Hostname: page-component-cd9895bd7-hc48f Total loading time: 0 Render date: 2024-12-23T20:00:20.530Z Has data issue: false hasContentIssue false

Aseptic Efficacy of Prefilled Syringes in a Polluted Environment

Published online by Cambridge University Press:  28 June 2012

Norifumi Ninomiya*
Affiliation:
Department of Emergency and Critical Care Medicine, Nippon Medical School, Tokyo, Japan
Yuichi Koido
Affiliation:
Department of Emergency and Critical Care Medicine, Nippon Medical School, Tokyo, Japan
Yasuhiro Yamamoto
Affiliation:
Department of Emergency and Critical Care Medicine, Nippon Medical School, Tokyo, Japan
*
Department of Emergency and Critical Care Medicine, Nippon Medical School Hospital, Sendagi 1-1-5, Bunkyo-ku, Tokyo 113-8603, Japan, E-mail: [email protected]

Abstract

Introduction:

To evaluate the aseptic efficacy of prefilled syringes compared with ampules when used in a polluted environment similar to that at a disaster site.

Methods:

The researchers tested epinephrine, 0.1%, atropine sulfate, 0.05%, and lidocaine hydrochloride solutions, 2% (Group A) as well as lidocaine hydrochloride, 10%, sodium bicarbonate, 8.4%, and glucose solutions, 50% (Group B), that frequently are used for intravenous injection and intravenous infusion respectively in Disaster Medicine.

Each of these solutions in 10 prefilled syringes (PFSs) and 10 ampules was placed in a box of contaminated soil along with needles and empty syringes for ampules. In the box, each was taken out of its package, all syringes were connected with a needle, and empty syringes were filled with a solution. After this procedure, all syringes were taken out of the box to check their contents for bacterial contamination.

Results:

No bacterium was observed in any of the 10 Prefilled syringes samples of Group A and B solutions. In contrast, out of 10 ampule samples, six of the 10 samples containing epinephrine, nine of the 10 containing atropine sulfate, all 10 samples containing lidocaine hydrochloride, 2%, and all of the ampule samples containing Group B solutions tested positive for bacteria. A statistically significant difference was observed between the PFS and ampule samples in all six solutions.

Conclusion:

Results indicate that, in environments with airborne contaminants, the use of prefilled syringes may be useful for preventing bacterial contamination of the medicine inside.

Resumen

Introducción:

Para evaluar la eficacia de las jeringas prellenadas asépticas, comparadas con ámpulas cuando se usaron en un ambiente contaminado similar al de un sitio de desastre.

Métodos:

Los investigadores probaron epinefrina, 0.1% sulfato de atropina, 0.05%, y soluciones hidrocloradas de lidocaína, 2% (Grupo A), así como hidroclorato de lidocaína, 10%, bicarbonate de sodio, 8.4% y soluciones de glucosa, 50% (Grupo B), que frecuentemente fueron usadas para inyección intravenosa e infusión intravenosa respectivamente en Medicina de Desastres.

Cada una de estas soluciones en 10 jeringas pre-llenadas (Prefilled syringess) y 10 ámpulas fueron puestas en una caja de tierra contaminada junto con agujas y jeringas vacías. Después de estar en la caja cada una fue sacada de su empaque y todas las jeringas fueron conectadas a una aguja, y las jeringas vacías fueron llenadas con solución. Después de este procedimiento, todas las jeringas fueron sacadas de la caja para verificar su contenido en lo referente a contaminación bacteriana.

Resultados:

No se observaron bacterias en ninguna de las muestras 10 Prefilled syringes del Grupo A y B de soluciones. En contraste, fiiera de 10 muestras de ámpulas, 6 de las 10 muestras que contenían epinefrina, 9 de las 10 que contenían sulfato de atropina y 10 muestras que contenían hidrocloruro de lidocaína 2%, y todas las ámpulas que contenían las soluciones del Grupo B, en las pruebas resultaron positivas para bacterias. Una diferencia significativa fue observada entre las Prefilled syringes y las muestras de ámpulas en todas las seis soluciones.

Conclusión:

Los resultados indican que en ambientes con contaminantes libres en el aire, el uso de jeringas prellenadas puede ser útil para prevenir la contaminación bacteriana dentro del medicamento.

Type
Original Research
Copyright
Copyright © World Association for Disaster and Emergency Medicine 2001

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Kawaguchi, Y: Frailty of hospital buildings in case of a major disaster. Japanese Journal of Disaster Medicine 1997;2(1):5763.Google Scholar
2.Koido, Y, Ninomiya, N, Yamamoto, Y: Questionnaire Survey Report, in Japanese, ‘Usefulness of prefilled syringes for emergency drugs at a disaster treatment.’ Japanese Journal of Disaster Medicine 2000;5(1),2228.Google Scholar
3.The Society of Japanese Pharmacopoeia: Sterility test (in English), The Japanese Pharmacopoeia 13th. ed. Tokyo, Yakuji Nippo, LTD. 1996;6971.Google Scholar
4.The Society of Japanese pharmacopoeia: Microbial limit test (in English). The Japanese Pharmacopoeia 13th. ed. Toyko, Yakuji Nippo, LTD. 1996; 4955.Google Scholar
5.Kuroyama, M, Hirayama, T, Shimada, S: Study of the usefulness of a newly developed dual chamber prefilled syringe kit: The second report, working efficiency (in Japanese). Jpn. J. Med. Pharm. Sci. 1997;37(1)177181.Google Scholar
6.Ninomiya, N, Koido, Y, Yamamoto, Y: A comparative evaluation on the preparation time report, in Japanese, “Usefulness of new prefilled syringe for emergency situation.” The Japanese Journal of Acute Medicine 2000; 24(13)18681874.Google Scholar