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The true exposure would be the number of implanted devices. Obviously,
this is difficult to obtain. Implanted devices that are not returned
to the manufacturer after explantation or patients that die with implanted
devices may not be accounted for.
Multiple-use devices: How do we determine how many times a device has
been used by a patient? In addition, you have many patients per device,
especially when you look at devices used for diagnosis or treatment, e.g.
mammography machines, x-ray machines, dialysis.
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