Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes.
diabetes mellitus
injection therapy
needle compatibility
pen needle
Journal
Medical devices (Auckland, N.Z.)
ISSN: 1179-1470
Titre abrégé: Med Devices (Auckl)
Pays: New Zealand
ID NLM: 101566041
Informations de publication
Date de publication:
2022
2022
Historique:
received:
07
12
2021
accepted:
14
03
2022
entrez:
5
4
2022
pubmed:
6
4
2022
medline:
6
4
2022
Statut:
epublish
Résumé
To test the compatibility of PiC Insupen needles with a broad range of pens produced by different manufacturers for the injection of subcutaneously administered drugs. The "extreme" products in PiC pen needles range were considered (G33x4 mm and G29x12 mm), to verify that the compatibility was not affected by the cannula diameter and length. Following the launch of the G34x3.5mm needle, additional tests were performed comparing G33x4 and G34x3.5 pen needles. A test medium with viscosity similar to insulin was used. Additional tests were performed with a liquid with a much higher viscosity. All the requirements of the technical standard ISO 11608-2 were satisfied, and the differences between G29, G33 and G34 were negligible. Therefore, the PiC Insupen needle G33x4mm was chosen as representative of the PiC pen needles. Dose accuracy and needle hub torque were assessed, according to the ISO 11608-2:2012 norms. For pens with variable volume, two different volumes were tested (Vlow and Vhigh) in random order, testing 60 needles with Vlow and 60 with Vhigh. Overall, 50 different pens were tested. Dose accuracy acceptance criteria were met for all the pens tested, with the only exception of Vhigh for Berlipen Precision pen. The removal torque was adequate for all pens, with the only exception of Berlipen 301 and Berlipen 302 pens. We documented that Pikdare needles are compatible with a large array of different pens for the injection of insulin and other drugs administered subcutaneously.
Identifiants
pubmed: 35378795
doi: 10.2147/MDER.S352849
pii: 352849
pmc: PMC8976478
doi:
Types de publication
Journal Article
Langues
eng
Pagination
71-77Informations de copyright
© 2022 Nicolucci and Leonardi.
Déclaration de conflit d'intérêts
Luca Leonardi is Pikdare S.p.A. employee. Antonio Nicolucci has received honoraria from AstraZeneca, Eli Lilly, Novo Nordisk, and research support from Alfasigma, Medtronic, Novo Nordisk, Pikdare, Sanofi, Shionogi, SOBI. The authors report no other conflicts of interest in this work.
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