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Multiple-dose vials: persistence of bacterial contaminants and infection control implications
Abstract:
Due to sporadic infections attributed to contaminated multiple-dose medication vials (MDV), some authorities have suggested discarding all MDV within 24 hours. We inoculated 11 commonly used medications with suspensions of 10 bacterial species previously associated with contaminated parenteral solutions and determined microbial persistence at both room and refrigerator temperature. At 22 degrees C, atropine, curare, folic acid, NPH insulin and triamcinolone did not allow microbial persistence beyond 4 hours. Lidocaine and heparin were sterile by 24 hours. Regular insulin, immune serum globulin, and myochrysine allowed persistence for up to 7 days. At 4 degrees C, bacterial persistence was significantly prolonged for all medications including those MDV requiring refrigeration. No organisms proliferated; however, F. meningosepticum and P. maltophilia were particularly persistent at both temperatures. The risk of persistent MDV contamination appears to be dependent upon specific pharmaceutical, microbe and storage temperature interactions. Recommendations for the refrigeration of MDV medications may require reevaluation on a product-by-product basis.
Insights
Discarding multiple-dose vials (MDV) within 24 hours may not be necessary for all medications. Microbial persistence varies by drug, bacteria, and storage temperature, requiring product-specific evaluations.
Area of Science:
- Microbiology
- Pharmaceutical Science
- Infectious Disease
Background:
- Contaminated multiple-dose medication vials (MDV) are linked to sporadic infections.
- Current guidelines sometimes suggest discarding MDVs within 24 hours due to contamination risks.
Purpose of the Study:
- To investigate microbial persistence in commonly used medications from MDVs.
- To evaluate the impact of storage temperature (room vs. refrigerator) on bacterial survival in MDVs.
Main Methods:
- Inoculated 11 common medications with 10 bacterial species associated with parenteral solution contamination.
- Assessed microbial persistence at room temperature (22°C) and refrigerator temperature (4°C).
Main Results:
- At 22°C, some medications (atropine, curare, folic acid, NPH insulin, triamcinolone) inhibited microbial persistence within 4 hours.
- Other medications (regular insulin, immune serum globulin, myochrysine) showed persistence up to 7 days.
- Refrigeration (4°C) significantly prolonged bacterial persistence for all tested medications, though no proliferation occurred. *F. meningosepticum* and *P. maltophilia* were notably persistent.
Conclusions:
- MDV contamination risk is influenced by drug-specific, microbe-specific, and temperature-specific interactions.
- Current recommendations for MDV refrigeration may need product-specific reevaluation.
- A universal 24-hour discard policy for all MDVs may be overly restrictive.