A summary of the regulatory actions, recalls, and standards activity relevant to sterile processing departments during May 2026.
FDA Activity
Two Class II recalls were issued for automated endoscope reprocessors during the month, both related to incomplete cycle documentation rather than disinfection efficacy. No Class I recalls affecting sterilization equipment were recorded.
Standards Updates
AAMI’s ST79 working committee continued review of revisions addressing flash sterilization documentation requirements. No final publication date has been announced.
Notable Research
Multiple peer-reviewed studies published this month examined hydrogen peroxide vapor penetration in complex-lumen devices, with mixed results depending on lumen diameter and cycle parameters tested.
What to Watch
Facilities using legacy washer-disinfector models should monitor manufacturer service bulletins closely, as several models referenced in this month’s literature are approaching end-of-support windows from their original manufacturers.