nature of the rubber stopper; rubber stopper thickness, type of metal needle bevel used to pierce the stopper, and puncture technique. For each one of 16 different situations, 40 medication vial rubber stoppers were punctured, and the contents filtered. The filters were then examined under optical microscopy and particles present counted and measured.

Rubber stoppers allow easy access to drugs contained in glass medication vials, as they can be readily punctured through with a needle or a cannula. In hospitals in general and in intensive care units in particular, the great use of injectable drugs packaged in glass vials with rubber stoppers means that such a practice is very common. For example, in the intensive care units of our hospital, approximately 99,000 rubber stoppers of various medication vials were punctured in 2015. The presence of visible particles of various sizes in medication drug vials, caused by the coring of the vial’s rubber stopper by injection or preparation medical devices, has been regularly reported in scientific literature. Isolated cases have been described, as well as several studies on particle incidence in used medication vials . The incidence of rubber stopper coring, assessed by the presence of visible particles, has been evaluated as ranging overall from 0 to 40 %, depending on the studies and the medical devices used for the piercing of the rubber stopper.

rubber vial stoppers. Literature has demonstrated that piercing of a rubber stopper results in measurable quantities of latex in the vial as well as measurable latex antigens in blood after injection. This risk is highest when a vial stopper is punctured multiple times, so some (including the American Society of Anesthesiologists and the American Association of Nurse Anesthetists) have recommended avoiding multi-dose vials for this specific reason, and recommendations have previously been made to the FDA to prohibit the use of these stoppers, without success. Clinical practice continues to vary, however, and despite calls for avoidance of multi-dose vials (for a multitude of reasons), many providers routinely still use single-dose vials for multiple patients (e.g., drawing two 5 mL syringes of succinylcholine from a single 10 mL bottle).

some vial stoppers are made with plastics or synthetic rubbers, there is no mandatory labeling for these vials and no simple way of determining if the vial stoppers are plastic or rubber. With the widespread availability of inexpensive non-rubber alternatives and the small but real risk of latex exposure and resultant harm, we suggest that the time has come to regulate the content of vial stoppers in the perioperative environment. We therefore recommend appropriate uniform labeling of medication vial stoppers, identification of rubber vial stoppers, or making plastic stoppers mandatory.

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