Abstract
Purpose:
Speaking during the intravitreal injection procedure causes aerial dispersion of oral bacteria known to cause post-injection endophthalmitis. To date, no studies have explored the effect of speaking during syringe preparation for intravitreal injection. The purpose of this study is to assess if speaking during syringe preparation for intravitreal injection causes contamination of the syringe needle and/or drug product.
Methods:
10 recent graduates of ACPE accredited pharmacy schools were recruited to prepare syringes for this study under 3 different conditions. In condition 1, analysts prepared syringes for intravitreal injection while speaking (counting out loud). In condition 2, analysts prepared syringes while speaking and wearing a mask. In condition 3, analysts prepared syringes while staying silent with no mask. Analysts repeated each condition 3 times. Syringe needles were then cut into tubes of Tryptic Soy Broth and drug product was spread onto blood agar plates for incubation. The analysts then completed 1 positive control plate for each aforementioned condition by holding an exposed blood agar plate at approximately the same distance required to prepare the syringes. Analysts held this position for the same mean duration of time that was required to prepare the syringes in each respective condition. All samples were incubated at 37°C for 72 hours.
Results:
A total of 90 syringes were prepared by 10 independent analysts. Each syringe preparation required an average of 91 seconds (range 41 - 193 seconds) to complete. No contamination of the syringe needle or drug product was observed in the speaking, or speaking with a mask, or silent conditions. Positive control plates showed bacterial growth on 5/10 plates in the speaking condition (range 0 - 17 colonies/plate) and 3/10 plates in the speaking with mask condition (range 0 - 2 colonies/plate). No growth was observed on the positive control plates in the silent condition.
Conclusions:
Speaking without a mask during syringe preparation causes bacterial dispersion into the drug preparation field but may not result in contamination of the syringe needle or drug product.