Medical devices as articles under hazard communication

January 5, 1990

Mr. Robert C. Wilbur
Vice President for Government Relations
Health Industry Distributors Association
[Recipient address omitted]
Dear Mr. Wilbur:

This is in response to your letter of August 30, addressed to Ms. Patricia Clark, Acting Director of the Directorate of Compliance Programs. You wrote regarding the definition of "articles" under the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS) 29 CFR 1910.1200. I apologize for the long delay of this response.

You expressed concern that manufacturers of medical supplies and devices are routinely developing material safety data sheets (MSDS) for these manufactured items, and that distributors of these items are burdened with transferring the accompanying MSDS to downstream users. You specifically requested an interpretation from OSHA that these medical devices be considered "articles" under the HCS. You also requested a statement from the Agency that incineration of medical devices does not constitute a "normal condition of use."

OSHA agrees with your understanding that medical devices such as metal bed pans and crutches are "articles" under the definition given in section (c) of the Standard. The article exemption is based upon a lack of employee exposure potential to hazardous chemicals during normal conditions of use of that article. Incineration of medical devices may be a routine disposal operation but does not constitute "a normal condition of use." "Use" is defined in the HCS as meaning to "package, handle, react or transfer." Such supplies and devices do not release material while workers are using them in the normal course of their employment.

The manufacturers of such items do not have to anticipate their ultimate destruction. For purposes of the HCS, the medical devices you inquired about would be considered "articles" under the HCS if, during their normal condition of use, no employee exposure potential to hazardous materials exists. Further, as you pointed out in your letter, the incineration of medical devices is performed in order to destroy biological hazards and standards governing the disposal and incineration of biological and other hazardous wastes are developed and enforced under the statutory purview of the Environmental Protection Agency. While OSHA is the Agency responsible for ensuring employee safety and health and the purpose of the HCS is to ensure employees have access to the information about hazardous chemicals that they work with, as explained above, manufacturers of articles do not have to anticipate exposures that might occur during the ultimate destruction (incineration) of the products they produce as long as exposures that could result from normal conditions of use are addressed on the MSDS and/or labels.

We hope this information is useful to you. Please contact me if you have any further questions.

Sincerely,
Thomas J. Shepich, Director
Directorate of Compliance Programs