Passage of California’s needle safety law heightens call for national regs

OSHA asks hospitals to submit data on needlestick prevention

Emboldened by passage of a landmark needle safety law in California, health care worker safety advocates are calling for federal agencies to follow suit and require hospitals nationwide to implement devices designed to prevent needlesticks.

Sponsored by Assemblywoman Carole Migden (D-San Francisco), assembly bill No. 1208 amends the state labor code to require use of sharps safety devices designed to protect workers from needlestick injuries that can result in occupational infections with HIV, hepatitis, and other bloodborne pathogens. (See highlights of law, p. 163.)

"Safety needles have been on the market for 10 years now," says Migden. "Failure to use this technology to protect workers has been unconscionable. We’ve finally changed that."

The first law of its kind in the nation, the California legislation was signed by Gov. Pete Wilson on Sept. 30 after 11th-hour discussions among legislators, union representatives, and hospital groups. To keep up the pressure, the Service Employees International Union (SEIU), which represents some 600,000 health care workers nationally, organized demonstrations and candlelight vigils by workers. Seizing the momentum from its California victory, the SEIU made clear it will now lobby federal regulators such as the Occupational Safety and Health Administration (OSHA) and the Food and Drug Administration (FDA) to require or encourage similar measures nationally. For its part, OSHA followed through with its previously announced plans by publishing a request for information on needlestick prevention and safety devices in the Federal Register, but the SEIU was critical of that approach in light of the dramatic developments in California.¹ (See related story, p. 164.)

"While we are proud of our role in protecting 13% of the nation’s health care workers through passage of the first statewide safer needle law, California’s action begs the question: Why haven’t OSHA and FDA acted to protect health care workers nationwide?’" says Andrew Stern, SEIU international president.

The California legislation directs the state division of Occupational Safety and Health (Cal-OSHA) to enforce the law by amending the state bloodborne pathogen standard — its version of the 1991 federal OSHA bloodborne regulation — by Jan. 15, 1999. Health care facilities in California will then have until Aug. 1, 1999, to comply. Cal-OSHA began the process of drafting a regulation while the legislation was under discussion and is expected to meet the January deadline. (See Hospital Infection Control, September 1998, pp. 129-133.)

Bill gives hospitals time to get up to speed

"The bill requires — ultimately — the use of safer needle devices," explains Allan LoFaso, staff aide to Migden. "But the bill accommodates hospitals’ need for phase-in time to review technology and gives them a chance to have lead time before compliance."

Moreover, the law allows health care facilities flexibility by not requiring specific types of needle safety devices, which include self-sheathing needles, retractable designs, blunting devices, and needleless connectors for intravenous lines. However, the law calls for Cal-OSHA and the state department of health services to compile and maintain a list of existing sharps safety systems to assist employers in complying with the requirements.

"Neither the bill nor the [Cal-OSHA draft] regulations are specific as to individual devices," LoFaso says. "We have done a lot of work to accommodate hospitals — not requiring specific devices, and [allowing] lead time for people to get up to speed. On the basis of those discussions, the California Healthcare Association and other organizations moved from opposition to support."

Still, with regulations to enforce the law still being drafted, it was not immediately clear to what degree California health care facilities will have to phase out conventional needle devices in favor of safety designs. At a minimum, the state law essentially appears to impose a kind of burden of proof on health care employers who have not implemented the devices. The law states that employers now will have to include sharps safety designs "as engineering or work practice controls, except in cases where the employer or other appropriate party can demonstrate circumstances in which the technology does not promote employee or patient safety or interferes with a medical procedure."

Infection control professionals in California should have key roles in evaluating the devices in order to comply with the new law and ensure both health care workers and patients are protected, says Claire Ginesi, RN, CIC, infection control coordinator at Sonoma (CA) Valley Hospital. A member of the product evaluation committee at the facility, Ginesi says her hospital already has implemented safety devices to prevent needlesticks when starting intravenous lines and drawing blood.

"We looked at where our risk was housewide — where our needlestick figures were — and started with those areas first," she says, adding that additional protective devices now will be considered in light of the new law.

