Special Report

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

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.

Sidebar: Ultrasonic Welding Earns Eco Accolades

If you are looking for ways to reduce the size of your shop floor's carbon footprint—and who isn't?—Alan Profit suggests you set your sights on ultrasonic welding equipment. As the director of Rainbow Medical Engineering Ltd. (Letchworth Garden City, Herts, UK; www.rainbow-medical.eu), which supplies ultrasonic processing systems, Profit can't be called impartial. But he does point to a number of facts to back up his assertion.

"Depending on the joining technique with which it is compared, ultrasonic welding is superior in a number of ways," says Profit. "You don't run into any of the environmental issues such as flammability or toxicity that are typical of adhesives and solvents." Laser welders are not as energy efficient as ultrasonic systems, he adds, and they are not as flexible in terms of the types of polymers that can be joined together. As for hot-plate welding and other thermal processes, they consume tremendous amounts of energy, notes Profit. The reason that ultrasonic welding has a much smaller carbon footprint than those techniques is because of its intermittent nature.

"Ultrasonic equipment only requires significant energy when the welding operation is being carried out," says Profit. "The rest of the time it consumes a few hundred milliwatts just to keep the circuits running." By contrast, thermal-based welding systems gobble up energy before, during, and after the work cycle. "Hot-plate welders typically have a start-up time of 20 minutes, and the platen is running more or less continuously to maintain a constant temperature," says Profit.

Energy consumption has become a concern for all major companies, adds Luigi Martini, director of strategic technologies, pharmaceutical development, at GlaxoSmithKline Pharmaceuticals (Harlow, UK; www.gsk.com). He has coauthored an article on ultrasonic welding with Profit. "Pharmaceutical companies are taking the size of their carbon footprint very seriously," says Martini. In some ways, the rediscovery of ultrasonic energy is like the rebirth of biodiesel, he adds. "Now that petroleum is becoming more difficult to recover, people are remembering that diesel used to be derived from vegetable oil and recycled fat," explains Martini. "In the same way, industry 'forgot' that ultrasonic equipment uses very little energy. The expression 'saving the environment using forgotten technology' comes to my mind," says Martini.

It seems safe to say that the technology's green credentials won’t be forgotten much longer, however. Profit and Rainbow Medical intend to see to that.

Sidebar: Supply-Side Sustainability

Plasma Processing Touted as Green Alternative to Bonding or Overmoulding Metal Parts

Surface preparation of metal components may require the use of caustic chemicals or other conversion coatings to ensure proper bonding. Plasma-enhanced chemical vapour deposition (PECVD) coating technology provides a more environmentally friendly way to achieve a similar or better result, according to PlasmaTech Inc. (Erlanger, KY, USA; www.plasmatechnology.com).

By depositing a thin polymerized coating, it is possible to create a tie or interface layer that permits direct bonding or overmoulding to the metal surface. The resulting bond performance often surpasses what can be achieved with conventional methods, according to the firm. Plasma polymerized thin films can be deposited directly onto a plasma precleaned substrate without exposure to the atmosphere. The continuous multistep process provides adhesion to the base substrate, as the polymerization occurs at the atomic level.

UV-Curing Adhesive Clears Air at Medical Disposables Production Plant

A manufacturer of PVC-based anaesthesia masks, respiratory equipment, and tubing products recently sought to update its production processes. One area that it targeted for improvement was the solvent adhesive technology it was using, which required intensive manual labour and caused health and safety issues. An air extraction system was needed to ensure the air was clean and free from harmful chemicals given off by the solvent-based adhesive. To bond a rigid PVC mask shell to a flexible PVC inflated mask cushion, Eurobond Adhesives Ltd. (Sittingbourne, Kent, UK; www.eurobond-adhesives.co.uk) recommended to the firm that it replace the solvent with a USP Class VI UV-curing adhesive.

