“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”
Institute of Medicine of the National Academies
The following sites offer important information about packaging issues:
Requirements for Unique Device Identification System
ERG Final Report: Unique Identification for Medical Devices
Detailed scenarios, statistics and applications for UDI, UPN and RFID.
Summary from the October 25, 2006 FDA Public Meeting on Unique Device Identification
Discussion on the mandate by the FDA for UDI (Unique Device Identification).
Visit www.21cfrpart11.com, your compliance resource.
Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI