The classification of a medical device

[MikeAurelius]

As we have been chatting back and forth about the pros and cons of on-line retailers, it has been brought up more than once that the public doesn't think of spectacles as medical devices, unlike most of us, who have been trained from the get-go that spectacles are indeed medical devices.

This got me to thinking, and in doing some research, I've discovered that toothbrushes carry the exact same classification (class I) as eyewear does. Now, granted, most consumers could care less about the medical device classification system, but it makes me wonder how we can have an informed discussion with the patient on the topic of medical devices when the comparison is to toothbrushes. Have you ever looked at the number of toothbrushes in the grocery store? My local grocery has a display that is probably about 6 feet long by 4 feet high.

There's been some talk lately at the FDA of combining class I and class II devices into one single category and upping the requirements for GMP as well as tying GMP to relevant standards. IMO, the latter part would be a good step as it would make compliance with Z80/Z87 part of the GMP process, but I don't agree with the classification change. (GMP = Good Manufacturing Practices)

So, lets talk about how we can start to change the view of the patient, or perhaps how we can further educate the patient about his/her pair of Theraputic Medical Devices (21 CFR 886).

http://www.accessdata.fda.gov/script...fm?CFRPart=886

http://www.accessdata.fda.gov/script...1:8.0.1.1.29.6

[Barry Santini]

Classes/smasses

They'll still gonna consider them glasses.

B

[MikeAurelius]

Barry, with all due respect, it is attitudes like yours that started this mess in the first place.

[Barry Santini]

I started this mess? Mike, please elaborate.

B

[Mizikal]

I would love for people to take glasses and contacts more seriously but I don't know that they ever will.At least once a month I have to explain to people their rx is expired for glasses or contacts.The response I usually get is but they are my eyes or I know my prescription has not changed so its okay. The only suggestion I could make is to educate the customer as best we can. However when they think they can buy contacts online without a script (everyone I talk to has a friend that does) or they don't understand how they can buy OTC readers for just $10.00 and our glasses cost so much more. I don't know of anyway to get people to fully understand that glasses and contacts are medical devices. I really wish I did. I see people abuse the only eyes they will ever have everyday and I when I tell them why its a bad I idea they tell me that their eyes or fine and they don't hurt or they are not red or anything Very frustrating.

[Uncle Fester]

Mike- I too am cynical as to us being able to change what's now going on. Wall Street has an interest in keeping the status quo if not even loosening it further and the big money we'd be up against brings to mind the saying "shoveling sand against the tide".

I'd love to be more optimistic but when a few years ago I read how the FTC has the CEO of 1800contacts as a board member adaptation to a changed environment makes more sense.

You'd need a strong liberal Congress appointing strict regulators to have any hope of making changes and that is nowhere in sight.

Just my 2 cents.

[Fezz]

I would love for people to take glasses and contacts more seriously but I don't know that they ever will.At least once a month I have to explain to people their rx is expired for glasses or contacts.The response I usually get is but they are my eyes or I know my prescription has not changed so its okay. The only suggestion I could make is to educate the customer as best we can. However when they think they can buy contacts online without a script (everyone I talk to has a friend that does) or they don't understand how they can buy OTC readers for just $10.00 and our glasses cost so much more. I don't know of anyway to get people to fully understand that glasses and contacts are medical devices. I really wish I did. I see people abuse the only eyes they will ever have everyday and I when I tell them why its a bad I idea they tell me that their eyes or fine and they don't hurt or they are not red or anything Very frustrating.

This post gets "The Fezz Two Thumbs WAY Up and Three Cheers Award" for the day!

:cheers::cheers::cheers:

[MikeAurelius]

I started this mess? Mike, please elaborate.

B

Please re-read what I wrote. I did not say YOU started it, I said that attitudes LIKE YOURS started it.

[optical24/7]

...that the public doesn't think of spectacles as medical devices.....

... Now, granted, most consumers could care less about the medical device classification system....

