Feds act on congressional demands to reduce sharps injuries among HCWs

Agencies ready plans for guidelines, alerts, and more in 1999

Federal agencies long entangled in what many perceive as finger-pointing and foot-dragging on the issue of reducing sharps injuries among the nation’s health care workers are now scrambling to comply with a congressional directive that holds them responsible for protecting workers from lethal viruses transmitted by occupational blood exposures.

Late last year, Congress spelled out a directive aimed at the U.S. Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), and the Food and Drug Administration (FDA), urging them to facilitate the use of safer needle devices and more accurate reporting of needlestick injuries in health care institutions. (See Hospital Employee Health, January 1999, pp. 6-7.)

The language, added to a major federal appropriations bill, was introduced by Sen. Barbara Boxer (D-CA), who charged that instead of taking action on the issue, federal agencies have wasted time making excuses and blaming each other for their lack of progress.

"The FDA says they don’t have the data; it’s up to NIOSH [the National Institute for Occupational Safety and Health] to pull the data together. NIOSH says they can’t do anything because they’re under the direction of the CDC. OSHA says it involves medical devices, so it’s not their problem, and the FDA says they don’t do worker-safety issues. We want them all to sit down together, figure out what belongs in whose bailiwick, and then address this problem," says Danielle Drissel, a spokeswoman in Boxer’s Washington, DC, office. "Those agencies have been promising to move on the issue but still haven’t."

However, spurred by congressional action as well as changes to the California bloodborne pathogens standard requiring health care facilities to purchase and use safer needle devices — the first such law in the nation — federal agencies are gearing up to take action on several fronts this year, including issuing safety alerts and drafting protection guidelines.

NIOSH, the worker safety arm of the CDC, is planning to release two needlestick-related documents in 1999, says Linda S. Martin, PhD, the agency’s director of HIV activity. She describes one as a "needlestick alert," resembling the format of the latex allergy alert NIOSH issued in 1997. The other most likely will be similar in intent to the agency’s recently issued sharps container guidelines, which gave hospitals criteria for selection, evaluation, and safe use of disposal boxes without specifically recommending certain products. (See Hospital Employee Health, May 1998, pp. 60-65.)

NIOSH presently is conducting focus groups at hospitals to obtain data about "what does and doesn’t work at a busy hospital" for sharps injury prevention, Martin says.

CDC to set selection guidelines

While NIOSH probably will produce the needlestick alert document, the CDC will take the lead in establishing guidelines for selecting and evaluating safer device technology.

Martin notes that increased national attention to the needlestick issue has spurred NIOSH and the CDC to move forward on issuing more guidance on safer needle devices for hospitals. In addition to the congressional directive targeting federal agencies, the California law also has had a huge impact. (See Hospital Employee Health, December 1998, pp. 144-146.)

"We’re happy that new emphasis has been placed on needlesticks, with the California law and the language in the budget for the CDC and NIOSH to look at additional surveillance activities," she says. "We have a lot of irons in the fire, and we’re hoping in the next six months to flesh out where we are with [producing] documents. It may take us a year or so to get it all sorted out, but I think in the end we’ll have one or more documents available for hospitals to help people decide how to evaluate devices and which ones they should choose."

While the specific format and scope of the documents remain undecided, Martin says NIOSH and the CDC want to give hospitals a "framework" for considerations in selecting and assessing safer devices for use in various hospital settings and conditions.

Reducing sharps injuries among HCWs is "on top of the priority list" for the CDC’s hospital infections program, says Linda A. Chiarello, RN, MS, CIC, an epidemiologist who will coordinate the program’s efforts to produce guidelines for selecting safer needle technology.

Chiarello formerly headed the infection control program for the New York State Department of Health, where she established a systematic approach for selecting and evaluating needlestick prevention devices.1 She says the guidelines "won’t tell people what to use, but will offer possible suggestions."

The NIOSH alert will focus awareness on the problem of needlestick injuries and the availability of safer technology, and will urge employers to promote its implementation. The CDC guidelines, a collaborative project with NIOSH, will target the evaluation process — what to look for in safer devices, how to evaluate them, and considerations for selection, she explains.

"We intend to be comprehensive and address what institutions need in the way of information," she says. "The CDC does not endorse products, and we would be careful to avoid that. We want to give tools for making decisions and setting priorities. Our belief is [setting priorities] should be driven by epidemiology, and that surveillance information can help identify how devices are used in an institution."

