Incorporating Sustainable Design in Medical Device Development
As the majority of hospitals incorporate sustainability into their purchasing decisions and countries regulate sustainable design (e.g. Brazil), it’s prudent for medical device manufacturers to consider sustainable design in their medical device development.
The environmental impacts of a medical device have to be balanced against other factors such as intended function, performance, safety, cost, marketability, quality and legal and regulatory requirements. Devices with different functions (e.g. life-saving vs. monitoring) might be treated differently. A manufacturer of a medical device might justify, as a result of risk management, that a medical benefit outweighs the associated adverse environmental impacts.
However, an environmentally conscious design is a good practice for medical device manufacturers as sustainability is an important issue for the healthcare industry.
Since the majority of the environmental impact of a product is determined during specification development and concept generation, utilizing sustainable design principals and tools early on is key. One tool, Life Cycle Analysis (LCA), should be used throughout the product life cycle to evaluate the environmental impact of products, identify problem areas, and make improvements at the most effective stages of a product's life cycle. Using LCA throughout the product life cycle effectively lowers the overall negative environmental effect as well as reduces cost.
Regarding standards that relate to sustainability, IEC 60601-1-9 was published in 2007 and amended in 2013. While it is required in Brazil, it is not yet a requirement for many countries; however, if a manufacturer wishes to make sustainability claims about their product, IEC 60601-1-9 provides a formal way of verifying such claims. The objective of IEC 60601-1-9 is the improvement of environmental impact, taking into account all stages of a product’s life cycle, from initial specification to end-of-life management.
The following are required to demonstrate compliance to IEC 60601-1-9:
•Design documents and process description relevant to the identification of environmental aspects and information from the supply chain
•Design documents relevant for the reduction of adverse environmental impacts
•Information on packaging
•Accompanying documents; sections relevant for minimizing environmental impact during normal use
•Information related to end-of-life management
Additionally, ISO 1400:2015 can be used as a guide when implementing processes for managing environmental concerns throughout a product’s lifespan. ISO 14001 pertain to the process of how a product is produced, rather than to the product itself. ISO/TR 14062:2002 describes concepts and current practices relating to the integration of environmental aspects into product design and development.
Finally, sustainability is an element of the overall risk management process, which should be performed in compliance with ISO 14971:2012. Risks must include mitigating hazards that may occur during the decommissioning and disposal process.
Incorporating sustainable design practices can produce environmentally friendly, higher quality, lower-cost medical devices. Medical device manufacturers that understand and embrace sustainable design prior to regulation potentially have a competitive advantage.