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基因毒性，具有充分证明的致癌、致突变和致畸作用。长期职业接触这些剧毒药物给每年接触化疗药物的550多万卫生保健工作者带来严重的健康风险（例如癌症、不孕症、流产、出生缺陷、自然流产和先天性畸形）。在配制药物并给病人用药的过程中，液体、颗粒或蒸气的泄漏可能发生在任何一个步骤中，一些研究表明，工作场所污染的可能性很普遍。封闭系统药物转移装置（CSTDs）最初是为了减轻这些风险而开发的，但现在市场上的设备存在主要缺点，包括泄漏、针扎、效率低下、使用困难、重复性应力损伤和复合/给药错误的风险增加。Corvida的技术目标是开发并商业化一套专有的医疗设备，以改善医疗保健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，并有潜力克服当前设备的限制，使医护人员不受保护。第二阶段的目标是通过广泛的测试和优化来充分验证这种新的CSTD。第二阶段包括三个目标，以推动Corvida CSTD的发展，并为医护人员提供更好的保护。在目标1中，CSTD将通过发布的台台测试标准进行设计和生产质量验证，包括荧光素钠（紫外线溶液）和四氯化钛（可见蒸气）测试。这些测试将确保这一点

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. PUBLIC HEALTH RELEVANCE: Millions of healthcare workers are at risk of exposure to hazardous drugs, such as chemotherapeutics used to treat cancer patients, during drug preparation and administration. Closed system transfer devices (CSTDs) were originally developed with the goal of protecting workers from the hazards of exposure to highly toxic drugs, but current devices have several shortcomings. This proposal describes an innovative design and approach for a new type of disposable CSTD that will provide better protection for healthcare workers and cancer patients alike, achieved by limiting the release of these hazardous drugs into the work environment.