Biomedical Engineering Reference
In-Depth Information
management. The episodes illustrate this continuous
improvement through the logic of investigation and
remediation.
To return to the several episodes mentioned before,
The
Jungle
can represent the issue of problem identifi cation and
triage. What is the evidence for a problem, and how important
is it? What is the risk, what is the severity associated with the
problem? When Sinclair's book was published, there was
substantial dispute in the press about the accuracy of his
account.
25
President Roosevelt sent Charles P. Neill and
James Bronson Reynolds to Chicago to ascertain and report
the truth of the topic's claims. Roosevelt delayed releasing
their report, which basically substantiated Sinclair's claims.
As Sinclair expressed it about the meatpacking industry,
“The packers worked on the President's sympathy [. . .] in
order to keep the true conditions from the public.” Sinclair
went on to insist that the Neill-Reynolds report be made
public.
26
The report was fi nally made public and contributed
to the signing of the Pure Food and Drugs Act in June 1906.
27
The Elixir Sulfanilamide poisoning episode can represent
the issue of investigation and RCA. What factors might have
contributed to a problem, and which is most likely the
fundamental, or root cause? A few days after 11 October
1937, when the fi rst cases of poisoning were reported from
Tulsa, OK, the American Medical Association (AMA) had
begun to investigate and suggested that it was the solvent,
DEG, that was the cause.
28
S.E. Massengill, the company
that had manufactured and distributed the Elixir, continued
to argue that the solvent was not the cause, that the poisoning
was the result of interaction of the Elixir with other drugs.
29
By carefully identifying the potential factors - the active
ingredient, the solvent, the other excipients, and other factors
(“other drugs”), then weighing their actual effects, the
chemists were able to identify the root cause, the toxicity of
