"Medical device manufacturers should consider investment in the standards development process as basic as paying for utilities or insurance. It is a fundamental cost of doing business and can provide significant long-term returns for those wise enough to make the investment," says Mike Schmidt, secretary of IEC subcommittee 62D and cochair of the AAMI Electrical Safety Committee. Schmidt is also the senior standards associate for Ethicon Endo-Surgery.

Since the Medical Devices Directive came into effect, compliance with harmonized European standards has been the easiest way for manufacturers to gain a presumption of compliance with the essential requirements. Compliance with standards has become a crucial tool in getting to market quicker, meeting customer and regulatory requirements, and mitigating liability.

"Participation in standards development is an opportunity for device manufacturers to fully understand requirements far in advance of their becoming accepted as state of the art," Schmidt says. "Making the investment in participation also gives the manufacturer a voice in the creation of the requirements they will ultimately be expected to meet."

One of the best examples of an international standard that has global implications for device manufacturers is IEC 60601-1, he says. This standard establishes general requirements for the safety of electrically operated medical equipment. It is published in Europe as EN 60601-1, in Canada as CSA C22.2 No. 601.1, and in the United States as UL 2601-1. Schmidt is concerned, though, because although most device manufacturers are familiar with this standard, he says many do not realize that it is currently under revision and that dramatic changes are slated for the third edition, scheduled for publication in 2004.

"Many manufacturers are unaware that current plans include the ultimate withdrawal of UL 2601-1 after publication of the U.S. version of the third edition of IEC 60601-1 by the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI)," he says.

Getting involved in standards development may seem difficult at first, but Schmidt encourages medical manufacturers to go to conferences such as the AAMI/FDA Conference on Medical Device Standards and Regulation (March 27­28 in McLean, VA). In addition to providing valuable information on advancements in standards and regulation, the conference provides access to key individuals, as well as presentations on technical issues associated with new or changing standards.

Sherrie Conroy, Editor
sherrie.conroy@cancom.com

Further information on the AAMI/FDA Conference on Medical Device Standards and Regulation can be found at: http://www.aami.org/meetings/intlstd/2002/index.html.