April 29, 1994

Mr. James J. Schramm
P.O. Box 406
Lake Villa, Illinois 60046

Dear Mr. Schramm:

Thank you for your letter of March 18 addressed to Elise Handelman in the Office of Occupational Health Nursing which provided a description of your proposed product, the Safety Shoe, a sample of the product and an instructional videotape. You have requested informal comments on the product and its acceptability for use by employees covered by the Occupational Exposure to Bloodborne Pathogens Standard (29 CFR 1919.1030).

The Occupational Safety and Health Administration (OSHA) does not review or endorse products as you have requested. The final determination of compliance must take into account all factors pertaining to the use of such devices at a particular worksite. This must include an evaluation through direct observation of employee work practices as well as an evaluation of the equipment or devices alone.

In the specific case of your product, it appears that the device is not a needle disposal system, but rather a recapping device which could also be used to transport the contaminated needle to a proper disposal container. For this reason, paragraph (d)(2)(vii)(A) of the standard would appear to apply. This part of the standard only permits recapping of contaminated needles under very specific and limited circumstances where the employer can demonstrate that no alternative is feasible, or that such action is required by a specific medical procedure. In general, recapping is prohibited by the standard.

Additionally, the standard requires that when recapping must be performed, it must be accomplished by the use of a mechanical device or a one-handed technique. Training must emphasize the need to use this as a one-handed recapping device and only in very specific circumstances; it is not to be used for two-handed recapping.

As you are aware, the Food and Drug Administration (FDA) may have jurisdiction over products like yours. We would advise you to continue your contact there for clarification. Specifically, you may want to contact the FDA's Division of Small Manufacturer's Assistance at 1-800-638-2041.

Thank you for your interest in worker safety and health. OSHA is pleased to see inventors like yourself take a genuine interest in protecting workers.

Best wishes in your endeavors.

Sincerely,



STEPHEN MALLINGER
Acting Director
Directorate of Technical Support




Ms. Elise Handelman
Department of Labor, OSHA
200 Constitution Avenue N.W.
Room N 3653
Washington D.C. 20210

Dear Elise,

It was good talking to you today. After our conversation, I actually made this video in about an hour and I feel it gets the job done.

My goal in contacting OSHA is to determine if use of my invention would be construed as violating the standards established for the safe disposal of contaminated sharps. I also would appreciate any advice or suggestions you might have. I am the original inventor of this product and would also be the manufacturer. I can not afford to tool up, manufacture the part, sell and distribute it and then find out its use constitutes a violation of OSHA's standards. The money to do this wouldn't be corporate R&D money but family savings.

Development of this product came about last year when one of our paramedics (I am a firefighter and a former paramedic) accidently stuck himself with a contaminated needle. The needle was not covered by a sheath because we do not resheath, but it had not been put in the sharps container yet because the sharps container is large and was not near the patient. (Fortunately, he suffered no ill effects from this exposure.) We then discussed the emergency scene. Often there are four to six people working around the critically ill patient simultaneously. They must move from side to side, head to toe, back and forth in close quarters, at times bumping into each other. In these instances it may not be practical to have a sharps box close to the patient, there is just no room. Carrying a contaminated sharp through this somewhat chaotic scene, passing it to the sharps box or leaving it near the patient uncovered opens a very real chance of someone being stuck.

Solutions we discussed included getting a small sharps box and keeping it in the tackle box/drug box we carry, but it didn't seem safe or appropriate to carry contaminated needles in the drug box. Hanging one on the outside was deemed impractical since these boxes take a pretty good beating. Carrying it in with us on calls was rejected because it's one more thing to carry and if the sharps box were dropped or bumped pretty hard, the flap door might well come open (you don't put it in the final lock position until it is full and the intermediate position is not very secure.) and contaminated needles could fall out. These disposal boxes seem to work best kept upright in a controlled environment.

