Part I of a two-part series

Needle safety devices now law of the land

Federal law amends OSHA bloodborne standard

Culminating a wave of state legislation on needle safety, President Clinton recently signed a federal law that formally amends the Occupational Safety and Health Administration’s 1991 bloodborne pathogen standard and requires that frontline workers be involved in the evaluation and selection of needle safety devices.

The Centers for Disease Control and Preven-tion estimates that some 380,000 needlesticks occur annually among health care workers in U.S. hospitals. Such injuries can lead to infection with the familiar gamut of bloodborne pathogens, including HIV, hepatitis B virus and, increasingly, hepatitis C virus.

The Needlestick Safety and Prevention Act essentially codifies a Nov. 5, 1999, compliance directive issued by OSHA to enforce needle safety in the nation’s hospitals. Under the law, hospitals can be cited and fined unless needle safety devices such as retractable or self-sheathing needles are being regularly evaluated. The law requires that employers must review and update the exposure control plan at least annually to reflect changes in technology, such as the use of effective engineering controls that can eliminate or minimize exposures. (See law highlights, p. 166.)

"It requires that employers solicit input from frontline health care workers in the evaluation and selection process," says Bill Borwegen, director of the occupational health and safety program at the Service Employees International Union (SEIU) in Washington, DC. "We are educating our members about their rights, and we are going to make sure the law gets enforced."

Representing some 600,000 health care workers, SEIU has long lobbied for the federal changes and pushed for passage of 17 state needle safety laws in the interim. However, some states still have occupational health plans that do not fall under OSHA requirements, and thus will not be affected by the federal law amending the standard. The SEIU will continue to lobby to bring those states into compliance, and the momentum behind them is considerable. "We are confident that there will be a ripple effect in the states, such as Pennsylvania and Florida, where public sector workers aren’t covered by OSHA," he says.

Moreover, the federal action should dovetail with the recently passed state laws rather than cause compliance conflicts, he argues.

"[State] laws usually are only preempted if there is a legal challenge, and I don’t know if there are going to be a lot of health care facilities [that] are going to come out as the poster child against safer needle laws," he says. "None of the laws contradict each other. I think they supplement each other."

Though questioning the overall impact of the law because it still exempts some states, an ICP consultant said the legislation is only the latest development in a switch to needle safety devices that has become inevitable.

"It’s a win-win situation," says Katherine West, MSEd, CIC, who deals frequently with OSHA compliance issues as a consultant with Infection Control/Emerging Concepts in Manassas, VA. "We are going to see a dramatic decrease in the number of contaminated sharps injuries. That is a benefit to the employee. The benefit to administration is that, though there is going to be a short-term initial cost increase in purchasing needle safety devices and doing the training, it’s going to be less costly in the long run than post-exposure follow-up. But people are still shocked to realize that going to needle safety systems is not an option."

All risks created equal

While a new compliance document is expected to be written by OSHA to enforce the law, the agency has not previously allowed ICPs to focus solely on devices at higher risk of seroconversion following an exposure (i.e., blood-filled needles). That appears to be the case with the new federal law as well.

"Whether it is a high- or low-risk needlestick is basically beside the point," says Patti Grant, RN, MS, CIC, director of infection control at RHD Memorial Medical Center and Trinity Medical Center, both in Dallas. "It disturbs me that there is no mention of the risk of seroconversion. It is blanket coverage."

Indeed, the situation in California, which passed the first state law on the issue for enforcement by its state OSHA plan, is that the relative seroconversion risk of the needle injury is not a factor, adds Cynthia Fine, MSN, CIC, infection control and employee health consultant for Catholic Healthcare West in Oakland, CA.

"You certainly want to start with the highest risk devices and focus your attention on phlebotomy and IV starts, but OSHA doesn’t recognize that as an issue at all," she says. "You can get a citation for a very low-risk device, even if they know that you are doing your best and you are starting with the higher risk [exposures]. OSHA has not been very tolerant of that."

In that regard, ICPs who have implemented devices for high-risk exposures should probably now begin evaluating devices for lower risk injuries (e.g., IV connectors), she notes.

"Hopefully, since the federal [OSHA] compliance directive came out about a year or so ago, they should have gotten started on this," Fine says. "But if they haven’t, I still recommend that they start with the higher risk devices, just because that is where you are going to get more bang for your buck.

"They just need to make sure they continue on and do the lower risk [devices too]. Probably the most important thing is to have the frontline health care workers involved in the decision making and to never stop the education. Because as soon as you think everyone knows how to use them, something will happen and someone will get a needlestick."

What are health care workers saying?

And what about the health care workers who are the target of all this technology?

Reaction in the Catholic West system has ranged from gratitude and enthusiasm to written protest on evaluation forms.

"We have to do a yearly reevaluation of the devices — and with this federal law, others will, too — and there is a space for comments on it," she says. "They write things like, Give us back our old needles! We think those are safer!’ There are some [who] love the new safety devices and are grateful, but there have been an awful lot of complaints about it."

[Editor’s note: Look in the January issue of Hospital Infection Control for Part II of this story, which will provide ICPs with more information on compliance and enforcement issues under the new federal law.]


1. Occupational Safety and Health Administration. 29 CFR 1910.1030. Occupational Exposure to Bloodborne Pathogens. OSHA instruction CPL 2.103. Field inspection reference manual. Washington, DC: Nov. 5, 1999.