February 3, 2015
FDA Consent Decree Suspends Some Operations of Getinge Group's Atrium and Maquet Facilities
February 4, 2105—The US Food and Drug Administration (FDA) announced that a federal judge from the US District Court for the District of New Hampshire has entered a Consent Decree of permanent injunction against Maquet Holding B.V. & Co. KG and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the Consent Decree: Atrium Medical Corporation in Hudson, New Hampshire; Maquet Cardiovascular, LLC, in Wayne, New Jersey; and Maquet Cardiopulmonary AG in Rastatt and Hechingen, Germany. Maquet Holding is subsidiary of the Getinge Group, based in Getinge, Sweden.
According to the FDA, between 2009 and 2013, investigators from the agency conducted ten inspections across the three Maquet facilities and uncovered major violations of the Quality System (QS) regulation, Medical Device Reporting (MDR) regulation, and Correction and Removal (CR) regulation. During that timeframe, the agency issued two warning letters to the three companies.
Additionally, between 2009 and 2014, the FDA is aware of 45 recalls of Maquet-manufactured devices, five of which were classified as Class 1—representing the most significant risk to patients. The FDA and Maquet entered into the decree to implement immediate controls, with the goal of bringing all facilities into compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act and its implementing regulations, including the QS, MDR, and CR regulations.
Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, stated in the press release, “Patients must be assured that medical devices are safe, effective, and high quality. The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance.”
Under the terms of the Consent Decree, Maquet will stop manufacturing and distributing devices from Atrium’s Hudson facility until the company makes appropriate corrections to ensure compliance with the FD&C Act. Atrium may continue to distribute certain products inside and outside of the United States that are deemed medically necessary under the decree, provided that the authorized representatives in the United States and international customers have signed a Certificate of Medical Necessity.
According to the FDA, the Atrium products that will be unavailable under the terms of the decree are the Flixene vascular graft and Ivena vascular patch as well as the ProLite hernia mesh, the ProLoop hernia mesh, and the C-QUR hernia mesh (including Vpatch, Tacshield, FX, Mosaic, and Film).
The FDA noted that 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 FD&C Act, and the QS, MDR, and CR regulations.
The Consent Decree also requires Maquet and its related companies to retain third-party experts to conduct inspections or audits and to help develop and implement plans to correct the violations found by the agency. The FDA will monitor the progress of the companies and their implementation of corrective actions through review of the third‑party expert reports and its own inspections, stated the FDA.
Getinge Group, the Swedish-based owner of the Atrium and Maquet companies under the umbrella of its Medical Systems business area, noted that the Consent Decree is a legal agreement entered into voluntarily by a company and the United States government that sets forth the terms that the parties agree are needed to resolve FDA quality system-related observations.
According to Getinge Group, this voluntary agreement establishes a framework that provides assurances to the FDA that Medical Systems will complete the improvements currently underway to strengthen its quality management system. More information about the Consent Decree and updates on Medical System’s progress is available at www.atriummed.com/consentdecree.
Getinge Group further states there is no indication that any of the products are unsafe, and the Consent Decree does not require Medical Systems to remove, recall, or perform corrective actions on any products currently in the market or at Medical Systems’ distribution facilities.
The company noted the restrictions from the Consent Decree 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. Products available under the Certificate of Medical Necessity include chest drains, local therapeutic infusion catheters, and covered stents.
Getinge Group announced that the overall financial impact, excluding the remediation costs, related to the Consent Decree is estimated to amount to Swedish kronor (SEK) 500 million (approximately $59.52 million) and will have a negative impact on the operating profit for 2015. The amount includes an initial payment of SEK 48 million ($5.71 million) to the United States government and also covers loss of revenue as a consequence of temporary unavailability of products, training and education of staff, and investment in customer relations.
Not covered in the SEK 500 million is the possibility of an additional payment of SEK 48 million if certain milestones in the enhancement program at Atrium’s Hudson, New Hampshire facilities are not completed within 6 months of the first payment.
Getinge Group has previously disclosed that it has committed SEK 995 million ($118.45 million) related to the remediation program for strengthening the quality management system within Medical Systems, which was recognized during 2014. The goal is to conclude the remediation program by the middle of 2016.
In the company’s press release, Getinge Group CEO Johan Malmquist commented, “We have learned from this experience, and this agreement with the FDA provides us with a clear path forward. 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.”
Mr. Malmquist hosted a conference call on February 4 to address these concerns. A recorded version of the conference will be available until February 11 in Sweden at +46 (0)8 5051 3897, in the United Kingdom at +44 (0)20 3427 0598, and in the United States at +1 (347) 366-9565. The passcode is 2760368. More information is also available from Kornelia Rasmussen, Head of Group Communications for Getinge Group, by telephone at +46 10 335 5810 and email at Kornelia.firstname.lastname@example.org.