Innovative Device to Improve Safety of Preparing and Administering Chemotherapy

描述(由申请人提供)：化疗药物往往具有高度的细胞毒性和遗传毒性，具有良好的致癌、致突变和致畸作用。长期职业接触这些剧毒药物会给每年接触化疗药物的550多万医护人员带来严重的健康风险(如癌症、不孕不育、流产、出生缺陷、自然流产和先天性畸形)。在合成药物并给患者服用的过程中，任何一个步骤都可能发生液体、微粒或蒸汽泄漏，几项研究表明，工作场所污染的可能性很大。封闭式系统药物转移装置(CSTD)最初是为了降低这些风险而开发的，但现在市场上的装置存在关键缺点，包括泄漏、针扎、效率低下、使用困难，以及重复应激损伤和合成/递送错误的风险增加。Corvida的技术目标是开发一套专有医疗设备并将其商业化，以改善医疗专业人员工作环境的安全性，并提高患者治疗的有效性。第一阶段成功地证明了Corvida方法的可行性，以及克服当前设备的局限性的潜力，这些设备使医护人员得不到保护。第二阶段的目标是通过广泛的测试和优化来充分验证这一新的CSTD。第二阶段包括三个目标，以推动Corvida CSTD的发展，并为医护人员提供卓越的保护。在目标1中，CSTD的设计和生产质量将通过已公布的台式测试标准进行验证，包括荧光素钠(UV溶液)和四氯化钛(可见光蒸汽)测试。这些测试将确保 CSTD符合或超过所有相关的USP和ISO标准，以验证其在性能和功能以及包装和灭菌方面实现了预期的设计和生产质量。在目标2中，将对CSTD进行测试，以证明它在最终用户工艺模拟条件下实现了遏制并保持了无菌状态，使用的是萘普生钠和胰蛋白酶酱油。在目标3中，终端用户将使用Corvida CSTD在多个药房环境中使用两种公认的化疗标志物药物环磷酰胺和氟尿嘧啶进行复合和模拟给药任务(不会向患者提供药物)。Aim 3的研究包括使用分析方法评估环境表面污染，并将提供任何设备故障的文件。一名独立的认证工业卫生师将收集和分析来自 用于评估CSTD前后污染的指定表面。将根据需要利用迭代设计来改进CSTD系统，以满足所有成功标准。正如设想的那样，基于非常有希望的第一阶段结果，在第二阶段完成后，Corvida CSTD将成为第一个满足NIOSH和USP CSTD定义的设备，并且Corvida设备将根据所有ISO标准和FDA要求进行验证，最终实现510(K)市场许可并实现成功的商业化。

DESCRIPTION (provided by applicant): Chemotherapy drugs tend to be highly cytotoxic and genotoxic, with well-documented carcinogenic, mutagenic, and teratogenic effects. Long-term occupational exposure to these highly toxic drugs presents serious health risks (e.g., cancers, infertility, miscarriages, birth defects, spontaneous abortions, and congenital malformations) to over 5.5 million healthcare workers who are exposed to chemotherapy drugs each year. Liquid, particulate, or vapor leakage can occur during any of several steps in the process of compounding the drug and administering it to the patient, and several studies suggest the potential for workplace contamination is widespread. Closed system drug-transfer devices (CSTDs) were originally developed to mitigate these risks, but the devices now on the market suffer from key shortcomings, including leakage, needle sticks, inefficiencies, difficulty of use, and increased risk of repetitive stress injuries and compounding/delivery errors. Corvida's technology objective is to develop and commercialize a proprietary suite of medical devices that improve the safety of working environments for healthcare professionals and enhance the efficacy of patient treatments. Phase I successfully proved feasibility of the Corvida approach and the potential to overcome the limitations of current devices that leave healthcare workers unprotected. The Phase II goal is to fully validate this new CSTD with extensive testing and optimization. Phase II includes three aims to drive development of the Corvida CSTD and provide superior protection to healthcare workers. In Aim 1, the CSTD will be validated for design and production quality via published bench-top testing standards, including fluorescein sodium (UV solution) and titanium tetrachloride (visible vapor) tests. These tests will ensure that the CSTD meets or exceeds all relevant USP and ISO standards to validate that it achieves the intended design and production quality for performance and functionality as well as packaging and sterilization. In Aim 2, the CSTD will be tested to demonstrate that it achieves containment and maintains sterility under end-user process simulation conditions using naproxen sodium and trypticase soy broth. In Aim 3, end-users will use the Corvida CSTD to conduct compounding and simulated administration tasks (no drugs will be delivered to patients) in multiple pharmacy settings using two well established chemotherapy marker drugs: cyclophosphamide and fluorouracil. The Aim 3 study includes assessment of environmental surface contamination using analytic methods and will provide documentation of any device failures. An independent, certified industrial hygienist will collect and analyze wipe samples from designated surfaces to assess pre-and-post-CSTD contamination. Iterative design will be utilized as needed to refine the CSTD system to meet all success criteria. As envisioned-and based on the very promising Phase I results-upon completion of Phase II the Corvida CSTD will be the first to meet the NIOSH and USP CSTD definition, and the Corvida device will have been validated against all ISO standards and FDA requirements, culminating in 510(k) market clearance and enabling successful commercialization.