The FDA filed a consent decree Tuesday against Steris to stop the Ohio-based company from distributing its unapproved and misbranded Steris System 1 processor.
Under the decree, Steris has developed a transition plan and rebate program to help U.S. customers switch to legally marketed sterilizers. The company can provide support for current SS1 customers, but the users must obtain a Certificate of Medical Necessity to receive parts, components, accessories and service until the transition period ends Aug. 2, 2011. Steris also agreed to destroy used SS1 devices, components, parts and accessories by Sept. 30, 2011.
Steris received a warning letter last May that said significant modifications to the SS1 required a new 510(k) to be submitted, and the devices were adulterated and misbranded. The consent decree will generally resolve the warning letter, Steris says. The FDA also posted a MedWatch alert for healthcare facilities last December, which says the agency received reports of malfunctions with the SS1 and facilities should transition to alternative sterilizers as soon as possible.
The company received 510(k) clearance for the SS1E earlier this month, an alternative to the the SS1. The company planned to begin accepting orders as soon as the transition plan was announced.
"We believe the Transition Plan will allow health care providers the time, financial support, and information necessary to make the best possible decisions for patients and caregivers," said Walt Rosebrough, Steris president and CEO.
- check out the FDA's release
- here's Steris' release