The potential risks associated with administration of medications supplied in glass ampules is much greater than realized by most practitioners. Opening a glass ampule produces a shower of glass particles, many of which enter the ampule and contaminate the contents. Some of the particles have been shown to carry bacteria, though the significance of this has not been determined.
The number of glass particles found in opened ampules varies, but most reports indicate approximately 100 particles, ranging in size from 10 to 1,000 �m, per 10-mL ampule. The particle count increases as the size of the ampule increases (ie, a 20-mL ampule will contain more glass particles than a 10-mL ampule). When the content of a 10-mL ampule is aspirated through an 18-gauge, 1.5-inch needle, the particle count is reduced by approximately one third (ie, approximately 65 particles remain in the aspirate), and the maximum particle size is reduced to less than 400 �m.
The potential risks associated with intravenous administration of glass particles are based on animal studies, though similar risks would apply equally to humans. It has been shown that glass particles cause inflammatory reactions (eg, phlebitis) and granuloma formation in pulmonary, hepatic, splenic, renal, and intestinal tissue. This represents a significant risk of an adverse patient outcome.
The effective removal of glass particles from an opened ampule can be accomplished by aspirating through a 19-gauge, 5-�m filter needle. Using this method decreases the average total number of particles in the aspirate to approximately �1, and the particle size to less than 200 �m. Using a 0.22-�m in-line filter offers little or no additional benefit, and is more costly and labor intensive--once the ampule content is aspirated into a syringe, the filter needle must be replaced with a standard needle prior to transferring or administering the medication.
Based on the available information, a filter needle is recommended when aspirating a medication from a glass ampule.
References
- Turco S, Davis NM. Glass particles in intravenous injections. N Engl J Med. 1972;287:1204-1205.
- Carbone-Traber KB, Shanks CA. Glass particle contamination in single-dose ampules. Anesth Analg. 1986;65:1361-1363.
- Waller DG, George CF. Ampules, infusions and filters. Br Med J. 1986;292:714-715.
- Kempen PM, Sulkowski E, Sawyer RA. Glass ampules and associated hazards. Crit Care Med. 1989;17(8):812-813.
- Sabon RL, Cheng EY, Stommel KA, Hennen CR. Glass particle contamination: influence of aspiration methods and ampule types. Anesthesiology. 1989;70(5):59-62.
- Falchuk KH, Peterson L, McNeil BJ. Microparticulate-induced phlebitis: its prevention by in-line filtration. N Engl J Med. 1985;312:78-82.
