High-level or hype? Disinfectants in Venezuela under review.

BACKGROUND

NTM soft tissue infection outbreaks in Venezuela (2006) exposed failures of locally marketed high-level disinfectants (HLDs), with only international products meeting standards. After renewed NTM outbreaks in 2024, we re-evaluated locally manufactured products claiming HLD, sterilant, or sporicidal activity.

METHODS

We collected 14 locally marketed disinfectants: 11 labeled HLD and three labeled intermediate-level. Active ingredients included QACs, glutaraldehyde, organic acids, alcohols, and a strong base. Efficacy was tested using EN 14348 (mycobactericidal) and EN 17126 (sporicidal) under clean and dirty conditions. HLD required ≥4-log10 spore reduction; intermediate-level required 4-log10 mycobacteria reduction.

FINDINGS: Only one glutaraldehyde-based product met HLD criteria. Three correctly labeled intermediate-level disinfectants showed mycobactericidal activity under both conditions. One HLD-labeled product demonstrated only mycobactericidal activity, warranting reclassification as intermediate-level. All other products failed, especially under organic load, and should be classified as low-level disinfectants.

CONCLUSIONS

Despite label claims, most locally marketed disinfectants failed efficacy standards, revealing a critical regulatory gap. For hospital disinfection, we recommend product selection rely on independently verified efficacy data, not manufacturer claims. Similar deficiencies likely exist elsewhere, underscoring the need for systematic regional testing to ensure effective infection control.