You answered your own question Mike. Folks don't dislike glasses because they are or aren't medical devices. They dislike them because of the hassle, inconvenience, cost and historic stigma of wearing glasses.

Barry's right. How many people would wear glasses if they didn't need them? (exclude sunglasses).

[MikeAurelius]

They dislike them because of the hassle, inconvenience, cost and historic stigma of wearing glasses.

Not sure about the stigma portion, sure, when I was a kid (mumble mumble years ago), but nowadays, there isn't much of a stigma that I've run across.

But the other part, THAT is exactly what drives people to the on-line operations!

Hassle, inconvenience and cost, all reduced or gone. Shop for glasses in the comfort of your living room, have them inexpensively in a week or less.

So, again, what do we, as medical device manufacturers/sellors, do about it?

[javguy]

Crutches are probably even considered medical devices, yet how many of them are sold at yard sales?

[Barry Santini]

Ok, attitudes like mine. How?

B

[optical24/7]

Not sure about the stigma portion, sure, when I was a kid (mumble mumble years ago), but nowadays, there isn't much of a stigma that I've run across.

But the other part, THAT is exactly what drives people to the on-line operations!

Hassle, inconvenience and cost, all reduced or gone. Shop for glasses in the comfort of your living room, have them inexpensively in a week or less.

So, again, what do we, as medical device manufacturers/sellors, do about it?

I swear Mike, are you really an on-line seller in disguise? :bbg:


I think you mis-interpreted what I was saying;

Stigma; Ask most any CL wearer why they choose contacts, they will answer this better than I.

Hassle; They don't "want" them. Any amount of time/money is more than they wish to "spend" in pursuit of them.

Inconvenience; Glasses fog, slip, break, loose screws, get lost/misplaced (put your own answer here).

Cost; See answer under "Hassle" above. There are 39 buck completes out there in most towns. It wasn't these types of *costs* I was referring to.

Lastly, to answer your question on how to compete against the internet, well, you'll just have to go look at the numerous threads I've responded to. All I'll say about it is that if you think the internet is a threat to your existence...You've got far larger problems..( and Mike, this last sentence wasn't directed at you personally, just towards anybody reading this with that mindset.)

[MikeAurelius]

( and Mike, this last sentence wasn't directed at you personally, just towards anybody reading this with that mindset.)

Well LOL, I *do* sell on-line, however, it is all niche specialty glass products. And no worries about the 'towards me'. I get it!

[Darryl Meister]

I started this mess? Mike, please elaborate

I, personally, blame all of the world's problems on Barry. It just makes things simpler. While watching Congressional news coverage, for instance, I often find myself shouting at the television in aggravation, "Those idiots really Santinied that up!" ;)

Best reards,
Darryl

[Darius1204]

I dont get the point of this topic. What about the classification of medical device do you want to change that will change people's perspective about contact lenses and prescription glasses? None.

[uncut]

I dont get the point of this topic. What about the classification of medical device do you want to change that will change people's perspective about contact lenses and prescription glasses? None.

Good point Darius1204, classification of any device, or changing it, won't change the attitude towards the device, not the stigma and or attitude.

Our industry has come a long way from the 50's when the attitude was strictly clinical , and unfashionable. The unfortunate result is a flood of product/diagnostic/surgical that is not scientifically derived, but profit motivated.

[Barry Santini]

I, personally, blame all of the world's problems on Barry. It just makes things simpler. While watching Congressional news coverage, for instance, I often find myself shouting at the television in aggravation, "Those idiots really Santinied that up!" ;)

Best reards,
Darryl

:bbg::bbg:

[cleyes]

As we have been chatting back and forth about the pros and cons of on-line retailers, it has been brought up more than once that the public doesn't think of spectacles as medical devices, unlike most of us, who have been trained from the get-go that spectacles are indeed medical devices.

This got me to thinking, and in doing some research, I've discovered that toothbrushes carry the exact same classification (class I) as eyewear does. Now, granted, most consumers could care less about the medical device classification system, but it makes me wonder how we can have an informed discussion with the patient on the topic of medical devices when the comparison is to toothbrushes. Have you ever looked at the number of toothbrushes in the grocery store? My local grocery has a display that is probably about 6 feet long by 4 feet high.

