Needleless vascular connectors and sharps protection

March 22, 2016

William Hyman, ScD

[Recipient address omitted]

Dear Dr. Hyman:

Thank you for your July 6, 2015, letter to the Occupational Safety and Health Administration's (OSHA) Directorate of Enforcement Programs regarding OSHA's Bloodborne Pathogens (BBP) 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 situation is summarized below, and your paraphrased questions are followed by our responses.

Background: The following questions are based on the assumption that a facility has established an Exposure Control Plan that complies with the requirements of the BBP standard at paragraphs 1910.1030(c)(1) through (c)(2).

Question 1: Does OSHA have an absolute requirement that needleless connectors be used on vascular access lines?

Response: Yes. Needleless connectors are engineering controls developed to eliminate needlestick injuries to healthcare workers. 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) (emphasis added). The term "needleless systems is defined as "...a device that does not use needles for: (1) The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; (2) The administration of medication or fluids; or (3) Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps." 29 CFR 1910.1030(b). The inclusion of needleless systems in the definition of engineering controls and the definition of "needleless systems" were mandated by Congress in the Needlestick Safety and Prevention Act, Pub. L. No. 106-430, § 3, 114 Stat. 1901 (2000). OSHA's BBP standard requires that employers use engineering and work practice controls to eliminate or minimize occupational exposure to bloodborne hazards to the lowest feasible extent in the workplace. [29 CFR 1910.1030(d)(2)(i) and Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, CPL 02-02-069, par. XIII.D.2 (2001)]. The most effective way of removing the hazard is to eliminate the needle completely by using needleless systems. 56 FR 64004, 64060 (Dec. 6, 1991).

Your letter states that needleless connectors may be sources of patient infection. However, there is evidence in the literature1 and guidance from the Centers for Disease Control and Prevention (CDC)2 that control of patient infections related to needleless connectors may be addressed by the following measures, among others:

• Selection and use of appropriately designed needleless connectors;

• Education and training of healthcare workers in hospital and manufacturer protocols for using the devices; and,

• Proper work practices, including the use of disinfectants and regular maintenance of the needleless connectors.

Question 2: Is it acceptable to use a safety-engineered needle syringe to access a non-needle-less ("traditional" or full septum) connector?

Response: As previously stated, a device that eliminates the needle completely is most effective in reducing the hazard to the lowest feasible extent. Unnecessarily re-introducing a needle defeats the intended purpose of the needleless connector.

Question 3: Assuming that the facility performs a proper assessment, can a safety-engineered needle syringe be used to access a needleless connector?

Response: See the responses to questions 1 and 2, regarding the introduction of a needle into a medical procedure that does not require the use of a needle. The introduction of a needle into a needleless system may also be incompatible with the design of the device or product approvals and may compromise the integrity of the connection to the patient.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA's requirements are set by statute, standards, and regulations. Our interpretation letters 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 assure that you are using the correct information and guidance please consult OSHA's website at www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2100.

Sincerely,

Thomas Galassi, Director

Directorate of Enforcement Programs

1. Tabak Y, Jarvis W, Sun X, Crosby C, Johannes R. "Meta-analysis on central line-associated bloodstream infections associated with a needless intravenous connector with a new engineering design." American Journal of Infection Control (2014), Vol. 42, Issue 12, 1278–1284.

2. O'Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011.html