IEC 60601 Leaves Companies Struggling with Sustainable Design
The issue of ‘sustainability’ is becoming increasingly important for the medical industry since the implementation of the ‘International standard for environmentally conscious design of electronic medical equipment’ (IEC 60601-1-9) introduced in 2007. This directive is considered to be the global benchmark for companies designing sustainable medical equipment and requires manufacturers to consider the environmental impacts of their devices throughout the product life cycle.
On 1st June 2012, the 3RD edition of IEC 60601- Medical Electronic Equipment will come into force in the EU and Canada with the US following on the 1st of July 2013. This makes compliance with part 9 ‘Requirements for environmentally conscious design’ obligatory rather than optional as it has been in the past.
The difficulty for many medical device companies is that despite long standing awareness of the standard they have little or no experience dealing with issues relating to the environmental impact of their designs, with the tools and information required to comply with the standard not readily available. The requirements IEC 60601-1-9 centre around the need for manufacturers to identify the environmental impacts of new products and identify actions to manage and reduce the major impacts over time. This process must be documented. The key stages of any product's life cycle are:
Manufacture – the extraction of the raw materials and manufacture of the components
Transport – moving the parts and assemblies within the supply chain and to the end user
Use – covering energy and consumables used during the product’s useful life
Disposal – disposal to waste streams or recycling
Obtaining useable data about the impacts of these stages and the processes within them has proven to be a major problem for companies large and small. This is confirmed by a recent conference paper by Brouet et al.[1] representing global pharma companies, (including, GSK, AstraZeneca, Novartis, Pfizer and Merck), in which they concluded that the medical industry was behind other industries with its adoption of sustainability.
At IDC we have been working to overcome these difficulties in order to help companies understand and manage their environmental and sustainability issues. As well as actively supporting companies (including some of the above mentioned pharma companies) with studies and consultancy work around sustainability and life cycle assessment, IDC has also developed a series of tools which manufacturers can use themselves to ensure they comply with legislation for product life cycle and design for the environment, including IEC 60601-1-9.
One such product is the LCA Calculator (www.lcacalculator.com), a simple, low cost software tool which requires no special training and can be accessed through a standard web browser. Using data from EcoInvent, the world’s leading source of life cycle inventory (LCI) data, the online tool, guides the user through the stages of a product's life, including a comprehensive inventory of materials and manufacturing processes, to deliver simple, clear and easy to interpret results. Analyses can be saved, copied and compared against comparable products or potential new designs and results can be exported as Excel data or a pdf report.
The use of the tool allows companies to meet the standard set in IEC 60601-1-9 regarding medical eco design. With the impending legislation it is important for companies to think about the most appropriate tool they can implement quickly at a minimal cost (£300 per user per year). Table 1 details how the LCA Calculator can be used to ensure new products comply with key requirements of IEC 60601-1-9.
Understanding and managing the environmental impact of products is a complicated process and one which even the largest companies have struggled with. Two of the biggest obstacles to companies addressing these issues have been a lack of available life cycle information or data in such complex formats as to be unusable. This has made it very difficult to build environmental design processes into rapid development projects. With the arrival of mandatory legislation, organisations can no longer ignore this problem but through the use of a simple tool such as the LCA Calculator, compliance with the standard and improved environmental performance can be achieved rapidly and cost effectively.
References:
[1] Brouel, et al, “Sustainability for Inhaled Products: A Catalyst for Change”, Drug Delivery to the Lungs 22, 2011 p327 -330.