Re-usable Disposable Medical Device Dispute
Belgium
Labeling medical devices as single-use devices has not stopped
many end-users from re-using the device time and time again. A
new term has been coined: 'Re-usable disposable'.
The original manufacturer is protected by the Medical Device
Directive which indicates that the party re-using a single use
device automatically becomes the 'new' manufacturer and has
to document (read CE Mark) once again that the requirements of
the Medical Device Directive have been met.
Belgium the last EU State to implement the Medical Device
Directive, has submitted a proposal requiring the original
manufacturers to provide scientific and technical proof to
support the single-use labeling. In their quest to reduce
healthcare costs the Belgian Government encourages the re-use
of certain products.
Seven other EU States and EUCOMED (European Confederation of
Medical Devices Association) have submitted objections to the
EU Committee, which delays the Belgian government from
implementing the re-use legislation for a three month period
ending December 2, 1999.
The US Health Industry Manufacturers Association and the Medical
Device Manufacturers Association have asked the US Department of
Commerce to raise formal objections with the European Commission
and the World Trade Organization.
Germany
The Federal Association of the Medical device Industry in Germany
(BVMED) is continuing its campaign against the reprocessing and
multiple use of medical devices intended for single use. As early
as Spring 99 BVMED started an information and education campaign
against the re-use of disposable devices. They called attention to
the medical and legal consequences, the motto of their campaign
is: 'Patient's safety first!'.
United States
The Health Care Financing Administration (HCFA) has announced that
it will no longer cover the use of reprocessed single-use devices
under Medicare, the US federal healthplan for the elderly.
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