Devices may not live up to marketing

While well aware of the risk posed by needles due to her experience as a frontline health care worker, Ginesi echoes other ICPs’ concerns in warning against "sound-bite solutions" to the complex issue of needlestick prevention.

"I’ve been a nurse on the front lines drawing blood and doing IVs on AIDS patients, so I know how people feel," she says. "But [ICPs] don’t just jump in and embrace something without understanding how it works and what the implications are for the facility. It is not that we don’t wish to protect workers. We do. But just because something is marketed as a needle safety device doesn’t mean that it is, or that it works, or is cost-effective."

Indeed, federal OSHA took a more cautious approach even as it pushed ahead on the issue by publishing its "Request for Information" on needle safety designs and prevention strategies.

"We have recognized the concerns in this area and we are going to look at it," says Susan Fleming, OSHA spokeswoman. "But nobody has a standard for a safer needle.’ A safer needle is to some extent in the eye of the beholder and in the eye of the manufacturer. Safer than what? Safer than something that was used in 1900? Safer than the one that your competitor is manufacturing?"

OSHA is aware that epidemiological studies must be conducted to ensure the appropriate device is used to prevent the specific kinds of needlesticks occurring at individual facilities, she says. Given such concerns, the agency decided to request more information.

"We will make a decision about where to go from here using that information," Fleming says. "We’ll see what kinds of programs have been effective and so on. It could lead to issuing some kinds of guidelines or something — it doesn’t have to be a regulatory process. It is an information-gathering process and it could lead to any number of other avenues."

Time to pay the price to reduce risk?

An SEIU official was critical of the OSHA approach, noting that the agency already cites needlestick prevention data on its Internet Web site and the Centers for Disease Control and Prevention previously published impressive efficacy data on some of the devices.²

"[The California law also] calls into question the fairly tepid, impotent response by federal OSHA to address an identical problem nationwide," says Bill Borwegen, health and safety director at the SEIU. "There is a tremendous amount of information out there already."

Likewise, the union is urging the FDA to issue a safety alert to the nation’s health care settings drawing attention to the efficacy and availability of the some 250 needle safety devices that it has evaluated and approved.

"Basically they have approved 250 [needle safety] devices and have disapproved a similar number," Borwegen says. "Yet they continually allow the inherently dangerous, obsolete, conventional needles in the market. They never evaluated them."

Likewise, OSHA doesn’t require employers in other industries to validate whether safety guards on machines are effective — they simply require them, he added.

"I don’t know why this situation should be any different except that it is health care, a sector that continues to be largely ignored in areas of occupational safety and health," Borwegen says.

The OSHA initiative was welcomed by one ICP, who says regulatory action might finally be in order because bottom-line cost concerns have too long delayed widespread needle safety implementation in the health care industry.

"It certainly is a step in the right direction because right now there are no teeth in the current language [in the OSHA bloodborne pathogen standard]," says Rita McCormick, RN, CIC, infection control practitioner at the University of Wisconsin Hospital and Clinics in Madison.

"I would like to think that we would have all done this voluntarily, but the fact that we still have 800,000 needlesticks occurring annually [nationwide] tells me that this volunteer effort isn’t working."

McCormick is wary of overly prescriptive regulations regarding devices, but says some generally worded regulations could improve worker protection without sacrificing clinical flexibility.

"I think we need a little boost from the government in terms of a mandate regarding our obligation," she says. "Worker safety is clearly an obligation of the employer."

McCormick says needlesticks at her hospital have fallen sharply since implementation of a needleless IV system, and trials are currently under way on phlebotomy equipment with retracting needles or blunting devices. While such devices can cost considerably more than conventional designs, McCormick is hopeful that market forces and competition will push prices down as safety designs are phased into more mainstream use. Comparing the needle safety issue to auto safety debates that preceded requirements for seat belts and other protective measures, she notes, "at some point you simply have to pay more money to reduce a risk."

Reference

1. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens: Request for information. 63 Fed Reg 48,250-48,252 (Sept. 9, 1998).