Landmark law enforces use of safer needles
State officials challenge OSHA to follow lead
California has become the first state in the nation to enact legislation requiring hospitals and other health care facilities to use safer needle devices designed to protect health care workers from hazardous needlesticks, a move that some see as a clarion call for the U.S. Occupational Safety and Health Administration to follow suit for HCWs nationwide.
Under the new law, health care employers must begin the move to safer devices beginning Jan. 15, 1999. California’s Occupational Safety and Health Standards Board has until Aug. 1, 1999, to issue final safety needle regulations.
The new law requires employers to provide safer needles or needleless devices except in circumstances where new technology is not available or is unsafe for patients or HCWs. Employers also must establish written plans for selecting safer devices, and they must keep a log of sharps injuries that includes the types and brands of devices involved.
The legislation, AB 1208, was introduced last summer by Assemblywoman Carole Migden (D-San Francisco) after a series of articles published in the San Francisco Chronicle reported that many safer needle devices have been on the market for nearly a decade, but safety officials were not requiring employers to provide HCWs with the newer technology that could prevent exposures to potentially fatal bloodborne infections.
California OSHA (Cal-OSHA) already had begun drafting changes to the state’s bloodborne pathogens standard mandating the use of safer needle devices, as well as administrative and work practices controls. However, Migden’s bill speeded the process by requiring Cal-OSHA to implement emergency legislation by the Jan. 15 deadline, and to have a final revised standard in place by Aug. 1.
In signing AB 1208, California Gov. Pete Wilson said the state law "will most likely become a model for a national standard." The "absence of federal guidance" prompted the state to establish "its own regulatory solution" to the problem of some 100,000 needlesticks per year among California HCWs, leading to possible exposures to HIV and hepatitis B and C, he said.
John Duncan, director of the state’s Department of Industrial Relations, says the law exemplifies California’s leadership in worker safety issues. "I challenge [federal regulators] to follow us," he states.
Federal OSHA recently published a formal request for information (RFI) on minimizing sharps injuries among HCWs, but is noncommittal about whether responses might be used to help formulate revisions to the bloodborne pathogens standard similar to those enacted in California.1 (See Hospital Employee Health, November 1998, pp. 129-132.)
When asked whether federal regulators might follow suit, an OSHA spokesman did not comment directly on the California law, but replied that the agency "recognizes the seriousness of the needlestick problem" and will "immediately begin analyzing [RFI] submissions" after the Dec. 8 deadline.
"We are serious in trying to tackle the problem," the spokesman says, "not only by looking at specific devices, but at the whole problem of sharps injuries, including engineering controls and work practices."
Industry/labor/government partnership
On a national scale, labor unions and other HCW safety activists have been the driving force behind efforts to revise the bloodborne pathogens standard. That was the case in California as well, with nurses’ groups and HCW unions strongly supporting the legislation. Nationwide, health care employers for the most part have been opposed to regulations requiring safer needle devices due mainly to the higher costs of purchasing new technology. However, in California, employers actually decided to endorse the legislation, saving it from possible doom and marking the first time that the health care industry has supported safe needle legislation.
The Sacramento-based California Healthcare Association (CHA), which represents more than 600 hospitals, health care systems, and physicians’ groups, at first opposed the measure, but then sent a letter to Wilson asking him to sign the bill.
"The original version had some incredible requirements that would have cost millions of dollars to implement," says Roger Richter, CHA’s senior vice president of professional services. "It required each hospital to determine on its own the most effective safety device for each application. Each hospital would have had to do its own efficacy testing of every device on the market, and there are not enough resources in terms of money or qualified personnel to do that."
Richter says that type of efficacy testing requires three to five years and about $1 million for each type of device, which would have been prohibitive. The CHA’s objections prompted a legislative revision that allows hospitals to evaluate several safer devices they deem most appropriate for certain procedures, instead of having to test every device on the market.
"That changed things for us because a consensus was reached among industry representatives, labor, and regulators," he explains. "Based upon that and the fact that there are certain exceptions, we think it’s a fair regulation."
