Biomedical Engineering Reference
In-Depth Information
CHAPTER 11
Labeling and Instructions for Use
11.1 Introduction
You should be quite used to me telling you “this is a part of your design”; and so it is for
these two important items. You need to remember that your device is going to be used
by someone who has never even met you let alone seen
you
use your device. Hence your
labeling and
instructions for use
(IFU) must make the whole process from delivery to final
use as easy and as stress free as possible. The only way to achieve this utopian outcome
is to think about the design of your labels and IFUs from the start. We will, however, see
that some of our work has been done for us by standards and guidelines. This chapter will
be split into three main sections: labels, IFUs, and surgical techniques. But we will see
that they are all interlinked and that there are some classic traps that can be avoided with
a little bit of forethought.
11.1.1 The Rules
All regulatory bodies have a section of their rules and regulations dedicated to correct
labeling of your device. It is impossible to demonstrate every possible permutation for every
possible country of sale - but it is possible to lay down some basic design rules.
The FDA and EC guidelines for labeling (and marking) are quite clear and well documented.
You should download these documents and adhere to them.
l
Label: a mark or printed label that is attached to (or printed on) an external package. It is
not permanently affixed to a device.
l
Marking: indelible/indestructible marks on a device used for recognition of said device a
long time after its initial use.
Table 11.1
lists some of the plethora of documents that will help you to design your labeling
and marking strategy. Unfortunately, the level of information you need to supply varies with
the classification of the device.
Table 11.2
attempts to illustrate the level of complexity that
this section of your design process hides. Your PDS should have addressed labeling and
marking requirements. The same methodologies of idea generation and selection we met
earlier in this topic should be used, as with the device itself. This will help make sure that
your labeling is foolproof.
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