CSTD

Occupational exposure of anticancer agents during their preparation has been recognized as a serious hazard. Closed system drug transfer devices (CSTDs) enable "safe" preparation of agents for medical personnel and ensure a safe hospital environment. However, artificial particles of infusion materials have been reported during CSTD use. Here, the incidence of insoluble fine particles during preparation of anticancer agents using CSTDs was examined. Visible insoluble fine particles were found in 465 (9.4%) of 4948 treatment cases at Ehime University Hospital with CSTD use...

The use of Closed System Drug-Transfer Devices (CSTDs) has increased significantly in recent years due to NIOSH and USP recommendations to use them during preparation of hazardous drugs. Mechanistic and material differences between CSTDs and traditional in-use components warrant an assessment of their impact on product quality and dosing accuracy. Using a combination of prevalent CSTDs with biologic molecules, we performed an extensive assessment of the effect of using CSTDs for dose preparation and observed no negative impact on product quality attributes...

PURPOSE: The primary aim of this study was to investigate the accuracy of the volumetric method for intravenous (IV) preparations and explore the utility of gravimetric methods in the medication preparation process within multiple institutions. Secondary outcomes of this study were syringe size percent variations and impact on drug expenditures. METHODS: A prospective, noninterventional, multisite study was conducted between March 2015 and December 2016 to generate baseline estimates of accuracy and precision in the volumetric medication preparation process...

Among alternative splicing events in the human transcriptome, tandem NAGNAG acceptor splice sites represent an appreciable proportion. Both proximal and distal NAG can be used to produce two splicing isoforms differing by three nucleotides. In some cases, the upstream exon can be alternatively spliced as well, which further increases the number of possible transcripts. In this study, we showed that NAG choice in tandem splice site depends considerably not only on the concerned acceptor, but also on the upstream donor splice site sequence...

PURPOSE: Androgenetic alopecia (AGA) is the most common cause of hair loss in males. Physical examination and history are the most important examinations in diagnosis of the disease. As yet, there is no diagnostic method to be able to determine which individuals will develop AGA. Shear-wave elastography (SWE) is a novel diagnostic tool, which can evaluate tissue stiffness. Superb microvascular imaging (SMI) can determine low flow in microvessels. The aim of the current study was to determine whether or not AGA would develop in individuals with normal hair and a family history of AGA using B-mode US, SMI, and SWE...

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...

BACKGROUND: Occupational exposure to cytotoxic drugs can lead to significant health problems. This study was designed to evaluate the risk of 5-fluorouracil (5-FU) contamination for nurses when disconnecting the infusion line of an elastomeric pump from a non-coring needle, by comparing three configurations: the first one using standard Male and Female Luer lock (Group 1), the second one using a needle-free connector (NFC) and a Male Luer lock (Group 2) and the third one using a closed-system transfer device (CSTD), Qimono® (Group 3)...

As a preventive measure for occupational exposure to anticancer drugs, the use of a closed system drug transfer device (CSTD)is not widespread. The main reason for this is the high cost of the equipment. For inpatient chemotherapy(Ⅳ)at our hospital, CSTD was used for the following 3 drugs, cyclophosphamide, ifosfamide, and bendamustine; however, from Nov. 2018, CSTD was used for all chemotherapy drugs. Meanwhile, the personal protective equipment (PPE) for ward nurses was simplified. The purpose of this study was to determine the effects of increased CSTD use and simplification of PPE on the cost of medical materials...

To address the challenges related to the interconnectivity between vial container closure systems and vial transfer devices, pharmaceutical, elastomer, and transfer device manufacturers have formed a working group under the Product Quality Research Institute (PQRI) to establish best practices for the evaluation of the assembly of vial transfer devices and vial systems. As part of the project, the first activity was to quantify the nature and frequency of issues (complaints). To this end, the working group conducted a survey with questionnaires related to categories and numbers of complaints, regions/countries where complaints were received, and the nature of the manufacturers who received the complaints...

INTRODUCTION: Closed-system transfer devices (CSTDs) were introduced into clinical practice to protect healthcare practitioners (HCPs) from exposure to hazardous drugs. However, ambiguous guidelines have led to confusion as to when CSTD use is required, as institutes are instructed to maintain their own hazardous drug lists and determine the appropriate level of personal protective equipment for their staff. This study seeks to understand the current use of CSTDs by Canadian oncology HCPs, the influence of various stakeholders on their use and the challenges faced by HCPs surrounding the use of these medical devices...

Development of nanoplatforms that can amplify the passive tumor targeting effect based on enhanced permeability and retention (EPR) effect is crucial for precision cancer nanomedicine applications. Herein, we present the development of core-shell tecto dendrimers (CSTDs) as a platform for enhanced tumor magnetic resonance (MR) imaging through an amplified EPR effect. In this work, poly(amidoamine) (PAMAM) dendrimers of generation 5 (G5) were decorated with β-cyclodextrin (CD) and then assembled with G3 PAMAM dendrimers premodified with adamantane (Ad) via supramolecular recognition of CD and Ad...

