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Frequency and component analysis of contaminants generated in preparation of anticancer agents using closed system drug transfer devices (CSTDs).

ABSTRACT: 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. Contaminants occurred more frequently during preparation of monoclonal antibodies than cytotoxic anticancer agents (19.4% vs. 4.1%, respectively, P < 0.01). A similar survey was conducted at nine hospitals to investigate the incidence of insoluble fine particles with or without CSTDs. Insoluble fine particles were detected in 113 (15.4%) of 732 treatment cases during preparation of monoclonal antibodies with CSTD use. In contrast, the occurrence of insoluble fine particles without CSTDs was found in only 3 (0.073%) of 4113 treatment cases. Contamination with CSTDs might cause harmful effects on patients during cancer therapy. We strongly recommend the use of in-line filters combined with infusion routes after CSTD use to avoid contamination-associated adverse events.

SUBMITTER: Sumikawa S

PROVIDER: S-EPMC8741972 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesThe United States National Institute for Occupational Safety and Health (NIOSH) is developing a protocol to assess the containment performance of closed system transfer devices (CSTDs) when used for drug preparation (task 1) and administration (task 2) and published a draft protocol in September 2016. Nine possible surrogates were proposed by NIOSH for use in the testing. The objectives of this study were to: (A) select the most appropriate surrogate; (B) validate the NIOSH protocol using this surrogate; and (C) determine the containment performance of four commercial CSTDs as compared with an open system of needle and syringe using the validated NIOSH protocol.Methods2-Phenoxyethanol (2-POE) was selected as a surrogate based on its water solubility, Henry's volatility constant, detectability by mass spectrometry, and non-toxicity. Standard analytical validation methods including system suitability, limit of detection (LOD), and limit of quantitation (LOQ) as well as system cleaning validation were performed. The amount of 2-POE released when the CSTDs were manipulated according to two tasks defined by NIOSH was determined using mass spectrometry coupled to thermal desorption and gas chromatography. This approach allows sensitivity of detection below 1 part per billion (ppb). Equashield, Tevadaptor (OnGuard), PhaSeal, and ChemoClave were assessed according to manufacturers' instructions for use.Results2-POE was tested and validated for suitability of use within the NIOSH protocol. A simple and efficient cleaning protocol achieved consistently low background values, with an average value, based on 85 measurements, of 0.12 ppb with a 95% confidence interval (CI) of ±0.16 ppb. This gives an LOD for the tests of 0.35 ppb and an LOQ of 0.88 ppb. The Equashield, Tevadaptor (OnGuard), and PhaSeal devices all showed average releases, based on 10 measurements from five tests, that were less than the LOQ (i.e. < 0.88 ppb), while the ChemoClave Vial Shield with Spinning Spiros showed average releases of 2.9±2.3 ppb and 7.5±17.9 ppb for NIOSH tasks 1 and 2 respectively at the 95% confidence level. The open system of needle and syringe showed releases, based on two measurements from a single test, of 4.2±2.2 ppb and 5.1±1.7 ppb for NIOSH tasks 1 and 2 respectively at the 95% confidence level.Conclusions2-POE proved to be an ideal surrogate for testing of CSTDs using the NIOSH protocol. We propose that a CSTD can be qualified using the NIOSH testing approach if the experimental LOQ is less than 1 ppb and the release values are below the LOQ. Equashield, Tevadaptor (OnGuard), and PhaSeal meet these acceptance criteria and can therefore all be qualified as CSTDs, but the ChemoClave system does not and so would not qualify as a CSTD.

Project description:BackgroundClosed System Transfer Devices (CSTD) have been developed to reduce healthcare worker exposure to hazardous drugs during medication handling. To evaluate CSTD performance in preventing the escape of drug vapors, the National Institute for Occupational Safety and Health (NIOSH) developed a 2015 draft testing protocol incorporating two compounding tasks utilizing 70% isopropyl alcohol (IPA) as a medication surrogate.PurposeThe objective of this study was to evaluate the performance of three CSTDs (Chemolock [ICU Medical Inc., San Clemente, CA], PhaSeal [BD, Franklin Lakes, NJ], and Equashield [Equashield, Port Washington, NY]) in preventing the escape of drug vapor in accordance with the 2015 NIOSH draft protocol during simulated compounding and administration tasks.MethodsThe protocol was modified for the CSTDs to be used in accordance with manufacturer instructions for use and to represent clinical practice through repeated CSTD connections. Tasks were executed with each of the three CSTDs using 70% IPA as the medication surrogate to simulate compounding of a lyophilized drug, intravenous (IV) bag preparation (task 1), and bolus administration through an IV set (task 2). A positive control was performed by completing both tasks in duplicate, utilizing a needle and syringe instead of the CSTD to simulate preparation and injection through luer connectors. Differences in time to complete each simulated task was also evaluated.ResultsThe three CSTDs had statistically equivalent performance and maintained IPA vapor levels below the limit of detection (LOD) of 1.0 ppm. Positive controls had mean vapor release of 17.40 ppm and 23.45 ppm for tasks 1 and 2, respectively. Positive controls also required statistically longer mean time to complete both tasks, followed in decreasing order by PhaSeal, Equashield, and Chemolock.ConclusionsThis study suggests that when evaluated in accordance with the 2015 NIOSH draft protocol, the three CSTDs are equivalent in their ability to prevent IPA vapor release while differences in time required for task completion may exist.Supplementary informationThe online version contains supplementary material available at 10.1007/s40267-022-00905-x.

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Frequency and component analysis of contaminants generated in preparation of anticancer agents using closed system drug transfer devices (CSTDs).

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