The FDA is giving healthcare facilities 18 more months to discontinue use of the Steris System 1 tabletop liquid chemical reprocessor and transition to a legally marketed alternative device.
In an update notice, the agency says it extended the recommended time period for replacing the SS1 after healthcare providers and professional organizations warned that the original 3- to 6-month transition period would be difficult for facilities to attain and therefore could "adversely affect patient care."
Facilities that fail to meet the 18-month deadline won't be penalized, but the FDA urges you to transition to FDA-cleared alternative reprocessing devices as soon as possible. "The current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims," the agency warns.
Irene Tsikitas
