Environmentally conscious design is an overall good practice for many industries, including medical devices. According to a 2014 Harris Poll commissioned by Johnson & Johnson, more than 80 percent of hospitals around the world are expected to incorporate sustainability into their purchasing decisions.1 It is easy to see why manufacturers would want to voluntarily design and develop environmentally conscious equipment. In order to make these claims, some countries require verification of sustainability in order. Others, like Brazil, are moving toward mandatory compliance with standards aimed at improving environmental impact of medical electrical devices. One standard can provide the guidance for manufacturers when it comes to such designs.
IEC 60601-1-9 was published in 2007 and amended in 2013. Its requirements are based on practical experience from the industry that illustrated cost savings and marketing benefits. While it is not a requirement for many countries and certification schemes, if a manufacturer wishes to make sustainability claims about their product, given the importance of such products to the industry, it is legally required that they provide verifiable data to support their claims. IEC 60601-1-9 provides a formal way of verifying such claims. Additionally, it will become legal requirement in Brazil later this year.
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. While it does not provide a simple list of eco-friendly design specifications, the compliance assessment checks specified in the standard are based on verifying that procedures are in place and evidence is documented to illustrate how environmentally friendly principles were included in the design and development process. The end goal is minimizing significant impact on the environment.
The core requirements of IEC 60601-1-9 can be summed us as “identification,” “instruction,” and “end-of-life management.” They include:
- Environmental protection as one element of the overall risk management process, which should be performed in compliance to ISO 14971. This standard deals with influences of medical devices on the environment, considering factors such as emissions of toxic materials and biological and chemical hazards. Assessing results at each stage of activity provides valuable input for the risk management process.
- Life-cycle thinking, in line with ISO 14001 Edition 2015, which can be used as a guide when implementing processes for managing environmental concerns throughout a product’s lifespan. Additionally, particular emphasis is placed on ISO 14062, integrating environmental aspects into product design and development.
- Establishing, implementing and maintaining a process to: identify and document the environmental aspects across all product life-cycle stages; determine aspects that may have significant environmental impacts across the life cycle stages; identify suppliers that contribute to significant environmental aspects and obtain from them information necessary to identify and assess the aspects.
- Establish and document targets for the significant environmental aspects to minimize adverse environmental impacts across all life-cycle stages. During this step, emerging or alternative technologies must be considered. Additionally significant aspects of a representative prototype of the final design must be assessed and documented, as should any deviations from the target.
- Make available all relevant information on the type and mass of packaging materials. Provide instructions in accompanying documents for minimizing environmental impact of the product during normal use.
- Provide organization/people accountable for the use and maintenance of the product with information for proper disposal at end of life.
In order to demonstrate compliance to IEC 60601-1-9, the following must be submitted:
- 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
Assessments of this documentation can be done independently from the evaluations of the other parts of the IEC 60601 series. A manufacturer can also use risk analysis to help decide on environmental improvement targets, but this is not required.
Acceptability of medical electrical equipment’s environmental impacts is balanced against other factors: intended function, performance, safety, cost, marketability, quality and legal and regulatory requirements. Balance can differ depending on the intended use of a device. A solution appropriate for life-saving or life-supporting equipment might not be appropriate for a device intended to correct a minor ailment. This means a manufacturer must also be prepared to justify that medical benefit outweighs the associated adverse environmental impacts.
The benefits of eco-conscious design in medical electrical equipment can be great. They can fulfill requirements, like those about to be made in Brazil, or they can simply indicate that a product is in line with what a majority of the industry prefers. Regardless of the motives, using IEC 60601-1-9 as a guide can help support sustainability claims and allow manufacturers to bring greener medical devices to the market.
- Harris Poll, on behalf of Johnson & Johnson. The Growing Importance of More Sustainable Products in the Global Health Care Industry. https://www.jnj.com/sites/default/files/pdf/JNJ-Sustainable-Products-White-Paper-092512.pdf. Last accessed 5/23/16