Requiem for reuse of single-use devices in US hospitals.

The subject of reusing single-use devices (SUDs) is one that has been discussed, debated, dissected, promoted, and damned seemingly forever. I have been attending conferences and professional and scientific meetings that discussed the pros and cons of reusing SUDs for more than 25 years and, until recently, it was the same story. Those who favored, and indeed practiced, reusing SUDs pointed out the substantial cost savings and the absence of records of adverse patient reactions. Those who opposed the practice listed many worrisome issues, especially for those devices that were complicated in design and function: cleaning and sterilization, infections and pyrogenic reactions, functionality and its validation, materials compatibility, germicide residue, patient consent, liability, ethics, and so on. The United States Food and Drug Administration (FDA) during those years stated that the Medical Device Amendments of 1976 of the Food, Drug, and Cosmetic Act gave the agency regulatory authority over the manufacture of medical devices but not their use. The FDA did not regulate medical practice, and those hospitals that chose to reuse SUDs were responsible for the device and accepted the liability for the device. The FDA expressed concern but did not recommend against the practice of reuse.