front |1 |2 |3 |4 |5 |6 |7 |8 |9 |10 |11 |12 |13 |14 |15 |16 |17 |18 |19 |20 |21 |22 |23 |24 |25 |26 |27 |28 |review

What is the true denominator? The sales data may only be a crude estimate of a denominator when determining incidence/prevalence of adverse events. How do you measure exposure if some devices are used multiple times on the same patient or numbers of different patients? Is this needed information? Duration of use may be difficult to measure especially in non-implantable devices. How do you capture information about usage or potential problems about a particular device that is an interchangeable component of a device system? For example, dialyzer membranes or filters as parts of a dialysis unit.