Vitralit 7989 is a medium-viscosity product that can be used for bonding products such as chest drain bags, blood pressure transducers, stopcocks, surgical masks, and arteriograph manifolds. By switching to this product, the aforementioned device manufacturer was able to semiautomate production and dismantle the air extraction system, thus reducing energy consumption. Preproduction trials carried out using Vitralit showed a 60% increase in throughput, a reduction in the amount of adhesive used to fulfill orders, and an overall healthier and safer environment for personnel.

Device Manufacturer Embraces Responsible Care Initiative

In addition to complying with ISO 14001 at all of its facilities, a manufacturer of medical devices, drug delivery systems, and personal care products has agreed to obey the tenets of the Responsible Care initiative at its main plant in Kontiolahti, Finland. Under the agreement, Medifiq (Vantaa, Finland; www.medifiq.com), formerly Perlos Healthcare, will pursue continuous improvement in all aspects of health, safety, and environmental performance and maintain open channels of communication about its activities.

A global voluntary initiative of the chemical industry, the goals of Responsible Care fall neatly in line with Medifiq's values of quality, commitment, and competence, says the company's quality manager, Janne Alava. The company promotes environmental, health, and safety principles internally through staff training and within society at large by communicating these values to the public, he adds. A focus on continuous improvement has led to an increase in the use of recycled materials, improvements in health and safety among the staff, and a year-on-year reduction in total waste output.

Materials Supplier Introduces Sustainable Polypropylene

Bio-based materials replace 50% or more of the petroleum content in a new family of resins, yet they have nearly the same physical characteristics and price point as traditional polyolefins. Introduced by Cereplast Inc. (Hawthorne, CA, USA; www.cereplast.com), Hybrid resins, also known as Bio-polyolefins, can replace conventional petroleum-based plastics in a number of sectors, including the medical device market, according to the firm.

"The Hybrid resin can be used in a variety of medical applications," says Kevin Oates, who handles public relations for the firm. "One example is medical trays, which hold an assortment of medical instruments, because the resin is capable of withstanding most sterilization processes. Another [application] might be the housings of monitoring and diagnostic devices."

The material can be used in a variety of manufacturing processes, including injection moulding, thermoforming, profile extrusion, and extrusion blow moulding. It meets toxicity requirements as set forth by ASTM D6400-04.

Bag-in-Box System Reduces Packaging

A bag-in-box packaging system for pharmaceutical products combines a cost-effective design for packing, storing, and distributing liquids, powders, and particulate products with environmental benefits.

Developed by Johnsen & Jorgensen (Dartford, Kent, UK; www.jjpack.com), the SmartPack comprises a plastic double-layer bag and corrugated outer box. It can be stored flat when not in use.

The stand-alone inner bag squares up when filled; it does not rely on external packaging to maintain its shape. The external corrugated box makes it easy to palletize the products and provides a large scope for printing.

The corrugated outer box, which is biodegradable, represents about half of the material used; the entire packaging system uses only a fraction of the plastics used by standard bulk containers. Because it can be shipped and stored flat when not in use, the packaging can help companies to dramatically reduce their carbon footprints. The SmartPack comes in five sizes and six closure types. An open-ended version is available.

Bureau Helps Med-Tech Manufacturers Explore Green Design

Regulatory and safety factors notwithstanding, medical companies need to be aware that environmental issues increasingly will have an impact on their bottom line, according to Insight Product Development (Chicago, IL, USA; www.insightpd.com), a design bureau that has worked with such firms as Johnson & Johnson and BD. Medical products that align with a green lifestyle will help the environment, but also create an emotive connection on the part of the user to the brand.

Safety concerns will hinder traditional approaches to sustainability such as reuse and recycling, but med-tech companies can implement green design principles in other ways, according to the firm. Selecting mate-rials based on their environmental credentials, reducing energy use in assembly and distribution processes, exploring sustainable packaging solutions, and adopting design-for-disassembly principles are just some of the ways in which device manufacturers can develop more-sustainable products, says the firm.

By evaluating the stages of a product's life cycle while taking into account the product's characteristics and regulatory constraints, the design bureau maintains that it can help med-tech manufacturers develop appropriate sustainable practices.

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.