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Home > News > April, 2010

Steris Reaches Agreement With FDA (Updated With New Website)

SS1 customers are eligible for a cash rebate or a trade-in allowance.

If you own a Steris System 1 liquid chemical sterilization system, you're eligible for a rebate under the terms of a consent decree that Steris has reached with the U.S. Food and Drug Administration that finally resolves the government's complaint that the SS1 had been modified to such a degree that it's no longer approved or cleared.

U.S. customers who purchased their SS1 processors directly from Steris, or who are current users of the SS1, are eligible for the rebate program. You have the option of either a pro-rated cash rebate or a trade-in allowance toward the purchase of new Steris capital equipment — earlier this month the FDA approved the successor to the SS1: the Steris System 1E Liquid Chemical Sterilant Processing System — or consumable products. As a condition of participation in the rebate program, SS1 units must be returned.

Steris's agreement with the FDA lets Steris continue to support SS1 customers, including the sale of consumables, parts and service, and accessories through Aug. 2, 2011, for those SS1 customers who document their need for continued support. Steris will also provide U.S. customers full credit for unopened SS1 consumables and accessories within the current shelf life expiration date. For customers with service contracts, credit will be applied for the unused portion of the contracts based upon the date of de-installation.

Steris representatives will contact customers shortly and provide specific transition plan information and certificates that must be completed and returned to permit continued support of their SS1 processors. As a result of the rebate program, the company will record a liability of up to $100 million during the first quarter of fiscal 2011 that will result in a one-time reduction of revenue and operating income on a pre-tax basis.

Update: Details about the rebate and other tools, including a downloadable form customers must fill out to continue receiving sterilant, accessories and parts for the SS1 during the transition period, are available at www.system1transition.com. Steris has also created a website for its newly approved Steris System 1E liquid chemical sterilant processing system.

"We are pleased that our plans for financial assistance and other support we will provide System1 customers during this transition are now final," says Steris President and CEO Walt Rosebrough in a prepared statement. "We apologize to our customers for the uncertainty this situation created over the last several months. However, we believe the [transition plan] will allow healthcare providers the time, financial support and information necessary to make the best possible decisions for patients and caregivers."

Dan O'Connor

More breaking news.

Categories: Infection Control, Legal/Regulatory, Product Reports, News
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