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FDA Impact
Resistance Proposal –
How Will it Affect You? |
Our industry often faces changes for both the good and the bad, but here we have an opportunity to make a difference. The FDA recently proposed changes to the impact resistance document better known to opticians as the "drop ball test." The major points of the FDA proposal (21CFR801.410) are outlined below, and I believe these changes could have a devastating impact on how we do business.
1. Q. What are the impact testing requirements for prescription (Rx) glass lenses?
A. The manufacturer must test each finished Rx glass lens individually for impact resistance (21 CFR 801.410(c)(3)). The lens must be capable of withstanding the impact test provided in 21 CFR 801.410(d)(2) as described under "Testing Apparatus and Procedure" below. You should perform testing after the lens has been edged (cut to the shape of the frame) but before the lens is put into the frame.
The lenses being tested after being edged means that any small office now fabricating eyewear will have the burden of testing and meeting these requirements or they will have to farm the jobs out to a larger lab, negating any savings in both time and cost associated with edging in-house.
4. Q. What are the impact testing requirements for prescription (Rx) and non-prescription plastic lenses?
A. Under 21 CFR 801.410(c)(3), you must test a statistically significant sample of prescription or non-prescription plastic lenses from each production batch. The sample must be representative of the finished forms as worn by the wearer, including forms that are of minimal lens thickness and have been subjected to any treatment. You must test all nonprescription lenses in uncut-finished or finished form. 21 CFR 801.410(c)(3). You should perform testing on a sample after the lens has been edged (cut to the shape of the frame) but before being put into the frame.
Using statistical testing methods is a sampling method best employed by large laboratories, this combined with testing edged lenses will create an unnecessary burden on the retailer, but also a costly one as most smaller offices that edge in-house will have too few jobs coming through the office to employ batch testing. The costs involved can in some cases double the production cost to the retailer which will undoubtedly be passed on to the end user.
8. Q. Is the manufacturer of semi-finished lens blanks required to perform the impact testing?
A. No. A semi-finished lens blank needs further processing that may weaken the lens. You should test the finished lens.
The wording used in question #4, particularly "uncut-finished" could create confusion with the term "semi finished" especially when the term uncut-finished is followed by finished then edged. Traditionally ophthalmic personnel have referred to lenses in three forms: semi finished, finished, and edged. This consistency in the terms used can help reduce the amount of confusion in the document.
10. Q. Does impact testing apply to retailers that put plano lenses in sunglass frames or that put lenses into an eyeglass frame in which one lens is plano and the other lens is corrective?
A. Yes. In general, it is the retailer who usually grinds and shapes lenses to fit the eyeglass frame. Retailers that process lenses (grind and shape) must render the plano lenses impact resistant and test them. However, retailers only need to test mass-produced plano lenses on a statistically significant, batch-sampling basis (21 CFR 801.410(c)(3)).
By moving the testing from the manufacturer to the retailer level, the cost of testing would significantly increase and the statistical methodology would be less efficient on the retail level than it would be on the manufacturer’s level.
11. Q. Does impact testing apply to finished non-prescription sunglass lenses, i.e., sunglass lenses that need only to be inserted into a frame?
A. Yes. Under 21 CFR 801.410(c)(3), you must test a statistically significant sample of sunglass lenses from each production batch. The sample must be representative of the finished forms, including forms that are of minimal lens thickness and have been subjected to any treatment used to impart impact resistance. You must test all lenses in uncut-finished or finished form. 21 CFR 801.410(c)(3). You should perform testing on a sample after the lens has been edged (cut to the shape of the frame) but before being put into the frame.
Same as previous questions the term uncut-finished, finished, and edged should be reconsidered.
12. Q. Are clip-on sunglass lenses subject to impact testing?
A. Yes (21 CFR 801.410 (c)(3)). However, FDA intends to exercise its enforcement discretion regarding impact testing based on the following factors:
1. Whether the clip-ons cannot be worn alone, but can only be worn with lenses that are impact resistant.
2. Whether the clip-ons are designed so that they may be worn only on the outside (side distal from the eye) of the prescription lenses.
3. Whether the clip-ons are the same size or smaller than the prescription lenses upon which they are intended to be worn.
The term clip-on makes it evident that these lenses are not designed to work alone, but require an underlying base pair of spectacles. If these base spectacles are treated then the clip-on will provide insignificant safety, and therefore should not be considered when judging the impact resistance of the eyewear.
21. Q. Who should perform the test for impact resistance?
A. The manufacturer must perform the test for impact resistance (21 CFR 801.410(d)(1)). Manufacturer is defined under 21 CFR 820.3(o) and would include the person (or firm) who puts the lens in the form ready for its intended use or who alters the physical or chemical characteristics of the lens by grinding, heat treating, beveling, applying scratch resistant coating, applying anti-reflection coating, cutting, or other pertinent actions. Retail laboratories that perform some or all of these processes are manufacturers. For the purpose of 21 CFR 801.410, the term "manufacturer" also includes a company that imports impact resistant lenses for eyeglasses, or who imports finished eyeglasses or sunglasses for resale. (21 CFR 801.410(g))
The lens should meet the impact standard before reaching the retailer, to make sure that adequate safeguards are in place. A sad but common fact known in the industry is that half the states in the USA have no licensing or training for ophthalmic personnel in the lab to perform these tests to ensure that the lenses meet these impact standards. It is my feeling that if the lenses meet the impact resistant standard in their finished un-edged form, the retailer will have a better chance of ensuring the end user is protected against impact induced trauma, while providing it at a significant cost savings over the retailer testing.
A document released by Ken Wood from the Vision Council of America covers some of the major concerns brought out by this new Q and A about impact resistant lenses.
1. Testing after edging – this creates an unnecessary burden on many in our industry.
2. Retailer testing – this creates an increase in the cost of production with higher amounts of lenses being discarded.
3. Manufacturers must test while labs need not – by changing the manufacturer from the lab to the retailer when operations such as tinting, edging, or coating are performed the labs are more likely to end the practice of testing surfaced and treated uncuts.
4. Edger sales – manufacturers of edgers rely on retailers as their major source of sales, if the responsibility of impact testing shifts from lab to retailer this will impact the sales of edgers.
5. Frames distribution – the change from retailers edging to labs edging will require that frame distributors will have to provide more accurate trace and drill data to labs to ensure quick processing of lenses for the retailer, or the labs will have to start stocking frames.
I personally though these points were well though out. I would just like to ad that testing moving testing from the lab to the retailer will ultimately require more untrained personnel to test lenses for impact resistance, therefore increasing the risk to the general public.
The full text of the proposal can be read here: http://www.fda.gov/cdrh/dsmica/guidance/23.pdf
If after reading this article you would like to help, the Opticians Association of America (OAA) and the Vision Council of America (VCA) have teamed up to provide the FDA with enough information to make the necessary changes to this document.
To make it easy to help the OAA has provided a form letter for ophthalmic professionals to easily contact the FDA and make their voices heard:
http://capwiz.com/oaa/issues/alert/?alertid=10631926&PROCESS=Take+Action
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