The Food and Drug Administration (FDA) is warning hospital risk managers, surgical service managers and infection control professionals that a device used in surgical and endoscopy suites for sterilizing or disinfecting medical devices has been modified, has not been approved by the FDA, and may not properly disinfect or sterilize instruments, which may pose a serious risk to patients and health care staff.
STERIS Corporation has modified its System 1 Processor, or SS1. The modified version has not been approved or cleared by the FDA, thus the agency has not determined whether it 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 does not do so properly, poses risks to patients and users, including transmitting pathogens to patients and health care staff, or exposing them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.
Some malfunctions of the SSI that had the potential to cause or contribute to serious injuries or infections to patients have been reported to the FDA. Infections that may have come from improperly sterilized or disinfected medical devices as a result of the SS1 may be difficult to attribute to the SS1 and may go unreported. The FDA has also received reports of injuries, mostly burns from exposure to the sterilant solution, to health care facility staff operating the device.
The FDA issued a warning letter to STERIS advising the company that its change to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act, and that those changes could significantly affect the safety or effectiveness of the device.
STERIS says it will work with customers to transition them to legally marketed replacements for the SS1.