Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 207

Table 9.2: Examples of Hazards Table 9.2: (Continued)

Examples of Energy
Hazards

Examples of Biological
and Chemical Hazards

Examples of
Operational Hazards

Examples of Information
Hazards

Acoustic energy
- ultrasonic energy
- infrasound energy
- sound

High pressure fluid
injection
Will it “inject”?
Can it cut?
Will it overinflate?

(Modified from ISO 14971:2009)

is meaningless. Hence I have taken this table and converted it into questions you should ask
yourself. This table is by no means complete; it is only a starter and you can use this to build
your own, more detailed, list of hazards.

As with earlier aspects of quality in design, it is worth using the following W questions:

Whom: Hazardous to whom? The patient? The end-user? Other devices!
What: What makes this a hazard?
Why: Why is it hazardous? (If this is not obvious, you may have to describe in more detail.
Things like electric shock or scalding need no expansion - apart from the potential degree.)

I have not completed the table, perhaps you would care to complete it?

You should foresee that this will be a lengthy process. It is very time-consuming and results
in loads of paperwork. But by the end you will have thought of just about any stupid thing
that could be done by every possible end-user. When you consider that you are about to
release a medical device onto an unsuspecting world - that may just kill someone - then this
exercise is highly worth it. In my experience it only takes a few days, but it is a few days well
spent. Remember, risk analysis is a mandatory exercise, so you may as well do it right! The
other thing to remember is that if you have written your PDS in the first instance, then all of
these risks will have already been mitigated!

9.2.2 Assessing Level of Risk
The similarity between FMEA and the ISO 14971 risk analysis form is no coincidence.
However they depart in one major aspect: FMEA was used to design out risk whereas the risk
analysis is to check whether any residual risks remain. If you designed your device using a
well constructed PDS then this analysis should return a “safe to use” result. What does “safe
to use” mean? It simply means that any risk of use is outweighed by the clinical benefits.