Prepare now for mandated needle safety devices in nation’s hospitals

Needlestick Prevention Act’ proposed; OSHA targets regulation this fall

Infection control professionals should begin preparing now for eventual needlestick safety regulation, whether by state or federal laws, by evaluating devices designed to prevent exposures that carry a high risk of bloodborne pathogen transmission. This includes devices to start intravenous lines, IV catheters, and phlebotomy equipment, sources advise Hospital Infection Control.

Spurred by California’s landmark needle safety law and similar legislative initiatives in some 20 other states, the United States Congress and the Occupational Safety and Health Administration (OSHA) are moving to make sharps safety requirements the law of the land.

The "Health Care Worker Needlestick Prevention Act of 1999" was introduced into Congress on May 20, 1999, by U.S. Reps. Pete Stark (D-CA) and Marge Roukema (R-NJ). The law would direct OSHA to amend its 1991 bloodborne pathogen standard in order to mandate needle safety devices to protect health care workers from occupational infections via needlesticks. That same day, OSHA announced it had received nearly 400 responses to its recent request for information (RFI) on the needle safety issue and will consider amending its bloodborne pathogen standard this fall.1 (See highlights of bill, p. 87; OSHA report, p. 89.)

While critics fear the interference of national mandates with local clinical judgement, the needle-safety issue has become a juggernaut since California passed a bill last year requiring state hospitals to implement the devices. In addition to the aforementioned federal initiatives, a growing number of states are in various legislative stages with similar laws. (See Hospital Infection Control, April 1999, pp. 45-49; February 1999, pp. 17-22.)

"We are finding that although it is not easy, it is doable," says Cynthia Fine, MSN, CIC, infection control and employee health consultant for Catholic Healthcare West (CHW) in Oakland, CA. "We are progressing with it in California, and I think in light of that it is going to roll across the United States."

Fine advises ICPs to start preparations by evaluating all devices designed to prevent exposures to bloodborne pathogens, including IV lines, catheters, and phlebotomy equipment.

"I think we all pretty much agree those are the highest-risk devices for actually transmitting disease," she says. "That’s where I’m suggesting people who are just starting put their time, money, and effort."

The sudden surge in proposed needle safety legislation apparently has divided the infection control community. Some ICPs caution against legislative solutions to clinical problems, while others concede that laws are finally needed to end years of foot-dragging on the issue. Fine says the issue warrants legislation, citing her ongoing conversations with ICPs having difficulty getting the safety devices approved by cost-conscious administrators in other states.

"I just had an e-mail conversation going on with someone in another state about IV catheter devices and the difficulties they have been having implementing them," she says. "They were turned down by their CEO because they were too expensive. So it is still happening, and unfortunately I think we need the legislation."

Still, others note that federal laws and OSHA mandates may force broad adoption of more expensive needle devices that may not be appropriate for all settings.

"In some hospitals that have a high needlestick injury rate and a patient population that is likely to have bloodborne pathogens with some frequency, it might be reasonable to consider these [devices]," says William Sheckler, MD, hospital epidemiologist at St. Mary’s Medical Center in Madison, WI. "The problem that I have is the one-size-fits-all regulatory approach either by law or by OSHA standard, which will inevitably lead to increased cost."

Modeled after the California law, the Stark-Roukema bill would direct OSHA to require that health care employers — unless they can cite one of the approved exemptions, such as concern for patient safety — use needleless systems or other engineered safety mechanisms. "The technology exists today to prevent the vast majority of these injuries," Stark says. "Safe needle devices are used in some facilities across the country, but our bill would make use of safe technology the norm rather than the exception."

The legislation also would enhance current needlestick reporting requirements and establish a national clearinghouse to collect data on safer technologies as a resource for employers. The bill drew the endorsement of health care worker unions, some health care employers and needle manufacturers, and the American Nurses Associ ation (ANA). The bill is being given a better political prognosis than Stark’s previous needlestick prevention legislation, "The Health Care Worker Protection Act of 1997," which stalled out before becoming law. For example, the current bill has bipartisan sponsorship that could mean less Republican resistance to its regulatory aspects, says Susan Wilburn, RN, MPH, senior specialist for occupational safety and health at the ANA in Washington, DC.

"Everyone has been stimulated by the California legislation," she tells HIC. "You can tell that the time has come in terms of other states that are enacting or proposing similar legislation as well as the bipartisan support of this federal legislation. There is more political momentum."

