Re: Cranial Helmets

Re: Cranial Helmets

In a message dated 7/20/2000 8:42:40 AM Central Daylight Time,
<Email Address Redacted> writes:

<< 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
  >>
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