Steris Corporation did not seek FDA clearance for the device, and FDA has not approved or cleared the SS1 for its labeled claims. As a result, the FDA announced in December that facilities using the devices should transition to an alternative within three to six months.
According to the FDA, the three-to-six-month recommendation was based on discussions with a number of outside constituents. However, since then, the FDA has heard from many other healthcare providers and professional organizations and believes that a three-to-six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care, according to the release.
The FDA does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period, but these facilities should be aware that the current SS1 is a misbranded as safe and effective for its labeled claims. Healthcare facilities should, therefore, transition to alternative reprocessing devices as soon as practicable, according to the release.
Read the FDA release on the Steris System 1 recall.
