Citing production violations that compromised product sterility and safety, officials from the Food and Drug Administration have seized all implantable medical devices from Shelhigh, a Union, N.J.-based manufacturer specializing in cardiothoracic surgical devices.
The action followed months of warnings from FDA officials that enforcement officers were prepared to take action if Shelhigh did not correct violations found during plant inspections, with the most recent one conducted last fall. Violations included manufacturing products in a poorly constructed and maintained clean room for sterilized devices; failing to monitor production environments for microbial contamination; failing to properly test devices for contaminants; and failing to scientifically support product expiration dates.
Up to 1 million products and components of products were confiscated, according to FDA spokeswoman Heidi Rebello. Pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts were among the products seized. The devices are used in open-heart surgery, neurosurgery and other surgical procedures.
FDA officials are advising physicians to consider using alternate devices for surgical procedures and recommending that they monitor patients who have received Shelhigh devices for infection and implant malfunction. A complete list of the seized devices can be found here. Shelhigh representatives were not available for comment at deadline. -- by Shawn Rhea