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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.
September 25, 2008
William F. Butler
Q Care International, LLC
680 Atlanta Country Club Drive
Marietta, GA 30067
Dear Mr. Butler:
Thank you for your letter to the Occupational Safety and Health Administration (OSHA) regarding the Q104 needle removal device as an engineering control under OSHA's bloodborne pathogens standard, 29 CFR 1910.1030. According to the information you provided, the device is designed to use electronic circuitry to heat and decontaminate a used needle and then remove the needle from its connection point to the syringe. During a phone conversation with a member of our staff, you clarified that you are requesting OSHA's written opinion on whether use of this product by employees in healthcare settings would violate the requirements of the bloodborne pathogens standard. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question(s) or scenarios not delineated within your original correspondence.
OSHA's bloodborne pathogens standard prohibits the bending, recapping, or removal of a contaminated needle or other contaminated sharp [29 CFR 1910.1030(d)(2)(vii)(A)]. The standard provides an exception where an, "employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure." The standard goes on to provide: "such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique" [29 CFR 1910.1030(d)(2)(vii)(B)].
For the limited circumstances where these criteria are met, the Q104 appears to be a type of mechanical removal device that could be considered. OSHA may not approve or endorse particular products.
The agency has previously responded to substantially similar questions regarding needle destruction devices (NDDs) and other products marketed as safer needle alternatives. Like sharps containers and NDDs, the Q104 is an engineering control for the point of disposal. In clinical settings, the Q104 may not always be located immediately next to the point of use and may necessitate moving across the room or work area to deposit an unprotected, contaminated sharp. This increases the potential for needlestick injuries between use and disposal.
These devices are designed to be used only with conventional syringes/sharps (i.e., those without a safety feature) that present a risk of exposure during use and prior to disposal. This is when most of the employee exposure occurs. According to 2004 data from EPINet at the International Health Care Worker Safety Center at the University of Virginia, most injuries from contaminated sharps occur during use (41%), between steps (12%), and during other activity after use, before disposal (15%). A greater proportion of the injuries documented occurred while using conventional needles.
A very compelling study was performed at Memorial Sloan-Kettering Cancer Center in New York City comparing the percutaneous injury (PI) rates at that facility prior to the intervention of sharps with engineered safety protections (SESIPs) with PI rates following the implementation and use of SESIPs. The study found a considerable decrease in PI incidence rates after the use of SESIPs was implemented. The mean annual incidence of PIs decreased from 34.08 per 1,000 full-time-equivalent employees prior to intervention to 14.25 post-intervention (i.e., overall incidence rate of PIs was lowered by more than 50%). It should be noted also that approximately 64% of the PIs which occurred during the post-intervention period resulted from conventional (non-SESIP) device use. It was also determined that a significant proportion of PIs that did occur with the use of SESIPs could be avoided by the provision of retraining or additional training on use of those devices.1
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 appraised 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.
Richard E. Fairfax, Director
Directorate of Enforcement Programs
1 SeJean Sohn, MPH; "Effect of Implementing Safety-Engineered Devices on Percutaneous Injury Epidemiology," Infection Control and Hospital Epidemiology (July 2004): 536-542. [ back to text ]