Biomedical Engineering Reference
In-Depth Information
A typical warning may be:
Take care when using the device with minors or patients who are not skeletally mature as
excessive traction forces may damage a growth plate.
You may notice that the two examples above are both sides of the same coin. The
contraindication bans anyone from using your device on this patient group, even if they
think it is possible. Anyone not following this contraindication is playing career suicide. The
warning, on the other hand, says they can use it but if they do and they damage a growth plate
(i.e., cause an injury) then it is their fault for not taking care.
Do not forget basic warnings. If your device is sharp, tell them it is sharp! Do not rely on
common sense - common sense does not exist.
11.6.3 Production of the Surgical Technique
It is without question that this document needs to be written with close cooperation of the
end-user. Even better, a professional end-user should write it. So if your device is to be used
by an oncologist then an oncologist should write it; if it is for a staff nurse…and so on. You
will find most companies obey this simple rule.
This is a very important document so do not rely on the first draft being correct. You should
follow the same design procedures, outlined earlier in this topic, for its design and production.
Only that path results in the first draft being close to the final outcome. As with the real
device, this document needs evaluating before release. Hence have a group of end-users ready
to go through the draft and make suggestions.
The final suggestion: a picture paints a thousand words. All technique manuals abound with
a plethora of images. In some cases photographs are used, in some drawings…but images are
always there to make a description obvious.
11.6.4 Document Control
The surgical technique is a controlled document, so it should contain all of the relevant
quality tagging one expects to see with all quality documents.
11.7 Declarations
11.7.1 Declaration of Conformity
Wherever you sell you will need to produce a declaration of conformity. This is a document
that sits in your product's technical file and can be produced on request. It is a highly specific
document and the regulatory bodies give substantive guidance on what they should contain.
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