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About 'Expected Device
Lifetime' of a Medical Device
As per the known definition, “device
lifetime is a period during which the device is intended to
perform its function per the risk and benefit profile of a medical
device, and maintain its benefits without adding an incremental
risk to the patient.” The expected medical device lifetime may
fall within the intended use as specified in the considerations as
under :
Consideration 1: Devices that are intended to be used only for a
specific period (i.e. catheters to deploy a stent) defined based
on their use duration.
Consideration 2: Devices that are intended to fully replace a body
function (i.e. a joint in the human body) , ideal for the rest of
the patient’s lifetime. It is acknowledged that state-of-the-art
devices for the intended use may have a finite service life and
may need to be removed/replaced based on physician follow-up and
evaluation.
Consideration 3: Devices that are intended to function in the body
for a limited time (i.e. absorbable implants) defined by their
therapeutic lifetime, their function plus the remaining time to
absorption dwelling in the human body.
Consideration 4: Devices that have a temporary function in the
human body (i.e. implants for bone healing or non-absorbable
sutures), is defined by their function in the human body up until
the point of removal.
The lifetime of a medical device may or may not be based on a
single element but is a combination of multiple characteristics to
carefully identify the safety duration. Elements include patient
outcome, product design, clinical utility, observed product
performance, benefits and risks, including positive/negative
impact on clinical outcome, the patient’s quality of life, and
outcomes related to
diagnosis, and positive/negative implications from diagnostic
devices on clinical outcomes.
There are external factors that could contribute such as patient
anatomy, disease progression. Depending upon the breadth of
external factors, there may not be a specific duration instead
based on the bench testing; therefore medical device manufacturers
should consider real-life factors and provide necessary
instructions to establish the safe performance.
(Ref :
https://www.mddionline.com/regulatory-quality/expected-medicaldevice-lifetime-glance
)
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