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

基本信息

批准号：
8840734
负责人：
Sylvia Bartel
金额：
$ 99.29万
依托单位：
J AND J SOLUTIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-17 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8840734
关键词：
Adoption Benchmarking Cancer Center Cancer Patient Clinic Containment Contracts Cyclophosphamide Data Defect Detection Development Device Designs Devices Diagnosis Disposable Equipment Dose Drug Compounding Drug Exposure Drug usage Ensure Exposure to Failure Fluorouracil Goals Grant Head Health Personnel Health Professional High Pressure Liquid Chromatography Hospitals Howard Temin Award Industry Infusion procedures Injection of therapeutic agent Investments Joints Legal patent Literature Malignant Neoplasms Manuals Manufacturer Name Marketing Medical Medical Device Medication Errors Metric Molds Outcome Patient Care Patients Performance Pharmaceutical Preparations Pharmacologic Substance Pharmacotherapy Pharmacy facility Phase Positioning Attribute Practice Guidelines Preparation Probability Process Protocols documentation Publishing Relative (related person)Risk Robotics Safety Sampling Secure Series Simulate Small Business Innovation Research Grant Speed Stainless Steel Sterility Surface Syringes System Technology Testing Toxicant exposure Treatment outcome Ultraviolet Rays Validation Vial device Work cancer therapy chemotherapy commercial application commercialization cost cost effective design expectation experience improved innovation meetings microbial novel operation patient safety prevent prototype public health relevance research and development response simulation trypticase-soy broth usability validation studies

项目摘要

DESCRIPTION (provided by applicant): Manual drug compounding of chemotherapy medications permits deadly dosing errors and toxic drug exposure and therefore poses unnecessary risks to patients and healthcare professionals. Some robotic compounding devices have been developed in response; however, poor drug containment safety capabilities and prohibitive cost and size have limited widespread adoption of existing compounding devices. Corvida Medical has developed a novel disposable closed system drug transfer device (CSTD) to protect health care workers from toxic exposure to hazardous drugs used in cancer treatments. During Phase II, the Corvida R&D team has completed further validation studies to show the Corvida CSTD meets the NIOSH and USP definition of a CSTD, and validated our device against ISO standards and most FDA requirements. Corvida has also developed an innovative compounding device that overcomes the safety, cost, and size limitations of existing compounding devices. At a fraction of the size and cost of current products, our technology will ensure reliable, accurate compounding to prevent patient medication errors, enhancing patient care, and will reduce exposure to toxic drugs by interfacing with disposable Corvida CSTD, optimizing both worker and patient safety. Phase IIB activities will focus on expanded testing requirements necessary to secure FDA 510(k) clearance of the disposable Corvida CSTD product, benchmarking studies against a commercial competitor, and on productizing the new compounding device through development of beta prototype that meets preliminary specifications, functions with the Corvida CSTD, and completing validation testing for process reliability, accuracy, containment, sterility, and system throughput. We aim to show a minimum 95% reliability, 95% accuracy, containment and sterility that meet USP standards, and system throughput in line with market expectations. Successful completion of these studies will help catalyze commercialization through clearing regulatory hurdles and by validating our novel compounding device that integrates the advantages of existing technology with the containment capabilities of the Corvida CSTD. Our device is more efficient and cost-effective, has a small footprint, provides accurate and reliable compounding and minimizes risks to both health professionals and patients. Once commercialized, these innovative products will help solve the significant problems of patient and healthcare worker safety though advancements in compounding equipment and disposable CSTDs as well as integration of these technologies into a complete and effective system.

描述（适用提供）：化学疗法药物的手动药物复合允许致命的给药错误和有毒药物暴露，因此对患者和医疗保健专业人员有不必要的风险。已经开发了一些机器人复合设备。但是，较差的药物遏制安全能力和禁止的成本和规模的宽度有限，对现有的复合设备的采用范围有限。 Corvida Medical开发了一种新颖的封闭系统药物转移装置（CSTD），以保护医疗保健工作者免受癌症治疗中使用的危险药物的有毒暴露。在第二阶段，Corvida研发团队已经完成了进一步的验证研究，以显示Corvida CSTD符合CSTD的NIOSH和USP定义，并根据ISO标准和大多数FDA要求验证了我们的设备。 Corvida还开发了一种创新的复合设备，该设备可以克服现有复合设备的安全性，成本和尺寸限制。在当前产品的大小和成本的一小部分中，我们的技术将确保可靠，准确的复合，以防止患者用药错误，增强患者护理，并通过与一次性的Corvida CSTD接口来减少对有毒药物的接触，从而优化工人和患者安全。 IIB阶段的活动将重点关注扩展的测试要求，以确保Corvida CSTD产品清除FDA 510（k），针对商业竞争者进行基准测试研究，并通过开发beta原型来生产新的复合设备，该β原型，可符合初步规范，可符合Corvida CSTD的功能，并通过corvida CSTD进行验证，并填充了进程，并可以构成可靠性，可准确地构成，可准确地，准确地构成。我们的目标是显示至少95％的可靠性，95％的准确性，遏制和不育，符合USP标准以及与市场期望一致的系统吞吐量。这些研究的成功完成将有助于通过清除监管障碍并验证我们的新型复合装置来催化商业化，从而将现有技术的优势与Corvida CSTD的遏制能力相结合。我们的设备更有效，更具成本效益，具有较小的占地面积，提供了准确可靠的复杂性，并为卫生专业人员和患者带来了风险。一旦商业化，这些创新产品将有助于解决患者和医疗保健工作人员安全的重大问题，尽管复合设备和一次性CSTD的进步以及将这些技术集成到完整有效的系统中。