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• Standard Number: 1910.1030

February 16, 1993

Mr. Barry J. Preston
Product Manager
Schiller America
3002 Dow Avenue, #122
Tustin, California 92680

Dear Mr. Preston:

This is in response to your letter of August 31, 1992, requesting clarification of the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens". We apologize for the delay in this response.

Specifically, you inquired about the sterilization of spirometry tubing between patients and whether your sterilization procedures were adequate. You, however, are operating under an incorrect belief that "saliva is considered as a potentially infectious material in the bloodborne pathogens law". The definition of "other potentially infectious materials" includes saliva in dental procedures as well as any body fluid that is visibly contaminated with blood. Saliva that is not the product of a dental procedure or which is not visibly contaminated with blood (or for which it would not be reasonable to anticipate that it could be contaminated with blood) would not be considered to be a potentially infectious material and would, therefore, not be covered under 29 CFR 1910.1030.

In general, OSHA does not believe that spirometry tubing presents a bloodborne pathogens hazard to employees. The recommendations of the Joint Council of Allergy and Immunology that the tubing be sterilized between patients is sound public health policy but does not fall within OSHA's jurisdictional mandate to protect the health and safety of employees. If employees were to handle tubing which was contaminated with blood or other potentially infectious materials, decontamination by means of bleach or an EPA-registered disinfectant would be necessary.

We hope this information is responsive to your concerns and thank you for your interest in worker safety and health.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs




August 31, 1992

U.S. Department Of Labor OSHA
3rd & constitution N.W.
Washington, D.C. 20210

Schiller America currently sells medical equipment to the hospital, family practitioner, and the occupational health marketplaces. Our product line consists of Resting ECG, Exercise ECG, and Spirometry equipment.

OSHA has recently issued a Bloodborne Pathogen guideline CFR 1910.1030. This information was made public in the Federal Register Dec. 6, 1991 issue.

Several organizations have since interpreted these guidelines in order to help the occupational health setting understand them.

The Joint Council of Allergy and Immunology has released a letter concerning these new guidelines. This letter is included for your review.

One section covers sterilization of the spirometer between patients.

It is a common known fact that all the organizations associated with lung function testing recommend sterilization of the spirometer to eliminate the potential of cross contamination between patients and the operators.

Older style spirometry testing only consisted of the patient blowing air out of their lungs. New technology enables the upper airways to also be tested (throat) by having the patient breathe air back into the lungs.

A recent study by the Infection Control And Hospital Epidemiology group has confirmed that spirometers can become contaminated with microorganisms and should be sterilized between patients (article included). This poses a threat not only to the patient, but to the health care worker as well.

Hepatitis B, Tuberculosis, and HIV are some of the main reasons for the blood pathogen guidelines. A recent article from the Respiratory Care magazine documents the great concern of cross contamination of TB with the health care workers (article included).

Schiller America has taken every precaution necessary to stop the possibility of cross contamination. Our specially designed sensor can be wiped by a germicidal cloth which not only cleans but eliminates diseases (brochure of germicidal wipe included).

Since saliva is considered as a potentially infectious material in the bloodborne pathogen law, does OSHA agree with the letter sent by the Joint Council of Allergy and Immunology that the spirometer tubing should be sterilized between patients to ensure the patient and worker safety?

If your answer is yes, does OSHA agree that the Schiller sterilization procedure is effective and safe for both the patient and worker? Thank you.

Sincerely,



Barry Preston
Product Manager


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