Surveillance information should include the types of injuries that occur with particular devices, to whom they occur, and identification of various mechanisms for preventing injuries. Implementation of a safety device is not always the only way to prevent needlesticks, she says, so the CDC plans to offer guidance for problem solving that includes possible work practice or policy changes that also could help prevent sharps injuries.

OSHA request generates interest and concern’

OSHA also made sharps injury prevention a priority last September when it published a request for information (RFI) on engineering and work practice controls for eliminating needlesticks among HCWs.2 (See Hospital Employee Health, November 1998, pp. 129-132.)

The comment period is now closed, and the agency has received nearly 400 comments, says Elise Handelman, RN, MEd, COHN-S, director of OSHA’s office of occupational health nursing and a preliminary reviewer of the public comments.

Handelman says the large response to the RFI indicates "a great deal of interest and concern" from health care institutions about needlestick issues.

"We received comments from a broad base of health care facilities, large and small, spread throughout the nation, from as far as Alaska and Puerto Rico. It was a wonderful response from the public, and we’re very pleased with that," she says.

Many responses provided comprehensive answers to 16 questions or "key issues" posed in the RFI regarding an institution’s percutaneous injury prevention strategies and included detailed graphs and charts, she notes.

However, the main question is what OSHA will do with the information once it’s analyzed, and that remains unanswered. Critics maintain that OSHA already has the information it needs to promote the use of safer needle technology in hospitals. Some point out that California OSHA has taken the lead in requiring hospitals to use the technology while federal OSHA lags behind in similar efforts.

Handelman says OSHA could take any of several actions based upon RFI responses, including revising the bloodborne pathogens standard, its enforcement, or compliance officer training. In any case, agency officials consider the RFI the first step in their plan to address the problem systematically.

FDA to issue safety alert

The FDA also is addressing the problem with immediate plans to issue a safety alert on hazardous glass capillary tubes used in phlebotomy procedures. (See related story, p. 27.) The warning will mark the agency’s second sharps-related safety alert. The first was issued in 1992, warning hospitals against using hypodermic needles to access intravenous lines. Additional safety alerts on unsafe syringes and needles also are being considered, says Tim Ulatowski, MS, director of the division of dental, infection control, and general hospital devices.

Ulatowski says the FDA has been working "in a cooperative manner" with the CDC, NIOSH, and OSHA in response to the congressional language, ironing out issues related to each agency’s contribution to reducing sharps injuries among the nation’s HCWs.

While the other agencies’ roles might be more apparent, the FDA’s part has been less defined. The agency has cleared about 300 safer sharps devices since the mid-1980s, and has maintained this is its major function despite requests from HCW unions and others for the agency to be more proactive in issuing safety alerts, banning injury-causing sharps, and establishing criteria for safer devices.

However, with plans for additional safety alerts and other actions, it now appears the FDA is pushing beyond its self-imposed limitations.

"Primarily, our role to this point has been evaluation of new products, and we continue to do that," Ulatowski says. "The other role we’ve taken is interacting with professionals regarding the use of safer devices, for example, through safety alerts. We’ve also submitted to OSHA, in response to their request for information, design features that [safer] devices should have to guide OSHA inspectors when they do on-site evaluations of engineering controls in hospitals."

Ban on conventional sharps unlikely

In 1991, the Washington, DC-based Service Employees International Union (SEIU) petitioned the FDA to ban what it considered unsafe sharps devices, but the agency was not responsive. Ulatowski says a ban still is not likely.

The California OSHA rule permits the use of conventional sharps when considered necessary for patient safety or in certain procedures when medically necessary. FDA officials say that is why a ban would not be possible.

"We do not want to inappropriately limit the practice of medicine, to deny physicians or nurses the opportunity to use devices they see as appropriate under certain conditions or in particular situations," Ulatowski says. "We don’t want to get in the way of their making that decision for their patients. How can one ban devices when you need the opportunity for certain devices to be used in certain situations?"

Nevertheless, the FDA is considering another SEIU request for labeling some sharps devices with a warning about possible injuries and directions for the user to substitute safer devices.

References

1. Chiarello LA. Selection of needlestick prevention devices: A conceptual framework for approaching product evaluation. Am J Infect Control 1995; 23:386-395.

2. 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).