Since I am the resident inventor I was "assigned" the task of developing a solution to this problem. I have heard that some people keep small blocks of styrofoam near where hypodermic procedures are going to be performed and the used needles are stuck in them. As soon as possible, the needles, block and all, are thrown into the sharps container. This seemed to hold promise, but I was worried that in the field the needle might go straight through. Another technique I have observed involves "chasing" the old sheath with the point of the needle. Once the point was in the old sheath, you would tip it up and pushing the needle toward the floor snap it into the original sheath. A one handed resheathing technique, if you will. Personally, I liked this the best since the sheath would always be there close to the patient and the plastic is a positive layer of protection, unlike the foam. Its major drawbacks were the opening is small and hard to hit and some I.V. designs, such as the butterfly, are nonsymetrical and even more difficult to snap together.

I think it's important to note here that although these methods are probably not endorsed as proper steps in safe disposal techniques, these people are attempting to make the needle less dangerous for themselves and others. They are doing the best they can to cover the needle point as quickly as possible while avoiding the obviously dangerous two handed resheathing method. Health care workers perceive a problem and at present there is no "off the shelf" solution.

My solution was to combine these two practices the result being the product you now see before you. It is designed and intended to be a "carrying or holding case" for the contaminated needle. It is not a "final" disposal container.

My design criteria were as follows: the device had to be easy to use, readily accessible to the medical provider and inexpensive. I believe I have achieved these criteria with this product. As you can see, the device is easy to use, requiring little training. The opening on the top is some 15 times larger than the opening on most sheaths, making insertion easier. Since you press the sharp into the foam, you don't have to tip the assembly up to lock the needle in place. The bright red color stands out and matches the standard for contaminated medical waste. While testing it, I was able to place three or four needles into the same safety shoe, a plus when you're not successful on your first I.V. attempt (but of course that never happens). I intend the product to be included as a part of an I.V. start kit, assuring that it will be right next to the patient. In the standards literature you sent me, proximity of disposal devices was considered very important. With its easy accessibility, I expect its use could become as habitual as cleansing the I.V. site. I have a target price of about $.10 once I am up to high volume production.

Often a manufacturer sells a product at a reasonable price, only to find the middle people run the price up on their end. . . "whatever the market will bear". If this appears to be happening, I would probably end up either assembling my own kits or have a kit manufacturer assemble them for me under private label. This way I should be able to control the cost. I truly want this product to be a solution to a problem at a modest cost, not another overpriced medical device.

As I said, this was designed for use by paramedics when starting I.V.s in the field. It's conceivable this product could be useful in other settings, including triage areas in Emergency Rooms and clinics, and could be used to hold small hypodermic needle/syringe assemblies. The Safety Shoe can hold up to a 5 cc syringe now. If a demand were to present itself, larger units could be made.

This pretty much sums up my invention. From my understanding of the waste disposal standards you sent me, this product falls into the cracks. Since it does not have a locking lid, it does not meet the criteria as a sharps disposal container. Unfortunately, adding a lid increases the cost considerably, complicates the ease of use and makes it larger and more difficult to fit in the I.V. start kit. I feel the negatives here outweigh the benefits. However, since it will be in the I.V. start kit, its proximity to the medical procedure will result in the contaminated sharp being contained more rapidly than it is now. This does address a major point in the standards and results in a big improvement. Medical providers presently perceive the amount of delay under certain situations to be a problem and are trying to resolve it with what is available to them. This product is a step forward from what they are doing now. I believe its use will reduce accidental sticks from contaminated sharps and it is, therefore, a worthwhile product.

I would appreciate any thoughts you might have informally. Any questions you have or problems you see from your point of expertise will help me a great deal. Ultimately, I would like to get an official written response as to the acceptability of this product. If such a response is not possible, any opinions or guidance on which to base my decision, whether to proceed or not, would be of enormous help to me.

Enclosed is a video tape demonstrating the use of this device, a prototype instruction sheet and a sample of the product.

Once again, thank you for your time. If you have any questions for me, feel free to call me anytime at home. If I am at the Fire Station, you may feel free to call me there. The phone number at work is 708-564-9677.

Sincerely,



James J. Schramm