OSHA restates edict: Don’t reuse tube holders
Information bulletin may spark enforcement
Consider this the final and official notice: The Occupational Safety and Health Administration (OSHA) has stated again that blood tube holders cannot be removed from devices for reuse.
OSHA’s information bulletin on blood tube holders is likely to lead to increased enforcement action. That will mirror the enforcement that has occurred in California, where Cal-OSHA has issued citations for reuse of blood tube holders since 1999.
"It’s not optional," stresses Deborah Gold, MPH, CIH, Cal-OSHA senior industrial hygienist. "[Hospitals] are going to need to make this change. They need to sit down and think about how they’re going to do this."
In case anyone didn’t understand OSHA’s previous compliance directive on the topic or a 2002 letter of interpretation, the bulletin stated: "Prevention of needlestick injuries during disposal of sharps, following phlebotomy procedures, depends on immediate disposal of the blood tube holder unit, with SESIP [sharp with engineered sharps injury protection] attached, and as a single unit after each patient’s blood is drawn."
If a blood tube holder must be reused for a procedure, OSHA requires "documentation by the employer that alternatives are infeasible or that this action is required by a medical procedure."
For clarification, the agency added, ". . . This includes a prohibition against the removal of contaminated needles from blood tube holders following a blood drawing procedure."
"Single-use blood tube holders, when used with engineering and work practice controls, simply provide the best level of protection against needlestick injures," OSHA administrator John Henshaw said in a release. "That is why the standard generally prohibits removing needles and reusing blood tube holders."
OSHA noted that some hospitals and other health care facilities may need to purchase new disposal containers to hold the single-use devices. "Many sharps containers are designed with openings that do not allow for disposal of a SESIP that is attached to the blood tube holder," the bulletin stated. "These containers would not be in compliance with the bloodborne pathogens standard. Employers must ensure that where blood is being drawn, the sharps container is appropriate for immediate disposal of sharps."
OSHA also addressed a specific scenario involving the removal of the needle from a tube holder:
"A situation may exist that necessitates using a syringe to draw blood and transfer the collected blood into a test tube before disposing of the contaminated syringe. In such a situation, a syringe with engineered sharps injury protection must be used. Removal of the safety-engineered needle must be accomplished after activation of the safety feature and using safe work practices [including use of mechanical means of removal whenever possible]. Transfer of the blood from the syringe to the test tube must be done using a needleless blood transfer device."
The switch to single-use blood tube holders has been a major adjustment for hospitals, as they dealt with greater quantities of medical waste. California hospitals began wrestling with this issue in 1999, when Cal-OSHA began enforcement action.
At some hospitals, phlebotomists use a small disposal container on their carts as they go from room to room. "Those small containers will obviously fill up faster," Gold says. Some hospitals have designated a "dirty room," where they temporarily keep red bag [medical] waste. "They dealt with it by just having a supply of the small containers on the floor."
Hospitals have fitted the trays or carts with larger containers or have added containers at the patients’ bedside, she says.
San Ramon (CA) Medical Center reevaluated its sharps containers and installed larger containers. Overfilled disposal containers create a hazard and have led to needlesticks, notes Cindy Fine, RN, MSN, CIC, director of infection control and employee health.
The hospital also was able to work with manufacturer Becton Dickinson to obtain a lower price for the Vacutainer devices, since they would be purchasing a much greater quantity, she says.
"Hospitals have been able to make this change, and it hasn’t had a huge financial impact," Fine says.
The cost of converting is outweighed by the astronomical cost of a single seroconversion to HIV or hepatitis C from a stick with the back end of a needle, notes Gold. Add to that the emotional cost — the anxiety felt by employees after a needlestick as they wait testing of the source patient or undergo post-exposure prophylaxis, she says.
"Dealing with that needlestick is not cheap, even with a needlestick that has the best outcome," Gold stresses.
Lab companies object to single use
Yet not everyone is on board with OSHA’s edict to switch to single-use devices. Clinical laboratories have argued that there virtually is no risk of needlestick from the back end of a needle if mechanical devices are used to release the needle into the disposal container.
EPINet data from the International Health Care Worker Safety Center at the University of Virginia in Charlottesville indicated that 11% of injuries from vacuum blood collection needles/tube holder sets occurred while the health care worker was disassembling the device. Of 114 descriptions of injuries from phlebotomy devices in the last two years, 12 health care workers reported being stuck by the back end of the needle.
The American Clinical Laboratory Association (ACLA) in Washington, DC, asked OSHA to retract its position on multiple-use holders. The single-use holders are "flimsy" and could actually increase the risk of needlesticks, the association asserted in a position paper. "[T]he perverse effect of OSHA’s arbitrary action is that phlebotomists will be exposed to more risk of needlesticks, not less," the ACLA said.
Use of single-use holders would create as much as 10 times the amount of waste, result in a fivefold increase in cost, and create risks from overfilled sharps containers, according to the association.
Using single-use holders is consistent with the bloodborne pathogen standard because "no alternative is feasible," the ACLA said. In fact, with large laboratories performing 50 million or more specimen draws a year, it is "presently not possible" to obtain enough single-use holders for clinical laboratories, it added.
Last spring, OSHA withdrew citations against corporate laboratory giants Laboratory Corp. of America and Quest related to the reuse of blood tube holders and met with industry representatives to discuss their concerns. However, with the information bulletin, OSHA makes it clear that the interpretation of the bloodborne pathogen standard has not changed.
(Editor’s note: For a copy of the information bulletin, go to: www.osha.gov/dts/shib/shib101503.html.)