Surgical Device Sterilization Equipment May be Defective, FDA Warns

The Steris System 1 (SS1) processor may not properly sterilize or disinfect surgical tools and medical devices, posing a risk of infection and the spread of disease among patients and medical staff, the Food and Drug Administration said.

The FDA is warning hospital risk managers, surgical service managers, and infection control professionals about recent changes the manufacturer made to the SS1 device, which the FDA has not approved and may result in improperly sterilized or disinfected medical devices.

“FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices,” the FDA warning said.

Improperly disinfected or sterilized surgical instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals, the FDA said. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.

Reports of Injuries, Malfunctions Received

The FDA has received some reports of malfunctions of the SS1 which could cause or contribute to infections and other injuries to patients. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device, the FDA said.

The FDA recommends healthcare facilities should use alternate methods to sterilize and disinfect needs until the recent modifications to the SS1 processor can be reviewed and approved.

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