FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk
The U.S. Food and Drug Administration today issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. Continue reading.