Competitors patch failure, page-22

February, 2015
FDA Orders Maquet to Temporarily Suspend Manufacturing at N.H. Facility
Company agrees it needs to improve its quality systems.
Published: February 6, 2015

Category:
Outpatient Surgery News and Trends > General Surgical News and Reports

If you buy Maquet hernia products, you're going to need another vendor for a least a while.

Citing a failure to correct various major quality and reporting violations, the FDA has entered into a consent decree with Maquet Holding, the parent company of Maquet Medical Systems, that will force the company to suspend manufacturing at its Atrium Hudson (N.H.) facility until it can demonstrate that it has made required improvements.

Customers who sign a Certificate of Medical Necessity may still buy certain products distributed both inside and outside the United States, but under terms of the decree, these products will no longer be available: ProLite hernia mesh, ProLoop hernia mesh, C-QUR hernia mesh (including Vpatch, Tacshield, FX, Mosaic and Film), Flixene vascular graft and Ivena vascular patch.

"We agreed it was the right thing to do, but in no way or at any time has any of our products been deemed to be unsafe for public consumption," Raoul Quintero, President and CEO of Maquet Medical Systems, told Outpatient Surgery Magazine. "This is about strengthening our quality systems internally."

In addition to the Hudson plant, the FDA news release also notes failures to correct violations at facilities in Wayne, N.J., and in Rastatt and Hechingen, Germany. The agency says there have been at least 45 recalls of Maquet-manufactured devices since 2009, including 5 classified as Class 1 (representing the most significant risk to patients), but Mr. Quintero says many of those were initiated by the company. "If we felt we didn't have the necessary quality systems, we took it upon ourselves to bring about the recalls," he said.

Maquet's diverse product line includes OR tables, anesthesia machines, cardiovascular devices, surgical lights and OR computers.

The company had already planned to move its New Hampshire facility to Merrimack, says Mr. Quintero, adding that there's no estimated timeline for when it will resume manufacturing in New Hampshire.

Maquet, a subsidiary of Sweden's Gettinge Group, has agreed to pay the federal government $6 million, and Mr. Quintero expects the company to sustain a hit of about $60 million overall.