Notice: CPHLN device testing for non-tuberculous Mycobacteria (NTM)
Published by: The Public Health Agency of Canada
Issue: Volume 43-3/4: Tuberculosis (TB)
Date published: March 2, 2017
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Volume 43-3/4, March 2, 2017: Tuberculosis (TB)
CPHLN device testing recommendations regarding non-tuberculous Mycobacteria (NTM) contamination in heater-cooler units
Source: Canadian Public Health Laboratory Network Device Testing Working Group (CPHLN DTWG) with consultation from the Infection Prevention and Control Expert Working Group and Health Canada. Canadian Public Health Laboratory Network (CPHLN) Device Testing Recommendations regarding Non-Tuberculous Mycobacteria (NTM) Contamination in Heater-Cooler Units.
It is the position of the CPHLN DTWG that testing environmental samples from heater-cooler units for M. chimaera is not recommended at this time given the lack of available evidence to suggest its value in determining the risk that individual devices pose.
Laboratory detection of M. chimaera in environmental samples collected from heater-cooler units presents numerous challenges, including but not limited to:
- Methods for sample collection, sample processing, and M. chimaera detection in environmental samples from heater-cooler units have not been standardized nor validated.
- Sensitivity, specificity, limit of detection, and negative and positive predictive value of testing are unknown making it impossible to accurately assess patient risk based on testing for M. chimaera from heater-cooler units.
- The patient safety risks associated with removing heater-cooler units from service for prolonged periods while waiting for environmental mycobacterial test results, and thereby delaying the initiation of surgical procedures deemed urgent, likely exceed the risk of M. chimaera infection.
- The paucity of available data regarding growth and viability of M. chimaera in heater-cooler units.
- The inability to determine the efficacy of decontamination procedures for heater-cooler units through testing.
These recommendations are similar to those of the U.S. Food and Drug Administration (FDA) and others and may evolve as new information becomes available. Any such changes will be made in the complete document.
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