Medical Pack Solutions
Gone are the days of partially preprinting
medical device labels and then adding the catalogue number and size with a
ballpoint pen. Of course all label systems must be validated before being put
into service. Much has been written about Medical Device
labelling so this section will not
summarise published standards.
Correct product identification is essential
with full traceability. Labels will
normally be printed under computer control using validated software. All
involved will be following the appropriate Standard Operating Procedure. No
product batch may be released until label quantities have been reconciled. The
use of computer controlled labelling systems has paved the
way for bar coded labelling and EDI.
Compliance with the
labelling requirements specified in FDA
Standards and the three EU Directives on medical devices is mandatory. The FDA
has a useful listing of
labeling information documents on it's CDRH
web site. The relevant European
Standards are EN 980 and EN 1041, be sure to have the current version. The
international standard ISO 15223-1, will eventually be merged with EN 980.
When selecting a Bar Code
symbology, the real estate on the label
must be considered. As time progresses one can expect migration to condensed
multiline symbols that take up little
space compared with current bar codes. The disadvantage of the multiline symbols
is that imaging technology is required to read a code rather than the current
simple scanners. Single line codes can be read with hand scanners but multiline
symbols need a camera. Radio Frequency Identification is an alternative none-contact method that is becoming less expensive and as the codes do not have to
be visible, they don't interfere with the appearance of labelling. The data
structure could be the same for all three product identification methods.
Both HIBCC and GS-1 have suitable data structures for bar coding medical devices.
Note: EHIBCC represents HIBCC in Europe. GS-1 was formerly known as EAN International.