Glass particulate adulterated in single dose ampoules: A patient safety concern

Abstract

Aims and objectives: To determine the amount, size and characteristics of glass particulate contamination inside single-dose ampoules. Background: Glass particulate contamination in an ampoule when opened can cause adverse effects on critically ill patients. Design: Crossectional descriptive study. Methods: Eight hundred 10-ml sterile water ampoules were inspected for glass particulate contamination upon opening. Ampoules were opened by nurses following their usual practices. Glass particulates were inspected by stereomicroscope. Further examination was conducted using a scanning electron microscope (SEM) to determine the size and amount of the particulates in the 20 positive and 20 negative samples from stereomicroscope inspection. The Strengthening the Reporting of Observational Studies in Epidemiology checklist was used for preparing this manuscript. Results: Seven hundred and ninety-eight ampoules were inspected, as 2 ampoules were broken. Glass particulates were detected in 65% of the ampoules (519/798). The size of glass particulates from 20 positive and 20 negative samples, ranged from 8 to 172 microns and 8 to 102 microns, respectively. The glass particulates were detected most at sized ≤ 50 microns in both positive and negative samples with the mean number of 47.8 ± 20.4 and 27.8 ± 21.8 particulates, respectively. Conclusion: Glass particulate contamination occurred while opening medication in glass ampoules. A safety tool is needed to prevent glass particulates from contaminating injection treatments. Relevance to clinical practice: Many critically ill patients and neonates need intravenous injections for treatment. Almost all medication solutions are stored in glass ampoules. Nursing personnel should be aware while drawing medication solutions from glass ampoules. Using filtered needles and leaning the ampoules can help reduce the number of glass particulates that pass into the solutions being drawn into the syringes.