The Mentor-based company’s modified SS1 sterilizer device has not been cleared as safe and effective.
Users have reported problems that could result in patients becoming infected from unsterile instruments, according to an FDA statement released late Thursday.
The FDA recommends physicians begin using alternative devices as soon as possible.
Steris shares plummeted $4.17, or 12.5 percent, to close at $29.14 Friday. The company did not return a call for comment.
FDA officials told reporters Friday that they are “considering all available options,” against Steris, but did not elaborate on a specific actions.
The FDA warned Steris in May 2008 about the problems with its devices, and the company was supposed to begin transitioning customers to alternative products.
“FDA is not satisfied that the firm has been working effectively to transition its customers,” the agency said. Steris representatives have been “reassuring customers that there is no need for a change in their clinical practice.”
Biomed Middle East Contacted Steris and they has informed us that they are looking into this very seriously, the company has established a web site section to give their point of view at (https://www.steris.com/ss1/internationalSS1.cfm)
According to Steris the The FDA Notice is applicable only to SYSTEM 1 devices marketed in the USA and has no effect
on CE marking of SYSTEM 1 and its conformity to the European Essential Requirements. STERIS will continue to sell, service and support SYSTEM 1, STERIS 20 Sterilant Concentrate, related accessories and service parts without restriction to all international users
STERIS unequivocally stands behind the performance of SYSTEM 1. Its 20+ year contribution
to healthcare speaks for itself
STERIS is notifying European Competent Authorities of this action in order to address any
questions they may have. If you have any questions, please contact your local STERIS Customer
Service. STERIS values our relationship with you as a Customer and we want to assure you of
our continuing support of SYSTEM 1 in your area.