Labeled Once, Used Twice: The Regulated but Rarely Disclosed Practice of Single-Use Device Reprocessing in U.S. Hospitals
Millions of Americans undergo procedures each year without knowing that the device entering their body may have been labeled 'single-use only' — yet legally cleaned, sterilized, and redeployed under FDA oversight. The $4 billion reprocessing industry operates within a defined regulatory framework, but documented cases of patient harm and unresolved sterility questions demand that every patient ask sharper questions before consenting to care.