Abstract
The Research Gap in Non-tuberculous Mycobacterium (NTM) and Reusable Medical Devices.
Highlights
These medical devices are regulated by the U.S Food and Drug Administration (FDA) and the Agency seeks to better understand the mechanism by which devices can transmit Non-tuberculous Mycobacterium (NTM)
Because NTM vary in their susceptibility to some disinfectants, it is unclear whether testing medical device disinfection with M. smegmatis as a surrogate is applicable to clinically relevant NTM species [11]
In a study of nine Mycobacterium spp., M. smegmatis, and M. marinum are highly susceptible to glutaraldehyde solutions; M. avium, M. kansasii, and M. scrofulaceum showed intermediate susceptibility; and M. tuberculosis, M. bovis, and M. intracellular were resistant, requiring higher concentrations and longer contact times to achieve reduction in counts
Summary
Patient infections with Non-tuberculous Mycobacterium (NTM) have been attributed to some reusable medical devices [1, 2], such as heater cooler devices [3,4,5], dental unit waterlines [6], bronchoscopes [7], and automated endoscope reprocessors [8, 9]. Comparative analyses between slow- and rapid-growing NTM tend to be limited and in some cases, have demonstrated notable variation, as well as intra-species differences [13, 14, 16, 17] This raises questions about the applicability of using one species of NTM ( referred to as surrogate NTM) in place of another for medical device testing.
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