- Standard Number:
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 http://www.osha.gov.
January 21, 1998
Wilson Sonsini Goodrich Rosati
Attention: David M Hoffmeister
650 Page Mill Road
Palo Alto, California 94304-1050
Dear Mr Hoffmeister:
This is in response to your letter dated October 20, 1997. In your letter you have provided information on the NiC1800 Needle Disposal System. This is a needle destruction device that destroys needles by incineration. You have requested that the Occupational Safety and Health Administration (OSHA) provide written communication that this product, when used according to instructions, is not in violation with OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030.
This needle removal system was not available at the time the standard was written. The incineration of needles is not prohibited by the Bloodborne Pathogens standard. Since the standard became final there has been a great surge in the production of medical devices. The Federal Food and Drug Administration approves these devices for marketing, and once the approval is obtained, these devices can be used in the workplace. Your letter indicates that the NiC1800 Needle Disposal System has been approved for marketing. OSHA cannot and does not endorse, review, or approve of medical devices. The real test of compliance with OSHA standards comes about by observation in the workplace, where the medical devices are in use. Medical devices generally have specific instructions that must be followed when using them. The safety features that they provide may become more of a hazard if the employee is not using the device correctly. Compliance with the OSHA standard can only be determined on a case by case basis.
Thank you for your interest in occupational safety and health hope this provides an answer to all your questions. If you have further questions, please feel free to call Wanda Bissell of my staff at (202) 219-8036 Ext.41.
John B. Miles Jr.
Directorate of Compliance Programs