Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 275

Remember: if your device has separate inner packaging the label must be replicated on any
inner packaging. This is especially important if your outer packaging is a multipack. If this is
not undertaken traceability will be lost.
11.3.2 Patient Labels
It is common practice, especially if your device is for use in theater, to supply patient labels.
These are small self-adhesive labels (normally 5) that can be peeled off and attached to the
patient's notes ( Figure 11.15 ). This makes life easier for the clinical and OR staff. The label
usually contains only the bare minimum information such as part number, batch/lot number, and
any other information deemed important to identify the device. Once again this is useful to enable
efficient communication should anything remiss happen. These labels are quite common for
sterile single use items.
11.3.3 Bar Codes
Many hospitals demand bar codes for inventory control. Normally they require three items of
information: part number (catalog number), batch/lot number, and packing date. For sterile/
perishable items this may also include a "use by" date. You should find which bar code system
the hospitals want; you should also have a printer and software that can print bar codes (many
thermal printers such as the Dymo TurboJet series come with this software as standard). It is
quite common to use the UCC/EAN128 bar code profile. It is also important to use the right
Figure 11.15
Example patient labels. (Courtesy Intelligent Orthopaedics Ltd) .