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Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes

PURPOSE: 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. PATIENTS AND METHODS: The “extreme” products in PiC pen needles range were considered (G33x4 mm and G29x12 mm), to verify t...

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Autores principales: Nicolucci, Antonio, Leonardi, Luca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8976478/
https://www.ncbi.nlm.nih.gov/pubmed/35378795
http://dx.doi.org/10.2147/MDER.S352849
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author Nicolucci, Antonio
Leonardi, Luca
author_facet Nicolucci, Antonio
Leonardi, Luca
author_sort Nicolucci, Antonio
collection PubMed
description PURPOSE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: We documented that Pikdare needles are compatible with a large array of different pens for the injection of insulin and other drugs administered subcutaneously.
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spelling pubmed-89764782022-04-03 Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes Nicolucci, Antonio Leonardi, Luca Med Devices (Auckl) Original Research PURPOSE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: We documented that Pikdare needles are compatible with a large array of different pens for the injection of insulin and other drugs administered subcutaneously. Dove 2022-03-29 /pmc/articles/PMC8976478/ /pubmed/35378795 http://dx.doi.org/10.2147/MDER.S352849 Text en © 2022 Nicolucci and Leonardi. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Nicolucci, Antonio
Leonardi, Luca
Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes
title Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes
title_full Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes
title_fullStr Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes
title_full_unstemmed Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes
title_short Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes
title_sort compatibility of pic insupen needles with a broad range of pens for the injection of subcutaneously administered drugs for diabetes
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8976478/
https://www.ncbi.nlm.nih.gov/pubmed/35378795
http://dx.doi.org/10.2147/MDER.S352849
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