Medical equipment gets thorough physical
Designers of electrical medical equipment now must adhere to a new standard, ensuring eco-design principles are maintained. Where did it come from and what will it demand of the medical industry?
Dr Aidan Turnbull
Environmental consultancy Environ has launched a best-practice club in conjuntion with the European medical technology industy association, Eucomed. It aims to help all medical device manufacturers to manage regulatory and customer requirements by applying the new standard.
The list of environmental regulatory requirements affecting product design continues to increase. Capturing these requirements at the initial stage of the design process is vital to ensure market access and avoid expensive rework.
Packaging was the first issue to be targeted. Packaging materials restrictions and marking requirements have been in place for several years in Europe and South East Asia. Next came restrictions on materials in the product.
The Chinese version of RoHS required medical devices containing restricted materials to be labelled from 1 March, 2007, and the current exemption from the RoHS Directive in Europe may be removed for some medical devices from 2012. Article 11 of the WEEE Directive requires member states to encourage manufacturers to design equipment that facilitates dismantling and recovery to allow reuse and recycling of components and materials.
California is leading the way in the US, with restrictions on materials from January 2007 for video display devices containing a screen greater than 10cm. All external power supplies sold in California had to comply with Energy Star energy efficiency requirements from 1 July, 2007, and more stringent requirements will become mandatory from this July.
The Batteries Directive will become law in Europe in September. It places requirements on the design and labelling of batteries, including batteries which are incorporated into medical devices. Article 11 of the directive requires manufacturers to design equipment so that waste batteries can be readily removed, and to provide removal instructions.
But these requirements will not apply where a permanent connection with the battery is required to ensure continuity of power supply for safety, performance, medical or data integrity reasons. In practice, infected medical equipment will also be exempt from these requirements.
From 2011, an amendment to the Medical Devices Directive requires all medical devices sold in Europe to be labelled if they contain phthalates (compounds that make plastics
flexible). The REACH (Registration, Evaluation and Authorisation of Chemicals) Regulation may also introduce new restrictions on certain chemicals and substances.
Medical device manufacturers are also facing increasing pressure for environmentally conscious design from customers in the US and Europe.
"As part of our sustainable procurement policy, we intend to introduce procedures and guidance requiring detailed environmental requirements to be developed for each tender specification," says David Wathey, who is the sustainable development manager for the NHS Purchasing and Supply Agency.
"The environmental requirements will reflect the significant environmental impacts associated with the particular contract, product or technology. Where relevant, the tender specification will also include requirements for environmental performance data, for example, water consumption of a pathology analyser," he adds.
Government health care funding in Sweden is decentralised to 20 county councils, each of which is taking a different approach to integrating environmental requirements into their purchasing policies. For example, under Stockholm County Council's procurement policies, PVC has been virtually phased out of all disposable medical products, and DEHP is avoided in products for neonates (feeding tubes etc).
In the US, Hospitals for a Healthy Environment (H2E) promotes environmentally friendly purchasing and has assisted several large health care trusts to include environmental product specifications in the tenders issued by their group purchasing organisations. In addition to a directory of environmentally friendly products and services, H2E also issues annual environmental excellence awards that generate a considerable amount of publicity and interest from heath care trusts.
The new IEC 60601-1-9 standard provides medical device manufacturers with a practical framework for managing regulatory compliance and responding to customer pressures.
The standard requires manufacturers to demonstrate how they have introduced procedures to integrate environmental design and compliance requirements into their new product design process. This includes identifying environmental aspects that are significant across the product's life cycle, setting design targets to reduce these significant aspects, assessing environmental performance of a representative prototype and providing environmental information to users and recyclers.
The diagram below summarises the typical steps that a company would go through to implement the standard.
IEC 60601-1-9 is a collateral standard to IEC 60601-1, the global benchmark for medical electrical equipment. Many companies view compliance with IEC 60601-1 as a de facto requirement for most markets for product registration, attaining a CE UL and CSA marking, contract tenders, and defence against claims in event of problems, etc. The latest edition IEC 60601-1:2005 requires compliance with all collateral standards in order to maintain compliance with the main standard IEC 60601-1.
The US, Canada, Japan, Australia and New Zealand have not yet set transition dates for their national versions of this latest standard, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. But the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.
IEC 60601-1-9 emphasises that the design and development phase is key to influencing environmental impacts of all of the product's life cycle stages. This includes minimising the materials, utilities and wastes involved in (and therefore environmental impact of) product manufacture, use, service and repair, and ultimate disposal and recycling.
"Environmental design is an aspect of good design practice and overlaps with many other design approaches, such as lean manufacturing, design for assembly/disassembly and cost-down," says Dr Freimut Schröder, head of environment, health and safety and medical product testing at Siemens Medical Solutions.
"Health care product design teams should already be addressing many aspects of environmental design. However, all companies can benefit by using the IEC 60601-1-9 standard to formalise their approach to environmental design." Applying the standard at Siemens Medical Solutions has reduced product costs by between 30% and 50% in some cases.
The best-practice club
Working with the European Medical Technology Industry Association Eucomed, environmental consultancy Environ launched a Best Practice Club which can help all medical device manufacturers to manage regulatory and customer requirements, and also gain business benefits from applying the new IEC 60601-1-9 standard.
"The club concept and approach was developed following consultation with Eucomed", says Seamus Healy, chair of the Eucomed Environment Focus Group. "Eucomed is represented on the Steering Group and Eucomed members are playing a leading role in co-ordinating industry comments and suggestions to Environ for action."
The club trains and supports health care product design teams to use a web-based system for environmental compliance, so logging into www.medical-ecodesign.com becomes an integral part of the product design process. The auditable system is based on checklists and worksheets that the product design team completes at each stage. For example, the web-based system includes structured checklists to capture relevant product environmental regulatory requirements at the initial planning stage.
The practical integration of the web-based system has been tested by global medical device manufacturer Smiths Medical. This built on previous product environmental design work carried out at Smiths Medical sites in the UK, US and Germany.
"Smiths Medical is planning to roll out the web-based system across all sites worldwide," says Paul Harris, the firm's medical communications director.
Details about the EcoDesign Best Practice Club are available at
For a three-week trial of the system, contact Aidan Turnbull on 01249 700104 or email firstname.lastname@example.org.
Dr Turnbull will be giving a presentation about IEC 60601-1-9 at the Medtec Stuttgart Conference, 11-13 March 2008