Archive Notice - OSHA Archive

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.

August 8, 1990

Mr. Michael R. Anderson Director of Marketing Hemox, Inc. Post Office Box 362115 Melbourne, Florida 32936-2115

Dear Mr. Anderson:

This is in response to your letter of June 12, addressed to Jessica Sandler of my staff. You requested that she review the literature associated with your Hemox Safe Deposit System and the product itself and provide you with her opinion of it.

As Ms. Sandler has discussed with you, the Occupational Safety and Health Administration (OSHA) does not endorse or approve any particular type of product or medical device. The current compliance directive (OSHA Instruction CPL 2-2.44B: "Enforcement Procedures for Occupational Exposure to Hepatitis B Virus and Human Immunodeficiency Virus") requires that sharp items be placed in puncture-resistant containers for disposal. The proposed standard on Occupational Exposure to Bloodborne Pathogens requires that the containers be closable, puncture- resistant, and leakproof on the sides and bottom as well as appropriately labeled or color-coded.

Your "Safe Deposit System" appears to comply with the intent of the current OSHA requirements. Of course, the final determination regarding compliance with OSHA's requirements in the area of bloodborne hazards must be made in the workplace by direct OSHA compliance officer observation of employee work practices while utilizing your product.

I hope this information is helpful to you.

Sincerely,

Patricia K. Clark Director Designate Directorate of Compliance Programs

June 12, 1990

Ms. Jessica Sandler DOL/OSHA 200 Constitution Ave., NW Room N3469 Washington, DC 20210

Dear Ms. Sandler,

Thank you very much for stopping by the HEM0X, Inc. booth at the recent Association for Practioners of Infection Control exhibits last week.

It was a pleasure to finally meet you after speaking with you on the telephone.

As I mentioned on the telephone and again when we met, HEM0X, Inc. is a manufacturer of containers used for the collection and disposal of infectious waste, primarily sharps.

As you observed at our booth and can see from the samples and literature enclosed, the HEMOX Safe Deposit System for sharps disposal is made of a fiberboard material. This is good news for the environment as most infectious waste is incinerated and the plastic containers emit toxins, furans, dioxins, HCl and C02 into the atmosphere when burned. Our containers burn clean.

Additionally, the HEMOX containers have been independently tested and proven to resist needle penetration better than the plastics. The test results are enclosed.

The samples provided are for your information and evaluation as you deem appropriate. We ask that you abuse them as you see fit, just subject the plastic ones to the same abuse.

The video tape provides a short segment on our company portrayed by a local TV station and is followed by the testing we have conducted in house to demonstrate the safety and effectiveness of our sharps containers.

We recognize that you cannot endorse a product, it would be appreciated however if you could let us know if we comply with OSHA requirements.

If you require any additional information, please contact me.

Sincerely,

Michael R. Anderson Director of Marketing

MRA/rem incl.