Knock, Knock, Knocking on Shelhigh's Door

Union, NJThe U.S. Food and Drug Administration (FDA) has gone after Shelhigh Inc. again, this time with a formal request to the company to voluntarily recall all its medical devices remaining in the marketplace, including those that may be lingering in hospital and clinic inventories, because of sterility concerns.

In a press release issued May 2, the FDA advised that it had sent a formal written request to that effect to Shelhigh the same day.

This request follows the April 17, 2007 seizure by U.S. Marshals, at the FDA's request, of all medical devices including components at Shelhigh's Union, New Jersey facility. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company refused to do so.

A complaint filed with the U.S. District Court of New Jersey claims that the company's deficiencies may affect the safety and effectiveness of the devices. The RDA says that Shelhigh's own records indicate a number of sterility test failures, and that its testing and retesting procedures were not properly performed.

The FDA is recommending that doctors and hospitals consider using alternative products.
"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."

Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.

For its part, Shelhigh is vigorously disputing the FDA claims. The day after the FDA release, May 3, Shlomo Gabbay, M.D. founder of Shelhigh, stated: "This is the first formal request by the FDA for Shelhigh to recall its products, and since the FDA allegations are unfounded, Shelhigh has no intention to initiate a product recall. The FDA should understand that it must prove its allegations before it can make a request and their newest statements do not provide any further factual support for their claims".

"I just hope that the FDA halts its public posturing and returns to discussions with Shelhigh," Gabbay continued. "I prefer that we close out any remaining issues that the FDA may have through constructive dialog so that Shelhigh can return to the business of saving lives."

Or is it the business of saving money? No one is talking about it, but the cost of recalling all its products already sold to hospitals and clinics must be significant. Why else is Shelhigh so strenuously resisting pulling the products back into the shop?