FDA Questions

Steve Firth steve at firthcom.demon.co.uk
Fri Jul 14 10:08:37 EST 1995


In article <950710143833_111729917 at aol.com>,
DjayR at aol.com wrote:

>IF it is FDA approved and the test
>fails who is responsible?  Is FDA approval required for all diagnostics tests
>on humans?

Responsibility is a line drawn in the sand by the legal profession.
Determining responsibility after a misdiagnosis is often thrashed out by
the lawyers representing the physician(s), diagnostics manufacturer and
patient. I have been involved in preparing evidence for a diagnostics
manufacturer defending themselves against a claim made by a physician. In
this case, the diagnostics manufacturer was found to have no responsibility
for the misdiagnosis as the physician had (a) misinterpreted the assay
results (b) ignored the evidence obtained from a physical examination of
the patient.

It is my experience that every case is unique and the manufacturer is in a
better position than the physician since the manufacturers records must be
complete and traceable to get FDA approval and the physicians records are
frequently a disorganised muddle. Hence a judge is inclined to think badly
of the physician from the moment he sees the evidence.

The FDA cannot be held responsible for any malpractise, they do not certify
that the kit is a reliable diagnostic device, simply that the manufacturer
has shown "due dilligence" in design and manufacture of the kit. Also the
FDA and manufacturer do not have control over how a kit is used, and abuse
of diagnostic materials by laboratories is still relatively common, for
example some labs dilute all reagents 50:50 before use to reduce test
costs. This ruins the analytical performance of the kit.


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