FDA and Crainial Molding Helmets,AFO'S,Prosthetics,Ect...
Jan Saunders
Description
Collection
Title:
FDA and Crainial Molding Helmets,AFO'S,Prosthetics,Ect...
Creator:
Jan Saunders
Text:
Does anyone have any information what the National Offices are actively doing
with the FDA in regard to not allowing us as Certified & Licensed
Practitioners to pull plastic and a foam liner on a mold. We are allowed to
cast the patient, modify the mold and then send it to Orthoamerica for a
technician to pull the plastic. Not to sound condescending, but if a tech go
to work for Orthoamerica and works there for one week he can learn to pull
the plastic on my helmet! Don't get me wrong I love Orthoamerica, I think
they do great work of high quality, and I 'am glad they are able to
manufacture the helmets or at least pull the plastic.
Here is the big question.......? where does it stop. Prosthetics fit a lot
more intimately then helmets, and can cause a lot more severe damage, the
same with intimate fitting braces. If we don't stop this and quickly get the
FDA to understand, and change their position on this, it won't be long before
we are not allowed to fabricate any of the appliances we currently make. I
want to know what our National Offices and Assn.'s are doing about this.
with the FDA in regard to not allowing us as Certified & Licensed
Practitioners to pull plastic and a foam liner on a mold. We are allowed to
cast the patient, modify the mold and then send it to Orthoamerica for a
technician to pull the plastic. Not to sound condescending, but if a tech go
to work for Orthoamerica and works there for one week he can learn to pull
the plastic on my helmet! Don't get me wrong I love Orthoamerica, I think
they do great work of high quality, and I 'am glad they are able to
manufacture the helmets or at least pull the plastic.
Here is the big question.......? where does it stop. Prosthetics fit a lot
more intimately then helmets, and can cause a lot more severe damage, the
same with intimate fitting braces. If we don't stop this and quickly get the
FDA to understand, and change their position on this, it won't be long before
we are not allowed to fabricate any of the appliances we currently make. I
want to know what our National Offices and Assn.'s are doing about this.
Citation
Jan Saunders, “FDA and Crainial Molding Helmets,AFO'S,Prosthetics,Ect...,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 6, 2024, https://library.drfop.org/items/show/216519.
