December 15, 2000

Ms. Carol Vierling
Manager, Regulatory Affairs
Bard Peripheral Technologies
C.R. Bard, Inc.
13183 Harland Dr., NE
Covington, GA 30014

Dear Ms. Vierling:

Thank you for your October 13, 2000 letter to the Occupational Safety and Health Administration's (OSHA's) Atlanta Regional Office. Your letter was forwarded to the Directorate of Compliance Programs at OSHA's National Office for a response to your question regarding the applicability of the Bloodborne Pathogens Standard (29 CFR 1910.1030) and the newly passed Needlestick Safety and Prevention Act to biopsy needles and instruments. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any situation not delineated within your original correspondence. Your question is restated below followed by our response.

"It may not be possible to design a biopsy needle or instrument with engineered sharps injury protection (ESIP) that allows a tissue sample to be taken with the quality necessary for diagnosis. Are (biopsy needles and instruments) included in the safety needle legislation...?"

As you know on November 6, 2000 President Clinton signed "The Needlestick Prevention and Safety Act" which directs OSHA to make several changes to the Bloodborne Pathogens standard. These changes must be incorporated into the standard before May 2001. Currently however, paragraph 1910.1030(d)(2)(i) already requires the use of engineering and work practice controls where employee exposures can be eliminated or minimized to the lowest extent feasible. It further states that "(e)ngineering controls shall be examined and maintained or replaced on a regular schedule to ensure their effectiveness." Some examples of engineering controls used to control the hazards of needlesticks include needleless intravenous (IV) systems, "self-sheathing," and/or "self-blunting" needles. OSHA Instruction [CPL 02-02-069 (formerly CPL 2-2.69)], Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, further clarifies the requirements of the standard.

[CPL 02-02-069] explains that the prevention of exposures to bloodborne pathogens requires a comprehensive program, including engineering and work practice controls. If engineering and work practice controls do not eliminate exposure, the use of personal protective equipment is required. Of course, engineering controls must be implemented where their use is feasible. If the use of an engineering control, in this case a sharp with engineered sharp injury protection (SESIP), compromises patient safety or procedural integrity, it would not be considered feasible.

The standard and the new act also recognize that market availability is another limiting factor in implementing the use of engineering controls and must be considered in both your choice of an engineering control and our enforcement of their use. The appendix of the directive has several resources designed to aid the employer in evaluating safer medical devices and SESIPs.

Again, it is important to safeguard both patients and employees during medical and surgical procedures. Therefore, the employer must determine what engineering and work practice controls effectively minimize hazards without unduly interfering with medical procedures. However, please be aware that where exposures have been determined and where engineering controls are feasible, they must be used.

Another related issue is the disposal of contaminated biopsy needles. The standard requires that, "(i)mmediately or as soon as possible after use," contaminated sharps must be placed in appropriate containers until properly reprocessed or disposed. The requirements for disposal containers are detailed in paragraph 1910.1030(d)(2)(viii).

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 Enforcement Programs]

[Corrected 6/2/2005]