AR: FDA has alerted healthcare facilities that it's concerned about the Steris System 1 Processor, which is also known as the 'SS1'. This device is used to reprocess medical devices in endoscopy and surgical suites.
MB: Over time, Steris has made a number of changes to the SS1 that could significantly affect the safety and effectiveness of this device. FDA has not approved or cleared these modifications, so it hasn't been determined whether the SS1 is safe or effective, or if the claims in its labeling are accurate, including claims that it sterilizes medical devices.
AR: Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also have an adverse effect on the quality and functionality of the reprocessed instruments.
MB: FDA has received reports of malfunctions of the SS1 that had the potential to cause or contribute to serious patient injuries, such as infections. There have also been reports of injuries to operators of the device, mostly burns from exposure to the sterilant solution.
AR: Here's what FDA recommends: If a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, it should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess both its patient-care needs, and sterilization and disinfection requirements, and take steps to obtain legally-marketed substitutes for the SS1.

标题
Steris Processor Warning (FDA)

视频介绍
FDA Patient Safety News - February, 2010 - Show #95
FDA has alerted healthcare facilities that it's concerned about the Steris System 1 Processor, which is used to reprocess medical devices in endoscopy and surgical suites.