FDA Warns of Problems With Steris Device

The U.S. Food and Drug Administration (FDA) has issued a notice to doctors and hospitals to stop using the System 1 surgical tool sterilizer made by Steris Corp. The device typically is used in surgical and endoscopy suites for reprocessing–sterilizing or disinfecting–medical devices.

The notice is related to a warning letter the FDA sent Steris in May last year.

In the notice released on Dec. 3, the FDA said the company had “significantly modified the SS1,” and that the agency “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.”

The agency added that the use of a device that is promoted to sterilize or disinfect a medical or surgical device but does not properly perform these functions, poses risks to patients and users.

“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,” according to the FDA’s notice. “The agency cautions that use of a device promoted to sterilize/disinfect medical or surgical devices but that does not properly perform those functions poses risks to patients and users, including risks of transmitting and/or exposure to hazardous chemicals.”

The FDA says it has received some reports of malfunctions of the SS1 and reports of injuries, primarily to healthcare staff from burns from exposure to the sterilizing solution. According to FDA, in January this year, Steris advised its customers it would help them transition to other devices, in addition to steps the company would take to respond to FDA’s concerns.

“Based on a recent inspection of Steris and meetings with the firm, FDA is not satisfied that the firm has been working effectively to transition its customers to replacements for the SS1,” the agency wrote. “FDA is therefore sending this letter to make recommendations on actions that you should take.”

Steris disagrees with the agency’s assessment, but says it indeed is working with the FDA to resolve the matter.

In its response, Steris said since its introduction in 1988, more than 23,000 System 1 units have been used safely and effectively in more than 5,000 hospitals and clinics in the United States, sterilizing more than 300 million medical devices.

“There has not been a documented case of infection directly caused by a System 1 Sterile Processing System when proper guidelines and instructions are followed by certified health professionals,” according to the company.

Full text of the notice can be found at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm