Feds Crack Down on Reuse of Rectal Probes
A medical device manufacturer is accused of encouraging docs to reuse single-use devices, including rectal probes, by covering them with a glove or condom.
Source: mddionline.com
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Medical Device Manufacturer's Director of Clinical Services Pleads Guilty to Causing the Adulteration of Rectal Pressure Sensors
Clini cal Director for The Prometheus Group Pleads Guilty for Role in Causing the Reuse of Single-User Rectal Pressure Sensors on Multiple Patients GRAND RAPIDS, MICHIGAN — U.S. Attorney Andrew B. Birge announced today that Denise D’Andrea pleaded guilty to one count of causing the adulteration of a medical device. In the criminal information, the government alleged that Ms. D’Andrea, the Director of Clinical Services at The Prometheus Group (“Prometheus”), a device manufacturer headquartered in Dover, New Hampshire, trained medical practitioners in the Western District of Michiga...
Source: fda.gov