Downloads
GAO Report to Congress – Single use Medical Devices 2008 (pdf)(553KB)
AHRMM Reprocessing Advisory 2004 (.doc) (27 KB)
AORN’s Guidance statement on reuse 2001 (.pdf) (55 KB)
GAO report to Congress 2000 (.pdf) (254 KB)
Labeling requirements
and,
Guidance for Industry and FDA Staff (.pdf) (681 KB)
Premier White paper - summary of reprocessing decision parameters (.doc) (47 KB)
Premier's position (.pdf) (16 KB)
Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors: Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions (.pdf) (31 KB) (7/16/03)