…a great way to stay on top of the dynamic field of Opticianry and make some friends in the process.
…a great way to stay on top of the dynamic field of Opticianry and make some friends in the process.
This is an important alert. You can read further details about this on the OAA link above and at the ATO website as well for further details. What’s happening is the following from the FDA. The FDA wants to make the one who edges in house the “manufacturer.
2007D-0364 – Impact-Resistant Lenses: Questions and AnswersGuidance
FR Type: Notice
Action: Availability.Guidance.Level 1
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Impact-Resistant Lenses: Questions and Answers. To reduce the number of eye injuries, eyeglasses and sunglasses must be fitted with impact-resistant lenses. All lenses must be capable of withstanding the impact test described under 21 CFR 801.410(d)(2). This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, the lens testing apparatus, record maintenance, and exemptions to testing.
The FDA is accepting comments right now until January 24th 2008. The OAA has some great guidelines to follow. My comments sent to the FDA are as follows. Feel free to use this as inspiration.
Comments to FDA:
Pharmacists and doctors are not responsible for the efficacy of pharmaceuticals they dispense or prescribe. Similarly, eye care professionals (ECPs) should not become the “manufacturers” of lenses they did not manufacture. To place the liability on ECPs would greatly burden many practices. Aside from higher costs that would inevitably be passed on to patients due to the lens testing, practices would now be incurring higher costs because of greater liability. Just like pharmaceutical companies test their own products, lens manufacturers and labs need to test their own products to ensure that they pass any guidelines required of them. Manufacturers have decades of experience with drop-ball testing and ensuring lens safety. The eyeglass industry as a whole has an excellent safety record. The frequency of eye injury litigation is about one claim per year of about 146 million people that wear eye glasses. With this in mind, I urge the FDA to discard these new lens guidelines. They are not needed and are more of a detriment to any problem it attempts to solve.
Optician n. One who is extensively trained in the interpreting of ophthalmic prescriptions and applies that knowledge to obtain the optimum visual and safety performance for the patient in a pair of spectacles or contact lenses.
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rneiderman@opticiansfriend.com
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February 21st, 2008 at 9:32 am
I have been in this busines for 32 years.
The ONLY serious eye injuries I have ever seen or heard about came from GLASS lenses.
This is just another way for the FDA to favor big business and force the small or independent optician out the door.