A Manufacturer and User Facility Device Experience Analysis of Upper Aerodigestive Endoscopy Contamination: Is Flexible Laryngoscopy Different?

Abstract

Objectives/hypothesis: Several recent studies have observed a high incidence of duodenoscope microbial contamination and an association of contamination with healthcare-acquired infections. This study sought to quantify nasopharyngoscope microbial contamination relative to that of other endoscope categories and characterize the manufacturers, outcomes, and microbial profiles associated with these cases.

Study design: Retrospective, cross-sectional study.

Methods: A total of 3,865 adverse events were collected from 2013 to 2019 using the US Food and Drug Administration Manufacturer and User Facility Device Experience database. The fraction of total device failures associated with contamination was quantified for nasopharyngoscopes, bronchoscopes, duodenoscopes, and gastroscopes. Odds ratios of nasopharyngoscope contamination compared to that of bronchoscopes, duodenoscopes, or gastroscopes were calculated, and significance was assessed by χ² analysis. The Kruskal-Wallis test was used for nonparametric testing of significance.

Results: Nasopharyngoscope device failures were reported at an incidence of 0.646 per month; 34.1% involved contamination, comparable to the frequency observed for bronchoscopes (23.4%, P = .118), duodenoscopes (29.2%, P = .493), and gastroscopes (45.3%, P = .178). The frequency of device contamination was observed to be significantly higher for a particular endoscope manufacturer regardless of endoscope category (Kruskal-Wallis P = .021). In instances of contamination, nasopharyngoscopes were significantly less associated with patient harm or death than bronchoscope (odds ratio [OR] = 10.2) and duodenoscope (OR = 4.81) cases.

Conclusions: Although the rates of contamination were comparable across all endoscope categories, nasopharyngoscope contamination was less commonly associated with patient harm or death. In an era of rising healthcare costs, determining adequate disinfection standards for nasopharyngoscopes and their impact on patient safety is crucial.

Level of evidence: NA Laryngoscope, 131:598-605, 2021.

Keywords: Diagnostic flexible laryngoscopy; Manufacturer and User Facility Device Experience; OpenFDA; endoscopy; microbial contamination; nasopharyngoscopy.