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Medical devices seized because of infection concerns

Infection Control Monitor, April 20, 2007

Concerned about their safety, U.S. marshals and investigators from the Food and Drug Administration (FDA) this week began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company, the Associated Press (AP) reported.

Officials seized all implantable medical devices from Shelhigh, Inc. after the FDA said it had found significant problems in the Union, NJ company's manufacturing processes. The FDA recommended physicians consider using alternative devices and also advised them to monitor patients with a Shelhigh implant for infections and proper functioning.

Officials fear the manufacturing problems could compromise safety and effectiveness, including the sterility of the implants. The products include pediatric heart valves and conduits, as well as surgical patches, arterial grafts and annuloplasty rings used to help repair heart valves, the AP reported.

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