Multi-dose vial: difference between revisions
Diff·revision 31 → 32·15:54, 19 Jul 2025
Difference between revision 31 and revision 32 of Multi-dose vial. 8 lines changed; the page grew by 1,490 bytes.
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| 97 | Surface disinfection before each entry is the practice measure addressed at the other end of the problem. Once a flip-off button is removed, the exposed face of the closure is a surface like any other, and guidance expects it to be disinfected with an appropriate agent and allowed to dry before each penetration. Studies of contamination of vial closures in clinical use have found organisms recoverable from a proportion of them, which is the empirical basis for the practice.{{r|mattner2004,cdc_injection}} | 97 | Surface disinfection before each entry is the practice measure addressed at the other end of the problem. Once a flip-off button is removed, the exposed face of the closure is a surface like any other, and guidance expects it to be disinfected with an appropriate agent and allowed to dry before each penetration. Studies of contamination of vial closures in clinical use have found organisms recoverable from a proportion of them, which is the empirical basis for the practice.{{r|mattner2004,cdc_injection}} |
| 98 | 98 | ||
| + | 99 | == Documented infection events == | |
| + | 100 | The literature on infection associated with multiple-dose vials divides into two classes, and the distinction matters because the mechanisms and the remedies differ. | |
| + | 101 | ||
| + | 102 | '''Contamination of the vial as a reservoir.''' Prevalence studies have sampled multiple-dose vials in clinical use and cultured their contents. Reported contamination rates are low but non-zero, and organisms recovered are typically skin and environmental flora. A prevalence study in a German hospital setting reported contamination in a small percentage of vials sampled, and a study in a teaching hospital in Iran reported a higher figure in a setting with less consistent aseptic practice. The general finding is that preserved formulations in routine use are usually sterile, and that the exceptions correlate with technique rather than with vial age.{{r|mattner2004,motamedifar2009}} | |
| + | 103 | ||
| + | 104 | '''Transmission via the vial as a vector.''' The larger public-health events have involved a syringe used on one patient being reintroduced into a shared vial, contaminating the vial with blood, which is then drawn into a syringe for the next patient. Preservatives are irrelevant to this mechanism, since blood-borne viruses are unaffected by them. | |
| + | 105 | ||
| 99 | == References == | 106 | == References == |
| 100 | {{reflist}} | 107 | {{reflist}} |
| ⋮ | ⋮ | ||
| 108 | <ref name="fischer2010">Fischer GE, Schaefer MK, Labus BJ, et al. "Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008." ''Clinical Infectious Diseases'' 51(3):267–273 (2010).</ref> | 115 | <ref name="fischer2010">Fischer GE, Schaefer MK, Labus BJ, et al. "Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008." ''Clinical Infectious Diseases'' 51(3):267–273 (2010).</ref> |
| 109 | <ref name="mattner2004">Mattner F, Gastmeier P. "Bacterial contamination of multiple-dose vials: a prevalence study." ''American Journal of Infection Control'' 32(1):12–16 (2004).</ref> | 116 | <ref name="mattner2004">Mattner F, Gastmeier P. "Bacterial contamination of multiple-dose vials: a prevalence study." ''American Journal of Infection Control'' 32(1):12–16 (2004).</ref> |
| + | 117 | <ref name="motamedifar2009">Motamedifar M, Askarian M. "The prevalence of multidose vial contamination by aerobic bacteria in a major teaching hospital, Shiraz, Iran, 2006." ''American Journal of Infection Control'' 37(9):773–777 (2009).</ref> | |
| 110 | <ref name="brange1993">Brange J, Langkjaer L. "Insulin structure and stability." ''Pharmaceutical Biotechnology'' 5:315–350 (1993).</ref> | 118 | <ref name="brange1993">Brange J, Langkjaer L. "Insulin structure and stability." ''Pharmaceutical Biotechnology'' 5:315–350 (1993).</ref> |
| 111 | <ref name="manning2010mdv">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010).</ref> | 119 | <ref name="manning2010mdv">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010).</ref> |