Update On Shelhigh/US Agreement

Shelhigh, Inc. has agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with Food and Drug Administration (FDA) standards. The company manufactures pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings, and arterial grafts.

The US District Court of New Jersey entered the consent order forbiding Shelhigh from distributing all devices. Its manufacturing methods, facilities, and controls must be in compliance with the FDA’s current good manufacturing practices, quality systems regulation for medical devices, and the medical device reporting requirements. On April 17, 2007, the government seized all finished devices and components of the devices at Shelhigh’s manufacturing facility over concerns of potential risk of nonsterility.

“It is critical that companies comply with FDA’s manufacturing rules so that medical devices, especially the kind of implantable devices made by Shelhigh, are safe and effective,” said Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health.

The consent order requires that the company hire independent expert consultants to inspect its facility and certify to FDA that corrections have been made. The agency will monitor these activities through its own inspections. The FDA did not mandate that Shelhigh recall its devices, and Shelhigh did not recall its devices.Shelhigh may resume manufacturing, but not distributing, its devices in phases, once FDA has approved its compliance plan. After the company has taken corrective actions and is allowed to resume manufacturing, it is required to hire an independent auditor to inspect its facility at least once a year, with the results being reported directly to the FDA. If Shelhigh fails to comply with any provision of the consent order, or violates FDA law or regulations, the FDA has the authority to order the company to again cease manufacturing and distributing its devices, to recall the devices, or any other actions deemed appropriate.