The Food and Drug Administration is warning medical facilities to stop using the Steris System 1 Processor because the product has been significantly modified and the FDA has not approved the modified version, according to a notice by the FDA.
The SS1 is typically used in surgical and endoscopy suites for sterilizing or disinfecting medical devices.
According the FDA notice, Steris significantly modified the SS1, and the FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices.
The FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device, according to the FDA.
On May 15, 2008, FDA issued a Warning Letter advising Steris that its changes to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug and Cosmetic Act. In response, Steris stated that it would work with its customers to transition them to legally marketed replacements for the SS1.
On Jan. 20, 2009, Steris advised its customers of this commitment and the steps that it would take to respond to the FDA's concerns. However, based on a recent inspection of Steris and meetings with the firm, the FDA is not satisfied that the firm has been working effectively to transition its customers to replacements for the SS1.
The FDA recommends that facilities with an acceptable alternative to the SS1 transition to the alternative as soon as possible to ensure continued patient safety. Facilities without an acceptable alternative should promptly assess their patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.
Read the FDA's notice on the Steris System1 Processor.
The SS1 is typically used in surgical and endoscopy suites for sterilizing or disinfecting medical devices.
According the FDA notice, Steris significantly modified the SS1, and the FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices.
The FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device, according to the FDA.
On May 15, 2008, FDA issued a Warning Letter advising Steris that its changes to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug and Cosmetic Act. In response, Steris stated that it would work with its customers to transition them to legally marketed replacements for the SS1.
On Jan. 20, 2009, Steris advised its customers of this commitment and the steps that it would take to respond to the FDA's concerns. However, based on a recent inspection of Steris and meetings with the firm, the FDA is not satisfied that the firm has been working effectively to transition its customers to replacements for the SS1.
The FDA recommends that facilities with an acceptable alternative to the SS1 transition to the alternative as soon as possible to ensure continued patient safety. Facilities without an acceptable alternative should promptly assess their patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.
Read the FDA's notice on the Steris System1 Processor.