Nontuberculous Mycobacterium (NTM) Infect ions Associated with Heater-Cooler Devices

Joseph Perz, DrPHTeam Leader, Quality Standards & Safety

Prevention and Response BranchDivision of Healthcare Quality Promotion

Centers for Disease Control and Prevention

HICPACNovember 5, 2015

Office of Surveillance, Epidemiology, and Laboratory ServicesScientific Education and Professional Development Program Office

Nontuberculous Mycobacterium (NTM)

NTM = mycobacteria that do not cause tuberculosis

Slow-growing

Found in surface water, tap water, and soil

Opportunist ic

Healthcare Immunocompromised patients

Breaches in normal host defenses

Novel exposure pathways

• Direct and indirect exposures to water

MMWR / October 23, 2015 / Vol. 64 / No. 41

• Four patients with M. chelonae infection after LASIK surgery at an ASC

• A consumer grade misting humidifier was contaminated with M. chelonae

• Laser device manufacturer specified 40-50% relative humidity

Clinical Infect ious Diseases 2015;61(1):67–75

• Invasive M. chimaera in 6 patients• Open-chest, implants, 2008-2012• Investigation of possible water sources• Heater-cooler unit used for heart-lung

machine and cardioplegia

www.livanova.sorin.com/products/cardiac-surgery/perfusion/hlm/3t#product_download_area

M. chimaera detected in heater-cooler water circuits and air samples collected w/ units operat ing

Clinical Infect ious Diseases 2015;61(1):67–75

On June 15 2015, Sorin Group USA, issued a Field Safety Notice, followed on July 15 2015 by a Class II Recall:

• Stating that “although water from the heater cooler device is not intended to contact the patient directly, fluid leakage from the device or aerosolization generated by a contaminated water circuit during device operation may create conditions in which the organisms could potentially contact the patient and subsequently contaminate the surgical site.”

• Indicating an Error in Labeling, requiring revisions to instructions for cleaning and disinfection.

Recent US Outbreak Invest igat ion

July 20, 2015 – PA DoH notified of a cluster of NTM infect ions among cardiac surgery pat ients

Heater-cooler units were removed and replaced

CDC provided on-site assistance with invest igat ion

8 cases of invasive NTM (MAC/M. chimaera) infect ion

Preliminary epidemiologic and laboratory findings substant iate that heater-cooler units = source

Hospital has not ified affected pat ients/families as well as over 1300 potent ially exposed pat ients

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm

October 15, 2015

• Scope: All heater-cooler devices• Recommendations include:

• Adhere to current manufacturer instructions • Sterile or filtered water• Direct exhaust away• Remove units w/ signs of contamination• MedWatch reporting

www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf

Aim: amplify FDA alert and provide guidance on identifying patients with infection

Questions / Discussion

Thank you

For more information please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the officia l position of the Centers for Disease Control and Prevention.

Office of Surveillance, Epidemiology, and Laboratory ServicesScientific Education and Professional Development Program Office