California needle-safety law: Is it a prelude to a national regulation?

Exceptions, cost factors are unresolved issues in new California law

In what many suspect is a preview of national regulatory action, infection control professionals in California are scrambling to comply with a landmark state law requiring use of needle-safety devices to prevent bloodborne infections in health care workers.

The first law of its kind in the nation, the California legislation requiring implementation of needle-safety devices was signed into law Oct. 1, 1998. The statute directs the state division of Occupational Safety and Health (Cal-OSHA) to enforce the law by amending the bloodborne pathogen standard, the state version of the 1991 federal OSHA bloodborne regulation. Cal-OSHA issued an emergency amended standard on Dec. 17, 1998. That regulation still is subject to review and revision prior to issuance of a final enforcement standard, but health care facilities in California essentially have until Aug. 1, 1999, to come into compliance by implementing the use of needle safety devices.

As a result, observers report that health care purchasing departments in California are being inundated with safety products that include such designs as self-sheathing needles, retractable devices, blunting devices, and needleless connectors for intravenous lines. That makes it all the more important for ICPs to get involved in the evaluation process and determine the most appropriate method of compliance for their facility, says Marguerite Jackson, RN, PhD, CIC, FAAN, administrative director of the medical center epidemiology unit at the University of California in San Diego.

"The purchasing people are being bombarded with widgets," she tells Hospital Infection Control. "It is absolutely critical that the ICP be a key player in this process."

The Cal-OSHA regulation does not require specific safety devices by brand name, but calls for use of needleless systems or sharps with engineered injury protection designs. In effect, the regulation requires that health care employers replace conventional needle devices with such designs unless they can cite one of Cal-OSHA’s regulatory exceptions, which are market availability of the device, patient safety, safety performance, and availability of safety performance information. (See box, at right.)

"There are four exceptions, and you can use your own data to support decisions you make," Jackson says. "Obviously, no one can afford to buy everything that is out there."

While heading up a task force at her facility to respond to the law, Jackson also has participated in several state meetings with other ICPs in her role as infection control advisor to the California Healthcare Association. She is stressing the importance of forming multidisciplinary evaluation committees that allow front-line health care workers, union representatives, and other key players to participate in the process of device evaluation.

"The first thing that [committees] need to do is assess their need for safety devices for hollow-bore needles that are blood-filled," she says. "That is where the major exposure risk is, so everybody needs to develop an action plan to systematically evaluate the classes of devices that are available, and then determine whether there is efficacy data for these devices that is not manufacturer-derived."

Indeed, data from the EPINet surveillance system in Charlottesville, VA, indicate that many hospitals nationally have implemented needleless intravenous systems, for example, to prevent needlesticks. But the IV line injuries being prevented are generally considered at relatively lower risk for transmission of bloodborne patho gens, while protective devices for prevention of higher-risk exposures during phlebotomy or IV catheterization have not been as widely used. (See related story, p. 22.)

Similar findings were reported by Cynthia Fine, MSN, CIC, infection control and employee health consultant for Catholic Healthcare West (CHW) in Oakland, CA. Fine is heading up a comprehensive evaluation and compliance program for some 50 CHW hospitals. She has developed an overall action plan and is working with individual ICPs at the other hospitals to bring the CHW system into compliance with the new state law. Tools used to implement the plan include a checklist of criteria for device selection and sharps evaluation forms, which Fine created from various sources. (See checklist, below; form, p. 20.)

"We’ve been trying to pull in the front-line workers to look at these devices and give us their feedback," she says. "Then we evaluate them using the standard criteria. Those that meet our criteria are going to trial. We have selected five or six hospitals that are interested in working with us on [trials]. We are going to trial them, and then we will make recommendations to business services."

The effort began with a survey of 39 CHW hospitals to collect baseline data as Fine launched the program. Of the 30 facilities that responded, 100% have implemented a needleless or needle-safety device for IV fluid/medication administration. But when looking at devices designed to prevent exposures that have a higher risk of transmission of bloodborne patho gens, Fine found that only 53% of the facilities had implemented safety devices for IV catheter insertions, and 40% reported use of safety-designed phlebotomy devices. Devices to prevent exposures during phlebotomy and insertion of IV catheters are among those that will be trialed under the program, she adds. Though no decision on the issue has been made yet, such findings raise the question of whether hospitals can defer some of the money spent on IV line safety systems to purchase devices designed to prevent injuries with a higher risk of transmission, Fine explains.

