Frequently Asked Questions

What is a consent decree?

A Consent Decree (Decree) is a legal agreement that a company voluntarily enters into with the U.S. Food and Drug Administration (FDA). It requires the company and its employees to take and/or continue to take certain actions to ensure compliance with the Decree, and FDA-related laws and regulations. A Consent Decree also provides FDA with additional remedies should the Company be non-compliant. This does not mean that the Company has violated the FDA-related laws and regulations, only that an agreement has been reached as to future actions.

Atrium Medical Corporation and three other affiliated Maquet companies have reached an agreement concerning a Decree with the FDA. This voluntary agreement has been approved by a federal judge in New Hampshire and establishes a framework that provides assurances to FDA that Atrium and Maquet will complete the improvements currently underway to strengthen its quality management system.

 

Why did Atrium and Maquet enter into a consent decree with the FDA?

Following inspections in 2013, FDA found issues with the company’s quality management system and outlined corrective actions that needed to be taken. We have already taken significant actions to enhance our quality management system and will continue to do so. As improvements were underway, FDA indicated that because of its past concerns, it wanted to make sure that the Company’s commitment to compliance took the form of a Decree that would provide further assurances to FDA.

The Decree provides a clear path forward for the company to complete the enhancement of its quality management system and to continue to provide products of the highest medical quality. There has been no indication that any of the products are unsafe. The consent decree does not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.

 

What are the terms of the Consent Decree?

Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.

Some other products manufactured by Atrium will become temporarily unavailable, once existing inventory located at our distribution facilities has been exhausted. Atrium will communicate directly with customers who are impacted. Temporarily unavailable products include vascular grafts and surgical meshes manufactured in Hudson, NH. These restrictions do not apply to vascular grafts that are manufactured at other facilities and sold under the brand names of Hemashield, Intergard, Fusion and Exxcel Soft.

Operations at three Maquet locations that also fall under the decree – Wayne, New Jersey and Rastatt and Hechingen, Germany – will be subject to additional inspections, but will continue to produce and distribute products globally. All other Maquet locations and companies inside and outside of the U.S. are not part of this Decree.

 

What products will be impacted?

Products available under a Certificate of Medical Necessity include:

  • Chest drains and accessories
  • ClearWay
  • iCAST (US)
  • V12 (OUS)

Temporarily unavailable products include vascular grafts and surgical meshes manufactured at Atrium’s facilities in Hudson, NH:

  • Vascular grafts (Flixene and Advanta product lines)
  • Surgical meshes (Prolite, Prolite Ultra, ProLoop, and C-Qur product lines)

These restrictions do not apply to vascular grafts that are manufactured at other facilities and sold under the brand names of Hemashield, Intergard, Fusion and Exxcel Soft.

 

What are medically necessary products?

Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.

A certificate of medical necessity is a form that an authorized representative of the customer signs, certifying that – after learning of the FDA findings at Atrium’s Hudson manufacturing facilities, and evaluating the relevant risks and benefits – there is an immediate medical need for the continued use and purchase of certain Atrium products.

 

Has the FDA raised any safety concerns in its observations?

There has been no indication that any of the products are unsafe. The consent decree does not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.

 

How long will these products be unavailable?

Temporarily unavailable products include vascular grafts and surgical meshes manufactured at Atrium’s facilities in Hudson, NH. These products will become temporarily unavailable once existing inventory located at our distribution facilities has been exhausted.

Atrium has long planned to move manufacturing operations now in Hudson, NH, to a new facility in Merrimack, NH. Once production is transferred to Merrimack, these products will be available to customers inside and outside of the U.S. We expect manufacturing in Merrimack to begin in early 2015.

 

Do you anticipate any layoffs as a result of the Consent Decree?

Based on the current budgeting forecast we do not foresee any change in staffing levels as a result of the consent decree.

 

How long will the company be under a consent decree?

There is no explicit end date for the Decree. It will continue to be in effect unless and until the Court enters an order terminating the Decree. Historically, the FDA has considered terminating a Decree after approximately five years if a company has complied with the terms of Decree.