Device Makers Urged to Guard Against Terrorism

Originally Published MDDI September/October 2003

NEWSTRENDS

Erik Swain

In this era of heightened terrorism threats, U.S. businesses must take precautions against them. The medical device industry is no different, an FDA official says.

Steven M. Niedelman, associate commissioner for regulatory affairs, told industry members that they might want to think about evaluating their operations for risks pertaining to counterfeiting, tampering, and other adverse acts that could be committed by a third party. His message came at the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington, DC) in June.

Niedelman explained that while he is not aware of any formal directives that FDA has given industry, nor has the concern been prompted by any specific incidents, FDA wants to encourage firms to keep these issues in the forefront.

"I suggested that they start considering these types of things, as we've become aware of the potential risks of tampering, counterfeiting, and such," he said. "This is certainly not a requirement. It is nothing other than a common-sense approach."

The reason for the generalized comments, he said, is that "what works for one company may not work for another. Therefore, what makes most sense for us to suggest is that they start evaluating the conditions in their own facilities."

FDA has made counterterrorism one of its own largest priorities. The agency's annual counterterrorism budget before September 11, 2001, was $8.2 million; it is now $159 million. And FDA has named as its first counterterrorism goal preserving the safety and security of regulated products, including devices.

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