From: Ellen Smith [esmith@morehead.org]
Sent: Thursday, August 29, 2002 9:15 AM
To: fdadockets@oc.fda.gov
Subject: Reprocessing of open, unused single use devices

While we do not reprocess single use devices of any kind in our
hospital, I feel compelled to comment on this issue.  It is very
beneficial for hospital suppliers to sell single-use devices---they can
(and do) charge a whole lot of money for them, and you have to throw
them away after they are used.  I'm sure that they have a very powerful
lobby in Washington.  They are unwilling to share reprocessing
information because they don't want you to reprocess their
product....they want to make all the money they can.  Some items are
sold as reuseable and as single-use, when it is the exact same product.
They are in it for the money, not in it to protect patients from harm.
Ergo, I feel that comments from industry are worthless in determining
any reprocessing issues.
Hospitals, on the other hand, have a vital interest in patient outcomes,
as does the federal government.  However, restraints and rules imposed
by the government on hospitals have made it more expensive to deliver
quality care at a time when reimbursement for care is falling.  This is
just another instance.
If manufacturers would provide the information needed to safely
reprocess their products, hospitals could save a lot of money, but
industry is not going to do that.  Instead, they'll have the FDA come in
and mandate expensive remedies for those who want to reprocess a
single-use device, even one that has never touched a patient, but might
have a tear in the wrapper.  This is a huge deterrant to health-care
institutions, but a real boon to the makers of medical supplies.
I'm sure that after the suppliers get their way with this measure, they
will go after the companies that reprocess devices and sell them back to
hospitals at a discount.  In the meantime, the nursing shortage grows
because hospitals can't afford to pay them a decent salary because they
have to spend so much on supplies.  Patient care suffers because there
aren't enough nurses to care for the sick, so regulatory agencies step
in and impose more rules.that make it more expensive to deliver care.
It's a never-ending cycle, and the only people who benefit are
maufacturers of medical devices.
My suggestion:  Mandate that companies who make single-use devices share
reprocessing information with hospitals.
Thank you,
Ellen Smith, RN, BS, CNOR
Director of Surgical Services
Morehead Memorial Hospital
Eden NC

PS:  We never reuse a single-use device that has been used on a
patient.  We do send our open but unused products to an FDA approved
reprocessor.