Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 204

CASE STUDY 9.1
Consider a single use device that is supplied nonsterile and relies on the end-user using a steam
ster ilization process before use. Using Table 9.1 consider any potential hazards.
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?

Single use device to be steam sterilized before
use.

Factors that should be
considered include:
2.8.1. Whether the
medical device is intended
for single use or reuse
packaging

✓

Can it be mistakenly used nonsterile?
Can it be mistakenly reused?
Does the packaging make its sterility status
obvious?

✓

2.8.2. Shelf life issues Will the device deteriorate over time on the

stock shelf, in transit, or in the hospital?
Once sterile how long will the device remain
sterile and in what conditions?

✓

2.8.3. Limitation on the
number of reuse cycles

Will resterilization (due to not being used)
cause issues?
How many times can it be resterilized without
having detrimental effects?

✓

2.8.4. Method of product
sterilization

Can the device be washed/cleaned in normal
clinical machines?
Do we have a certificate stating it is
sterilizable?
Have we checked that it can be sterilized using
normal clinical methods?
Have we checked that the sterility conforms to
standard procedures in all states in which it is
being sold?
Will the device store heat and hence be able to
burn/scald patient end-users?

✓

2.8.5. The impact of other
sterilization methods
not intended by the
manufacturer

What happens if the device is ETO sterilized?
What happens if it is irradiated?
Do either have detrimental effects?
Do either cause any issues related to usability?

Once you have identified related areas (using Annex C), you will also need to think of the
appropriate hazards to be inserted in the Comments column. In most cases this is like asking
“How long is a piece of string?” However, ISO 14971 comes to the rescue again. Annex E
helps us to imagine particular issues. Although Table E2 is useful, for the first-time user it