Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

Abstract

A wide variety of materials and chemicals are used in the development, production, cleaning, packaging, sterilization and shipment of medical devices. Some of these materials are used in large quantities and are often a source of waste. Some materials, such as poly vinyl chloride (PVC) plastics, have toxicity concerns. Additionally, many chemicals including chlorinated solvents and ethylene oxide are carcinogenic or highly toxic and can be detrimental to the environment and public health. While the medical device industry is highly regulated in the United States by the Food and Drug Administration, new green initiatives in the European Union are modifying the regulatory oversight of chemicals, materials, and their manufacture. In addition, hospitals are working to reduce waste and pollution as part of their operations and are increasingly asking vendors to assist them. Minimizing waste and pollution associated with medical devices can improve a company's environmental performance and save money. The primary focus in medical device manufacturing is patient safety and compatibility. Environmental considerations, which can include potential cost savings, are often overlooked in the design and process development phases. Numerous pollution prevention and energy efficiency options exist for medical device manufacturers. These options can be integrated into the development, design and process protocols, and engineering change orders when designing a new product or improving an existing part. By having a process design evaluation plan that includes environmental considerations, companies can effectively manage the creation of waste streams, toxicity of material inputs, and process efficiencies as a mechanism at both the front-end and the duration of the product line. These options often cut costs and can help reduce current and prospective regulatory burdens. The Minnesota Technical Assistance Program (MnTAP) at the University of Minnesota has been assisting businesses with pollution prevention and cost savings for 25 years. MnTAP's engineers and scientists have worked with the medical device industry to reduce the quantity of packaging and waste associated with cardiac catheters, reduce the use of toxic cleaning solvents, minimize the use of PVC, and research safer disinfection and sterilization methods. This poster includes case studies of the above mentioned projects, an overview of less toxic sterilization methods, and tools for medical device manufacturing that meet FDA requirements, but reduce waste and toxicity during production and use.