Vial Stoppers: The Hidden Latex Risk in the Perioperative Environment

Fredrick Ntumy, MD; Kathryn Reck, DO; Roy Soto, MD

Letter to the Editor:

To the Editor:

Latex is a known cause of allergy and anaphylaxis in the perioperative period. The most common source of exposure has historically been gloves; however, other medical devices also contain natural latex rubber. The FDA required that medical devices containing latex be appropriately and uniformly labeled in 1997; however, vial closures were not included in these regulations. Awareness of latex risk is high, and operating room staffs routinely have protocols in place to minimize exposures in patients at increased risk of allergy or anaphylaxis. Over the past 20 years, in fact, most of our operating theaters have become generally "latex free," with traditional non-sterile latex gloves being replaced with nitrile or vinyl, and latex containing anesthesia equipment (breathing circuit bags, blood pressure cuff tubing, tourniquets) being replaced with non-latex alternatives.

One source of latex, however, still exists in the perioperative environment: 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).

Although 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.

Fredrick Ntumy, MD Kathryn Reck, DO Roy Soto, MD Department of Anesthesiology Beaumont Health System Royal Oak, MI


References

  1. Holzman R. Taskforce on Latex Sensitivity. Natural rubber latex allergy: Considerations for anesthesiologists. ASA Publications. 2005
  2. Proposal to prohibit the use of natural rubber latex for use in elastomeric closures for injection. Pharmacopeial Forum. 1996; 22:2886-7
  3. Primeau M, Adkinson F, Hamilton R. Natural rubber pharmaceutical vial closures release latex allergens that produce skin reactions. J Allergy Clin Immunol. 2001;107:959-62.
  4. Heitz J, Bader S. An evidence-based approach to medication preparation for the surgical patient at risk for latex allergy: Is it time to stop being stopper poppers? J Clin Anesth 2010;22:477-83.