The bill is seen by some as a way of giving OSHA "legislative cover" to act on a controversial issue in much the same way that the law in California mandated regulation and enforcement by the state’s Cal-OSHA program. The previous Stark legislation used possible withholding of Medicare dollars as the enforcement mechanism. Under the current bill, that threat would only be used to coerce public hospitals owned by state or local governments and thus not technically bound by federal OSHA standards. In addition, state OSHA standards, which have to be at least as "effective" as federal OSHA standards, also may apply to such hospitals, according to a spokesman in OSHA’s Washington, DC, office.

The Chicago-based American Hospital Association immediately came out against the bill, describing it as "well intentioned but unnecessary" because OSHA already has the authority under its bloodborne pathogen standard to accomplish the same goals. Indeed, OSHA has "clearly signaled that it would strengthen these requirements," says Jonathan Lord, MD, AHA chief operating officer. "We’ll continue to work with OSHA to ensure appropriate flexibility for caregivers when it comes to deciding what’s best for patients and workers."

In that regard, the same day the federal needlestick bill was announced, U.S. Secretary of Labor Alexis Herman emphasized that OSHA was taking several steps to address the issue. Though agency officials declined requests for additional interviews, OSHA released a statement saying the agency "will take steps to amend the bloodborne pathogens standard by placing needlestick and sharps injuries on its regulatory agenda this fall." OSHA also will revise its bloodborne pathogens compliance directive later this year to reflect that newer and safer sharps technologies are now available, the agency reported.

The OSHA bloodborne pathogens standard requires engineering and work practice controls to be used to eliminate or minimize employee exposures, but the agency left something of a loophole that it now appears ready to close. For example, OSHA’s compliance directive for enforcing the standard states that "employers do not automatically have to institute the most sophisticated engineering controls (e.g., needleless IV connectors, self-sheathing needles)," but it is their responsibility to continually evaluate the effectiveness of existing controls and review the feasibility of implementing more advanced devices.

However, in reviewing comments received in response to its RFI on the issue, OSHA reported that though a variety of safer devices exists to protect workers from needlesticks, "these devices are not being used widely enough to substantially reduce the hundreds of thousands of injuries each year." Moreover, in the area of record keeping, OSHA found that many needlesticks are not being reported in the OSHA 200 logs hospitals are required to maintain. As OSHA regulations are currently written, needlesticks that do not result in medical care beyond first aid are not required to be entered into the OSHA log, but the agency is expected to now toughen those reporting requirements to ensure more injuries are recorded.

"That is critically important," Wilburn says. "If we are not collecting data about the nature of the injuries and exposures, then we have a really difficult time defining the illness for workers’ compensation. We have a really difficult time saying we need to implement safer devices to prevent needlestick injuries if we can’t say how many we are going to prevent."

Indeed, a by-product of all the legislative and regulatory activity may be a much clearer picture of the number and nature of needlestick injuries, as both state and federal regulations are requiring more documentation on injuries and devices.

Now that California has passed a needlestick prevention law, the Washington, DC-based Serv ice Employees International Union (SEIU) — which represents about 650,000 health care workers nationwide — has launched a state-by-state campaign to introduce needlestick prevention legislation. The SEIU says some 20 states are now at various stages of legislative discussions. As this issue went to press, Maryland and Tennessee had passed legislation, and Texas had a bill awaiting the governor’s signature.

Maryland passed a "study bill" that sets up a multidisciplinary committee to look at the issue and make a recommendation to the state legislature in January 2000. A bill signed into law in Tennessee on March 19, 1999, calls for the state health and labor commissioners to review sharps injury prevention technology and determine which work settings should implement the devices. The devices will not be required if employers can demonstrate that they are medically contraindicated or no more effective than alternative measures to prevent exposures to employees. In addition, written exposure control plans must be revised to reflect improvements in sharps technology, the law states.

"We are having to put this in our OSHA plan, identify all of our safety devices, and implement as many as we can," says Sandy Garret, RN, MSN, CS, CIC, infection control nurse at the Veterans Affairs Medical Center in Nashville, TN. "I think it’s a good thing. But the federal VAs had already somewhat mandated that we get all sharps prevention devices that we can. We basically had implemented everything, so it is a lot easier for us. Now, for facilities that didn’t have [safety devices] and are going to have to buy them without having any funds appropriated, it is going to be a lot more difficult and they probably won’t be as receptive."

ICPs in Texas are finding themselves a lot more receptive to legislation there after a few critical revisions were made to a proposed law to ensure the state requirements will remain in sync with expected changes made by federal OSHA, says Patti Grant, RN, BSN, MS, CIC, who spearheaded the response to the bill as president of the Texas Society of Infection Control Practitioners.

