FDAnews Device Daily Bulletin

DEBATE CONTINUES IN BAY STATE OVER REPROCESSED DEVICES

June 29, 2006
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A device industry organization in Massachusetts wants more hospital oversight to curtail potential reuse of single-use products.

The Massachusetts Medical Device Industry Council (MassMEDIC) wants more rigorous state legislation to force hospitals to reveal when they are cleaning and disinfecting single-use devices for reuse.

The products include blades, tracheal tubes and cardiac catheters that could potentially endanger patients when residue is left on them. MassMEDIC officials contend patients should be informed when physicians plan to use such devices and should have the option to refuse treatment with them.

AdvaMed has noted that the risk of cross-contamination and declines in product functionality are high when products designed for a single use are reprocessed.