On 3 February 2015, Maquet—the Getinge Group’s Medical Systems business area—reached an agreement with the US Food and Drug Administration (FDA) concerning a consent decree related to three of its manufacturing sites: Atrium Medical Corporation (Atrium) in Hudson, USA; Maquet Cardiovascular in Wayne, USA; and Maquet Cardiopulmonary in Rastatt and Hechingen, Germany.
According to the FDA, between 2009 and 2013, investigators conducted 10 inspections across the three Maquet facilities, and uncovered violations of the Quality System regulation, Medical Device Reporting regulation, and Correction and Removal regulation. By entering into the decree with the FDA, Maquet has agreed to implement immediate controls with the goal of bringing all facilities into compliance with the respective regulations.
In a statement sent by Maquet to Vascular News, the company explained that the area principally affected by the decree is its affiliate Atrium Medical Corporation. Following the decree, certain products manufactured at Atrium’s facilities in Hudson will be temporarily suspended while corrections are being made. This means that some products manufactured by Atrium will become temporarily unavailable, once existing inventory located at their distribution facilities has been exhausted. Temporarily unavailable products include vascular grafts and surgical meshes manufactured in Hudson. However, 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. Therefore, once the company has sold all existing inventory of ePTFE grafts manufactured at Atrium they can offer customers Fusion grafts as an alternative.
Maquet stated: “First and foremost, it is important to point out that at no time did the FDA give any indication of any safety defect in the company’s products. The consent decree does not require Medical Systems to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.”
The company also informed that certain products currently manufactured at the 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 USA, provided that an authorised representative of the customer signs a Certificate of Medical Necessity form. Therefore, Atrium’s V12 covered stents are still available.
Furthermore, Maquet added that Atrium has long planned to move manufacturing operations from Hudson to a new facility in Merrimack, also in New Hampshire. “Once production is transferred to Merrimack, products previously suspended under the consent decree will be available to customers inside and outside of the USA. Atrium will start manufacturing in Merrimack once processes have been validated—which they expect to happen within the next four to six months,” the statement included.
According to the FDA, Maquet will be allowed to resume normal manufacturing and distribution from Atrium’s Hudson facility once the FDA has notified the company that it has completed all of the corrective actions required by the consent decree, and finds that the manufacturing, processing, packing, holding, and distribution of devices from Atrium are in compliance with the decree, the Food, Drug & Cosmetic Act, and the Quality of System, Medical Device Reporting, and Correction and Removal regulations.
All other Medical Systems locations and companies inside and outside of the USA are not part of this decree.
“We have learned from this experience, and this agreement with the FDA provides us with a clear path forward,” says Johan Malmquist, CEO, Getinge Group. “We have taken this situation very seriously and have committed substantial investments into the quality management system. The remediation work is well underway and has already led to significant improvements.”
More information regarding products and the decree can be found on www.atriummed.com/consentdecree