Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 279

11.5.1 Instructions for Use Leaflet
This is the most common form of IFU for all devices. It is normally brief and will state
what the device can be used for, its indicative use, and any contraindications (where it is not
to be used). It will have the relevant CE mark (if in the EC) and state whether the device
is supplied sterile or nonsterile. It should also give any warnings required (from your risk
analysis). The IFU must also state the single point of contact for complaints, reporting of
hazards, noncompliance or vigilance. Some countries (Canada, for example) have specific
requirements in relation to point of contact so make sure your IFU meets the requirements for
the country in which you intend to sell.
If you are able to, use your end-users to supply you with examples of IFUs from their other
suppliers. Some medical device suppliers have them as live documents on their websites. You
will be able to build your own picture of what is required.
The IFU is a controlled quality document so will need the standard quality tagging (document
revision, etc.); it will also need formal approval. Hence it is worth having a standard IFU
that you can complete when new products/devices come along. A typical format is shown in
Figure 11.18 .
Note that in the EC a single use item's IFU must include a statement as to why it is single use.
This may sound silly, but its intention is to stop manufacturers from making items single use
when they do not need to be - and hence drive up sales, sneakily.
11.5.1.1 Nonsterile Items
Most nonsterile items will need to be cleaned and sterilized before use. Your IFU must
describe how this is to be done and which sterilization method is recommended. If your
device is to be steam sterilized make sure you state the harmonized steam cycles (ISO 17665-
2:2009) within your IFU ( Table 11.3 ). If you do not include these instructions you will
find your device will be returned to the clinician from the sterilization center with a rather
nasty letter, and you will get a very nasty phone call. It is also without question that anyone
inspecting your systems will ask for the IFU and will look for this.
Whatever you do, do not specify a process that a hospital or clinic cannot achieve. This is no
use to anyone.
11.6 Surgical Technique
For items that are more complex it may be necessary to produce a more detailed document
describing how to use your device correctly. This is called a surgical technique . This is
equivalent to the operating handbook you would expect to get with a new DVD player. It is
common to supply one (or more) with the original first delivery. For more complex devices,