Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 281

11.6.1 Assembly and Disassembly Instructions
If your device is to be assembled at point of use you will need to supply assembly
instructions. If your device is to be assembled sterile then remember that the instructions will
need to go into the sterile field and so should be cleanable and easily wiped; paper copies
will not do.
It is when you come to develop the assembly instructions that you start to appreciate all of the
effort you put into the design of the device earlier on. If you really considered the end-users'
comments your assembly will be easy to describe….if you did not the assembly process will
be horrendous. So a word of warning: do not forget this important aspect in the life of your
device.
If you are to base your assembly and disassembly instructions on anything in particular, then
IKEA is a good example. They manage to get people to assemble complex furniture with no
training at all. What makes their instructions even better is that they are all done with pictures
- no translation required!
Do not forget to include a manifest of all of the components in your instruction sheet. All
hospitals count in and count out during a procedure, so it helps if they know what they are
counting.
11.6.2 Warnings and Contraindications
The surgical technique document is a good place to provide any warnings and
contraindications. Why is this so? It is more likely that the practicing clinician will read the
technique before using your device; they will (in all practical environments) not look at the
IFU sheet.
Contraindication: Any patient profile or situation where the device MUST NOT be used.
Do not provide blanket contraindications - this can limit the scope of your device.
Concentrate on your risk analysis and make sure that your device does not compromise any
situation where the risk is unacceptable.
A typical contraindication may be:
This device is not to be used in minors or persons who are not skeletally mature.
Warnings: Any patient profile or situation where the device, if inappropriately used may be
hazardous.
Once again, your risk analysis will highlight what these contraindications should be.