Akeau Unahalekhaka
Chiang Mai University, Thailand
Title: Glass particles contamination in single dose ampoules: Patient safety concern
Biography
Biography: Akeau Unahalekhaka
Abstract
Abstract
Background: Glass particle fragmentation and ampoule contamination upon opening have been previously reported for more than 5 decades.
Aim: This study aimed to determine whether there were still glass particles contaminated in single dose glass ampoules.
Methods: Eight hundred (800) 10 ml sterile water for injection ampoules were inspected for glass particle contamination upon opening. Ampoules were opened by 400 nursing personnel of 3 tertiary care hospitals using their normal practices (2 ampoules per 1 nurse). Glass particle contamination was inspected by stereomicroscope and size and number of particles were inspected by scanning electron microscope (SEM). Data were analyzed using descriptive statistics.
Results: 798 ampoules were inspected. Glass particles were detected in 65% of ampoules (95% CI: 61.6-68.3). Size of particles, detected from 20 positive samples from stereomicroscope inspection, ranged from 8-172 micron. The mean numbers of glass particles detected were: 47.8±20.4 for particle size <50 micron, 3.7±3.2 for size 51-100 micron and 0.6±1.07 for size 101-200 micron. Among 20 negative samples from stereomicroscope inspection (no glass particle detected), SEM could detect glass particles with sizes ranged from 8 to 54 microns. The mean numbers of glass particles detected were: 27.8±21.8 for particle size <50 micron, 0.75±1.2 for size 51-100 micron and 0.5±0.2 for size 101-200 micron.
Conclusion: Glass particle contamination occurs on opening single dose glass ampoules. Hospital personnel should be aware and carefully draw the content in the ampoule.