Cranial Helmet (summery of replies) #1

Cranial Helmet (summery of replies) #1

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
=============================================================
Replies (in order they came in):

Well i can tell you in Orlando Hanger is doing them I would love to find out
it is not legal
------------------------------------------------------------------------------
------------------------------------------
I understand that Orthomerica has just received FDA approval to fab the
helmets, which is somewhat near you. I'm sure there are more. If I understand
correctly, here is no problem w/ O & P professionals casing and fitting these
helmets, just the fabrication needs approval.
------------------------------------------------------------------------------
--------------------------------------------
Dear Wade:
 My name is Tom DiBello, I'm a CO in Houston Texas and also Pres. Elect of
the Academy. This spring I organized a task force to look into this problem.
It is one that has angered and frustrated members across the country. Several
mons. ago we circulated a call for information to all certifies (you may have
received this by fax, or e-mail) asking that those practitioners that are
involved in providing these devices have their referral sources submit
letters to the FDA in support of our position (check the Academy web site for
complete details).
Additionally, AOPA has engaged the services of an attorney that is preparing
a case to present to the FDA.
To answer your questions in order:
   1. The FDA reg. specifies that the DOC Band and any cranial orthosis
used in the treatment of non-synostotic positional plagiocephally are Class
II medical devices the manufacture of which require FDA approval. In one fell
swoop the FDA has thrown us in with all other types of medical device
manufacturers. Compliance requires the submission and subsequent FDA
acceptance of a 510K application.
    The Academy Board feels that this requirement establishes an undesirable
precedence that we must do our utmost to reverse. Experts that we have spoken
to feel that the FDA simply failed to do their homework and that these types
of classifications typically are not applied to custom made devices or
embossed upon the service provider.
   2. Continuing to provide these orthosis is a personal decision. Many
practitioners have stopped, some continue. Please note that we do know that
two practitioners have been cited by the FDA for providing these without FDA
approval.
   3. Yes, licensure and certification are not relevant to the FDA. They are
only concerned in the manufacturing process.
   4. I know of no alternative device that could get around the any cranial
orthosis designation.
   5. You can submit a 510K. If you are hospital affiliated you may be able
to get an exemption from the FDA by working through your hospitals IRB and
getting a case by case exemption. This is being worked on but has not yet
been successfully accomplished.
    In short we are working on this from several different fronts but it has
proven to be slow going. Remember we are working with a very large
bureaucracy. If you like you could call you local Senator or Congressman and
explain the inequity in this situation. If they need any additional
information just have them give me a call.
    If you have any further thoughts or questions don't hesitate to e-mail or
call.

Best Regards: Tom DiBello CO LO
------------------------------------------------------------------------------
------------------------------------------
As Marketing Director for Orthomerica, I am responding directly to you
regarding your post on Cranial Helmets. Cranial orthoses (protective &
remolding) are Class II devices which require strict regulatory controls by
the FDA. In order to manufacture Class II devices, a supplier must submit a
510(k) application and receive official approval by the FDA. Companies that
fabricate these orthoses without a 510(k) approval may be found in violation
of federal law. Historically, the FDA did not realize that O&P professionals
were providing cranial orthoses. As a result, the FDA stepped up their
compliance efforts as the original 510(k) approved manufacturer advised them
of O&P companies that were in possible violation.

The O&P trade associations and practitioners have been diligent in their
efforts to petition the FDA and Congress to reclassify cranial protective
helmets as Class I devices. While there are some companies that have
submitted 510(k) applications for cranial orthoses, Orthomerica is the only
other company that I am aware of that has received its 510(k) approval to
manufacture a cranial remolding orthosis on a central fab basis to O&P
companies. If you would like more information, please e-mail me for more
information or call Orthomerica at 800.446.6770.
------------------------------------------------------------------------------