Re-processor caught between rock and two FDA offices

摘要

Rockville, MD.―Although a re-processor of single-use medical devices has agreed to halt production, the president of the Lubbock, Texas-based company says the Food and Drug Administration's (FDA) claim that Adven Medical Inc. failed to properly validate cleaning, disinfecting and sterilization processes is "false and inflammatory." Mark W. Aldana, Adven's president and chief executive officer, told CleanRooms that the company can support its claim with pre-market notifications (510ks) containing complete cleaning validation and sterilization protocols and results, which were submitted and cleared by the FDA's Office of Device Evaluation.