April 18, 1997

Mr. Kurt L. Christensen
President/CEO
American Health & Safety
Post Office Box 46340
6250 Nesbitt Road
Madison, Wisconsin 53744-6340

Dear Mr. Christensen:

This is in response to your letter of March 5, expressing concern for the lack of public awareness of the limitations of eyewashes and requesting a review of your new product, The Eye Irrigator(TM).

Please be advised that the Occupational Safety and Health Administration (OSHA) does not approve or endorse products. The variable working conditions at worksites and possible alterations or misapplication of an otherwise safe product could easily create a hazardous condition beyond the control of the manufacturer.

OSHA would prefer that employees' eyes be protected from injury by wearing the proper personal protective equipment when handling chemicals. The eyewash/facewash station in the workplace is the fallback method of reducing injury caused by chemical splashes that do occur to the eyes. When properly installed, the eyewash is immediately available and can be easily self-administered. The facewash provides additional benefit by washing the area around the eyes where additional chemical has usually splashed. Despite the limitations, this is the minimum that OSHA expects for treatment from the employer.

Employees suffering from chemical eye injuries, or any other serious injuries, should be referred to a healthcare professional. The professional should use his/her own judgment to make the determination of whether further treatment is required. The extent of incomplete first aid follow-through is unknown, but whenever chemicals and the eyes are involved, we hope the first responder and the emergency room are consciously evaluating the need for further irrigation. The literature that you enclosed with your product does indicate that The Eye Irrigator could provide improved irrigation of the eye especially inside the upper eyelid. However, its intrusive nature also indicates it would be best placed in the hands of such a healthcare individual or a trained first responder (EMT).

We thank you for your concern about employee safety and their potential loss of eyesight.

Sincerely,



Stephen Mallinger, Acting Director
Office of Health Compliance Assistance

March 5, 1997

Mr. Steve Malinger, Activity Director
Office Compliance
US Department of Labor/OSHA
Francis Perkins Bldg
200 Constitution Ave NW, Rm N-3467
Washington, DC 20210

Dear Mr. Malinger,

On my recent visit to Washington DC, I had the opportunity to meet with Marthe Kent, who suggested I contact you regarding an exciting new method of eye irrigation. As a member, of the ISEA, (Industrial Safety Equipment Association), I recently joined the Committee which created the new pending Emergency Eye Wash Standard. My first meeting was on the day they were finalizing the new standard and they were not receptive to including any addendum, which would include a new method of eye irrigation.

Every one of the manufacturers of eye wash units on this committee agreed that the Eye Irrigator(TM) was an excellent product and that it indeed did a better job of irrigating the eye. They acknowledged that it is extremely difficult for a victim to pry their eyes open over a standard eye wash unit and keep them open for fifteen minutes of flushing. They also agreed that it was virtually impossible to irrigate (with a standard eye wash) the upper inner eyelid, which is where most chemicals/particulates tend to be trapped.

With the new Eye Wash Standard, I'm concerned that many people will be lulled into thinking that a standard eye wash will do an adequate job of irrigating their eyes after a chemical splash. Indeed, the statistics from the Department of Labor indicate that many eye injuries result in blindness that might otherwise be prevented with a more thorough method of irrigation.

By using the Eye Irrigator, a First Responder is able to quickly, easily, and painlessly insert the Eye Irrigator(TM) even if the patient is squeezing their eyes shut in blepharospasm or bell reflex response...which usually occurs after a chemical or particulate is splashed into the eye. The irrigating loop also hydroplanes over the eye... thoroughly irrigating the upper inner eyelid, where again, chemicals/particulates tend to become trapped.

Other devices which would also do a more thorough job of irrigation would include the Morgan Lens and, of course, the old standby of rolling the eyelid back with a Q-Tip and irrigating with a bag of saline and irrigating tubing.

I'm enclosing for you a short eight minute video on the Eye Irrigator(TM) along with a non-sterile sample of the #2021, so you can get an idea of how it works. I've also enclosed literature and brochures for your better understanding.

I would greatly appreciate your assistance in increasing the awareness of these other methods of eye irrigation and the need for further action, above and beyond the first emergency response, which should, of course, still be an emergency eye wash unit. YOUR ACTION CAN DEFINITELY MAKE A DIFFERENCE IN SAVING EYES!

I look forward to hearing from you soon.

Warm Regards,

Kurt L. Christensen
President/CEO

P.S. I've enclosed the language that we have asked the ISEA to include as an addendum to the new standard, which would include these other methods of irrigating by a First Responder. Experts agree and recommend that a secondary and supplementary irrigation be used after emergency eye wash and as soon as a trained Emergency Response person arrives on the scene. This addendum was written at the suggestion of Dr. Bernard Blais, who is a consultant to American Health & Safety on eye protection. Dr. Blais is also on the following committees...

    Clinical Professor of Ophthalmology, Albany Medical Center,
         Albany, New York
    Consultant to the Eye Safety and Sports Ophthalmology
         Committee of the American Academy of Ophthalmology
    Chairman of the Eye and Vision Committee, American College of
         Occupational and Environmental Medicine

encl.     2021 Eye Irrigator sample
           8 Minute Video
           Eye Irrigator
           Literature/Articles