Biomedical Engineering Reference
In-Depth Information
Potential Hazard
Whom?
What?
Why?
Biological
Bio-burden?
Bacteria?
Viruses?
Other agents (e.g.,
prions)
Re- or cross-
infection?
Animal-based
products?
Any of the above
due to reuse?
Labeling
Are the instructions
for use adequate?
Are the indications
clear?
Contraindications
clear?
Are the
performance
criteria clear?
Are the above
written for all end-
users?
For example, we all know that x-rays are an ionizing radiation and hence pretty dangerous things.
After all, if Marie Curie had the benefit of hindsight she may not have carried isotopes around in
her pocket! However, how would modern medicine get along without the x-ray machine? How
would your dentist examine your roots without this device? While it is impossible to remove all
of the risk, we are able to reduce it to levels where the benefits outweigh the risk. As such all
hospitals, all dentists, and all veterinary practices have an x-ray machine.
The same argument must be applied to your medical device. You must be able to prove, using
risk analysis, that “
the medical benefits outweigh the risk
.”
In order to be able to make this statement, we must consider the risks/hazards presented in
the previous section; and then for each one identify the root cause or (if applicable) the root
causes. To illustrate this
Figure 9.1
is a typical FMCA pro forma; this has been modified from
ISO 14971 to coincide with terms we have already met.
Use of Annex C will identify potential failures/hazards. The relevant section number of Annex C
is entered into box 1 (see
Figure 9.1
for numbering of boxes). You may have a number of different
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