Conventional wisdom says that regulatory authorities approve assays that have the highest quality, meaning that the errors are small enough that no or little harm will arise because a clinician makes a wrong medical decision based on test error.
It is also true, although not talked about, that in most countries healthcare is rationed – the cost of treating everyone with every possible treatment is too high.
So here’s a hypothetical example using glucose meters.
First, we start out with the status quo for existing glucose meter quality and assume that on average, across all tests there will be some harm due to glucose meter error. The percentage of tests that harm people is unknown as is the range of harm but assume that these can be ascertained and do occur.
As for the hypothetical part…
There are 2 new glucose meters seeking approval
Meter A costs 100 times as much as current meters and is guaranteed to have zero error, as it is a breakthrough technology. Its use will reduce patient harm due to test error to zero.
Meter B costs 100 times less than current meters but isn’t quite as accurate or reliable. Patient harm will increase with the use of meter B.
If meter A is approved, because of healthcare rationing, costs will have to be transferred from other parts of healthcare to pay for meter A.
If meter B is approved, costs can be transferred from glucose meter testing to other parts of healthcare.
The point is not to try to answer whether meter A or meter B should be approved, but to illustrate that the cost issues associated with healthcare policy always exist but are rarely discussed.