- 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.
August 24, 2001
Mr. Don Hamer
Executive Vice President
Edwards Medical Supply
495 Woodcreek Drive
Bolingbrook, IL 60440
Dear Mr. Hamer:
Thank you for your July 20, 2001 letter to the Occupational Safety and Health Administration (OSHA) regarding OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030, and the use of standard syringes in medical settings. Thank you for further clarifying your questions over the phone with a member of our staff. Your questions are restated below, followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original response.
Scenario: We are very much aware of OSHA's revisions to the Bloodborne Pathogens Standard, effective April 18, 2001. Currently, we are able to purchase standard syringes from the manufacturer and still receive requests from our customers for these products.
Question 1: Can we sell standard syringes if the manufacturer makes them available?
Reply: Yes. Standard syringes (non-safety-engineered syringes) may still be used in certain instances in the healthcare setting.
First, where there is no occupational exposure to blood or other potentially infectious materials (OPIM) (e.g., withdrawing medication from vials, some laboratory procedures) engineering controls would not be required. Second, where safer medical devices are not commercially available or appropriate for a specific medical procedure, their use would not be required. In these instances, it is the employer's responsibility to keep abreast of new and changing technology and to consider and implement new safer devices, as they become available. Until the time that safer options become available for certain, unique medical procedures or processes, the use of standard syringes may still be prudent. We do not anticipate that there are or will be many procedures where the use of safer medical devices would not be feasible.
In general, the standard requires employers to conduct an exposure determination to assess and document job classifications, tasks, and procedures in their facilities where occupational exposure to blood and OPIM is reasonably anticipated. When and where these potential exposures may occur (e.g., withdrawing blood from a vein or artery, administering medications intravenously), an employer must use appropriate engineering and work practice controls to eliminate or minimize employee exposure to blood or OPIM. Engineering controls, in this instance, would include needleless systems or sharps with engineered sharps injury protection. When choosing a safer medical device for a specific procedure or process, the employer must solicit input from non-managerial employees. This evaluation and selection process must be documented in the ECP.
Question 2: What liability, if any, would we as a distributor face selling standard syringes?
As previously stated, it is the employer's responsibility to comply with the requirements of the standard, not the medical supply company's. However, medical supply companies and manufacturers, alike, often perform in-servicing and training to educate facility staff about the requirements of applicable federal and local standards and to train them on the proper and safe use of a variety of medical devices. For this reason, it is important that your company and others stay informed about the requirements of standards relating to your customers' needs.
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.
Richard E. Fairfax, Director
Directorate of Compliance Programs
CC: Regional Administrator, Region V