FDA Warns of Problems with STERIS 1 Sterilizor

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Healthcare facility administrators and infection control healthcare professionals have been notified by the FDA of important information regarding the regulatory status of the STERIS System 1 Processor (SS1). The SS1 is used in sterilizing and disinfecting medical devices used in surgical and endoscopy suites.

STERIS has significantly modified the SS1, but the FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. 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.

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The FDA is recommending that if a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, then the facility 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 its patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.

Infections are a major source of healthcare problems and costs. When a sterilizer is not used properly or does not perform properly, then patients and healthcare workers are at increased risks of transmitted pathogens. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.

User facilities, including hospitals, are required to report suspected device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown (see http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/default.htm). Also, FDA solicits voluntary reports of adverse events from healthcare professionals. Adverse events may be submitted online.

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