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IAHCSMM
Speaks at Senate Committee Hearing on Reuse
For
immediate distribution - July 5, 2000
CHICAGO – The
International Association of Healthcare Central Service Materiel Management
had yet another opportunity to voice its opinion on the reprocessing
and reuse of single-use medical devices—this time on Capital Hill
before the Senate Committee on Health, Education, Labor and Pensions.
Anne Cofiell,
who represents the Association on reuse-related issues, was one of
only seven invited to give a written statement and speak before the
committee on June 27. For five minutes, she had the floor—and
the attention -- of Senators James Jeffords, Edward Kennedy and Christopher
Dodd.
“This
was such a big opportunity for IAHCSMM, especially considering there
were only seven witnesses invited to give a statement,” she said. “Any
time we get an opportunity to get our position out there is great
for the Association. It was quite an honor to be included.”
The six other
speakers covered virtually every angle of the reprocessing and reuse
debate, ranging from government officials and physicians to corporate
representatives from reprocessing and disposable device manufacturing
companies.
GAO
report cited
Although IAHCSMM’s statement to the Senate Committee did not differ significantly
from previous meetings on reuse, Cofiell had the opportunity to cite some additional
documents to help support the Association’s position.
The June
20 report on single-use medical devices from the U.S. General Accounting
Office was one of them. The report, entitled “Single-Use Medical
Devices: Little Available Evidence of Harm from Reuse, but Oversight
Warranted,” oversimplified the steps needed to perform the practice
properly, according to Cofiell.
More specifically,
she said the statement in the report that read “reprocessing involves
cleaning and sterilizing a device and verifying that it functions properly” further
highlights the lack of understanding on how complicated reprocessing
really is.
“It
sounds as simple as one, two, three, and it’s done. We would love
to have it that way, and if it were, we would not have the situation
we have right now,” she told the committee.
She continued
by outlining the intricacies involved in the process, including the
very first step—cleaning.
“There
are [more than] 6,000 hospitals in the United States. If only 20%, and
we know the number is much higher, are reprocessing single-use devices,
then 1,200 hospitals are out there doing their own thing. The materials
used in these devices are different. They need to be tested,” she
noted. “Regulation should bring out the quality system that is
needed to ensure a quality product.”
But even
the Association—which fully supports additional FDA oversight—understands
that implementing and enforcing tighter regulations won’t be easy.
Still, IAHCSMM
stands firmly in its belief that additional oversight is key to improving
the quality of reprocessing practices.
“We
do not know if the implementation of the FDA regulation will go smoothly.
No doubt, it is going to be difficult,” Cofiell said. “[But]
we feel the time is now. It is the right thing to do and IAHCSMM
is looking forward to it happening.”
About
IAHCSMM
The International Association of Healthcare Central Service Materiel Management
is a premier association for professionals in healthcare central service/materiel
management. IAHCSMM provides structured educational opportunities, professional
development and a forum for information exchange to more than 8,000 members.
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