Innovative Device to Improve Safety of Preparing and Administering Chemotherapy

点击翻译按钮获取中文摘要

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.