June 3, 2005

Mr. Craig Voellmicke
Product Manager
BD Medical
MC 208
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Mr. Voellmicke:

Thank you for your December 14, 2004, letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). Your letter requested clarification on the selection and use of engineering controls, e.g., sharps with engineered sharps injury protection (SESIPs), under the bloodborne pathogens standard 29 CFR 1910.1030. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. Your questions are rephrased below, followed by OSHA's responses. We apologize for the delay in providing a response.

Question 1: Does OSHA's definition for "contaminated sharp" include non-needle sharps such as blades and scalpels? If a facility used conventional blades and scalpels, and if safety-engineered options were commercially available, would healthcare facilities be required to use them?

Reply 1: As you know, the bloodborne pathogens standard defines "contaminated sharps" as "any contaminated object that can penetrate the skin, including but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires," 1910.1030(b). Scalpels and blades are included in this definition.

In response to the second part of this question, if safety-engineered blades and scalpels were commercially available, a healthcare facility would be required to evaluate them for appropriateness and effectiveness. Since no one device is appropriate for use in all circumstances, the decision to select a safety device is always based upon evaluation and a determination that the device is appropriate and effective for the particular procedure, 1910.1030(c)(1)(iv). Since safety-engineered blades and scalpels are types of engineering controls within the meaning of 1910.1030(b), their use is required by the employer if they are engineering controls which will eliminate or minimize employee exposure, 1910.1030(d)(2)(i).

Question 2: The standard does not require engineering controls if their use would compromise worker or patient safety or if they are not commercially available. Does the standard excuse an employer from using engineering controls because of practitioner preference?

Reply 2: In many cases, a practitioner's "preference" is a result of a familiarity with a device and a reluctance to break routine. It is true that clinicians might initially consider the use of a newly selected safety device to be cumbersome or awkward and in most cases they may simply need additional practice or training until they feel comfortable using a new and different device. Thus, practitioner preference is generally not an excuse for failure to use engineering controls. In some surgical procedures, however, the "feel" of a device in the hands of the surgeon may be crucial to properly executing the surgical technique. The importance of the "feel" of a device could be a critical factor which may affect the outcome of the procedure and, ultimately, the safety of the patient. The intent of the OSHA standard was never to usurp the practitioner's authority in deciding the best method of achieving a positive health outcome for a patient during a procedure. The standard requires that employers use engineering and work practice controls to eliminate occupational exposure to the lowest feasible extent, 1910.1030(d)(2)(i). OSHA recognizes there might be unique circumstances where the safety of the patient or the integrity of a procedure might be best served with the use of a device that is not a safety device. In those situations, it is important that good work practice controls, such as eliminating hand-to-hand instrument passing in the operating room, be implemented to provide protection to employees who are at risk of getting injured by an unprotected device.

Question 3: Practitioners may feel that in some specific procedures in certain clinical scenarios a situation may arise where implementation of an engineering control, such as SESIPs, might result in a potential negative clinical outcome. How must this be documented and demonstrated in order to fulfill compliance with the standard?

Reply 3: Engineering and work practice controls that the employer determines to be appropriate must be documented in the employer's Exposure Control Plan (ECP), 1910.1030(c)(1)(ii)(B). If a safer medical device compromises patient safety, worker safety or the medical integrity, its use would not be required. Whether or not an engineering control is chosen for a specific procedure, an annual review of safer medical devices is required and that review must be documented in the ECP, 1910.1030(c)(1)(iv)(B).

Thank you for your interest in occupational safety and health. We hope this provides the clarification you were seeking. 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 Enforcement at 202-693-2190.

Sincerely,


Richard E. Fairfax, Director
Directorate of Enforcement Programs