"There is now a statement in the bill that states that the Texas Department of Health shall write rules that are autologous to the OSHA bloodborne pathogen standard," she says. "Texas does not have to reinvent the wheel. As federal OSHA progresses, Texas will follow. That was extremely important, because we are already accountable to too many government agencies."

OSHA action inevitable?

Though OSHA basically addressed needle safety devices from the outset — and many hospitals in Texas already have implemented devices — it appears the agency is now going to strengthen its requirements, Grant notes.

"OSHA is going to act," she says. "I can’t imagine that an [agency] that large would go through the pain and effort of publishing a call for opinion in the Federal Register and then not do anything with it."

The Texas legislation is aimed at public or government-run hospitals that are not technically bound by federal OSHA standards, which apply to their privately owned counterparts, she explains. The Texas bill essentially requires more accountability from the hospitals, which must review the safety devices through their product evaluation committees and annually update the state regarding their implementation status or reasons for not using the devices. Working closely with the Texas Hospital Association, ICPs launched a letter-writing campaign and participated in hearings to preserve local flexibility in selecting and implementing devices, Grant notes.

"What we have now is a win-win situation," she says. "There has been increased awareness of safety engineered devices. [The bill] allows us to use epidemiology to make institution-specific decisions about the risk and the devices used."

For example, Grant argues that for low-risk procedures like intramuscular (IM) injections, a conveniently placed sharps container probably affords the worker more protection than a safety needle that must be manipulated to activate a protection device.

"If you ask me to push, pull, twist, or turn the barrel around the needle, my hand can slip," she says. "In my opinion, it is much safer to have an excellent, top-of-the-line sharps container [for IM injections]. Now if I get stuck with a needle that I just pulled out of somebody’s vein, that is a big deal. The way this law is written, it allows public hospitals in Texas to make that [device] decision, as does federal OSHA for the private institutions."

Grant recommends ICPs follow their state legislative activities through Internet legislature Web sites, generally taking a conciliatory rather than adversarial approach in trying to seek revisions to needle safety laws. "We have a lot of control," she says. "We just need to believe in ourselves, in our background in science, and our ability to affect change." Nevertheless, ICPs may be getting a bit gun-shy of the needle safety issue, as attempts to amend legislative provisions open ICPs to criticisms that they are not concerned about health care worker safety.

"One of the things that people don’t always appreciate is that hospital epidemiologists and infection control professionals are health care workers too," Sheckler says. "Many of us — certainly virtually all of the hospital epidemiologists I know — see patients also and are involved in patient care. We are just as concerned about our patients and ourselves as anybody else would be."


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

Needlestick Prevention Act proposed in Congress

Provisions include detailed incident reports

The "Health Care Worker Needlestick Prevention Act of 1999" that has been proposed in Congress calls for the Occupational Safety and Health Administration to amend the 1991 bloodborne pathogens standard and require employers to use needleless systems and safety-designed sharps. Other summarized provisions of bill H.R. 1899 include the following:

• All direct care health care workers shall be provided adequate training on the use of all needleless systems and sharps with engineered sharps injury protections which they may be required to use.

• Exceptions to using needle safety devices include circumstances in the employer’s work facility in which the devices do not promote employee safety, interfere with patient safety or interfere with the success of a medical procedure; or if the needleless systems and sharps injury protections required are not commercially available to the employer.

• Health care employers have to include in their exposure control plan an effective procedure for identifying and selecting existing needleless systems, sharps with engineered sharps injury protections, and other methods of preventing bloodborne pathogens exposures.

• In addition to the recording of all injuries from contaminated sharps on the OSHA Occupational Injuries and Illnesses 200 log or its equivalent, the employer shall maintain a separate contaminated sharps injury log.

• The sharps injury log shall contain (to the extent such information is known to the employer) information including the date and time of the exposure incident; type and brand of sharp involved; a description of the exposure incident; job classification of the exposed employee; department or work area where the exposure incident occurred; and the procedure that the exposed employee was performing at the time of the incident. If the sharp had engineered sharps injury protections, information should include whether the protective mechanism was activated; whether the injury occurred before the protective mechanism was activated or during activation.

• If the sharp causing the injury has no engineered sharps injury protections, the sharps injury log must include the injured employee’s opinion as to whether and how such a mechanism could have prevented the injury; and the employee’s opinion about whether any other engineering, administrative, or work practice control could have prevented the injury.