Biomaterial Database

Sterility and use patterns of multiple-dose vials. 1982

J C Bawden, and J A Jacobson, and J C Jackson, and R K Anderson, and J P Burke

The viability of microorganisms in multiple-dose vials (MDVs) and the use and in-use contamination rate of MDVs were investigated. Serial tenfold dilutions of stationary cultures of Escherichia coli and Pseudomonas aeruginosa were injected into 30-ml MDVs containing bacteriostatic agents, and samples were removed at 1, 16, 24, and 48 hours, and at seven days to test for viable organisms. All opened MDVs were removed from each patient-care area and the pharmacy in a hospital and tested for microbial contamination using an aliquot-sampling method. One nursing unit was visited each day, in random order, until all opened MDVs from all units and the pharmacy were collected. The day following collection, all newly opened MDVs at each unit were marked inconspicuously and tallied. On the first, sixth, and thirteenth day after marking, all marked MDVs remaining on the unit were tallied. Bacteria were isolated from deliberately contaminated MDVs when inoculated with 1-100 colony-forming units/ml or greater when the sample was tested within one hour after contamination. Only one product was positive in 16 hours, and none was positive beyond that time. A total of 928 opened MDVs was collected from 31 nursing units and the pharmacy; none was positive for microbial contamination, indicating that the contamination rate was probably less than 4 per 1000. Lidocaine, insulin, diluents, and heparin constituted 57% of collected vials. The length of time that opened vials remained on a unit and the number of opened vials per unit varied considerably between units. The cost, feasibility, and effectiveness of control policies regarding use of MDVs should be weighed objectively against potential benefits.

UI	MeSH Term	Description	Entries
D007273	Injections, Intramuscular	Forceful administration into a muscle of liquid medication, nutrient, or other fluid through a hollow needle piercing the muscle and any tissue covering it.	Intramuscular Injections,Injection, Intramuscular,Intramuscular Injection
D007275	Injections, Intravenous	Injections made into a vein for therapeutic or experimental purposes.	Intravenous Injections,Injection, Intravenous,Intravenous Injection
D011550	Pseudomonas aeruginosa	A species of gram-negative, aerobic, rod-shaped bacteria commonly isolated from clinical specimens (wound, burn, and urinary tract infections). It is also found widely distributed in soil and water. P. aeruginosa is a major agent of nosocomial infection.	Bacillus aeruginosus,Bacillus pyocyaneus,Bacterium aeruginosum,Bacterium pyocyaneum,Micrococcus pyocyaneus,Pseudomonas polycolor,Pseudomonas pyocyanea
D004340	Drug Contamination	The presence of organisms, or any foreign material that makes a drug preparation impure.	Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D004349	Drug Packaging	Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.	Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D004926	Escherichia coli	A species of gram-negative, facultatively anaerobic, rod-shaped bacteria (GRAM-NEGATIVE FACULTATIVELY ANAEROBIC RODS) commonly found in the lower part of the intestine of warm-blooded animals. It is usually nonpathogenic, but some strains are known to produce DIARRHEA and pyogenic infections. Pathogenic strains (virotypes) are classified by their specific pathogenic mechanisms such as toxins (ENTEROTOXIGENIC ESCHERICHIA COLI), etc.	Alkalescens-Dispar Group,Bacillus coli,Bacterium coli,Bacterium coli commune,Diffusely Adherent Escherichia coli,E coli,EAggEC,Enteroaggregative Escherichia coli,Enterococcus coli,Diffusely Adherent E. coli,Enteroaggregative E. coli,Enteroinvasive E. coli,Enteroinvasive Escherichia coli
D005069	Evaluation Studies as Topic	Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies.	Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.