The U.S. Food and Drug Administration today announced that a consent decree has been filed against the device manufacturer, STERIS Corp. of Mentor, Ohio. The decree stops the company from distributing unapproved and misbranded devices used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the STERIS System 1 Processor, or SS1, a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.
As part of the consent decree of permanent injunction, STERIS has developed a transition plan and rebate program for its U.S. customers to ease the transitioning to legally-marketed alternatives. The transition plan allows STERIS to continue to support existing customers who are using the SS1, but requires these customers to obtain a Certificate of Medical Necessity to get parts, components, accessories, and service during the transition period which ends on August 2, 2011.
“FDA’s oversight of medical devices helps ensure that patients are protected from unsafe or ineffective devices,” said Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division. “When device manufacturers fail to comply with FDA’s regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA’s regulations.”
In May 2008, the FDA advised STERIS in a Warning Letter that significant changes made to the SS1 caused the device to be adulterated and misbranded. In December 2009, the FDA sent a letter to health care facilities and infection control practitioners advising them that the agency had not cleared the current version of the SS1. The letter recommended users transition to a legally-marketed alternative.
Under the consent decree, STERIS agreed to destroy used SS1 devices, components, parts, and accessories in the company’s possession within the United States by September 30, 2011. Some specified unused devices and component can, with FDA approval, be retained.
The decree was filed in the U.S. District Court, Northern District of Ohio on April 19, 2010, and is subject to court approval.
User facilities, including hospitals, are required to report suspected device-related deaths to the FDA and to the manufacturer, and serious injuries to the manufacturer or to FDA1.
In addition, healthcare professionals and consumers are encouraged to report serious adverse events that may be related to the use of unapproved and misbranded products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
On April 5, 2010, the FDA cleared the STERIS System 1E (SS1E), which is an alternative to the SS1. The SS1E is a liquid chemical sterilant processing system. Liquid chemical sterilization is not equivalent to traditional sterilization (such as steam, ethylene oxide, and gamma irradiation). The SS1E can be used to process reusable heat-sensitive devices such as endoscopes and their accessories that cannot be processed using steam.
Voluntary Reporting may be done:
* Via Regular Mail: use postage-paid, pre-addressed Form FDA 35003. Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 800-FDA-0178
* Phone: 800-332-1088
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