INTRODUCTION: There is a need for an economic evaluation of the use of closed system (CSTD) in chemotherapy compounding, especially in resource-constrained settings. OBJECTIVE: The objective of this study was to assess the cost saving of the management of cancer drug leftovers before and after introduction of CSTD associated with an extension of the beyond-use date (BUD) of cancer vials. A secondary objective was to estimate the level of minimization of drug wastage...

Closed system transfer devices (CSTDs) have been used with hazardous drugs for several decades. The goal of this whitepaper is to increase awareness among healthcare professionals, device manufacturers, regulators, and pharmaceutical/biotech companies on the potential issues around the use of CSTDs with biologics drug products to allow their informed use in clinics. Specifically, we discuss the key topics related to the use of CSTDs with biologics products, including components and materials of construction, a breakdown of regulatory, technical, and clinical site-related risks and challenges associated with the use of CSTDs with biological products, gathered from stakeholder discussion at the IQ Working Group conference, and considerations on current testing requirements and communication strategies to drive further dialog on the appropriate use of CSTDs...

OBJECTIVES: The main objective was to identify all studies that present data regarding microbial contamination of vials used for preparation with closed-system drug transfer devices (CSTDs). Our secondary objective was to compare the reported contamination of vials punctured with a CSTD versus no CSTD and to evaluate the quality of data reporting as defined by the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. METHODS: A literature review was conducted on 31 December 2018 on PubMed, EMBASE and Cumulative Index to Nursing and Allied Health Literature...

Occupational exposure to anticancer drugs may increase the risk of cancer and the risk of miscarriage and stillbirth, and cause other adverse events such as hypersensitivity reactions, skin/mucous reactions, and digestive symptoms. Several studies have investigated the use of closed-system drug-transfer devices (CSTDs) to reduce the environmental pollution by hazardous drugs. However, few reports have verified whether CSTDs contain the hazardous drugs within the vials. The BD PhaSealTM System is a CSTD that is frequently used in Japan...

Purpose: In 2015, the National Institute for Occupational Safety and Health (NIOSH) published a draft vapor containment protocol to quantitatively evaluate combined liquid, aerosol, and vapor containment performance of commercially available closed-system drug-transfer devices (CSTDs) that claim to be effective for gas/vapor containment within a controlled test environment. Until the release of this proposed protocol, no standard method for evaluating airtightness of CSTDs existed. The aim of this study was to evaluate six commercially available CSTDs utilizing NIOSH draft protocol methodology to evaluate vapor containment under a robust vapor challenge...

In this study, Spirulina maxima derived pectin nanoparticles (SmPNPs) were synthesized and multiple biological effects were investigated using in vitro and in vivo models. SmPNPs were not toxic to Raw 264.7 cells and zebrafish embryos up to 1 mg/mL and 200 µg/mL, respectively. SmPNPs upregulated Il 10, Cat, Sod 2, Def 1, Def 2, and Muc 1 in Raw 264.7 cells and tlr2, tlr4b, tlr5b, il1β, tnfα, cxcl8a, cxcl18b, ccl34a.4, ccl34b.4, muc5.1, muc5.2, muc5.3, hamp, cstd, hsp70, cat , and sod1 in the larvae and adult zebrafish, suggesting immunomodulatory activity...

The Formulation Workstream of the BioPhorum Development Group (BPDG), an industry-wide consortium, has identified the increased use of closed system drug-transfer devices (CSTDs) with biologics, without an associated compatibility assessment, to be of significant concern. The use of CSTDs has increased significantly in recent years due to the recommendations by NIOSH and USP that they be used during preparation and administration of hazardous drugs. While CSTDs are valuable in the healthcare setting to reduce occupational exposure to hazardous compounds, these devices may present particular risks that must be adequately assessed prior to use to ensure their compatibility with specific types of drug products, such as biologic drugs, which may be sensitive...

PURPOSE: To describe the development of an innovative process to deliver bacillus Calmette-Guérin (BCG) to an offsite urology clinic for bladder instillation. SUMMARY: The use of BCG, a live virus vaccine for treatment of patients with localized cancer of the urinary bladder, has created many logistical problems for hospitals and infusion center pharmacies. Due to its short stability, the drug cannot be made ahead of time and coordination with a patient's arrival at an infusion site is challenging...

BACKGROUND: Many reports support the use of closed system drug transfer devices (CSTDs) to protect against exposure to hazardous drugs during their preparation. However, leakage may occur if the CSTD fails to maintain hermeticity when fitted into the vial. Our aims were to devise a measure to prevent HD exposure and to develop a test method to verify CSTD function when a BD PhaSeal™ protector is used in HD preparation. METHODS: We selected the BD PhaSeal™ System, which is the most commonly used CSTD device in Japan...