The cost of purchasing safer needle technology is still a concern, Richter adds, but "it’s secondary to the cost of efficacy testing." He also says needle manufacturers should decrease the cost of their safer products as demand for them increases.
"We believe that because California is roughly 10% of the nation’s health care market, the more these devices are going to be used, the prices had better go down," he states. "If the suppliers aren’t fair about lowering prices based on volume, competitors will be coming out within a year or two, and I can see the hospital system going with the lowest price."
The Kaiser Permanente health care system, which operates 29 California hospitals, had also endorsed the legislation. However, Enid Eck, RN, MPH, senior consultant for HIV and infectious disease for the California division of Kaiser, based in Pasadena, says she does not foresee manufacturers lowering prices.
Kaiser hospitals have been using many safer devices for about seven years, and "we have not seen a decrease by one penny in any [device] category," she says. "At this point, I’m not holding my breath for prices to come down. It would be lovely if that side of the industry were being regulated and manufacturers were being told these things cannot cost three, four, or more times as much [as conventional devices]."
For example, Kaiser examined a particular safety syringe that costs 38 cents, while the conventional version costs 5 cents. Kaiser purchases about 3½ million 3cc syringes per year.
"If these [devices] were cost-neutral or even within screaming distance of regular prices, the vast majority of the rest of the health care industry would have long since stepped up to the plate and made those changes," Eck says. "It’s the right thing for employers to do, but they’ve really been between a rock and a hard place. The company that makes these things cost-neutral is going to capture the market."
Kaiser is "supportive of the process and the principles" of the new law, she says.
"We want to be the employer of choice for people who want a career in health care, so we made the commitment a long time ago to provide a safe work environment; it’s a major priority for us. If there are engineering controls and work practices that we can assure happen, we do," she states.
Safety products won’t eliminate all injuries
Nevertheless, Eck points out that engineering controls to prevent injuries sometimes are not available.
"That’s part of the myth surrounding all of this," she says. "There is a fairly widespread thought that if we just put in these safety products, all of the injuries will go away. That’s not possible, and it’s absolutely untrue. Safety products do not exist for every application and will probably never exist."
Examples include a number of instruments commonly used in operating rooms. Devices such as trocars and orthopedic wires must be sharp, and even towel clips are capable of causing risky injuries, Eck says.
Also, sharps injuries can occur before a device’s safety features are activated. Phlebotomists and other HCWs who draw blood can be injured if a patient jumps or is combative during the process, dislodging the blood-drawing device before the procedure is completed. Even when sharps disposal containers are within arm’s length, something can happen to cause a needlestick in an instant because "health care is not a calm environment," she says.
However, many safer devices can be implemented to minimize or prevent injuries. Eck emphasizes that Kaiser has replaced conventional devices with safer devices in almost all major categories for which engineering controls exist. One blood-drawing device reduced needlesticks in that category by more than 80%, she says, while overall, sharps-related injuries have decreased by about 40% since safer devices have been implemented.
Eck and Richter agree that many safer devices on the market are first- and second-generation and therefore have limitations. Eck says Kaiser used a particular safety syringe for nearly three years and saw related needlesticks double because the device had an active safety feature that required HCWs to manually move the sheath over the needle after use. More than 50% of the time, users of such devices dispose of them without activating the needle sheath because it requires an extra step, she says.
Richter says some second-generation devices more effectively protect workers, and "third-generation products will be true safety devices."
The new law is "a start, not a cure-all," he adds, but Richter predicts that federal regulators "will be watching very closely."
The Washington, DC-based Service Employees International Union, which represents some 600,000 HCWs nationwide, has led the fight for similar revisions to the national bloodborne pathogens standard, as well as the California law.
William K. Borwegen, MPH, director of health and safety, says the union now has set its sights on repeating the California victory in New York State.
"But clearly we’re trying to push federal OSHA in the same direction," he says. "I’d hate to think we have to elect Pete Wilson as president before we can get federal OSHA to do something."
Reference
1. Department of Labor, Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens: Request for information. 63 Fed Reg 48,250-48,252 (Sept. 9, 1998).
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