June 11, 2001

Mr. Neil H. Wasser
Constangy, Brooks & Smith, LLC
Attorneys at Law
Suite 2400
230 Peachtree Street, NW
Atlanta, GA 30303-1557

Dear Mr. Wasser:

Thank you for your March 23 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Compliance Programs regarding the applicability of the Bloodborne Pathogens standard (29 CFR 1910.1030) to labeling and shipping contaminated medical devices. We appreciate your continued correspondence and contact with our staff regarding this rather complicated matter. We hope that this letter suits your needs. We have restated your scenarios and questions below and added our responses. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenario not delineated within your original correspondence.

Scenario 1:  In some instances, equipment that is contaminated with blood or other potentially infectious materials (OPIM) needs to be returned to the manufacturer in an un-tampered condition... The items are prepared for shipment (e.g., primary and secondary packaging, labeled, etc.) in such a way that there is no reasonably anticipated employee contact with the blood or OPIM. The employees who handle the equipment upon receipt are trained to do so in a safe manner (e.g., engineering controls, personal protective equipment, in-house decontamination, etc.).

Question 1:  Would such measures be in compliance with the OSHA (Bloodborne Pathogens) Standard?

Response:  Yes. If conscious efforts are made to decontaminate the equipment to the greatest extent feasible, proper labels are applied, employees are trained with regard to the handling of the equipment, and packaging is done in such a way that potential employee exposure is minimized, compliance would be achieved. In the scenario that you describe, it appears that the proper precautions and controls were implemented for shipping contaminated equipment.

It is OSHA's intent to protect all employees, on the packing, shipping and receiving ends, from potential exposures to blood and other potentially infectious materials (OPIM). If shipping and labeling contaminated medical equipment are done in accordance with the requirements of the standard, exposures are minimized and compliance is achieved. Paragraph (d)(2)(xiv) of the standard states that "(e)quipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible."

Specifically, for equipment prepared for shipment, the standard requires that "...(A) readily observable label in accordance with paragraph (g)(1)(i)(H) shall be attached to the equipment stating which portions remain contaminated. (B) The employer shall ensure that this information is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken." With respect to sections or entire parts of equipment that cannot be decontaminated, paragraph (g)(1)(i)(H) states, "(l)abels required for contaminated equipment shall... state which portions of the equipment remain contaminated." Where decontamination is not feasible for certain equipment, controls must be in place to protect employees, both of which must be documented in the employer's exposure control plan (ECP), as explained further below.

Scenario 2: Consider the situation where a shipment of equipment contaminated with residual human blood is being prepared for transport. It is my understanding that the Agency's hazard warning labeling requirements are only applicable to the actual container (e.g., bag, bottle, box, etc.) holding the shipped item. In the event that the outside of the primary container becomes contaminated, a biohazard label would also be required on a secondary container. OSHA regulations would not, however, require any labeling on the outer, tertiary shipping carton provided that the product is fully contained by the inner containers and there is no reasonably anticipated employee contact with blood.

Question 2:  Is this understanding correct? Would it also apply to shipping blood specimens?

Response:  Yes. The intent of the labeling requirements under the standard is to communicate the hazard of the blood or OPIM to the employees. If the primary and secondary containers are labeled appropriately, it is assumed that the hazard has been communicated and the employees would be protected on the packing, shipping, and receiving ends. Further, any labeling of tertiary or outermost containers would not be mandated by OSHA, but rather by the Department of Transportation.

Scenario 3:  ...At least one medical equipment manufacturer... has not yet identified a chemical sterilant or tuberculocidal disinfectant that is compatible with a particular type of equipment that performs numerous automated immunodiagnostic assays... The employer's exposure control plan explains the limitations of the decontamination process and includes protective measures to be followed when the equipment is serviced or shipped.

Question 3:  Is this an acceptable interim measure while a chemically compatible EPA-registered tuberculocide is being identified and validated?

Response:  Yes. In the scenario that you describe, complete decontamination of equipment may not be feasible. Therefore, it is important that the employer document all methods of compliance relating to potential blood and OPIM hazards in its exposure control plan (ECP), specifically those related to methods of decontamination and proper handling of contaminated equipment. The ECP must be reviewed and updated at least annually. When an appropriate decontaminant for this equipment becomes available, the employer would be required to use it and include that information in the ECP.

Question 4:  If the item to be shipped is a contaminated sharp, would OSHA agree that the sharp is required to be deposited directly into a puncture resistant container for shipping, and that prior to shipment decontamination is not necessary? Assume that the consignee is aware of the shipment, the shipper and consignee employers have incorporated instructions into their exposure control plans and trained employees, and the sharp is decontaminated upon receipt - prior to any manual handling.

Response:  According to paragraph (d)(4)(iii)(A)(1) of the standard "(c)ontaminated sharps shall be discarded immediately or as soon as feasible in containers that are: (i) closable; (ii) puncture resistant; (iii) leakproof on sides and bottom; and (iv) labeled or color-coded in accordance (with the standard)." The purpose for this requirement is to prevent occupational needlesticks and other percutaneous injuries from contaminated sharps. Therefore, OSHA requires that contaminated sharps (e.g., reusable scalpels, needles, etc.) be put directly in a sharps container after use, without individual device decontamination. This minimizes employee handling of devices, thereby decreasing the risk of an injury.

If a reusable sharps container is shipped to another facility to be decontaminated or reprocessed, of course, all the aforementioned labeling and shipping requirements would apply. When opening and emptying a container in order to decontaminate or clean the reusable items in it, the process to open that container must be done in a manner that is not manual, as discussed in paragraph (d)(4)(iii) of the standard. The procedures and protocols used for the disposal of and/or decontamination of reusable sharps must also be included in the ECP.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. 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. If you have any further questions, please feel free to contact the Office of Health Compliance Assistance at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Compliance Programs