Just thinking….
carey jinright
Description
Collection
Title:
Just thinking….
Creator:
carey jinright
Date:
4/15/2022
Text:
This excerpt come from the FDA website (don’t ask, why I was reading their website)
What types of devices are potential candidates for OTC status, including a switch from prescription (Rx) to OTC?
A: Like OTC drugs, OTC medical devices typically have the following characteristics:
They can be used outside of healthcare settings.
They are adequately labeled such that:
The device has low potential for reasonably foreseeable misuse.
The safety margin is such that the benefits of having an available OTC device outweigh the risks.
This just started me thinking. One of the biggest problems that we face in the Orthotics community is that of defining OTS, Custom Fit, and Custom Fabricated Devices. There has been a great deal of vagueness associated these definitions. I personally believe that this “vagueness” has been intentional. My question has always been, not the fitting of the product, but the selection of the appropriate clinically needed product. This is where the Orthotist is valuable and earns their Certification! So, I just put the FDA’s definition forward for discussion. They lay out the “switch from prescription (RX) to OTC” This is where I feel CMS is heading (just my opinion from 25 years of experience). So, do our products fall into the two listed categories or do government agencies just get to float their own independent definitions of the same terms:
The consumer (lay user) can self-diagnose their condition, self-select that the device is appropriate, self-treat, and self-manage the condition that the device is intended to treat or diagnose.
The consumer (lay user) is able to understand how to use the device correctly (based on the labeling, including the instructions) without any help from a healthcare provider.
Just as a funny side note—How many times have you turned a brace right side up after the patient came into your office with their “mail ordered” spinal brace? How many times have you had to see your OA knee patient three or four times over the fitting of their “prefabricated” OTS knee brace? It is what we do…..Happy Friday
I Am Second,
Carey Jinright, LO, MSM
What types of devices are potential candidates for OTC status, including a switch from prescription (Rx) to OTC?
A: Like OTC drugs, OTC medical devices typically have the following characteristics:
They can be used outside of healthcare settings.
They are adequately labeled such that:
The device has low potential for reasonably foreseeable misuse.
The safety margin is such that the benefits of having an available OTC device outweigh the risks.
This just started me thinking. One of the biggest problems that we face in the Orthotics community is that of defining OTS, Custom Fit, and Custom Fabricated Devices. There has been a great deal of vagueness associated these definitions. I personally believe that this “vagueness” has been intentional. My question has always been, not the fitting of the product, but the selection of the appropriate clinically needed product. This is where the Orthotist is valuable and earns their Certification! So, I just put the FDA’s definition forward for discussion. They lay out the “switch from prescription (RX) to OTC” This is where I feel CMS is heading (just my opinion from 25 years of experience). So, do our products fall into the two listed categories or do government agencies just get to float their own independent definitions of the same terms:
The consumer (lay user) can self-diagnose their condition, self-select that the device is appropriate, self-treat, and self-manage the condition that the device is intended to treat or diagnose.
The consumer (lay user) is able to understand how to use the device correctly (based on the labeling, including the instructions) without any help from a healthcare provider.
Just as a funny side note—How many times have you turned a brace right side up after the patient came into your office with their “mail ordered” spinal brace? How many times have you had to see your OA knee patient three or four times over the fitting of their “prefabricated” OTS knee brace? It is what we do…..Happy Friday
I Am Second,
Carey Jinright, LO, MSM
Citation
carey jinright, “Just thinking….,” Digital Resource Foundation for Orthotics and Prosthetics, accessed May 19, 2024, https://library.drfop.org/items/show/255868.
