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: 8314941
• 负责人: Stephen Mitchell
• 金额: $ 55.65万
• 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/8314941
• 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. 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.

描述（由申请方提供）：化疗药物往往具有高度细胞毒性和遗传毒性，具有充分记录的致癌、致突变和致畸作用。长期职业接触这些剧毒药物会带来严重的健康风险（例如，癌症、不孕不育、流产、出生缺陷、自然流产和先天性畸形），每年有550多万医护人员接触化疗药物。液体、微粒或蒸汽泄漏可能发生在配制药物并将其施用于患者的过程中的几个步骤中的任何一个步骤中，并且几项研究表明工作场所污染的可能性很大。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关键缺点，包括泄漏、针刺、效率低下、使用困难以及重复性应力损伤和混合/输送错误的风险增加。Corvida的技术目标是开发和商业化一套专有的医疗设备，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，以及克服当前设备限制的潜力，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充分验证这一新的科技促发委。第二阶段包括三个目标，以推动Corvida CSTD的发展，并为医疗工作者提供上级保护。在目标1中，将通过已发布的实验室测试标准（包括荧光素钠（UV溶液）和四氯化钛（可见蒸气）测试）确认CSTD的设计和生产质量。这些测试将确保 CSTD符合或超过所有相关USP和ISO标准，以确认其在性能和功能以及包装和灭菌方面达到预期设计和生产质量。在目标2中，将对CSTD进行检测，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性。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）进行配料和模拟给药任务（不向患者输送药物）。目标3研究包括使用分析方法评估环境表面污染，并将提供任何器械故障的文件。一个独立的，经过认证的工业卫生专家将收集和分析擦拭样品， 指定的表面，以评估前和后的CSTD污染。将根据需要采用迭代设计，改进科技促发委系统，使之符合所有成功标准。正如所设想的那样，基于非常有希望的第一阶段结果，在第二阶段完成后，Corvida CSTD将是第一个符合NIOSH和USP CSTD定义的产品，并且Corvida器械将根据所有ISO标准和FDA要求进行验证，最终获得510（k）市场许可，并成功实现商业化。 公共卫生相关性：数以百万计的医疗工作者在药物制备和给药期间面临暴露于危险药物的风险，例如用于治疗癌症患者的化疗药物。封闭系统转移装置（CSTD）最初是为了保护工人免受接触剧毒药物的危害而开发的，但目前的装置有几个缺点。该提案描述了一种新型一次性CSTD的创新设计和方法，通过限制这些有害药物释放到工作环境中，为医护人员和癌症患者提供更好的保护。