A NOTE FROM THE EDITOR
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The medical device industry has been quite successful over the years at exempting itself from some of the more burdensome parts of environmental legislation. In some cases, the immediate concern of saving lives trumped ecological considerations. Industry’s well-integrated risk/benefit methodology also has helped to silence the eco scolds. But the tide is turning. For George Howarth, who was group environmental affairs director at Smith & Nephew until he retired in 2002, the regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), in particular, has the potential to impact every single device manufacturer.
REACH requires chemical companies to take responsibility for the safety of their products. To meet this obligation, they must be aware of how their products are used by their customers, which include medical device and diagnostics manufacturers.
“For device manufacturers, compliance with REACH may simply mean that they need to be sure that the chemicals they use have been preregistered by their suppliers,” says Howarth. “But if the supplier fails to do that, the chemical in question may be removed from the marketplace. That could become a serious business continuity issue,” cautions Howarth, who addressed a session on this topic at the recent MEDTEC UK event in Birmingham.
To complicate matters, the deadline for preregistering chemicals is looming. The companies only have from June to November to do this, says Howarth.
If the suppliers miss that window, they will have to register the chemicals in 2009. “You can’t use a chemical unless it is preregistered or registered,” stresses Howarth. The regulation also applies to imported chemicals, preparations, or devices that release a substance. “Our American colleagues are under a great deal of pressure, as a lot of products are supplied from there. They have got to be very careful and ask themselves if any of their products have been designed to release a substance. If so, that substance has to be registered in Europe.”
European companies have jumped up and down to get the attention of US companies, which are responding to the regulation, says Howarth. Even so, “there has been criticism of some US companies that seem to think that REACH and other environmental mandates like RoHS will go away. They will not, and [the requirements] need to be addressed,” says Howarth.
Even if they do everything right, device manufacturers still will suffer some consequences. Regulatory measures entail a cost, and some estimates have REACH leading to a 10% increase in the price of chemicals. Moreover, some chemicals may simply disappear from the marketplace, either because the potential profit is too slim to offset the administration cost or because the risk is too great.
REACH and other environmental legislation such as RoHS and the Energy-using Products (EuP) directive are having an impact on device manufacturers like never before. Many companies are not set up to react in an efficient way, says Howarth. “I have a feeling that this type of product-focused legislation is not being picked up properly, even by large companies that have environmental managers and regulatory managers. The environmental manager is typically involved in manufacturing, while the regulatory person is looking after the MDD directives, compliance, and so forth. Who is going to take responsibility for environmental legislation affecting the products?” asks Howarth.
It can be a conundrum for companies, but one that must be resolved. “People, processes, and products are the three fundamentals of a business. When you talk about products, you are talking about the lifeblood of a business,” says Howarth.
Here is your action plan: be aware of the status of environmental legislation, make sure your company is properly structured to deal with it, and don’t procrastinate. “The deadlines are now, and the regulations are not voluntary,” says Howarth. “They are, in fact, becoming vital to your business.”
Consider that an inconvenient truth, and a timely reminder.
