Dear Continence Practitioners,
On the
29th August, I wrote to you advising that SWEP was unable to fund
open tip / supra-plus catheters for urethral use if this was not part of the
items' TGA approval or manufacturer guidelines.
Some
of you have raised concerns about how this might impact your clients who have
had a lot of success with these catheters being used urethrally.
Thanks
to the advocacy of one of your fellow practitioners, we have been able to
identify a product that is suitable for urethral use. This is the
SupraCath from Endotherapeutics. There may be also be others so if you have
identified them please let us know.
However, please be aware that there are other products on
the market that specifically state not for urethral use - SWEP is unable
to fund these if the intended use is urethral.
SWEP
is bound by the DHHS guidelines which states we can only fund items that
conform to Australian standards or TGA.
The
other reason is to protect you - the Australian Regulatory Guidelines for
Medical Devices references that whilst the TGA does not regulate nursing,
it does advise a healthcare professional may be professionally liable for any
harm visited on the patient if the information they provide to consumers
contradicts the information provided in the manufacturer's instructions for
use.
If you have any concerns regarding this
please contact swepcaho@bhs.org.au
Kind regards
