{"entity":{"id":"idea-upgrade-closed-system-transfer-device-outcome-trial","kind":"idea","name":"A trial of closed-system transfer devices that measures staff exposure properly, not only surface wipes","aka":[],"tldr":"Closed-system transfer devices are sealed connectors meant to stop chemotherapy escaping when it is prepared and given. US standards require them for giving hazardous drugs, but a Cochrane review found only weak observational studies and could not say whether they reduce staff exposure.","summary":"The evidence. The Cochrane review (2018) found 24 observational cluster studies in 359 hospitals and no randomised trials; all were at serious risk of bias, mostly in pharmacy staff, and mostly of one device. Very low certainty evidence was insufficient to show a difference in staff urine tests or surface contamination, and the authors wrote that \"no firm conclusions can be drawn\". They suggested multicentre randomised trials, or interrupted time series, measuring exposure to the drugs actually used and short-term health outcomes.\n\nThe standards. ASCO's safe handling standards (2019) rated the literature as low quality, noted that no standard test of device performance existed, and reported that USP chapter 800 requires the devices for nursing administration and recommends them for compounding. The devices add cost to every dose; adoption has not been measured by any source read.","asOf":"2026-11-11","links":[{"label":"Gurusamy et al., Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff (Cochrane Database Syst Rev 2018)","url":"https://doi.org/10.1002/14651858.CD012860.pub2"},{"label":"Celano et al., Safe Handling of Hazardous Drugs: ASCO Standards (J Clin Oncol 2019)","url":"https://doi.org/10.1200/JCO.18.01616"}],"tags":["protocol-upgrade","upgrade:untested","evidence:insufficient"],"related":[],"cancers":[],"sections":["chemotherapy"],"technologies":["closed-system-transfer-devices","pharmacy-automation"],"targets":[],"drugs":["cyclophosphamide","ifosfamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-workforce"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"In chemotherapy day units, closed-system transfer devices used for all hazardous drug connections reduce the proportion of nurses with detectable cyclophosphamide or ifosfamide in urine, compared with standard connections plus PPE.","rationale":"A device required by a standard and paid for on every dose should be shown to reduce the exposure it is meant to prevent, in the staff group (nurses) where the evidence is thinnest.","test":"A cluster-randomised or stepped-wedge trial across chemotherapy day units, with nurses' urine drug levels and surface wipe contamination as outcomes, and cost per dose, using a performance-tested device.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":3},"route":"/ideas/idea-upgrade-closed-system-transfer-device-outcome-trial/","neighbours":{"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"}],"technology":[{"id":"closed-system-transfer-devices","kind":"technology","name":"Closed-system transfer devices for hazardous drugs (PhaSeal, ChemoLock, Equashield)","route":"/technologies/closed-system-transfer-devices/"},{"id":"pharmacy-automation","kind":"technology","name":"Oncology pharmacy automation and compounding robots","route":"/technologies/pharmacy-automation/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"ifosfamide","kind":"drug","name":"Ifosfamide","route":"/drugs/ifosfamide/"}],"bottleneck":[{"id":"b-workforce","kind":"bottleneck","name":"Not enough oncologists, nurses, pathologists, physicists","route":"/bottlenecks/b-workforce/"}],"protocol":[{"id":"hazardous-drug-handling-in-clinical-areas","kind":"protocol","name":"Safe handling of hazardous anticancer drugs where they are given: protective equipment, closed systems, spills, waste and body fluids","route":"/protocols/hazardous-drug-handling-in-clinical-areas/"}]}}