How to develop greener medical devices

Just like all electrical products, electrical medical devices marketed in the EU must comply with a number of regulatory requirements and directives, including PPWD, REACH, RoHS, the Batteries Directive and WEEE, which all contain various environmental requirements (see fact box).

It might seem like there’s a lot to comply with, but responsible manufacturers of medical devices should consider going one step further to benefit the environment.

Fortunately, you don’t have to invent new and complicated processes in order to develop green designs. Your current quality and risk management processes might just need the odd tweak.

Environmentally conscious design and IEC 60601-1-9

One possibility is to comply with the IEC standard 60601-1-9 for environmentally conscious design, which purpose is to protect the environment and people from hazardous substances, reduce the consumption of natural resources and minimise the environmental impact from waste.

This involves integrating environmentally conscious design throughout the product life cycle, and considering environmental aspects in relation to specification, design, manufacture, sales, logistics, installation, use and final disposal.

The standard contains just three pages of actual requirements and as many as 15 pages of informative material to help you comply with the requirements.

Establish processes with the environment in mind

In order to comply with the standard, the manufacturer must establish, implement and maintain (and thus document) the following processes throughout the product life cycle:

• Identify environmental aspects including hazardous substances, emissions to air/water, waste, utilisation of energy and natural resources, noise, vibration, odour, transport, accidents and pollution.
  
  
• Qualitatively or quantitatively assess the most significant environmental aspects.
  
  
• Identify suppliers and supplies that contribute to significant environmental aspects and obtain relevant information for identification and assessment.
  
  
• Establish objectives to reduce the environmental impact and do an overall final assessment on a representative prototype.
  
  
• Provide information about the type and weight of used packaging materials and options on how to reduce the environmental impact during use and disposal.
  
  

The IEC 60601-1-9 standard is currently not harmonised and may, as the only collateral standard, be exempted when testing for compliance to IEC 60601-1, which applies to most medical electrical equipment.

The standard indicates that early environmental considerations, in addition to contributing to a healthier environment, can also lead to savings, increased innovation and creativity, new business opportunities and improved product quality.

Systematic environmental thinking from the get go

It is important that environmental aspects are systematically considered in each development project from the get go. It may seem unachievable, when you have to consider things like quality management, risk management and usability right from the start as well. But the argument remains the same: There is greater flexibility in the earlier stages of a project, and thus more room to make design choices, which can then be integrated optimally. In the later stages, there is less room for change, which often leads to patchwork solutions.

Risk management should be the central focus of the overall life cycle of any medical product. For most medical companies, the most important focus area of the company's risk management activities is protecting users, such as patients, operators and relatives.

However, risk management, which is usually carried out in accordance with ISO 14971, must not only deal with physical damage to people, but also damage to property and the environment. The latter two tend to be bottom of the list.

Risk levels in relation to the environment

ISO 14971 works with the terms ‘Probability’, the probability that a potential hazard will lead to harm, and ‘Severity’, which is the consequence of the harm, if it occurs. Both are typically quantified in three to five levels from ‘unlikely’ to ‘very likely’ and ‘discomfort’ to ‘death’. A combination of the two (e.g. the product ‘P x S’) is used to estimate the risk level.

If we apply the principles of risk management in relation to environmental considerations, the group concerned expands from one to potentially involving many. The result can have global effects spanning generations, so environmental aspects are absolutely central. It is the responsibility of the individual manufacturer to quantify this. Of course, it is difficult to set up an effective model, but we will come back to that.

As an example, wastewater discharge can be an environmental aspect taken into account. The result of wastewater discharge can lead to an environmental impact in the form of surface water or groundwater contamination. Translated into risk management terms, a potential discharge can be considered as a “Hazard”, while water pollution resulting in fish being killed can be considered as ‘Harm’.

Similarly, transport aspects in relation to manufacturing, distribution and service can potentially lead to an environmental impact in the form of climate change (CO₂) and the depletion of natural resources. Table 1 shows several examples of the relationship between environmental aspects and environmental impacts.