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Medical device automation; device reuse controversy

Further evidence of advancing medical device packaging automation surfaced during the January 30 MD&M West Conference in Anaheim, CA. Following Belco Packaging Systems' Tom Misik's presentation, Equipment Considerations for Tray Sealing, I asked him if he notices medical device makers beginning to ask for more complex controls on their packaging machinery, as is often the case with food, beverage, and pharmaceutical firms. Misik said medical device companies were driving the use of advanced machine controls and, in fact, had influenced the development of some of Belco's sealing equipment.

On another device-related matter, a healthy discussion developed during the conference's lunch break when attendees at my table brought up a recent article in the Washington Post . The article's lead graph said, "A growing number of U.S. hospitals...are saving money by reusing medical devices designated for one-time use, ignoring the warnings of manufacturers, which will not vouch for the safety of their reconditioned products."

Will hospitals use the same quality standards used by device makers? And what about accounting for different methods and procedures at different hospitals? Some voiced a concern that the Food and Drug Administration may not monitor hospital procedures as it does those of medical device makers. What's your take on this matter?

--By Jim Butschli, Editor
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