Biomedical Engineering Reference
In-Depth Information
too. So I now intend to present these to you; but they should not be a surprise as they are very
similar to those we saw in FMEA.
9.2.1 Identifying Risks/Hazards
This aspect of the clinical evaluation process is to ascertain risks and hazards. The first port
of call is Annex C of ISO 14971 (see Appendix C for a full table).
Table 9.1
illustrates one
small subsection of Annex C. The whole table, if worked through, helps you to identify risks
pertaining to your device.
The whole aim of Annex C is to get you thinking about risks when the device is in the real
world, as opposed to in your design office. You should consider all aspects related to your
device. You should put yourself in the place of use. If you are unable to imagine this then you
need to gain some experience related to the place of use or get hold of someone who has.
Some of the questions posed by Annex C will not be related to your device. If so, simply
state N/A and then state why in the Comments column. Also, you will find that some sections
repeat themselves. This is perfectly reasonable - the repetition may have occurred so make
sure you look at all angles. When completing this table consider issues at the hospital, at your
suppliers, and in your warehouses. You need to use these questions to think of
any
potential
risk - no matter how negligible it may seem. It is only when we come to do the analysis that
we consider the level of risk.
Table 9.1: Subsection of Annex C ISO 14971
Subsection
Applicable/Not Applicable
Comments
c.2.8 Is the medical device
supplied sterile or intended to
be sterilized by the user, or are
other microbiological controls
applicable?
Factors that should be considered
include:
2.8.1. Whether the medical device
is intended for single use or reuse
packaging
2.8.2. Shelf life issues
2.8.3. Limitation on the number
of reuse cycles
2.8.4. Method of product
sterilization
2.8.5. The impact of other
sterilization methods not intended
by the manufacturer
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