Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.

Closed-system drug transfer devices (CSTDs) are used to prevent occupational exposure to hazardous drugs in health care providers. They are considered Class II medical devices by the US FDA and are cleared but not approved before marketing. While compatibility tests are conducted by CSTD manufacture...

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Autores principales:	Shao-Chin Chiang, Mandy Shen, Chen-Chia Lin, Hui-Ping Chang
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/b780054f1752427db2aa00c0a52269b7
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spelling	oai:doaj.org-article:b780054f1752427db2aa00c0a52269b72021-12-02T20:14:06ZEstablishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.1932-620310.1371/journal.pone.0257873https://doaj.org/article/b780054f1752427db2aa00c0a52269b72021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0257873https://doaj.org/toc/1932-6203Closed-system drug transfer devices (CSTDs) are used to prevent occupational exposure to hazardous drugs in health care providers. They are considered Class II medical devices by the US FDA and are cleared but not approved before marketing. While compatibility tests are conducted by CSTD manufacturers, the procuring institution needs to consider performing its own studies before buying these devices. Herein we tested the compatibility of the components of the Needleless® DualGuard CSTD system (vial access clips, vial access spikes, and administration adaptors) with 10 antineoplastic drugs, under simulated clinical conditions, including compounding and administration, and examined drug potency maintenance, plasticizer migration, and device functionality. All drugs maintained potency within 5%. Diisononyl phthalate leakage was observed from the administration adaptors for paclitaxel and concentrated etoposide solution. In addition, white particles were discovered in CSTDs storing busulfan solution and small cracks were observed on devices which stored melphalan. Thus, it was concluded that even in simulated clinical conditions, instead of extreme conditions, there are still concerns regarding the efficacy and safety of CSTD components. The methodology may be used to implement and detect possible interactions between antineoplastic agents and CSTD components before procurement.Shao-Chin ChiangMandy ShenChen-Chia LinHui-Ping ChangPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 9, p e0257873 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Shao-Chin Chiang Mandy Shen Chen-Chia Lin Hui-Ping Chang Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
description	Closed-system drug transfer devices (CSTDs) are used to prevent occupational exposure to hazardous drugs in health care providers. They are considered Class II medical devices by the US FDA and are cleared but not approved before marketing. While compatibility tests are conducted by CSTD manufacturers, the procuring institution needs to consider performing its own studies before buying these devices. Herein we tested the compatibility of the components of the Needleless® DualGuard CSTD system (vial access clips, vial access spikes, and administration adaptors) with 10 antineoplastic drugs, under simulated clinical conditions, including compounding and administration, and examined drug potency maintenance, plasticizer migration, and device functionality. All drugs maintained potency within 5%. Diisononyl phthalate leakage was observed from the administration adaptors for paclitaxel and concentrated etoposide solution. In addition, white particles were discovered in CSTDs storing busulfan solution and small cracks were observed on devices which stored melphalan. Thus, it was concluded that even in simulated clinical conditions, instead of extreme conditions, there are still concerns regarding the efficacy and safety of CSTD components. The methodology may be used to implement and detect possible interactions between antineoplastic agents and CSTD components before procurement.
format	article
author	Shao-Chin Chiang Mandy Shen Chen-Chia Lin Hui-Ping Chang
author_facet	Shao-Chin Chiang Mandy Shen Chen-Chia Lin Hui-Ping Chang
author_sort	Shao-Chin Chiang
title	Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
title_short	Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
title_full	Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
title_fullStr	Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
title_full_unstemmed	Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
title_sort	establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/b780054f1752427db2aa00c0a52269b7
work_keys_str_mv	AT shaochinchiang establishingaprotocolforthecompatibilitiesofclosedsystemtransferdeviceswithmultiplechemotherapydrugsundersimulatedclinicalconditions AT mandyshen establishingaprotocolforthecompatibilitiesofclosedsystemtransferdeviceswithmultiplechemotherapydrugsundersimulatedclinicalconditions AT chenchialin establishingaprotocolforthecompatibilitiesofclosedsystemtransferdeviceswithmultiplechemotherapydrugsundersimulatedclinicalconditions AT huipingchang establishingaprotocolforthecompatibilitiesofclosedsystemtransferdeviceswithmultiplechemotherapydrugsundersimulatedclinicalconditions
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Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions.

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