cranial helmets (summery of replies) #2

cranial helmets (summery of replies) #2

original post:

I was wondering what the current status is in my ability to fit pediatric
cranial helmets. The last I heard, the FDA has regulated the procedure and
limited its production/provision to just one company. Has everyone else in
the US stopped providing this service? Does this mean that I, as a licensed
and certified practitioner cannot provide this orthotic device in my local
community? I would love to hear feedback on how it has affected other
practitioner practices? Does anyone else provide an alternative device? Are
there any legal ways to work around the FDA regulation?

Thanks in advance.

Wade Bader, CPO
Tampa, FL
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Summery #2:

I had a call to make one today and called the manufacturers of DOCS band,
they will not sell to anyone and are opening satellites all over the states
and are the only company that is FDA approved (talk about a monopoly).
Please let me know if you find any other info.
I thought as orthotists, we were able to make custom devices without FDA
approval, but that seems to have changed, Maybe soon we will no longer be
able to make custom knee orthoses?
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I too would like hear what others have to say on this matter.
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Wade,
    We (an eighty bed Rehab hospital with in house o&p) did suspend, for a
time, taking in any new helmet kids. But we are not about to allow this
stupid situation to go on unchallenged!
We are: 1) making application to FDA to provide these orthoses
         2) working on the national level (through the Cranial Helmet Task
Force) to get the ruling reversed
that moved these helmets from class 1 items to class 2 type items
         3)we have contracted with a nearby manufacturer, who already
has FDA clearence, to produce them for us until we are successful in
changing this silliness.
    So we are working at changing this restrictive and repulsive situation.
It is true that any one dispensing helmets made to address plagiocephaly is,
at this time, in violation of a federal law. However, it has been that way
for ten years and if you have 'dispensed' in the past you have been in
violation for the the past ten years, too.
    I have heard of a place (in Oklahoma) that closed down their helmet
practices all together, very sad. I also know of at least one major facility
(state university) that said that they would rather take their chances on
the static from the feds than to have a patient's family sue them for
refusing services. Not only a lesser of two evils - but they don¹t like the
idea of turning away kids they could, should and would help.
    The one facility that you are referring to is in the southwest and
they do provide helmets (for around $3,000.00), the practitioner there is
not a CO, and she requires that the patient travel to her office, and that
the helmets (she calls them bands) be manufactured by her lab.
    Her lab was the one that petitioned the FDA to get the ruling changed in
the first place. The reasons are obvious - she is now sole source, at least
sole legal source. So, the rest of us have a few choices:
      1) Business as usual and join the crap shoot that the feds won't bust
us
      2) Be brought to our knees by one little old lady running a monopoly .
. . or
      3) Use every legal,active,talent and resource we have to get this
changed.
  If helmets are a good part of your business, or if you hate the idea that
you have to turn away infants that you know you could easily help, or if you
hate being dictated to by the noncertified as to how to run your practice,
or if its all of the above - please take a second and contact:
         Thomas A. Gorski,CAE
         Executive Director - AAOP
         1650 King Street, Suite 500
         Alexandria, VA 22314
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Dear Wade:

Last week I responded to a posting regarding the cranial molding helmet
situation. In that post I failed to mention a recent and very positive
development in regard to this issue. OrthoAmerica recently received approval
from the FDA to manufacture cranial molding helmets. They are the first
manufacturer from within our field to complete the 510K process. They should
be congratulated for their success in dealing with the complexities of the
FDA approval process. As a result you do have another option at this time.
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I was recently asked to provide a protective soft shell craniel helmet (ie
Danmar prefab) to a child for protective reasons only. Not a custom made
helmet intended to dirrect growth. Is this an item that requires a special
license to provide like the custom ones?? Confussed with all this helmet
stuff!!
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Dear Wade,
I herd a practioner was visited by the FDA and was injuncted against
providing the devices he may even have received a fine(?) The only other
company with FDA approval is Orthomerica. I would go with them until
something better comes along. I researched the FDA approval process,
contacted 5 seperate lawyers the net story is it would cost approx. 100K
that's right $100,000 to see this through. Then the FDA imposes good
manfacturing practices and limit you to the helmet design you submitted to
them with your application. Good luck