washington@fda.hhs.gov. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08737.pdf?ref=fdaweb.com).