It takes a certain amount of
clout to push back the FDA. Olympus Corporation has the necessary clout.
To those who do not know
Olympus Corporation, they have been providing minimally invasive therapeutic
and diagnostic technologies globally since 1919. Since then, Olympus has gained
over approximately 70% of the $2.5
billion gastro-intestinal endoscope market.
Olympus has been of recent interest
to more than just endoscopy patients due to an outbreak of a “super-bug” at the
Ronald Reagan UCLA Medical Center. Healthmap.org
wrote an article explaining the details of the infectious parasite: “Carbapenem-resistant
Enterobacteriaceae bacteria are part of a family of bacteria commonly found in
the colon. Over time, some of these gut-dwelling pathogens have developed
high-resistance against many widely used antibiotics.”
The FDA has been aware of
these colon bacteria for years and drafted up new guidelines in 2011 that would
“set non-binding recommendations for manufacturers of many types of medical
devices, including the complex, hard-to-clean instruments called duodenoscopes
that recently harbored deadly drug-resistant bacteria at UCLA Medical Center
and other hospitals. The day after the UCLA outbreak came to light, the FDA
warned that the instruments involved may be impossible to fully sanitize.”
It would seem that the federal
government’s agenda is to hold Olympus solely accountable for the sanitation of
their devices at point-of-use. This can be compared to the infamous 1994 case, Liebeck
v. McDonald’s Restaurants, aka the hot coffee lawsuit, where the law favored the
consumer and awarded $2.86 million to the plaintiff. A quick reminder that it was
the consumer who decided to put the 180-190 degree coffee in her lap and then proceeds
to drive her vehicle. The government is not doing its due diligence nor is it
being logical in its demeanor. Why is it afraid to admit that the user, the
person, the consumer has partial responsibility for the appropriate use of a product?
Is the government thinking that the average Joe cannot handle average
responsibilities? There should be shared responsibility when it comes to preventing
defects and infections.
It seems what the government
is trying to do is use Olympus as a scapegoat.
But what Olympus Corporation is trying to do is due diligence and
logical thinking. The company makes no claims that its devices require no
pre-procedure sanitation, so, how can it be held solely responsible for the
lack of purification at point-of-use? Why are the hospitals or cleaning
companies not involved in this matter?
Olympus
Corporation has already made many efforts to describe the necessary effort
to sanitize its machines. “Olympus’s instructions warn that if the scopes ‘are
not immediately cleaned after each patient procedure, residual organic debris
will begin to dry and solidify,’ making them harder to disinfect. Hospital
staff are supposed to “pre-clean” the devices before they leave the room where
the procedure took place.” This is not an issue of negligence, but an issue of
shared responsibility.
We can take this issue out of
the scope of medical devices and the life sciences field and to supply chains
in general. It is in fact up to the end user (the consumer) to choose whether
or not to use a product, a device, or a service based off ratings and reviews
of its necessary requirements. The beauty of a free market, of capitalism, is
the choice to let a company go under because it is not at the level which the
consumer desires. The government has divisions to oversee fair trade and to
seek out corruption and public deception. The government looks out for the
safety of its citizens but should not control the fate of companies working in
its domain.
In the end it is the last stop
of the supply chain, the company that the consumer sees and purchases from,
that will always get the largest blame when defects and incidents arise. It is
up to that company to control the quality of its materials, but when it comes
to the consumer using, cleaning, and maintaining the product purchased, we
cannot alleviate responsibility and blame from the consumer as well.
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