July 1, 1994

Mr. Mitchell Davis
President
Protect Aide, Inc.
605 White Hills Drive
Rockwall, Texas 75087

Dear Mr. Davis:

This if in further response to your letter of April 19, addressed to Assistant Secretary of Labor for OSHA, Joseph A. Dear, regarding your concerns about the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." You expressed concerns about appropriate quality standards for personal protective equipment, in particular, clothing.

OSHA has not established specific standards for personal protective clothing resistance against biological agents.

OSHA's Bloodborne Pathogen Standard requires appropriate PPE to be used to prevent blood or OPIM from passing through to, or contacting the employees' work or street clothes, undergarments, skin, eyes, mouth, or other mucous membranes, unless engineering controls and work practices have eliminated occupational exposure. The type and amount of PPE shall be chosen to protect against contact with blood or OPIM based upon the type of exposure and quantity of these substances which can be reasonably anticipated to be encountered during the performance of a task or-procedure. A gown which is frequently ripped or falls apart under normal use would not be considered "appropriate PPE".

Use of protective body clothing, such as gowns, aprons, laboratory coats, clinic jackets, surgical caps, or shoe covers, and the degree to which such PPE must resist penetration, are performance based. The employer must evaluate the task and the type of exposure expected and, based on the determination, select the "appropriate" personal protective clothing in accordance with section (d)(3)(i) of the standard. For example, laboratory coats or gowns with long sleeves shall be used for procedures in which exposure of the forearm to blood or OPIM is reasonably anticipated to occur. However, if the amount of blood exposure is such that the blood penetrates the clothing and contaminates the inner surface, the penetration itself would constitute exposure and the clothing would be inappropriate.

OSHA directs compliance officers to evaluate the task being performed and the degree of anticipated exposure by direct observation, employee interview, or review of written standard operating procedures.

Regarding the use of gloves as PPE, gloves of appropriate sizes must be made available in accordance with section (d)(3)(iii) of the standard.

At a minimum gloves shall be used where there is reasonable anticipation of employee hand contact with blood, OPIM, mucous membranes, or non-intact skin; when performing vascular access procedures; or when handling or touching contaminated surfaces or items. Studies have shown that gloves provide a barrier, but that neither vinyl nor latex procedure gloves are completely impermeable. Thus, OSHA requires hand- washing after glove removal.

While disposable gloves shall be replaced as soon as practical when contaminated, obviously some critical procedures (i.e., surgery, delivery) cannot be interrupted to change gloves. The key words to evaluate are "practical" and "feasible".

Disinfecting agents may cause deterioration of the glove material; washing with surfactants could result in "wicking" or enhanced penetration of liquids into the glove via undetected pores thereby transporting potentially infectious materials into contact with the hand. For this reason, disposable (single use) gloves may not be washed and reused. Plastic film food handling gloves ("cafeteria" or "baggie" gloves) are not considered to be appropriate for use in exposure-related tasks. They are not strong enough to provide protection to the hands nor would they fit the employee as required by paragraph (d)(3)(ii) of the standard.

There are currently no available standardized methods of testing and classification of performance specifications for resistance of clothing to biological hazards. However, we appreciate your efforts in providing to customers products that have met other agencies' guidelines and regulations with safety in mind.

We hope this information alleviates your concerns. Thank you for your interest in worker safety and health.

Sincerely,



John B. Miles, Jr. Director
Directorate of Compliance Programs




April 19, 1994

Mr. Joseph A. Dear
Asst. Secretary of Labor for OSHA
U.S. Dept. of Labor
200 Constitution N.W.
Washington, DC 20210

Dear Mr. Dear:

Dr. Harwood recommended that I write to you in regard to a dilemma that my company, as well as many health care practitioners and first responders, is facing.

In 1988 we began assembling personal protection packs. To the best of my knowledge we were the first company solely dedicated to manufacturing, assembling and distributing personal protection packs to the pre-hospital/industrial setting. We have developed a number of innovative designs of protective apparel and have gone through much effort and expense to make sure that we have complied with all G.M.P. and F.D.A guidelines and regulations.

We have obtained F.D.A. 51(k) authorization on all of our garments as is required by the Safe Medical Devices Act of 1990. Our garment material Gas passed the ASTM ES22 Test, which is required in order to make an impervious claim for a product of our kind. We do not believe that the standards we adhere to are overkill rather than the minimum standards necessary when addressing the potential high risk situations that many of our endusers confront.

Since our inception, we have assisted the U.S. Department of Transportation, F.A.A., Bell Helicopter, and the Department of the Interior in their P.P.E training. We have also assisted in writing the specifications for and distributing P.P.E. kits to the U.S. Marshals, U.S. Customs, U.S. Coast Guard, AT.F., D., F.B.I., F.D.k, as well as many other government, state, and municipal agencies.

Since OSHA passed its regulation regarding universal precautions, many individuals and companies are taking advantage of what they perceive as a short term opportunity to profit from inexperienced buyers of these products. These companies are showing no regard for any quality performance standards, and use price as their only criteria.

For instance, the State of Arkansas D.O.T. asked us to assist them, through one of our distributors, in defining what PPE equipment they need and the minimum standards that should be established for their P.P.E. After having done so, and the bid was sent out, the DOT chose the lowest bid with no regard for quality. I let them know that the product that they chose not only did not meet the specifications that the bid required, and does not meet the standards that F.D.A. requires, but most importantly, does not meet the standards that the employees of the State of Arkansas deserve. The response to my concerns was ignored. We are also working with an identical situation with the G.S.A. on a contract for the U.S. Forestry Service

One of my greatest fears is that if the existing F.D.A. and OSHA standards for performance of these types of products are not enforced, these substandard products will be perceived as acceptable standards. In turn, our first responders in this country will be given a false sense of security when performing their required tasks and will continue to contract harmful, and in a increasingly number of instances, fatal diseases. This will not only increase the cost of health care, but most importantly will increase the loss of lives of those individuals whose job it is to protect us.

I am requesting your help in directing me to whatever agency in Washington that I need to communicate with regarding these issues. The healthcare practitioners and first-responders in this country depend on appropriate quality standards and enforced parity with respect to these standards. I do not believe that I should morally or legally (according to current regulations) diminish our products' quality standards. Again I would appreciate any assistance that you are willing to provide. Thanks very much for your time.

Sincerely,



Mitchell Davis
President

MD/mp

P.S. For your reference, I have enclosed a sample of ProtectAide's Biohazard Clean-Up Kit No. 29777, along with a sample of a competitors product that was accepted as equivalent to ProtectAide's Kit No. 29777.