In the latest round of a dispute between the FDA and Shelhigh (Union, New Jersey), the company has agreed to stop distributing its implantable medical devices used in heart surgery and other procedures until it brings its production processes in line with FDA standards.

Although the agency noted that the agreement was made under a court order, the company contends that it was not ordered by the court, but rather is a mutual no-fault settlement that the court agreed to sign so that the agency and the company could “resume good relations” and so that Shelhigh could resume delivering its “life-saving products.”

Regardless of the semantics, the U.S. District Court for the District of New Jersey entered the consent order of injunction agreed to by Shelhigh. According to the FDA, the consent order forbids Shelhigh from distributing all devices until its manufacturing methods, facilities, and controls are in compliance with the agency’s current good manufacturing practice (CGMP) and Quality Systems (QS) regulation for medical devices and the medical device reporting (MDR) requirements.

In April U.S. Marshals seized all finished devices and components of the devices at Shelhigh’s manufacturing facility due to concerns of potential risk of nonsterility (Medical Device Daily, April 19/April 24, 2007).

Shelhigh makes pediatric heart valves and conduits (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.

Douglas Goldman, a spokesman for Shelhigh, told Medical Device Daily that the company and the FDA have been “hashing it out” ever since the agency quarantined its products in April. He said the company is “very happy” with the settlement it reached last week with the FDA.

“It’s completely a step in the right direction and I think it makes a lot of sense for both sides,” Goldman said. “There’s no sense in going through a trial if both sides want the same thing in the end, and that is for the company to be able to continue producing its products.”

In May the agency issued to Shelhigh a formal written request to recall all of its medical devices from the marketplace, including hospital inventories, because of “sterility concerns.” In response, the company said at that time that it did not believe the FDA allegations were valid and that it had no intentions to initiate a recall (MDD, May 4, 2007).

In response to the settlement agreement, Goldman told MDD, it is “important for people to know there was never a recall, either by the FDA or by Shelhigh, and the company continues to have confidence in the safety and efficacy of its products for their intended use.”

The consent order requires that the company hire independent expert consultants to inspect its facility and certify to FDA that corrections have been made. FDA said it would continue to monitor these activities through its own inspections.

“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.

According to the FDA, Shelhigh may resume manufacturing — but not distributing — devices in phases, after the agency has approved its plan for bringing its seized products and manufacturing processes into compliance with FDA law. After Shelhigh has completed corrective actions and been allowed to resume manufacturing, the company must hire an independent auditor to inspect its facility at least once a year. Results of these audit inspections will be reported directly to FDA.

If Shelhigh fails to comply with any provision of the consent order, or violates FDA law or regulations, FDA may order the company to again cease manufacturing and distributing its devices, to recall the devices, and to take other actions deemed necessary by the agency, including payment of money for continuing violations.

“I am extremely pleased that the FDA and Shelhigh were able to reach a settlement that will permit us to resume shipments of our life-saving products to patients around the world,” Shlomo Gabbay, president/CEO and chief scientific officer for Shelhigh said in a statement. “Shelhigh has always been committed to maintaining a good working relationship with the FDA, while providing its life-saving products to patients in need. As is well-documented, Shelhigh’s track record of providing effective and revolutionary products is extraordinary, and we are pleased to demonstrate that our manufacturing process is exact and complete, and in full compliance.”