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Cardiovascular devices include a wide array of products that contact the vasculature or the heart in one way or another. The device could be as simple as an intravenous catheter for delivering fluids to the patient, or as complex as arterial or cardiac implants. The device may have blood and soft tissue exposures, such as a pacemaker with a heart/blood contact lead, but also may contain an implanted battery source that does not contact blood.
Depending upon the exact nature of the device, a range of biological
effects may have to be evaluated (See ISO 10993). For example,
vascular devices which will have less than 24 hours exposure to the
blood, vasculature or the heart would require less scrutiny than a
permanently implanted stent or heart valve. In addition to the usual
questions one would ask about testing requirements, one needs to
thoroughly address blood compatibility. The effect that the device
might have on formed elements (various blood cells), clotting factors
and thrombogenicity may need to be known. NAMSA scientists can
best determine the extent and type of blood compatibility testing to
perform once the nature of the device is known. Not all devices, no
matter how similar, require the same testing program. Each device is
examined anew and the testing program proposed to meet the unique
requirements of each device.
NAMSA Technical Specialists and Scientists are adept at developing
pre-clinical testing programs for such products. Veterinary surgeons
on staff are experienced at implanting and evaluating the biocompatibility
and functionality of such devices.
Standards and Regulation
First consideration should be given to vertical standards (an FDA
guideline or ISO standard in use for a specific device). In the absence
of such guidance, ISO 10993 should be consulted to determine potential
areas of concern for these devices.
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