SPECIAL REPORT

The list of environmental regulatory requirements affecting product design continues to in­crease, and the medical industry is not immune to this trend. IEC 60601-1-9, Environmentally Conscious Design of Medical Electrical Equipment, was published in July 2007. It draws on extensive practical experience at Siemens Medical Solutions and Philips Medical Systems, which shows that applying the standard can also deliver cost savings and marketing benefits. An initiative launched in consultation with the pan-European medical technology industry association EUCOMED aims to help medical device manufacturers apply the new standard and manage regulatory and customer requirements while gaining business benefits.

Rules of the Global Playing Field

As the number of environmental-related regulatory requirements rises, capturing these requirements at the initial stage of the new product design process is vital to ensuring market access and avoiding expensive rework.

Packaging was the first issue to be targeted. Restrictions on materials and marking requirements have been in place for several years in Europe and Southeast Asia.

Next came restrictions on materials in the product. China’s Restriction of Hazardous Substances (RoHS) regulation requires medical devices containing restricted materials to be appropriately labelled starting on 1 March 2007. In Europe, the current exemption of some medical products from the RoHS Directive may be removed in 2012. California is leading the way in the United States. Since January 2007, RoHS materials restrictions have affected video displays with a screen larger than 4 inches, measured diagonally. All external power supplies sold in California must comply with Energy Star energy efficiency requirements since July 2007; more-stringent requirements will become mandatory in July 2008.

The Batteries Directive, which will become law in Europe in September 2008, places requirements on the design and labelling of batteries, including batteries that 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. However, 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.

Looking to the future, the European Parliament passed an amendment to the Medical Devices Directives in March 2007 that will require all medical devices sold in Europe to note on the label if they contain phthalates. The requirement will come into force across the European Union in 2011. The (Registration, Evaluation, and Authorization of Chemicals) REACH regulation also may introduce new restrictions on certain chemicals and substances.

Meeting Customer Demands

Medical device manufacturers are also facing increasing pressure for environmentally conscious design from customers in the United States and Europe.

“As part of our Sustainable Procurement Policy, we intend to introduce procedures and guidance mandating detailed environmental requirements to be developed for each tender specification,” says David Wathey, sustainable development manager for the UK National Health Service (NHS) Purchasing and Supply Agency (PASA) (www.pasa.nhs.uk). “The environmental requirements will reflect the significant environmental impact associated with a particular contract, product, or technology. Where relevant, the tender specification will also include requirements for environmental performance data, such as the water consumption of a pathology analyzer, for example,” says Wathey.

Government healthcare funding in Sweden is decentralized to 20 county councils, each of which is taking a different approach to integrating environmental requirements into its purchasing policies. For example, under Stockholm County Council’s procurement policies (www.stockholmsustainableregion.se), PVC has been virtually phased out of all disposable medical products and DEHP is avoided in feeding tubes and other products for neonates.

In the United States, Hospitals for a Healthy Environment (www.H2E-online.org) promotes environmentally friendly purchasing and has assisted several large healthcare trusts to include environmental product specifications in the tenders issued by their group purchasing organizations. In addition to a directory of eco-friendly products and services, H2E also issues annual Environmental Excellence Awards that generate a considerable amount of publicity and interest from healthcare trusts.

Setting a New Environmental Standard

Figure 1: The typical steps involved in applying the IEC 60601-1-9 standard are shown in this figure. (click image to enlarge)

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 the environmental performance of a representative prototype, and providing environmental information to users and recyclers. Figure 1 summarizes the typical steps that a company would take 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 involving product registration; CE, UL, or CSA marking; contract tenders; and/or as a defence against claims in event of problems. 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 United States, Canada, Japan, Australia, and New Zealand have not yet set transition dates for the national versions of IEC 60601-1:2005, but the national versions published thus far require conformity with IEC 60601-1-9. The European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.

Cost Savings and Marketing Benefits

Table I. Applying IEC 60601-1-9 at Siemens Medical Solutions benefited both the environment and the company’s bottom line. (click image to enlarge)

IEC 60601-1-9 emphasizes that the design and development phase is key to influencing the environmental impact of a product’s entire life cycle. This includes minimizing the materials, utilities, and waste involved in—and, therefore, environmental impact of—product manufacture, use, service and repair, and ultimate disposal and recycling at end of life.

“Environmental design is an aspect of good design practice and overlaps with many other design approaches such as lean manufacturing, design for assembly and disassembly, and cost down,” says Freimut Schröder, PhD, Head of Environment, Health & Safety and Medical Product Testing at Siemens Medical Solutions (www.med ical.siemens.com). “Healthcare 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 formalize their approach to environmental design.” Schröder notes that applying the standard at Siemens Medical Solutions has reduced product costs by as much as 50% in some cases (see Table I).

EcoDesign Best Practice Club

Working with Eucomed (www.eucomed.be), the environmental consultancy Environ has launched a Best Practice Club (www.medical-ecodesign.com) that can help all medical device manufacturers 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 Eucomed 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 coordinating and communicating industry comments and suggestions to Environ for action.”

The club trains and supports healthcare product design teams to use a Web-based system for environmental design and compliance, so that logging into www.medical-ecodesign.com becomes an integral part of the new product design process. The auditable system is based on checklists and worksheets that the product design team completes at each stage. For example, structured checklists capture relevant environmental regulatory requirements at the initial planning stage. Hyperlinks to the online database provide the product design team with further details and guidance on compliance issues and options. A prerecorded Web demonstration can be accessed at www.medical-ecodesign.com/webcasts/overview.

The practical integration of the Web-based system into the new product design process has been tested by global medical device manufacturer Smiths Medical (www.smiths-medical.com). This built on previous product environmental design work carried out at Smiths Medical sites in the United Kingdom, United States, and Germany. “Smiths Medical is planning to roll out the Web-based system across all sites worldwide,” says Paul Harris, Smiths Medical communications director.

Global verification, testing, and certification company SGS (www.sgs.com) has evaluated the system against the compliance assessment checks that are specified in Clause 4 of the standard. “We have reviewed the Web-based system and confirm that it is suitable for a company to use to prepare for certification to the IEC 60601-1-9 international standard,” says SGS international sales manager Jeff Dowson.

Further Information

Details about the EcoDesign Best Practice Club are available at www.medical-ecodesign.com. Environ is offering interested parties a free three-week trial demonstration of the Web-based system. To find out more, contact Aidan Turnbull via e-mail, aturnbull@uk.environcorp.com, or phone, +44 1249 700104.

Turnbull will also be hosting a session on IEC 60601-1-9 and the EcoDesign Best Practice Club at the MEDTEC Exposition and Conference to be held 11–13 March in Stuttgart, Germany. For more information about the event, go to www.medtecstuttgart.com.

Aidan Turnbull, PhD, is head of WEEE, RoHS, and EcoDesign at Environ UK Ltd., Hartham Park, Corsham, Wilts SN13 0RR, UK; phone: +44 1249700104; fax: +44 1249 700105; www.environcorp.com.