Cato Institute
Policy Analysis
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Page 36
doctors to make better decisions.
Doctors and medical practitioners will be reluctant to
rely on devices that lack third-party listing.  The only
consumers who would use such devices would be those willing
to bear a great deal of risk.  Riskier devices, such as
implantables, require a doctor for their installation, and
complicated diagnostic and treatment devices that require
specialized knowledge for their operation are prohibitively
expensive to operate outside of a clinical setting.  It is
difficult even to conceive of a patient being successful in
forcing his doctor to implant an unsafe pacemaker or buying
a radiation therapy machine for his own unsupervised use.
As a final preventative, there is that store of knowledge
the FDA has habitually denigrated or denied: the consumer's
common sense.
"Fly-by-night" manufacturers, by definition, are not
concerned about the long-run effects of reputation on prof-
its.  The market cannot prevent such producers from taking
devices to market, but their devices will not be certified.
Shoddy products will not get the mark, and will therefore
sell for less.  Thus, the market will be protecting itself
against fly-by-nighters by supplying two interrelated types
of information: a specific certifier's mark, or lack there-
of, and the price.  Under the current regulatory scheme, one
government-mandated amount of information is supposed to
cover all contingencies, and there is no information about
effective devices that involve more risk than the FDA has
decided to allow.  There is much less information under the
present regime than consumers or their doctors would have in
the free market.
Anything man-made can break down and cause disastrous
consequences.  Likewise, no quality certification scheme can
work so efficiently that it never approves an unsafe device.
Some FDA mistakes have been mentioned, and UL makes an occa-
sional one as well.
A New York Times reporter summarized the result of one
UL mistake:
Two decades ago, hundreds of homes nationwide were
damaged and dozens killed or injured in fires
caused by aluminum wiring, a product that UL had
listed.  Numerous other fires were reported in
commercial establishments.  Investigations showed
that aluminum connections at outlets and switches
could deteriorate over time and overheat.  Eventu-
ally, the wiring was no longer installed.64