Tri-State Hospital Supply Corp., Howell, MI, May 3 (Atlanta).During an inspection of Tri-State Hospital Supply's facility located in Salisbury, NC, Jan. 18-26, an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. investigator determined the reprocessor of various types of surgical stainless steel Surgical stainless steel is an alloy of iron, carbon, chromium (12–20%), molybdenum (0.2–3%), and sometimes nickel (8–12%). The chromium gives the metal its scratch-resistance and corrosion resistance. The nickel provides a smooth and polished finish. instruments--such as, scissors scissors Cutting instrument or tool consisting of a pair of opposed metal blades that meet and cut when the handles at their ends are brought together. Modern scissors are of two types: the more usual pivoted blades have a rivet or screw connection between the cutting ends , forceps, hemostats hemostats Surgery A hand-held surgical instrument with flattened opposing surfaces used to occlude blood vessels for hemostasis and needle holders--was not in conformance with the current GMP GMP (guanosine monophosphate): see guanine. requirements for medical devices. Significant violations included failure to validate processes whose results could not be fully verified by subsequent inspections and tests, and failure to approve the validation according to established procedures. Specifically, FDA said the firm failed to adequately validate its reprocessing operations. The FDA investigator noted that on three separate occasions, instruments were reprocessed by subjecting them to an ethylene oxide (ETO) cycle of one hour and 20 minutes exposure time. On another three separate occasions, the instruments were subjected to an ETO cycle of two hours and 30 minutes. Moreover, initial validation of some reprocessed instruments did not specify a minimum ETO exposure time and/or specific sterilization cycles for reprocessed instruments. Additionally, the validation data from the bioburden profiles and the fractional studies was taken from instruments that had been already been subjected to an ETO exposure cycle. Ster, Val; Doc. 13794W |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion