FDA Raids Union Maker of Medical Devices Over Safety Risks

The Food and Drug Administration yesterday seized all of the medical devices from a New Jersey company, including pediatric heart valves, because of a concern the products pose a serious safety risk.

The FDA said its investigators and U.S. marshals raided Shelhigh of Union and confiscated all implantable medical devices after finding “significant deficiencies in the company’s manufacturing processes.”

“The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility,” said the FDA.

No one answered the company’s telephone late yesterday afternoon.

The FDA said the products include pediatric heart valves and tube-like devices for blood flow; surgical patches; dural patches to aid in tissue recovery after neurosurgery; annuloplasty rings to help repair heart valves, and arterial grafts.

The tissue-based devices are used in surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.

Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices, the FDA said.

The agency said Shelhigh’s violations include manufacturing products in a facility that is poorly constructed and poorly maintained.

It accused the company of failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

The FDA advised physicians to consider using alternative devices and to monitor patients with Shelhigh implants for infections and proper functioning over the expected lifetime of the device.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as warnings that Shelhigh’s failure to correct its violations could result in an enforcement action. The FDA also alerted the company of its manufacturing deficiencies and other violations in two warning letters.

SOURCE: THE STAR LEDGER