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• Standard Number: 1910.1030

September 27, 1993

Mr. Jeff Baker
Vice President
The HealthChair Group
2601 South Constitution Boulevard
West Valley City, Utah 84119-1998

Dear Mr. Baker

Thank you for your letter of August 19, regarding the Occupational Safety and Health Administration's (OSHA) final rule for Occupational Exposure to Bloodborne Pathogens (29 CFR 1910.1030), and your request for an endorsement that your product, the Power Station, can be used in compliance with the standard's requirements.

The agency does not approve or endorse products as you have requested. The final determination of compliance with OSHA's standards must take into account all factors pertaining to the use of such devices at a particular worksite with respect to employee safety and health. This must include an evaluation, through direct observation of employee work practices and all conditions of use in the workplace as well as an evaluation of the equipment or devices alone.

Your letter did not mention whether or not your device has received clearance from the Food and Drug Administration (FDA) for marketing. If not, please be advised the FDA must clear your product before it can be legally marketed, and the FDA plans to consider employee safety and health in its evaluation of products submitted for marketing clearance.

We hope this information satisfactorily addresses your concern. Thank you for your interest in occupational safety and health.

Sincerely,



Ruth McCully, Director
Office of Health Compliance Assistance




August 19, 1993

Roger Clark
Director of Directorate
of Complete Programs
U.S. Department of Labor/OSHA
Room #N3468
200 Constitution Avenue, N.W.
Washington, D.C. 20210

Dear Mr. Clark:

Mr. Kevin Landkrohn of your agency suggested, during our telephone conversation of last week, that I write you. This letter is intended to obtain interpretation or clarification on the application of a vacuum system in the field of otolaryngology (ENT). We have been manufacturing this same system since the early 1970's for the dental field. This application is called wet vacuum because the aspirated wastes, in the case of dental applications which include saliva, blood, tooth particles, etc., are drawn from the individual operatory through the pump, mixed with water, and injected directly into the building sewer system. The injected water not only acts as a medium to help covey the suctioned materials through the pump but also aids in creating a water seal for generation of relatively high levels of vacuum. The interpretation we seek is to find out if it is permissible to apply this same system to the ENT field where suctioned wastes would include mucous, ear wax and some blood which may be vacuumed up as a result of treatment of nose bleeds, etc. Obviously, these materials could be infectious and contain bloodborne pathogens.

Our product will be marketed under the name of "The Power Station" and is designed to apply to individual doctor offices to supply central vacuum. Currently, their vacuum needs are satisfied by individual vacuum pumps in each examination room. There is a vacuum canister located between the pump and the patient. That canister, located inside a cabinet, collects the aforementioned suctioned wastes and periodically a nurse or medical technician disconnects the tubings from the canister, removes the lid of the canister and pours the contents down the drain, then washes the lid and canister out after disposal of the suctioned materials. The canister is replaced and the hoses are reconnected. Since the Power Station is a closed system, it draws the suctioned material to it and injects it directly into the building sewer system. Neither the doctor or nurse/medical technician ever again comes in contact with the wastes.

We have developed this product and packaged it for an ENT application because we felt it will be a great benefit to the practice of otolaryngology and because it does not represent new technology. The Power Stations' method of waste disposal is, as I said, commonly used in the dental field and even in households where blood and mucus are disposed of via the sewer system. We would appreciate a response from your agency as soon as possible regarding whether the use of the Power Station complies with existing laws or regulations. Thank you in advance for your prompt attention to this matter.

Sincerely yours,



Jeff Baker
Vice President

DMI

JB/td

P.S. For your information, we have sent a similar letter to the EPA for their consideration.


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