Dataset Information

Evaluation of three barrier-type closed system transfer devices using the 2015 NIOSH vapor containment performance draft protocol.

ABSTRACT:

Background

Closed 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.

Purpose

The 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.

Methods

The 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.

Results

The 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.

Conclusions

This 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 information

The online version contains supplementary material available at 10.1007/s40267-022-00905-x.

SUBMITTER: Szkiladz A

PROVIDER: S-EPMC8925293 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Evaluation of three barrier-type closed system transfer devices using the 2015 NIOSH vapor containment performance draft protocol.

Szkiladz Andrew A Hegner Shawn S

Drugs & therapy perspectives : for rational drug selection and use 20220316 4

<h4>Background</h4>Closed 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.<h4>Purpose</h4>The objective of this study was to evaluate the ...[more]

PMID: 35313703

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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:BackgroundDisease severity in coronavirus disease 2019 (COVID-19) may be associated with inoculation dose. This has triggered interest in intubation barrier devices to block droplet exposure; however, aerosol protection with these devices is not known. This study hypothesized that barrier devices reduce aerosol outside of the barrier.MethodsAerosol containment in closed, semiclosed, semiopen, and open barrier devices was investigated: (1) "glove box" sealed with gloves and caudal drape, (2) "drape tent" with a drape placed over a frame, (3) "slit box" with armholes and caudal end covered by vinyl slit diaphragms, (4) original "aerosol box," (5) collapsible "interlocking box," (6) "simple drape" over the patient, and (7) "no barrier." Containment was investigated by (1) vapor instillation at manikin's right arm with video-assisted visual evaluation and (2) submicrometer ammonium sulfate aerosol particles ejected through the manikin's mouth with ventilation and coughs. Samples were taken from standardized locations inside and around the barriers using a particle counter and a mass spectrometer. Aerosol evacuation from the devices was measured using standard hospital suction, a surgical smoke evacuator, and a Shop-Vac.ResultsVapor experiments demonstrated leakage via arm holes and edges. Only closed and semiclosed devices and the aerosol box reduced aerosol particle counts (median [25th, 75th percentile]) at the operator's mouth compared to no barrier (combined median 29 [-11, 56], n = 5 vs. 157 [151, 166], n = 5). The other barrier devices provided less reduction in particle counts (133 [128, 137], n = 5). Aerosol evacuation to baseline required 15 min with standard suction and the Shop-Vac and 5 min with a smoke evacuator.ConclusionsBarrier devices may reduce exposure to droplets and aerosol. With meticulous tucking, the glove box and drape tent can retain aerosol during airway management. Devices that are not fully enclosed may direct aerosol toward the laryngoscopist. Aerosol evacuation reduces aerosol content inside fully enclosed devices. Barrier devices must be used in conjunction with body-worn personal protective equipment.Editor’s perspective

Dataset Information

Evaluation of three barrier-type closed system transfer devices using the 2015 NIOSH vapor containment performance draft protocol.

Background

Purpose

Methods

Results

Conclusions

Supplementary information

Publications

Evaluation of three barrier-type closed system transfer devices using the 2015 NIOSH vapor containment performance draft protocol.

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