Biomedical Engineering Reference
In-Depth Information
combine research work, training and external services whose founding is usually
promoted by public investment to aid the purchase of facilities and equipment.
A good strategy for choosing the right centre is to visit the various pre-selected
centres and speak to the people in charge, to deal not only with technical matters but
also with schedules and costs to help make the fi nal decision.
Another key issue for the success of in vivo tests is the right choice of animal
model to be used. Working with live animals to support a medical device develop-
ment project is a privilege not to be taken lightly, and exhaustive planning should
aim at reducing the required number of animals needed. To help choose the most
suitable animal model, the following procedure may be followed:
• Study the animals used in similar developments.
• Analyse the species whose anatomy is most similar to humans (for the organ
associated with the device in question).
•
Exchange opinions with other researchers in the same area.
•
Consult the main scientifi c publications.
•
List the equipment needed (which will also help choose the centre for the tests).
•
Calculate the number of animals required.
•
Decide if the operations will be terminal or not.
•
List all the parameters wished to be studied.
Only after an exhaustive planning stage and assigning the right responsibilities to
all the participating personnel (particularly regarding the centre where the in vivo
tests will be conducted, as they are not usually part of the initial development team),
the in vivo work can be begun. The ethical guidelines contained in the “Helsinki
Declaration” may assist and guide the participants in this kind of project in their
decision-making.
17.6.2
Verifying Biocompatibility
As already explained, the term biocompatibility refers to the interaction between a
medical device and the tissues of the patient treated with that device. A biocompat-
ibility evaluation is part of the overall quality assurance and safety process for medi-
cal devices. It must be taken into account throughout the development process from
the initial selection of materials even though it must be evaluated by using the end
device, since the body's response depends on many factors.
Some of the factors that usually infl uence the biocompatibility of a device are as
follows:
• The physical-chemical nature of the device materials
• The type of tissue exposed to the device
• The length of contact
•
Device geometry
•
Sterilisation method
•
The patient themselves
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