ABSTRACT
PURPOSE: This study was done to examine how medication contamination in a single-dose glass ampule is affected by minute glass flakes generated in different methods of cutting the ampule. METHOD: Sixty medicationcontaining glass ampules were randomly assigned to two groups. The number of glass flakes, resulting from two different cutting methods (with cotton and without cotton), were counted under the microscope. Contamination was evaluated by extracted the medication with a syringe and culturing it in E. coli, coliform, and aerobic bacteria culture media. Result: Fewer glass flakes were found in the ampules when the ampule was cut with cotton. The use of cotton, however, did not significantly change the degree of drug contamination. CONCLUSION: Although minute glass flakes generated in the ampule cutting operation did not significantly contaminate the medication and the use of cotton decreased the number of glass flakes in the ampules, glass flakes injected into the blood and tissues of the patient remain a risk factor. Therefore, pre-filled syringes or syringes with filters would be alternative methods and safeguards against the possible injection of glass flakes generated while cutting the ampule.
Subject(s)
Humans , Bacteria, Aerobic , Culture Media , Drug Contamination , Glass , Risk Factors , SyringesABSTRACT
PURPOSE: The purpose of this study was to examine the factors influencing glass particle contamination in single dose glass ampules upon opening. METHOD: The study was single case experimental design. Different methods of opening ampule (hand, wooden stick), different sizes of ampules(1cc, 2cc) and different sizes of needles(17gauge, 23gauge, 5micrometer filter) were evaluated. Eighteen ampules were randomly assigned in each group. The number of glass ampule particles > or =10micrometer was counted by microscope. RESULTS: There was no significant difference in the number of particles aspirated by opening methods. But number of glass particles was much lower when using 1cc ampules rather than 2cc ampules and was also much lower when using smaller size needles and needles which include a 5micrometer filter rather than larger size of needles. CONCLUSION: We suggest that larger bore or unfiltered needles increase the risk of aspirating more glass particles than smaller bore or filter needles. In addition, these data show that a wooden stick can be used as a method opening glass ampules.
Subject(s)
Glass , Needles , Research DesignABSTRACT
PURPOSE: Glass particle contamination of the contents of single-dose glass ampules can occur upon opening. Different aspiration techniques, different sizes of needles, different sizes of ampules, and different cutting methods were studied to determine if they had any effect on glass particle contamination. METHOD: Different aspiration techniques(with filter, without filter), different sizes of needles(18G, 25G), different sizes of ampules(2ml, 20ml), and different cutting methods(with cotton, without cotton) were evaluated. METHOD: Twenty ampules were randomly assigned in each group. Three slides containing glass particles for each ampule were made and counted under a microscope by 3 study blind persons. RESULT: The number of glass particle contamination is much less when using a filter rather than without a filter. The number of glass particle contamination is much less when using a 25G needle rather than on 18G needle. The number of glass particle contamination is much less when using 2ml ampules rather than 20ml ampules. The number of glass particle contamination is much less when using cotton rather than without cotton. CONCLUSION: It was shown that using a filter, a small size needle, smaller sized ampules and using cotton when cutting the ampule will decrease the risk of parenteral injection of glass particles.
Subject(s)
Humans , Drug Contamination/prevention & control , Drug Packaging , Equipment Design , Filtration/instrumentation , Glass , Needles , Safety Management/methods , SuctionABSTRACT
Single dose glass ampules have been developed for ease of administration, accuracy of measurement of dosage, sterility and use in prepackaged kits. Glass particle contamination of the contents of single dose glass ampules can occur upon opening. In our study, we determined whether different ampule size, different aspiration techniques or different methods of ampule opening had any effect on glass particle contamination. Different ampule sizes (1, 2, 20 ml), different aspiration techniques (19G, 22G needle) and different methods of ampule opening (one point ampule, cutting with circular etching, cutting with one plane etching) were evaluated. There was no signifcant difference in the number of particles aspirated by any given aspiration technique, ampule size and method of ampule opening. But intravenous glass particle administration is associated with patholagic responses, so the use of a filter needle, and in-line filter devices and a low pressure infusion system is advised.