Re: Mr. Gorski Replys to Helmets-Please Read

Re: Mr. Gorski Replys to Helmets-Please Read

Thomas Gorski

5/9/2001

Mr. Saunders,

I’m sorry for any misunderstanding you may have had about this issue and the
Academy’s involvement. Let me attempt to bring you up to date:

The bottom line is you cannot fabricate plagiocephaly cranial helmets
without authorization by the FDA. This regulation was effective August 31,
1998.

Here is the chronology of what occurred.

The FDA regulation focused on the need for FDA approval of plagiocephaly
helmets and was brought to our attention by a number of clinicians – Rob
Kirstenberg among them. The implication of this classification is that only
Class II devices approved by the FDA may be used to treat deformational
plagiocephaly. Dynamic Orthotic Cranioplasty Band (DOCTM Band) manufactured
by Cranial Technologies, Inc., and a small handful of companies and
university-based facilities that completed a 510(k) application for the
approval of their manufacturing process are the only ones approved by the
FDA.
Several newsletter articles were written to inform Academy members of its
ramifications and a task force was created to develop strategy. A special
information session was held at the San Diego Annual Meeting in March 2000,
which attracted about 50 practitioners. The consensus of those attending
that meeting was practitioners should not be treated as manufacturers in the
same light as other medical device manufacturers, and that the FDA exemption
on O&P appliances as Class I devices should also include cranial helmets.

Letters were collected from dozens of practitioners, doctors, and others
from all over the country describing the impact of the FDA ban. AOPA hired
a special attorney and questioned the FDA regarding whether the regulation
should apply to all cranial helmets, and their letter was answered seven
months later indicating that protective helmets are not included in the ban.


A Citizens Petition was filed in March to classify protective helmets as
Class I devices and exempt them from 510(k) requirements, and as approved.
(Responses to Citizens Petitions are part of a formal process and are
legally binding.) A formal request for the shaping of plagiocephaly helmets
was submitted and later denied.

From the Academy’s perspective the issue is not dead. That is one reason
why we wish to form a Cranial Helmet Society and the Board is studying what
avenues remain to change the FDA’s opinion.

If I can be of further assistance to you, please don’t hesitate to call.

Tom Gorski, CAE
Executive Director
American Academy of Orthotists and Prosthetists


-----Original Message-----
From: Jan Saunders
To: <Email Address Redacted>
Sent: 5/9/01 11:29 AM
Subject: [OANDP-L] Mr. Gorski Replys to Helmets-Please Read

Mr Gorski,
You have obviously missed the point! I'm happy to hear Rob Kistenberg
C.P. is
trying to form a Cranial Helmet Society. Forget the grass roots effort
from a
small Cranial Helmet Society get the National Office, of which you are
the
Executive Director off it's butt and do something before it is to late,
and
we as Practitioners are no longer allowed by the FDA to fabricate the
appliances we cast and fit. I feel the first thing your office needs to
do is
educate the FDA we are not suppliers/manfacturers, and that our level of
education should allow us to continue to do our own manufacturing.
I feel it is the responsibility of the organizations we pay substantial
dues
to, step ahead and get the job done! It's been too long.
Jan Saunders