FDA Asks for Medical Device Recall; Shelhigh Rejected Agency’s Prior Request

Two weeks after raiding the New Jersey headquarters of Shelhigh, the Food and Drug Administration yesterday formally requested the company recall all of its implanted medical devices from hospitals because of concerns about sterility and health risks.

The FDA said its latest action follows rejection of an earlier informal request that the company undertake a voluntary recall of its products. If the company does not comply now, the FDA could seek a court order mandating the recall.

Last month, the FDA seized all of Shelhigh’s medical device inventory from its facility in Union, including pediatric heart valves, after it said the company did not heed two earlier warning letters and did not correct inspection violations.

“Since these are critical devices implanted into seriously ill patients, ensuring their sterility is absolutely essential to preventing infection,” said Daniel Schultz, director of the FDA’s device center.

Schultz said there were “critical deficiencies” in the manufacturing of a host of Shelhigh’s implanted devices that may compromise their safety and effectiveness.

Douglas Goldman, the marketing director of the privately held company, said the FDA has “no information to justify any action with regard to our devices,” adding that “no recall is in effect.”

He said the company just received the formal written recall request, but not any data to back it up.

“Our products are safe and effective and have never been demonstrated to be unsterile,” said Goldman.

He declined to say how many Shelhigh devices are on hand at hospitals, or their monetary value, but said “thousands and thou sands of the company’s implants have been used since Shelhigh began distributing products 10 years ago.” He said the company, with about 50 employees, markets its devices domestically and internationally.

The FDA said its earlier inspection of the company’s New Jersey plant indicated “a number of sterility test failures,” and it warned doctors that the products were made in a way that may have “contaminated” the devices with “bacteria, fungi or endotoxin.”

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.

The FDA urged doctors to monitor the health of patients already implanted with any of the devices. It said critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

“We are aware of published reports of premature (accelerated) failure associated with some Shelhigh devices,” the FDA said. The FDA provided no details of the device failures.

The FDA also accused the company of failing to properly monitor critical manufacturing environments for contamination and failing to properly test products for sterility and fever-causing containments.

SOURCE: THE STAR LEDGER