Nursing Management 's Infection Control Special Report (June 2002) highlights a number of important IC topics. Of the many pertinent issues addressed, the news brief regarding single-use devices requires clarification.
Whereas the news item states, "Hospitals that reuse single-use devices (SUDs) must register with the FDA..." it's actually hospitals that reprocess (that is, clean, package, and sterilize for clinical re-use) SUDs that must register with the FDA. All reprocessors, regardless of other business conducted, must submit the proper pre-market documents to the FDA and follow their Quality System Regulations-formerly referred to as Good Manufacturing Practices.
The FDA doesn't require that reprocessed devices be followed from reprocessing to final disposal. To merely use reprocessed SUDs, regardless of who reprocesses them, requires no FDA approval or other contact with that federal agency.
Steven Avalos-Bock, RN, CIC
Celebrate the Heroes Among Us
Nursing Management calls for JPG files, slides, or photos of the nurse leaders and staff members who tirelessly served in New York City, N.Y., and Washington, D.C., on and after the September 11 terrorist attacks.
The staff of Nursing Management will use these actual depictions to honor and celebrate the Heroes Among Us at Congress2002, October 13 to 16, at the Hyatt Regency Dallas at Reunion, Dallas, Tex.
Please forward materials to:
Nursing Management-Call for Photos
1111 Bethlehem Pike, P.O. Box 908, Springhouse, PA 19477-0908
E-mail JPG files to: [email protected].