Materials

Butyl stoppers can be used when PTFE is not required. Butyl/PTFE septa are an economical choice with low background peaks. Molded PTFE/butyl septa offer the tightest seal of all PTFE items, as well as low background peaks. PTFE/silicone septa are excel

In order to test two different types of rubber (made from bromobutyl or chlorobutyl elastomer), with two different thicknesses (measured at the centre of the stopper), and two different needle bevels, the following commercially available products were purchased.

In order to test two different types of rubber (made from bromobutyl or chlorobutyl elastomer), with two different thicknesses (measured at the centre of the stopper), and two different needle bevels, the following commercially available products were purchased.

Medication vials with stoppers (marketed as single dose vials)

1. 2 mm thick chlorobutyl vial stoppers from Amoxicillin 1 g vials (Panpharma, Fougeres, France), batch 301907, expiry date 01/2017
2. 2 mm thick bromobutyl vial stoppers from Amoxicillin/Clavulanic acid 1 g/200 mg vials (Sandoz, Levallois Perret Cedex, France), batch DW9334, expiry date 12/2015
3. 4 mm thick chlorobutyl vial stoppers from Lidocaine 200 mg/20 mL vials (Aguettant, Lyon Cedex 07, France), batch T-7688C, expiry date 02/2017
4. 4 mm thick bromobutyl vial stoppers from Propofol 500 mg/50 mL vials (Fresenius Kabi France, Louviers, France), batch 16HC0243, expiry date 02/2017

Medication vials with stoppers (marketed as single dose vials)

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.

1. –

   2 mm thick chlorobutyl vial stoppers from Amoxicillin 1 g vials (Panpharma, Fougeres, France), batch 301907, expiry date 01/2017

2. –

   2 mm thick bromobutyl vial stoppers from Amoxicillin/Clavulanic acid 1 g/200 mg vials (Sandoz, Levallois Perret Cedex, France), batch DW9334, expiry date 12/2015

3. –

   4 mm thick chlorobutyl vial stoppers from Lidocaine 200 mg/20 mL vials (Aguettant, Lyon Cedex 07, France), batch T-7688C, expiry date 02/2017

4. –

   4 mm thick bromobutyl vial stoppers from Propofol 500 mg/50 mL vials (Fresenius Kabi France, Louviers, France), batch 16HC0243, expiry date 02/2017