"We are focusing on the high-risk devices for IV starts, phlebotomy, and the hollow-bore syringes," she says. "My hope is that [Cal-OSHA] would be understanding if a facility put its money into high-risk devices and saved it on IV tubing. We’ll see."

Indeed, compliance cost issues are critical as the California health care system begins a large-scale implementation of devices that often are much costlier than conventional needles. According to one industry estimate, for example, a phlebotomy device that demonstrated a 76% reduction in injuries costs about 22 cents more per unit than a conventional blood-drawing needle, resulting in an estimated overall increase of $14,500 annually for a 350-bed hospital.1 (See related story in Hospital Infection Control, February 1998, pp. 20-21.) Of course, ICPs trying to justify the purchase of such equipment often factor in cost savings due to reduced exposures and worker follow-up, which has become more expensive with the new postexposure prophylaxis regimens for HIV. It also is hoped that the opening up of such a large state health care market will contribute to mass production, competition, and lower device prices.

"It’s going to be expensive and difficult, but it is something that we are supporting as an industry," says Roger Richter, senior vice president of professional services at the California Healthcare Association. "We think it is realistic when [the] exceptions are allowed. . . . Cost is the big change. We are just hopeful that the vendors will start bringing their prices down, since they will be selling more products."

Fine notes she has been instructed to ignore cost when selecting devices for use in CHW facilities, and business and administrative officials will work out the purchasing contracts.

"We have contracts currently, but if we find devices that meet our needs better, we can go outside of our contracts," she says.

While costs and impact will vary, there is some question of whether the regulation will translate to budget crunching and pared-down clinical and support staffs at some facilities in California. The costs will be borne by institutions rather than through patient reimbursements, Jackson notes.

"I’m quite sure — since California often leads the way — that this will be reviewed very carefully [nationally]," she says. "What is going to be important is whether there are any outcome data that suggest it makes a difference. Because it is going to have a substantial financial impact on an industry that is already very stressed financially."

Again, the best way to protect workers in a cost-effective manner is to target high-risk exposures for needle-safety devices, emphasizes Julie Sellers, RN, CIC, chairperson of the governmental affairs committee at the Washington, DC-based Associa tion for Professionals in Infection Control and Epidemiology (APIC). APIC has followed the California situation closely and recently issued a position paper on the issue of needle-safety devices in light of such state and national efforts.2 (See related story, p. 21.) But Sellers says the exceptions are so narrowly written in the California law that it will "be very difficult for a facility to opt out."

To head off a similar situation occurring on a national scale, APIC has offered to assist federal OSHA in educational efforts to help facilities conduct appropriate epidemiological assessments to enable them to target needle-safety devices toward prevention of high-risk injuries.

"That’s the approach we want to advocate: a smart approach instead of a blanket approach," Sellers says. "We know the sticks that are risky — hollow-bore needles that have been deep in tissue and have visible blood."

Regardless, in the wake of the California law and a recent request for information on needle-safety devices by OSHA, there is a growing consensus that regulatory action nationwide will follow.

"I don’t know that it is necessarily going to be like the California regulation in terms of content, but I do believe OSHA is going to develop some type of revision to the bloodborne standard that might provide them with more enforceable language in the section about engineering controls and specifically sharps devices," Sellers says.

Despite the cost issues, even some ICPs — a group traditionally opposed to legislative solutions to clinical problems — see benefits of regulatory action in light of the longstanding problem of needlesticks and foot-dragging on the part of some facilities in purchasing safety devices.

"Even amongst our ranks, there is concern because there are facilities that have not responded responsibly," Sellers says. "There are practitioners who feel the need of regulations in order to get accomplished what they know needs to be done."

Indeed, Fine prefers to look at the challenge as "an opportunity," noting that many ICPs have been trying for years to prevent needlesticks and implement safer devices. Still, the situation has created a difficult balancing act in which legitimate safety concerns of workers must be weighed against real-world issues of cost and compliance.

"If we advocate for the use of funds foolishly, we recognize that there are other programs within institutions that might not get funded that could also impact worker safety," Sellers reminds. "We have to look at the big picture. We are absolutely advocates of safety, but we are also agents of our facilities and we have to be fiscally responsible."

References

1. Centers for Disease Control and Prevention. Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures — Minneapolis-St. Paul, New York City, and San Francisco, 1993-1995. MMWR 1997; 46:21-25.

2. Association for Professionals in Infection Control and Epidemiology. APIC 1997 and 1998 Guidelines Committees. APIC position paper: Prevention of device-mediated bloodborne infections to health care workers. Am J Infect Control 1998; 26:578-580.