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

Abstract

There is currently no evidence to support or refute the routine use of closed-system drug transfer devices in addition to safe handling of infusional hazardous drugs, as there is no evidence of differences in exposure or financial benefits between CSTD plus safe handling versus safe handling alone (very low-quality evidence). None of the studies report health benefits.Well-designed multicentre randomised controlled trials may be feasible depending upon the proportion of people with exposure. The next best study design is interrupted time-series. This design is likely to provide a better estimate than uncontrolled before-after studies or cross-sectional studies. Future studies may involve other alternate ways of reducing exposure in addition to safe handling as one intervention group in a multi-arm parallel design or factorial design trial. Future studies should have designs that decrease the risk of bias and enable measurement of direct health benefits in addition to exposure. Studies using exposure should be tested for a relevant selection of hazardous drugs used in the hospital to provide an estimate of the exposure and health benefits of using CSTD. Steps should be undertaken to ensure that there are no other differences between CSTD and control groups, so that one can obtain a reasonable estimate of the health benefits of using CSTD.

Occupational exposure of pharmacy technicians and cleaning staff to cytotoxic drugs in Dutch hospitals

“…However, our results show that the present protocols using spikes in safety cabinets provide adequate protection. This finding is substantiated by a recent study in a large cohort of 83 hospitals in Canada by Chauchat et al (2019), which showed no benefit from reducing surface contamination by using such devices, as well as by a large Cochrane meta-analysis by Gurusamy et al (2018) on the same subject, which concluded that there is no scientific basis for the implementation of CSTDs. Moreover, our results show that our aims to improve worker protection further, should better be directed at the preparatory tasks in the pharmacy before the actual compounding, as we show that these result in the highest levels of exposure and probability of exceeding the threshold limit.…”

<p>Advanced Medical Devices for Preparation and Administration of Chemotherapeutic Agents: Results from a Multi-Dimensional Evaluation</p>

“…Results from the literature review are synthesized in the Prisma Flow Chart (Figure 1): 28 different technologies investigated. Out of the eight papers, one evidence referred to a Cochrane analysis on CSTD; 29 papers focused the attention on the implementation of closed system devices in the preparation phase or in the administration phase, 9,10,30,31 and three papers considered the benefits related to the adoption of a traceable workflow, based on gravimetric control. 16,17,32 The literature review revealed the lack of scientific evidence concerning the head-to-head comparisons among the four scenarios under assessment, in terms of safety and efficacy.…”

“…The strategic relevance of the topic is also supported by the presence of a Cochrane review on CSTDs in the preparation phase. 29 Despite the presence of a medium-quality scientific evidence, because of the presence of a low-risk of bias derived from ROBIN-I tool and the Newcastle-Ottawa Scale, important strengths are found in the safety and in the efficacy dimensions, in terms of a decrease in the professional exposure and increase in the identification errors, thus achieving the two-fold objective of cancer care. Why are closed systems not implemented in the routine clinical practices?…”

Overcoming Challenges of Implementing Closed System Transfer Device Clinical In-Use Compatibility Testing for Drug Development of Antibody Drug Conjugates

“…[1][2][3][4][5][6] Since the introduction of these devices in early 2000, there have been multiple studies demonstrating their effectiveness at reducing leakage and associated surface contamination in the health care setting. [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] Swab or wipe tests using a range of surrogate drugs have clearly shown lower contamination levels on isolator surfaces, gloves, prep mats, and the surface of infusions when drug is prepared with a CSTD. 7,23 Other studies report leakage rates that vary based on device as well as device and surrogate agent dependent reductions in contamination.…”