April 20, 2004

Mr. Mark Licata
V.P. Regulatory Affairs
[PDMP, Inc.
105 Loudoun SW
Leesburg, Va 20175]

Dear Mr. Licata:

Thank you for your December 9, 2003 letter to the Occupational Safety and Health Administration (OSHA) regarding the applicability of [PDMP, Inc.] Needleguard^™, which uses a method of disabling the needle of a luer-type syringe after use. The Needleguard^™ as an engineering control for use in a hospital setting. Your letter addresses a specific issue, which has been restated below, followed by OSHA's response. We apologize for the delay in providing you a response.

Issue: [PDMP, Inc.] has developed a product, Needleguard^™, which uses a method of disabling the needle of a luer-type syringe after use. The Needleguard^™ is a portable encapsulation device designed to permanently adhere the luer lock and bottom hub of the syringe into a sheath after the healthcare provider has used the syringe on a patient. [PDMP, Inc.] has been asked by the Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH) to get an opinion from OSHA regarding the use of the Needleguard^™ in a hospital environment.

Response: The information you provided us described the Needleguard^™ as "a self-contained sharps disposal device that permanently and fully encloses, by encapsulation, the needle of a luer-type syringe." The bloodborne pathogens standard establishes several requirements for containers used for discarding contaminated sharps. The standard requires that such containers be (1) closable, (2) puncture-resistant, (3) leak proof on sides and bottom, and (4) labeled or color-coded [29 CFR 1910.1030(d)(4)(iii)]. If the Needleguard^™ meets this definition, then, like other sharps disposal containers, this device is proper sharps container. Because the Needleguard^™ is intended to eliminate the needle after use, it may be beneficial in reducing or eliminating exposure to downstream workers. However, it provides no protection to an employee after contamination with blood or other potentially infectious materials (OPIM) and prior to placing the needle in the device. This is where employee exposure occurs.

In hospitals and other healthcare facilities where medications are administered using syringes, devices are currently available that will reduce exposures prior to the point of disposal. OSHA has previously responded to a substantially similar question regarding another product (Letter to George Salem, September, 2002). In that response, OSHA stated: "Where feasible, the most effective way of removing the hazard of a contaminated needle is to eliminate the needle altogether by converting to needleless systems. In other situations, the hazard can be reduced through using a sharp with engineered sharps injury protection (SESIP), which isolates the sharp from the healthcare worker as it is withdrawn from the patient." Additionally, OSHA has previously stated that, "the most effective way of removing the hazard of a contaminated needle is to eliminate the needle completely by converting to needleless systems. If this is not possible, removal of the hazard as soon as possible after contamination is required. This is best accomplished by using a sharp with engineered sharps injury protection (SESIP)" (Letter of Interpretation to Congressman LaTourette, June 27, 2001).

To comply with 29 CFR 1910.1030, an employer must evaluate, select and ensure use of engineering and work practice controls that will "eliminate or minimize employee exposure" [29 CFR 1910.1030(d)(2)(i)] and employers must solicit input from non-managerial employees in the selection process [29 CFR 1910.1030(c)(1)(iv)-(v)]. In previous interpretation letters OSHA stated the use of SESIPs provided a first line of defense against needlesticks. As such, Needleguard^™ may be most appropriate for clinical procedures where SESIPs are either not feasible or not commercially available (for example, certain procedures in pediatrics, dermatology, or the administration of certain allergy medications).

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 athttp://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
[Corrected 07/02/2007]