Innovative Device to Improve Safety of Preparing and Administering Chemotherapy

提高化疗准备和实施安全性的创新设备

• 批准号: 8549159
• 负责人: Prasad Sunkara
• 金额: $ 101.42万
• 依托单位: J AND J SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-17 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8549159
• 关键词: Address; Adverse effects; Adverse event; American; Cancer Patient; Classification; Clinic; Code; Congenital Abnormality; Containment; Contracts; Cumulative Trauma Disorders; Cyclophosphamide; Data; Development; Device Designs; Devices; Documentation; Dose; Drug Compounding; Ensure; Environmental Pollution; Equipment Malfunction; Exposure to; Extravasation; Failure; Fluorouracil; Funding; Goals; Grant; Guidelines; Health; Health Personnel; Health Professional; Health system; High Pressure Liquid Chromatography; Hospitals; Industry; Infertility; Investments; Lead; Left; Liquid Chromatography; Liquid substance; Literature; Malignant Neoplasms; Marketing; Medical; Medical Device; Methods; Naproxen sodium; National Institute for Occupational Safety and Health; Needlestick Injuries; Occupational Exposure; Outcome; Particulate; Patient Care; Patients; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacopoeias; Pharmacy facility; Phase; Poison; Positioning Attribute; Preparation; Process; Production; Protocols documentation; Publishing; Risk; Robotics; Safety; Sampling; Secure; Series; Simulate; Small Business Innovation Research Grant; Societies; Sodium Fluorescein; Solutions; Specific qualifier value; Spontaneous abortion; Staging; Stainless Steel; Sterility; Sterilization; Surface; Syringes; System; Technology; Testing; Titania; Titanium; Update; Validation; Vial device; Workplace; base; chemotherapy; commercial application; commercialization; cost; cytotoxic; design; efficacy testing; ergonomics; experience; hazard; health definition; improved; innovation; iterative design; mass spectrometer; meetings; microbial; multidisciplinary; novel; prevent; prototype; simulation; success; trypticase-soy broth; usability; vapor

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.

描述（由申请人提供）：化疗药物往往具有高度细胞毒性和基因毒性，具有明确的致癌、致突变和致畸作用。每年有超过 550 万名接触化疗药物的医护人员因长期职业接触这些剧毒药物而面临严重的健康风险（例如癌症、不孕、流产、出生缺陷、自然流产和先天畸形）。在配制药物并将其给予患者的过程中的任何几个步骤中都可能发生液体、颗粒或蒸气泄漏，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 (CSTD) 最初是为了减轻这些风险而开发的，但现在市场上的装置存在主要缺点，包括泄漏、针刺、效率低下、使用困难以及重复性应力损伤和复合/输送错误的风险增加。 Corvida 的技术目标是开发一套专有的医疗设备并将其商业化，以提高医疗保健专业人员工作环境的安全性并提高患者治疗的功效。第一阶段成功证明了 Corvida 方法的可行性以及克服当前设备使医护人员得不到保护的局限性的潜力。第二阶段的目标是通过广泛的测试和优化来充分验证这个新的 CSTD。第二阶段包括三个目标，即推动 Corvida CSTD 的发展并为医护人员提供卓越的保护。在目标 1 中，CSTD 将通过已发布的台式测试标准（包括荧光素钠（紫外线溶液）和四氯化钛（可见蒸气）测试）来验证设计和生产质量。这些测试将确保 CSTD 满足或超过所有相关的 USP 和 ISO 标准，以验证其在性能和功能以及包装和灭菌方面达到了预期的设计和生产质量。在目标 2 中，将测试 CSTD，以证明其在使用萘普生钠和胰蛋白酶大豆肉汤的最终用户工艺模拟条件下实现了遏制并保持无菌。在目标 3 中，最终用户将使用 Corvida CSTD 在多个药房环境中使用两种成熟的化疗标志物药物（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 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记录。独立的、经过认证的工业卫生员将收集并分析来自 指定表面来评估 CSTD 前后的污染情况。将根据需要利用迭代设计来完善 CSTD 系统，以满足所有成功标准。正如预期的那样，基于非常有希望的第一阶段结果，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，最终获得 510(k) 市场许可并实现成功的商业化。