Terumo Cardiovascular Group
- About Consent Decree
- Progress Report
- Fact Sheet
- Frequently Asked Questions
- Status of Terumo CVS Products
- Glossary of Related Terms
Questions or concerns about the Terumo CVS' Consent Decree?
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About Terumo CVS' Consent Decree
Frequently Asked Questions
Terumo Cardiovascular Systems (Terumo CVS) agreed on the terms of a consent decree with the U.S. Food & Drug Administration (FDA) regarding quality system improvements at the company's Ann Arbor, Michigan facility. The consent decree became effective on March 29, 2011.
Terumo CVS has tried to anticipate the most commonly asked questions regarding its consent decree and provided answers below.
About a Consent Decree in General
Q. What is a consent decree?
A. A consent decree is a legal agreement approved by a judge. In the medical device industry, a consent decree is an agreement between the FDA and a device manufacturer that defines the terms under which the company can continue to conduct business while it addresses the FDA's concerns.
Q. What is a disgorgement?
A. A disgorgement can be one of the terms in a consent decree. It is a remedy imposed by the courts that requires a company to relinquish profits. A disgorgement is not a penalty.
Q. Have other medical device companies entered into a consent decree?
A. Yes. There have been other major medical device manufacturers who have entered into consent decree.
About Terumo CVS' Consent Decree
Q. Why did Terumo CVS and the FDA enter into a consent decree?
A. The consent decree was in response to deficiencies in the Quality System — the processes and procedures used by Terumo CVS to manufacture products — at its Ann Arbor factory. The FDA noted the deficiencies during prior inspections of the facility.
Terumo CVS and the FDA entered into the consent decree in 2011 under mutually agreeable terms so that the company can continue to do business and support its customers while addressing the FDA's concerns with the Quality System in the Ann Arbor factory.
Q. What are the terms of the consent decree?
A. The key terms of the consent decree required that:
- Terumo CVS develop a work plan to address deficiencies noted in an independent audit of its Quality System. Terumo CVS will submit the plan to the FDA for approval. Terumo CVS' progress will be documented by the independent auditor on a regular basis.
- Terumo CVS restrict distribution of certain products built at its Ann Arbor factory to existing customers who deem the products medically necessary until it completes the actions in the plan. Products manufactured at the factory include heart-lung machines and CDI® blood parameter monitoring systems used in cardiac surgery.
- Terumo CVS pay the FDA a disgorgement of $35 million.
Q. What was NOT required by the consent decree?
A. Terumo CVS could continue to distribute products that are not manufactured in Ann Arbor without restriction, including:
- Terumo CVS products manufactured at its other factories in Ashland and Elkton, including, but not limited to, oxygenators, perfusion circuits, shunt sensors, and Sarns™ Disposable Centrifugal Pumps.
- Products manufactured by third parties, but distributed by Terumo CVS.
- Products manufactured by any other Terumo entity.
The consent decree does NOT require Terumo CVS to remove, recall or perform any corrective actions on the products currently in use (or in inventory) at customer facilities.
Q. Has Terumo CVS ever been under consent decree before?
About Safety and Quality of Terumo CVS Products
Q. Are Terumo products made in Ann Arbor safe for use?
A. Terumo CVS customers used — and can continue to use — our products with confidence.
Terumo CVS undertook significant action to invest in and build a world class Quality System. As part of the process, Terumo CVS reviewed historical Quality System records, upgraded processes and procedures, and hired additional associates to implement improved systems.
Terumo CVS products continue to be used in more than 1,200 life-saving surgical procedures every day.
Q. What steps did Terumo CVS take to resolve the FDA's concerns about deficiencies in its Quality Systems?
A. Terumo CVS implemented new Quality System procedures in accordance with its work plan. A third-party expert reviewed Terumo CVS' progress on the plan daily and reported to the FDA on a quarterly basis. All activities in the work plan have been completed to the satisfaction of the expert.
The corrective action plans for all sections of the new Quality System were implemented and the new Quality System procedures are in use.
Terumo CVS completed a retrospective review of its Quality System records dating from 2004 and implemented appropriate actions to correct or recall products based on its re-evaluation of the records.
To ensure the quality of the products it shipped from the Ann Arbor factory during the time it was completing its work plan, Terumo CVS implemented additional safeguards to its existing procedures.
Q. Were there any product recalls or corrective actions associated with this consent decree?
A. No. The terms of the consent decree did not require Terumo CVS to recall or perform corrective actions on any products in use at user facilities.
The decision to voluntarily initiate any future product recalls will be based — as it has been — on Terumo CVS' current Quality System, which requires that the company issue a safety advisory, or perform a correction or removal, if it discovers a product defect that would pose even a remote possibility of patient risk.