Vial coring and fragmentation incidence after angled penetration of rubber stoppers with single-use hypodermic needles

Abstract

Objectives Particles due to fragmentation present a clear risk to the patient. Reported fragmentation rates vary, and an insertion angle at 45°, as opposed to 90°, has been proposed as a mitigation strategy. So, this study evaluated the fragmentation rates induced by single-use hypodermic needles using different angled penetration techniques. Methods Needles underwent fragmentation testing using two penetration techniques. In method 1, the needle was inserted through the stopper at 45° and rotated to 90° upon exiting the stopper underside, and in method 2 the needle was rotated only after the bevel was fully enveloped by the stopper. Methods were tested with 18, 20, and 22-gauge needles with bevel faced up, down, and sideways. Fragmentation data sets were subjected to ANOVA and a fit to a General Linear Model was attempted to ascertain the significance of needle size, bevel position, and penetration method; p-values less than 0.05 indicated statistical significance. Results Incidence varied from 0 to 49% and depended on the test method. Needles larger than 22-gauge induced fragmentation the most when the bevel was down. The bevel up position induced fragmentation the least. Generation of large fragments designated “cores” depended on all factors examined, and generation of small fragments designated “fragments” depended on all factors except for the penetration method. Conclusions Clinical context and intended application need to be communicated to manufacturers and considered for functional testing when devising end-user recommendations which must reflect a combination of factors.

Practical Clinical Guidelines for Natalizumab Treatment in Patients With Relapsing Multiple Sclerosis

“…The bevel-up position induced the least fragmentation, while bevel down with needles >22 gauge yielded the most. Consistent with other studies,35 penetration of rubber stoppers on vials with a blunt needle has a greater incidence of fragmentation and “coring” (parts of the rubber stopper enter the vial) 34. To minimize the risk of coring, it is advised to push through the middle of the bullseye design on the rubber stopper with a 45° angle and bevel up while smoothly and simultaneously rotating the needle to a 90° angle after exiting the underside of the stopper 34.…”

“…One study tested 18-, 20-, and 22-gauge needles with bevel facing up, down, and sideways using 2 penetration techniques. 34 The bevel-up position induced the least fragmentation, while bevel down with needles >22 gauge yielded the most. Consistent with other studies, 35 penetration of rubber stoppers on vials with a blunt needle has a greater incidence of fragmentation and “coring” (parts of the rubber stopper enter the vial).…”

“…Particulate matter can elicit a systemic reaction to latex or embolization in the patient receiving the infusion. One study tested 18-, 20-, and 22-gauge needles with bevel facing up, down, and sideways using 2 penetration techniques 34. The bevel-up position induced the least fragmentation, while bevel down with needles >22 gauge yielded the most.…”

“…Storage/stability requirements and administration have been detailed previously 34. Briefly, after dilution, the prepared natalizumab solution should be infused immediately or refrigerated at 2°C to 8°C (36° to 46°F), but not frozen, and infused within 8 hours of preparation.…”

The impact of needle size and angle on rubber coring after multiple puncturing of multi-dose propofol vial rubber stoppers

“…The risk of coring may be reduced by using the smaller needle compared to the larger one, however, seeing this small particle is more difficult [ 7 ]. Another important factor is the bevel position, Rase et al [ 8 ] reported the bevel up position resulted in fewer particles than the bevel down position. To date, there has been no study to compare needle size with the occurrence of particles.…”