There's been some talk lately at the FDA of combining class I and class II devices into one single category and upping the requirements for GMP as well as tying GMP to relevant standards. IMO, the latter part would be a good step as it would make compliance with Z80/Z87 part of the GMP process, but I don't agree with the classification change. (GMP = Good Manufacturing Practices)

So, lets talk about how we can start to change the view of the patient, or perhaps how we can further educate the patient about his/her pair of Theraputic Medical Devices (21 CFR 886).

http://www.accessdata.fda.gov/script...fm?CFRPart=886

http://www.accessdata.fda.gov/script...1:8.0.1.1.29.6

Put two or more people together and see how quickly you can lose the thread of a conversation,degenerate into accusations, throw in an innuendo, and the result is ...what was the subject? Nobody remembers.
My take on the original question is that there wasn't an argument in it. It seems to be at the root of our problems, and it was inviting opinions as to how we solve this huge dilemma. It is a question of many answers, but at the end it will have not solved the problem. We each will only be able to have a few converts . We are in the unfortunate position of trying to sell a device that is universally resented, inconvenient, expensive, and until recently ugly as well. So how do we educate those are not our faithful customers? We all need more ammunition, more "talking points" for our patients to see the light. We humans are very good at denying major health issues that impact our quality of life, our very longevity......why should we take glasses seriously? This thread is looking for answers to that question. Can't wait to see other explanations I could plagiarize.

[optical24/7]

Until the general public see glasses as a *want* based item rather than a *needs* based item there will always be reluctance to buy eyewear, no mater what it's classification.

We need a study that proves glasses improve your sex life instead of the current thinking that they are birth control devices. :bbg:

[uncut]

Until the general public see glasses as a *want* based item rather than a *needs* based item there will always be reluctance to buy eyewear, no mater what it's classification.

We need a study that proves glasses improve your sex life instead of the current thinking that they are birth control devices. :bbg:

Could we apply for a grant from Luxschmottica?

[cleyes]

When discussing glasses with my patients, I stress the importance of high quality, ACCURATE lenses and workmanship put into a frame that is complementary, comfortable, light, fashionable and makes them feel good about their choice. I tell them that just because they have to wear glasses they shouldn't punish their face with something that is not complimentary. After all, this medical device is also face jewelry, and a poor choice of frame lasts way longer than a bad haircut looking back at you in the mirror, also good quality lasts longer and wears better than cheap. I always recommend avoiding the chains to make sure of the quality of their finished product.

[Darryl Meister]

Honestly, given that the current FDA classification for spectacle lenses commands all of the respect of products like toothbrushes, I suspect that most consumers already perceive eyeglasses to represent a more serious medical device than the government does, simply because they need a prescription in order to buy or "fill" them.

Best regards,
Darryl

[MikeAurelius]

Put two or more people together and see how quickly you can lose the thread of a conversation,degenerate into accusations, throw in an innuendo, and the result is ...what was the subject? Nobody remembers.
My take on the original question is that there wasn't an argument in it. It seems to be at the root of our problems, and it was inviting opinions as to how we solve this huge dilemma. It is a question of many answers, but at the end it will have not solved the problem. We each will only be able to have a few converts . We are in the unfortunate position of trying to sell a device that is universally resented, inconvenient, expensive, and until recently ugly as well. So how do we educate those are not our faithful customers? We all need more ammunition, more "talking points" for our patients to see the light. We humans are very good at denying major health issues that impact our quality of life, our very longevity......why should we take glasses seriously? This thread is looking for answers to that question. Can't wait to see other explanations I could plagiarize.

*applauds*

Thanks!!

[opticianbart]

We need a study that proves glasses improve your sex life instead of the current thinking that they are birth control devices. :bbg:

Could we apply for a grant from Luxschmottica?

And can I be a test subject in that study?