AAMI Encourages More Government Participation in Standards


The Association for the Advancement of Medical Instrumentation (AAMI) says it wants more federal agencies to take part in standards development as a way to create better standards.

"Other agencies could provide different perspectives, and therefore increase the level of national (and international) consensus regarding the appropriate content of our standards," AAMI says in comments submitted to the federal government.

The National Institute of Standards and Technology (NIST) put out a call for comments on the effectiveness of federal agency participation in standards development.

AAMI works extensively with the U.S. Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH) to create medical device standards. CDRH representatives are leaders on a number of AAMI standards committees.

More government participation in standards could help prevent two different agencies from adopting different and conflicting standards, AAMI says.

An example of a lack of consensus surrounds IEC 60601-1, the electrical equipment standard. Last year, CDRH recognized the third and latest edition of the standard.

The Occupational Safety and Health Administration (OSHA) uses the previous edition of 60601-1 for a different purpose than FDA, and is "now indicating it will not recognize the third edition," AAMI says. "This presents some serious difficulties for industry."

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