在使用 RIVATM 化合机器人过程中对抗癌药物化学污染的评估:试点研究。

IF 1 4区 医学 Q4 ONCOLOGY
Myriam Bouchfaa, Michèle Vasseur, Justin Courtin, Marine Pinturaud, Nicolas Beauval, Delphine Allorge, Pascal Odou, Nicolas Simon
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引用次数: 0

摘要

前言目前,许多医院都在投资使用机器人配制系统来配制细胞毒剂。本研究旨在描述 RIVATM 机器人(ARxIUM,加拿大温尼伯)内外的细胞毒性污染情况:材料与方法:我们采用风险分析法来确定应监控配料机器人内部和外部的哪些位置。在清洁机器人之前,用湿拭子(使用 0.1 毫升无菌水)拭擦采集样本。使用 LC-MS/MS 对机器人配制的 10 种细胞毒性药物进行了筛查。我们确定了机器人内部(CRin)和外部(CRout)的污染率百分比以及每种污染物的含量(单位:纳克/平方厘米)。如果发现样本呈阳性,就会采取纠正措施:我们的风险分析突出了机器人内部的 10 个位置和外部的 7 个位置。共进行了 10 次采样(每次 10 个样本)。平均 CRin(40%)明显高于平均 CRout(2%;p -4)。吉西他滨和环磷酰胺是主要污染物。在采取纠正措施(如每天用 SDS/ 异丙醇清洗)后,CRin 从 60% 降至 10%:讨论/结论:机器人配料的污染频率低于隔离器中的人工配料。然而,机器人配制往往会产生更多的平均污染物;这与配制后处理注射器时发生飞溅等事件有关。纠正措施的实施有效地降低了污染物的浓度。需要进一步的长期研究来证实这些结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of chemical contamination by cancer drugs during use of the RIVATM compounding robot: A pilot study.

Introduction: Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVATM robot (ARxIUM, Winnipeg, Canada).

Material & methods: We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CRin) and outside (CRout) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented.

Results: Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CRin (40%) was significantly higher than the mean CRout (2%; p < 10-4). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CRin fell from 60% to 10%.

Discussion/conclusion: The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. Further longer-term studies are required to confirm these results.

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来源期刊
CiteScore
2.70
自引率
7.70%
发文量
276
期刊介绍: Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...
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