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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 the 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 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. While not common, there have been other major medical device manufacturers who have successfully navigated consent decrees.

About Terumo CVS' Consent Decree

Q. Why did Terumo CVS and FDA enter into a consent decree?

A. The consent decree is in response to deficiencies in the Quality System — the processes and procedures used by Terumo CVS to manufacture products — at its Ann Arbor plant. The FDA noted the deficiencies during past inspections of the facility.

Terumo CVS and FDA entered into the consent decree under mutually agreeable terms so that the company can continue to do business and support its customers while addressing FDA's concerns with the Quality System in the Ann Arbor plant.

Q. What are the terms of the consent decree?

A. The key terms of the consent decree require 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' goal is to complete all actions in the work plan within two years.
Terumo CVS restrict distribution of certain products built at its Ann Arbor plant to existing customers who deem the products medically necessary until it completes the actions in the plan. Products manufactured at the plant include heart-lung machines and cannulae used in cardiac surgery. Refer to the Status of Terumo CVS Products for a complete list of restricted and non-restricted products.
In addition, Terumo CVS will fully restrict two products that are not part of its current product portfolio:
- CDI™ 101 Hematocrit/Oxygen Saturation Monitoring System (until the updated device receives a 510(k) clearance)
- Tenderflow™ Pediatric Arterial Cannula
Terumo CVS pay the FDA a disgorgement of $35 million.

Q. What is NOT required by the consent decree?

A. Terumo CVS can continue to distribute products that are not manufactured in Ann Arbor without restriction, including:

Terumo CVS products manufactured at its other plants in Ashland and Elkton, including, but not limited to, oxygenators, perfusion circuits that do not include Terumo® Cannulae, shunt sensors, and Sarns™ Disposable Centrifugal Pumps.
Products manufactured by third parties, but distributed by Terumo CVS.
Products manufactured by any other Terumo entity.

Refer to the Status of Terumo CVS Products for a complete list of restricted and non-restricted products.

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. How long will the consent decree be in effect?

A. Terumo CVS expects it will complete the work plan and achieve recertification of the Ann Arbor plant by Fall, 2013, thus beginning unrestricted distribution of all products, and will fully exit the consent decree five years after that.

Q. Has Terumo CVS ever been under consent decree before?

A. No.

Impact on Terumo CVS' Business

Q. What is Terumo CVS doing to help ease the inconvenience to customers during the consent decree?

A. Terumo CVS' ultimate goal during the consent decree is minimizing the inconvenience or disruption to its customers while it builds its new quality system.

In the course of executing its work plan, and rebuilding its Quality System, Terumo CVS has implemented a series of safeguards at the Ann Arbor to ensure the products it ships are of the highest quality. At times, these additional measures may decrease efficiencies and require extra time.

Terumo CVS recognizes this can be burdensome for its customers and will extend or enhance all customer service and support functions to ensure that customer questions and concerns are addressed promptly and accurately.

Q. How has Terumo CVS alerted customers to the consent decree?

A. Terumo CVS notified all customers via email or express mail on the day the consent decree was announced, March 29, 2011. Each customer was also personally contacted by a company representative within two to three days of the announcement.

Q. Will Terumo CVS remain in Michigan?

A. Yes. Terumo CVS is, and will remain, an important member of the southeast Michigan business and life sciences communities as it completes the terms of the consent decree.

About Safety and Quality of Terumo CVS Products

Q. Are Terumo products made in Ann Arbor safe for use?

A. Terumo CVS customers can continue to use our products with confidence.

Our primary concerns are patient safety and product quality and we are taking significant action to invest in and build a world class Quality System. As part of this process, we are reviewing historical Quality System records, upgrading processes and procedures, and hiring additional associates to implement improved systems.

Terumo CVS products continue to be used in more than 1,000 life-saving surgical procedures every day.

Neither FDA nor Terumo is recommending that customers stop using these products.

Q. What steps are Terumo CVS taking to resolve FDA's concerns about deficiencies in its Quality Systems?

A. Under the terms of the consent decree, Terumo CVS and the FDA will agree on a work plan to resolve any deficiencies in Terumo CVS' Quality System and that will provide a formal, definitive, agreed-upon plan for the company to achieve full compliance with FDA regulation.

The focus of the work plan is the development and implementation of a new Quality System for the Ann Arbor plant.

Q. Are there any product recalls or corrective actions associated with this consent decree?

A. No. The terms of the consent decree do 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.

More information on Terumo CVS' policies regarding recalls »

Q. Are there any patient populations currently at risk due to Terumo CVS' inability to supply certain products during the consent decree?

A. No. In the terms of the consent decree, certain products have been identified as medically necessary and will be made available to customers who sign a Certificate of Medical Necessity.