Don't get a false sense of security that if an object is FDA approved that
you are protected from liability.  There is a distinct difference in
"MacGivering" some duct tape and aluminum foil together to make a tool and
using it yourself versus making something up like this and then giving it to
the person to use later. The use of the syringe, reversed, cut and  using the
plunger to pull out the nipple is a very clever and helpful idea.  It's use
should be encouraged if the professional believes that it will be helpful.
 These companies will never seek the approval to make and market such an item
because: The FDA approval process would be too long and be too expensive; the
market available is too small to make it pay for them to market it.
There is a long list of medical therapies that are used in ways that are not
yet approved by the FDA.  The best example is Inderal or propranalol for use
in migraine headaches.  This drub was first used for people with blood
pressure and anginal problems until somebody discovered that it helped many
people from having migraine headaches as often.  This use was studied in
reasearch settings the results published and eventually it became approved by
the FDA for this use.  The important thing is not whether something is
*approved* for use but rather if the use is commonplace, accepted by other
peers in the medical community, and wether you can produce previously
published journal citations, case reports, or even letters to the editor
documenting the use of a product or drug in a way that supports your use.  I
forgot now who first reported on lactnet about the use of the syringe but if
this was written up somewhere in any journal you should feel very safe in
using it in your own hands for the benefit of the patient (Can some
lactnetter resubmit if this use was published somewhere?).  It is important
to document in your notes this fact......*this (device, process, drug) was
used in this fashion for the benefit of the patient*  this helps document
that this was used with the intention to help a clinical situation.

The issue of giving the syringe to a mother for home use is a little more
touchy since now you have a non-approved device in the hands of a lay-person
not a professional.  This still should not prevent you from giving one to the
mother if you take care of some documentation items. Document that you
instructed and observed the mother using the syringe in a proper fashion,
have her sign a consent acknowledging that she requests the use of the
syringe for her benefit and she realizes this is a custom made device.  This
should give you some increased measure of protection ( and is really just
good patient management.  Since the syringe is open on both ends,(can't be
used for illicit IV injections, and since it doesnot contact the baby, the
potental for problems is greatly reduced.
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Jon Ahrendsen, MD, FAAFP, LLLI Medical Associate *
215 13th Ave, SW                                                    *
Clarion, Iowa, 50525  USA                                        *
phone 515-532-2836                                                 *
Fax 515-532-2523                                                    *
Email [log in to unmask]                                           *
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