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 attempt to 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.