16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
I am amazed at the apparent lack of concern for patient health and well-being of this proposed rule. I have no problem with providing every patient with a copy of their glasses, contact lens, low vision device, or medication (OTC or Legend) prescription. I keep a copy of it in their record. Each one has (and should have) an expiration date. Should anything go wrong, I will be held responsible, not the seller. If the device doesn't function properly, the patient will look to me to remedy the problem, not the seller. If you decide I need to ask my patients to sign another piece of paper, I will....but it will not do anything to protect them to a greater extent from harm due to improper use of a medical device. Manufacturers are glad that I monitor the patients' use of their product. The complainers, the ones who are asking you to loosen the controls of sales via the promulgation of this rule, are the ones who sell vast quantities of the product. They have no responsibility for the safety of the device or the use of it by the consuming public. They have no compunction about substituting brands without authorization. They are cavalier in stating that only moderate to severe cases of microbial keratitis will really cause harm to a patient, but they are not bound by the Hippocratic Oath or any other oath for that matter. The thing that stands in the way of upping their sales is the expiration date on a prescription...and that's what this is really all about. Do what you will, but see this for what it is: a bid to sell more controlled devices and make more money with less regulation and no responsibility for the consequences of their actions. Thanks for your consideration.