February 8, 2023

Dr. Michael Sinnott, MBBS, FACEM, FRACP
Staff and Patient Safety
P.O. Box 5677,
West End,
Brisbane, Queensland, 4101
AUSTRALIA

Dear Dr. Sinnott:

Thank you for your November 29, 2021 letter to the U.S. Department of Labor, Occupational Safety and Health Administration's (OSHA) Directorate of Enforcement Programs, regarding questions related to OSHA's Occupational Exposure to Bloodborne Pathogens standard, 29 CFR § 1910.1030. Specifically you are requesting clarification on what is considered to be "Engineering Controls" and "Administrative Controls" pertaining to the Bloodborne Pathogens standard. This letter constitutes OSHA's interpretation only of the requirements herein, and may not be applicable to any questions not delineated within your original correspondence.

Question 1:Is a single-handed scalpel blade removal device used during the removal of scalpel blades considered an engineering control to prevent injuries?

Response:OSHA's Occupational Exposure to Bloodborne Pathogens standard requires employers to use engineering and work practice controls to protect employees [29 CFR § 1910.1030(d)(2)(i)], and prohibits the bending, recapping, or removal of contaminated needles or other contaminated sharps [29 CFR § 1910.1030(d)(2)(vii)(A)]. The standard defines engineering controls as "... controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." [29 CFR § 1910.1030(b)]. To comply with the standard, an employer must use engineering and work practice controls that will "eliminate or minimize employee exposure" [29 CFR § 1910.1030(d)(2)(i)]. OSHA's Bloodborne Pathogens compliance directive explains that under this requirement "the employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent" [OSHA CPL 02-02-069, Section XIII, D.2.].

Please note that OSHA does not register, certify, approve, or otherwise endorse commercial or private sector entities, products, or services. In regard to the single-handed scalpel blade removal device you are inquiring about, like sharps containers and needle destruction devices (NDDs), a single-handed scalpel blade removal device is an engineering control for the point of disposal (See OSHA's September 25, 2008 letter to William F. Butler). However, it must be used as intended by the manufacturer, and used in accordance with the Bloodborne Pathogens standard (e.g., located as close as possible to the point of use, use of one-handed technique). Hand-to-hand passing in the operating room must be eliminated.
In addition, the use of a single-handed scalpel blade removal device does not replace the employer's responsibility under the Bloodborne Pathogens standard to first evaluate the efficacy of the use of safer medical devices, such as safety engineered scalpels. As stated in OSHA's December 22, 2005 letter to you, a single-handed scalpel blade removal device can be used to comply with 29 CFR § 1910.1030(d)(2)(vii)(B) as the use of a mechanical device only after an employer has demonstrated that the use of a scalpel with a reusable handle is required by a specific medical or dental procedure or that no alternative is feasible.

Question 2: Are the use of artery forceps, needle holders, and Kelly forceps/grips considered engineering controls for the removal of scalpel blades since they are not specifically designed to isolate a sharp hazard from the healthcare worker?

Response:The use of artery forceps, needle holders, and Kelly forceps/grips to remove scalpel blades are not considered engineering controls because they do not isolate or remove the bloodborne pathogens hazard from the workplace. The Bloodborne Pathogens standard strictly prohibits removal of contaminated sharps unless the employer can demonstrate that no alternative is feasible or that such actions are required by the procedure. In situations where an employer has demonstrated that the use of a scalpel with a reusable handle is required by a specific medical or dental procedure or that no alternative is feasible, the blade removal must be accomplished through the use of a mechanical device or a one-handed technique [29 CFR § 1910.1030(d)(2)(vii)(B)], such as a single-handed scalpel blade removal device as described in Question 1.

Question 3: Are training requirements, work practice controls, and exposure control plans (ECPs) considered to be administrative controls per CDC, NIOSH, and OSHA publications?

Response:The term "administrative controls" is used in a variety of ways across the field of occupational safety and health describing a multitude of controls to assist in hazard prevention and control. In the OSHA publication you refer to, Recommended Practices for Safety and Health Programs (October 2016), OSHA suggests using a multi-element approach to implement safety and health programs, first describing management leadership, followed by worker participation, hazard identification and assessment, hazard prevention and control, education and training, program evaluation and improvement, and lastly, communication and coordination for host employers, contractors, and staffing agencies.

As part of a comprehensive approach to managing occupational exposures to bloodborne pathogens, both work practice controls (also called administrative controls) and training are required to be part of the implementation of an ECP per 1910.1030(c)(1)(ii)(B). Work practice controls fall under the hazard prevention and control step of the OSHA recommended practices, and training falls under the education and training step, both of which are part of the overall ECP.

Question 4:Are "how to use" videos and "instructions for use" videos for engineering controls considered to be administrative controls?

Response: See response to Question 3.

Question 5: Are interactive training applications on how to use engineering controls considered to be administrative controls?

Response: See response to Question 3.

Question 6: Are educational presentations and sessions about sharps injuries considered to be administrative controls?

Response: See response to Question 3.

Question 7: Is it correct that personal protective equipment (PPE) should always be used in conjunction with higher levels of control and never as a substitute for higher levels? Response: Yes. As outlined in the OSHA publication, Recommended Practices for Safety and Health Programs, PPE is the least effective control in a safety and health program. In addition, the Bloodborne Pathogens standard, 29 CFR § 1910.1030(d)(2)(i) states, "Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used."

Response: Yes. As outlined in the OSHA publication, Recommended Practices for Safety and Health Programs, PPE is the least effective control in a safety and health program. In addition, the Bloodborne Pathogens standard, 29 CFR § 1910.1030(d)(2)(i) states, "Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used."

Thank you for your interest in occupational safety and health. I hope you find this information helpful. OSHA's requirements are set by statute, standards, and regulations. Letters of interpretation do not create new or additional requirements but rather explain these requirements and how they apply to particular circumstances. This letter constitutes OSHA's interpretation of the requirements discussed. From time to time, letters are affected when the agency updates a standard, a legal decision impacts a standard, or changes in technology affect the interpretation. To ensure that you are using the correct information and guidance, please consult OSHA's website at www.osha.gov. If you have further questions, please feel free to contact OSHA's Office of Health Enforcement at 1-202-693-2190.

Sincerely,

Kimberly A. Stille, Director
Directorate of Enforcement Programs