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: 7999568
• 负责人: Stephen Mitchell
• 金额: $ 24.98万
• 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 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7999568
• 关键词: Address; Adoption; Adverse effects; Adverse event; Age; Ambulatory Care Facilities; Area; Bypass; Cancer Patient; Cessation of life; Characteristics; Chemotherapy-Oncologic Procedure; Clinic; Clinical; Clinics and Hospitals; Community Clinical Oncology Program; Computer-Aided Design; Congenital Abnormality; Containment; Culture Media; Cumulative Trauma Disorders; Detection; Development; Device Designs; Device or Instrument Development; Devices; Drug Compounding; Drug Residues; Drug usage; Engineering; Ensure; Environment; Environmental Pollution; Equipment; Exposure to; Extravasation; Failure; Feedback; Fluorescein; Fluoresceins; Goals; Growth; Health; Health Personnel; Healthcare; Hospitals; Human; Human Resources; Infertility; Injection of therapeutic agent; Knowledge; Legal patent; Life; Link; Liquid substance; Maintenance; Malignant Neoplasms; Manuals; Manufactured Materials; Marketing; Measures; Medication Errors; Modeling; Molds; Needlestick Injuries; Nursing Staff; Occupational Exposure; Particulate; Patients; Performance; Performance at work; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacopoeias; Pharmacy facility; Phase; Population; Positioning Attribute; Preparation; Procedures; Process; Production; Protocols documentation; Puncture procedure; Reproducibility; Research Personnel; Risk; Robot; Robotics; Running; Safety; Series; Simulate; Small Business Innovation Research Grant; Solutions; Spontaneous abortion; Sterility; Surface; Syringes; System; Technology; Testing; United States; Urine; Validation; Vial device; Vision; Visual; Work; Workplace; analytical method; base; cancer cell; chemotherapy; cost; cytotoxic; design; experience; hazard; improved; innovation; killings; meetings; microbial; novel; oncology; operation; point of care; pressure; prevent; prototype; public health relevance; reconstitution; response; robotic device; simulation; success; vapor

DESCRIPTION (provided by applicant): Drugs used for cancer chemotherapy 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 to the healthcare personnel who routinely prepare and administer chemotherapy, such as cancers, infertility, miscarriages, birth defects, spontaneous abortions, and congenital malformations. Leakage in the form of liquid, particulate, or vapor 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 transfer devices (CSTDs) were originally developed to mitigate these risks, but the devices that are currently available in the marketplace suffer from a number of shortcomings, including leakage, needle sticks, inefficiencies, difficulty of use, and repetitive stress injuries. The objective of this Phase I SBIR proposal is to test the feasibility of a new, innovative disposable CSTD design that has the potential to provide superior drug containment capabilities. Feasibility will be determined by pursuing two specific aims. In Aim 1, this unique concept will be refined through a series of design iterations linked to fabrication and testing of rapid prototypes, culminating in production of a proof-of concept, working prototype that can be rigorously tested to establish its performance characteristics in Aim 2. Performance of the working prototype will be validated under real-life, process simulation conditions to determine whether it can contain leakage and maintain sterility during operation under the most challenging and stressful conditions encountered during drug compounding. Containment will be measured by sensitive visual and analytical methods, and sterility will be determined using United States Pharmacopeia standards for media fill. Successful completion of the phase I design and development studies will establish the groundwork for this novel, disposable CSTD as the cornerstone of a disruptive technology that will undergo further development in Phase II. As the population ages and the number of cancer patients grows, the demand for chemotherapy drug compounding is expected to increase, especially the preparation of tailored therapies for point-of-care use. The unique approach described in this proposal will benefit healthcare staff and patients alike by reducing the risks of occupational exposure and improving the accuracy of patient medications, while simultaneously increasing efficiencies and reducing costs. We anticipate our innovative CSTD will introduce unprecedented safety and efficiency improvements, strategically positioning J&J to capitalize on a rapidly growing $500 million market while reducing the risks associated with compounding and administering hazardous chemotherapy drugs. 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（由申请人提供）：用于癌症化疗的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、职业性暴露于这些高毒性药物对常规准备和实施化疗的医护人员造成严重的健康风险，如癌症、不孕症、流产、出生缺陷、自发性流产和先天性畸形。 液体、微粒或蒸汽形式的泄漏可能发生在配制药物并给予患者的过程中的几个步骤中的任何一个步骤中，几项研究表明工作场所污染的可能性很大。封闭系统转移装置（CSTD）最初被开发用于减轻这些风险，但是目前市场上可用的装置遭受许多缺点，包括泄漏、针刺、效率低下、使用困难和重复性应力损伤。 本阶段I SBIR提案的目的是测试一种新的、创新的一次性CSTD设计的可行性，该设计具有提供上级药物遏制能力的潜力。可行性将通过追求两个具体目标来确定。在Aim 1中，这一独特的概念将通过一系列与快速原型的制造和测试相关的设计迭代进行改进，最终生产出概念验证的工作原型，可以通过严格的测试来确定其在Aim 2中的性能特征。将在真实工艺模拟条件下验证工作原型的性能，以确定在药物配制过程中遇到的最具挑战性和压力的条件下，其是否能够在操作过程中包含泄漏并保持无菌性。将通过灵敏的目视检查和分析方法测量密封性，并将使用美国药典培养基灌装标准测定无菌性。 第一阶段设计和开发研究的成功完成将为这一新颖的一次性CSTD奠定基础，作为第二阶段进一步开发的颠覆性技术的基石。随着人口老龄化和癌症患者数量的增长，对化疗药物复合的需求预计将增加，特别是为护理点使用定制治疗的准备。本提案中描述的独特方法将通过降低职业暴露风险和提高患者用药的准确性，同时提高效率和降低成本，使医护人员和患者受益。我们预计，我们的创新CSTD将带来前所未有的安全性和效率改进，战略性地定位强生，以利用快速增长的5亿美元市场，同时降低与合成和管理危险化疗药物相关的风险。 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。