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Impending IEC 60601 Leaves Medical Companies Struggling with Rules on Sustainable Design

Tue, 05/15/2012 - 5:48am
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 third 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 Industrial Design Consultancy (IDC) we have been working 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. This includes 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.

 Table 1 - Requirements in Section 4 of IEC 60601-1-9

Clause

Requirement

Use of LCA Calculator

4.1

Identify the environmental aspects of the new product design across all of the product’s life cycle stages.

A simple step-by-step process allows you to enter the information about the product’s manufacture, transport, use and disposal and gives a CO2 impact associated with each element and stage.

4.2

Determine which of these environmental aspects can have significant environmental impacts across the product’s life cycle stages. These are identified as significant environmental aspects.

The results’ report, automatically highlights the three largest impacts to allow you to focus on these first. All other impacts are also listed in detail.

4.3

Gather information during the concept and design stage from suppliers whose products and services are likely to contribute significant environmental aspects to the final product.

Data source note for manufacturing processes are given to allow comparison with impact data obtained direct from your suppliers.

4.4

Set targets for the significant environmental aspects to minimise as far as reasonable the product’s significant environmental impacts across all life cycle stages. The design concept and specification setting stages shall consider novel, emerging or alternative technologies and/or solutions that can reduce the product’s significant environmental impacts.

Use the tool to examine ‘what if’ scenarios for new designs, materials and technologies to allow targets to be set.

4.4

Assess the actual significant aspects of a representative prototype across all life cycle stages. Any deviations from the targets shall be assessed and documented for consideration in future designs.

Analyse potential design options before undertaking the detailed design based upon what you currently know and refine the analysis as more design information becomes available through the process.

4.5.1

Make available information on the type and mass of packaging materials.

The impact of different packaging materials can easily be compared.

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.

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