Impact of closed-system drug transfer device on exposure of environment and healthcare provider to cyclophosphamide in Japanese hospital

Miyake, Tomohiro; Iwamoto, Takuya; Tanimura, Manabu; Okuda, Masahiro

doi:10.1186/2193-1801-2-273

Cited by 38 publications

(28 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…None of the institutions used a CSTD for both preparation and administration, 39 The effectiveness of reducing surface (environmental) contamination with CSTDs is well established. 13,[17][18][19] In 2010, Sessink et al 13 collected 114 wipe samples across 22 pharmacies in the United States. Chemotherapy agents tested were cyclophosphamide, ifosfamide, and fluorouracil (5-FU).…”

Section: Engineering Controlsmentioning

confidence: 99%

Systematic Review of Control Measures to Reduce Hazardous Drug Exposure for Health Care Workers

Crickman

Finnell

2016

Journal of Nursing Care Quality

View full text Add to dashboard Cite

Because of their involvement in the transport, handling, preparation, administration, or disposal of hazardous medications, health care workers across multiple settings are at risk for adverse health consequences from exposure to these drugs. This review presents evidence-based strategies to mitigate the harmful exposures. These include engineering controls, full use of personal protective equipment, medical and environmental monitoring, hazard identification, and the need for a comprehensive hazardous drug control program that includes education and training for health care workers.

show abstract

Section: Engineering Controlsmentioning

confidence: 99%

Systematic Review of Control Measures to Reduce Hazardous Drug Exposure for Health Care Workers

Crickman

Finnell

2016

Journal of Nursing Care Quality

View full text Add to dashboard Cite

show abstract

“…Various methods used to detect abnormalities, lifestyle factors, amount of exposure to cytotoxic drugs, and variable use of safety measures impact the usefulness of these studies in attributing causation to these health risks. The addition of protective measures such as biologic safety cabinets (BSCs), CSTDs, and personal protective equipment (PPE) markedly decreases, but does not always eliminate, evidence of drug contamination …”

Section: Defining the Problemmentioning

confidence: 99%

ACVIM small animal consensus statement on safe use of cytotoxic chemotherapeutics in veterinary practice

Smith

Klahn

Phillips

et al. 2018

Veterinary Internal Medicne

View full text Add to dashboard Cite

The purpose of this report is to offer a consensus opinion of ACVIM oncology diplomates and technicians on the safe use of cytotoxic chemotherapeutics in veterinary practice. The focus is on minimizing harm to the personnel exposed to the drugs: veterinary practitioners, veterinary technicians, veterinary staff, and pet owners. The safety of the patient receiving these drugs is also of paramount importance, but is not addressed in this statement. Much of the information presented is based on national recommendations by Occupational Safety and Health Administration, National Institute for Occupational Safety and Health, United States Pharmacopeia, and other published regulations. These directives reflect an abundance of caution to minimize exposure to medical personnel, but large‐scale studies about the consequences of long‐term occupational exposure are not available in veterinary medicine. Challenges in the delivery of optimal treatment safely and economically to veterinary patients in general practice without access to a veterinary oncologist or other specialist, because of costs or proximity, remain.

show abstract

“…CSTDs reduce the risk of needle-stick injuries and the formation of aerosols during the compounding and administration processes, which are common sources of contamination [3,7]. CSTDs help to reduce exposure by containing any aerosol, liquid, or vapor releases.…”

Section: Introductionmentioning

confidence: 99%

Performance testing protocol for closed-system transfer devices used during pharmacy compounding and administration of hazardous drugs

Wilkinson¹,

Allwood²,

Morris³

et al. 2018

PLoS ONE

View full text Add to dashboard Cite

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.

show abstract

Impact of closed-system drug transfer device on exposure of environment and healthcare provider to cyclophosphamide in Japanese hospital

Cited by 38 publications

References 30 publications

Systematic Review of Control Measures to Reduce Hazardous Drug Exposure for Health Care Workers

Systematic Review of Control Measures to Reduce Hazardous Drug Exposure for Health Care Workers

ACVIM small animal consensus statement on safe use of cytotoxic chemotherapeutics in veterinary practice

Performance testing protocol for closed-system transfer devices used during pharmacy compounding and administration of hazardous drugs

Contact Info

Product

Resources

About