
What does
Nancy Leveson’s
classic
analysis of the
Therac-25 recommend?
(“An Investigation of the Therac-25 Accidents,”
by Nancy Leveson, University of Washington and
Clark S. Turner, University of California, Irvine,
IEEE Computer, Vol. 26, No. 7, July 1993, pp. 18-41.)
“Inadequate Investigation or Followup on Accident Reports.
Every company building safety-critical systems should have audit trails
and analysis procedures that are applied whenever any hint of a problem
is found that might lead to an accident.” p. 47
“Government Oversight and Standards.
Once the FDA got involved in the Therac-25, their response was impressive,
especially considering how little experience they had with similar problems
in computer-controlled medical devices. Since the Therac-25 events, the FDA
has moved to improve the reporting system and to augment their procedures
and guidelines to include software. The input and pressure from the user
group was also important in getting the machine fixed and provides an
important lesson to users in other industries.” pp. 48-49
The lesson being that you have to have built-in audit, reporting,
transparency, and user visibility for reputation.
Which is exactly what Dennis Quaid is asking for.
Remember, most of
those 99,000 deaths a year from medical errors
aren’t due to control of complicated therapy equipment:
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