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FDA Warns STERIS Corp. Sterilizing Device May Malfunction, Should Not be Used

Dec 7, 2009 | Parker Waichman LLP

Health care facilities have been warned not to use the  STERIS System 1 Processor  (SS1), according to a posting on the Food & Drug Administration (FDA) Web site.  The  SS1 is used in surgical and endoscopy suites for sterilizing medical instruments and devices.

According to the FDA, it has received some reports regarding malfunctions of the SS1 sterilizer, which have the potential to cause or contribute to serious injuries to patients, such as infections.  Because such infections may take place after use of the SSI, they may not be attributed to the device and go unreported.

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

Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users, the FDA said.   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 adversely affect the quality and functionality of reprocessed instruments.

If a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, the FDA says 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.

In a press release responding to the FDA's safety notice, STERIS Corporation said it disagreed, and are  "working to engage in further dialogue with the Agency about this matter."  

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