Kaiser hospital cited for splattering safety device
August 1, 2001 6 minutes read
Kaiser hospital cited for splattering safety device
Cal-OSHA action raises needle safety questions
In an action that raises questions about just what is a safety device, the California Division of Occupational Safety and Health (Cal-OSHA) cited the Kaiser Permanente Los Angeles Medical Center for using a safety syringe that splattered blood. To activate the safety feature of the Becton Dickinson Eclipse blood collection device, health care workers flip a shield over the needle. But when the shield clicks into place, blood may splatter from the needle.
Becton Dickinson officials say in their tests, the splattering occurs only 4% of the time and is mostly contained in the shield. The citation, which is being appealed by Kaiser, notes that safety devices may not cause "splashing, spraying, spattering, and/or generation of droplets of blood."
"In this particular situation, the evidence we saw suggests there’s a problem with this device, at least the way Kaiser is using it," says Len Welsh, special counsel for regulatory development at Cal-OSHA in Los Angeles. Welsh notes that the impact of the citation is limited to the single Kaiser hospital, one of 27 Kaiser facilities in California.
Yet the issue is further complicated by the fact that other safety devices also can splatter blood. The Food and Drug Administration’s adverse event reporting database includes 39 reports of devices from 1992 to 2001 that splattered blood, including an Eclipse needle, a retractable syringe, and a needleless IV connector. Some splattering may be related to the way the health care worker activates the device. But the vibration or force of the activation may actually expel a tiny amount of blood from the needle, needle safety experts say.
How are hospitals to know if the device they have chosen is safe enough to avoid a citation?
"They should look at the blood spatter issue and they should look at the needlestick issue and they should have a good handle on those issues as the device is used at their institution," advises Welsh. "If they reasonably conclude that there is not a blood spatter issue and there is not a needlestick issue, it would be hard for us to cite them. We did conclude in the case of Kaiser that there is an issue, a significant one. We could be wrong, but that’s our conclusion."
In contrast, the U.S. Occupational Safety and Health Administration (OSHA), which administers safety regulations in 26 states, has not focused on the splatter issue related to safety devices and has not issued any citations for failure to use the "safest" safety device.
An OSHA inspector would focus on the exposure control plan and documentation that the hospital had included frontline health care workers in the evaluation of available products, a senior OSHA inspector said.
SEIU decries less safe’ safety needles
The Kaiser citation stemmed from a complaint by the Service Employees International Union (SEIU), which had criticized Kaiser’s shift from a self-blunting Bio-Plexus needle to the Becton Dickinson device. "We found five people who got stuck with the Eclipse so-called safer needle when they were in the process of activating the safety feature," says Bill Borwegen, MPH, SEIU occupational health and safety director in Washington, DC.
Having won the passage of federal legislation mandating the use of safer needles, Borwegen’s focus has shifted toward promoting what he considers to be the better safety technology. The union’s views were recently aired in a segment of the 60 Minutes television news show, in which it contended that group purchasing contracts prevent health care workers from using the devices they would prefer. A phlebotomist featured on the show who had suffered a needlestick was the same person involved in the Kaiser complaint. Becton Dickinson also was a target of that television segment. (See Hospital Employee Health, May 2001, p. 56.)
"The biggest problem with the implementation of the safer needle law is that people are going to try to comply on the cheap," Borwegen says. "They’re going to try to find the cheapest safer needles." The Cal-OSHA citation, Borwegen says, is "the first case where an employer has been cited for using safer needles that aren’t really that safe."
Yet some needlestick experts question the union’s tactics and its focus on a particular manufacturer and device. Employee health professionals say health care workers take many issues into consideration when selecting devices, including the impact on patient care, and they may choose the shielding device over a device that must be activated while the needle is still in the patient.
"Frontline workers have evaluated all the products that are in use," says Jim Anderson, a Kaiser spokesman. "Even at the facility involved, there is ongoing work with a labor-management partnership committee to work on safe sharp issues, and that will continue."
Two years ago, during a complaint-related inspection of Seton Medical Center in Daly City, CA, Cal-OSHA asked about splatter caused by the BD Eclipse. The hospital demonstrated that health care workers were trained in proper techniques and could activate the device without splatter. Cal-OSHA did not issue a citation, says Cynthia Fine, RN, MSN, CIC, infection control and employee health manager at Catholic Healthcare West in Oakland, CA.
Fine also adds that health care workers evaluated a range of technologies, including retractable and self-blunting needles, and were allowed to select products not contained in the group purchasing organization contract. Most hospitals in the Catholic Healthcare West system chose the BD Eclipse or a similar Portex product, she says.
Borwegen notes that Becton Dickinson actually includes a warning about the potential for splatter on its box labeling of the Eclipse product. "All devices probably splatter to some degree. It’s a question of quantity of splatter," he says. "We’re talking about significant quantities."
Krista Thompson, CMT(ASCP), vice president and general manager of BD Preanalytical Solutions in Franklin Lakes, NJ, and a former medical technologist, cites the labeling as evidence of BD’s commitment to health care worker safety. "Even though we weren’t required to do so, we voluntarily labeled our packages to make sure health care workers are aware of this risk," she says. "We try to make health care workers aware of every potential risk. Our data suggests that this product splatters significantly less than other products we have tested on the market."
Thompson asserts that proper use minimizes splatter, and that most splatter is contained in the shield. The remaining splatter would amount to the size of a period at the end of a typed sentence, she says. "We have over 2,800 individual sites that are using this product," she says. "It is the most widely used product on the market. Most customers have chosen the product after extensive evaluation and involving frontline health care workers in the decision. It’s been a very successful product, being used every day successfully."
It disappoints Janine Jagger, MPH, PhD, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville, to see this argument focus on a particular safety device when the medical field still has so much work to do to switch from conventional to safety devices. Needlesticks represent a far greater risk to health care worker safety than the small splatter that may occur, she notes.
"The problem is that many if not most needles with engineered sharps safety features result in some splatter," she says. "This is not a new issue. It has been there from the time that the first safety devices were introduced on the market. I have been personally aware of splatter being an issue with safety devices since about 1989."
A crackdown on safety devices that may emit a small splatter when activated could have unanticipated ramifications, says Jagger. "I think this citation is very troublesome because we can’t apply the splatter criteria to one device without applying it equally to other devices," she says. "If this citation is an indication that regulatory agencies are going to apply a zero-tolerance’ criteria on the splatter issue, then we are in big trouble because a whole boatload of safety devices won’t pass; not just blood-drawing needles but retracting syringes, IV catheters, the whole range of devices."
Instead, devices should be evaluated based on their effectiveness, in large-scale studies, in preventing needlesticks, she says. "Although no splatter is better than any splatter, the most important performance criteria of an engineered sharps safety device should be it’s performance in a real-world setting in preventing needlesticks," she says.
As the Cal-OSHA appeal was pending, Kaiser and other hospitals in California continued to use the Eclipse. Anderson expressed confidence that this and other citations issued in the same Cal-OSHA inspection ultimately would be dismissed. "For people who are wondering what this all means, the best thing they can do is wait for the final resolution," he says. "Anyone who would take any action based on this stage of the process would be well advised to wait for the conclusion."
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