As feds hone sharps regs, ICPs should assess risk rather than buy to comply

OSHA, NIOSH call for use of needle safety devices

Despite mounting pressure from the Occu pational Safety and Health Administration to implement needle safety devices, infection control professionals should not abandon epidemiological principles and simply purchase new sharps equipment in a blind salute to compliance, OSHA-savvy ICPs advise Hospital Infection Control. Though Washington, DC-based OSHA has turned up the heat in recently revising its compliance guidance to inspectors, needlestick surveillance and risk assessments still should be used to determine if and where safety devices are needed, reminds Katherine West, MSEd, CIC, who deals frequently with OSHA compliance issues as a consultant with Infection Control/Emerging Concepts in Manassas, VA.

"Because [new devices] may not help," she notes. "That may not be where the problem is, or there may not be such a device. You’re going to have to look at the kinds of sharps that are used in each area as part of a risk assessment. [ICPs] have to be able to document that they are looking at exposures and deciding what needs to be done to reduce them. Is it an education and training problem, the way you’re doing a procedure, or do you need to buy a new piece of equipment?"

For example, in a recent consultation with a paramedic service, West found that needlesticks were occurring when blood was being drawn from patients prior to hospitalization. "We could have bought expensive new equipment that would allow us to do that more safely, or we could choose to delete that procedure," West says. "That’s what we chose to do, and we notified the hospitals that we will no longer draw blood to fill blood tubes in the field. So instead of buying more equipment that cost more money, we just did away with the task. I’m not sure that people are looking at [this issue] that comprehensively."

OSHA, NIOSH take action

In recently revising its compliance directive for inspectors enforcing the 1991 bloodborne pathogen standard, OSHA mandated that needle safety device evaluation efforts must be documented at least annually in the exposure control plan.1 (See compliance highlights, p. 3.) If a combination of engineering controls (i.e., shielded needle devices) and work practice controls (i.e., eliminating hand-to-hand instrument passing in the operating room) does not eliminate or minimize exposures, the employer shall be cited, OSHA determined.

"This directive provides guidance to our compliance officers and the regulated community that seven years have gone by since we last updated the compliance directive, and there’s lots of new technology available that would fit our definition of engineering controls," says Melody Sands, MS, director of the OSHA office of health compliance assistance in Washington, DC. "What we are saying by this is that you better be using some of these things — at least by now. Because they are readily and commercially available. It doesn’t change the standard at all; it just amplifies the requirements of the standard, which have been in existence all along."

On the heels of the OSHA move, the National Institute for Occupational Safety and Health (NIOSH), a Washington, DC-based research branch of the Centers for Disease Control and Prevention, issued an alert on needlesticks that also emphasized using needle safety devices to prevent exposures to health care workers.2 (See alert highlights, p. 6.) "[There] was recognition by NIOSH that this was an area where we had not come out strongly with a clear message," says Thomas Hodous, MD, lead author of the alert and associate director for science in the NIOSH division of safety research in Morgantown, WV. "Putting NIOSH backing [behind] these newer engineering controls was needed." The alert advises ICPs to give "highest priority" to implementing the use of safety needle devices designed to prevent exposures more likely to result in occupational infection (i.e., hollow-bore needles used in veins and arteries).

In that regard, a Dallas ICP has styled her interventions to the risk of the exposure, finding in one situation that a better sharps container rather than a new needle device was the answer. Needlestick injuries were occurring during disposal because the sharps containers required too much activity on the part of health care workers, says Patti Grant, RN, MS, CIC, director of infection control at RHD Memorial Medical Center and Trinity Medical Center, both in Dallas. "Employees had to manually open and close them, and you could easily overfill them," she says. "Needles could easily be standing straight up if they fell the wrong way."

The needle devices commonly disposed of in the containers were needles used for intramuscular (IM) injections, as opposed to needles placed into veins to draw blood or start IV lines, Grant explains. Therefore, rather than invest substantial dollars in a protective needle for relatively low-risk procedures such as IM injections, Grant opted to replace the sharps boxes with a design that requires little activity on the part of the worker and eliminates exposures due to overfilling.

"Based on my 1998 assessment of our occupational exposure incidents at both my institutions, I found out that some 30% to 40% of my needlesticks were occurring at point of use of the sharps container," she says. "So we upgraded our sharps container and it virtually eliminated that problem. We are not having those type of needlesticks anymore. That is an example of looking at your own internal surveillance, applying the epidemiological principle of a high-risk vs. a low-risk needlestick, and implementing an engineering control that really had nothing to do with a safer sharps device."

Grant plans to document the action in her exposure control plan and expects that it will pass muster with OSHA inspectors, particularly because she also has implemented needle safety devices hospitalwide to prevent high-risk exposures such as starting peripheral IV lines. "We have removed all choice at my institutions of using a non-protective needle for starting peripheral IVs," she says. "I took a practical approach to the low-risk needlesticks and got a top-of-the-line sharps container. And for the high-risk needlesticks, we have gone the total opposite direction and spent large amounts of money on a needlestick that very rarely even occurs. But the consequences of that needlestick are so potentially devastating that we were no longer willing to give the health care worker the choice of using the unprotected device."

Too much subjective judgment?

While Grant purchased new sharps containers for the lower-risk exposures, Sands reminds that OSHA does not sanction focusing prevention efforts exclusively on high-risk exposures like phlebotomy. If there is "potential" exposure in other areas, it must be addressed in prevention efforts and the exposure control plan, she says. But Grant also expressed concern that one area of the OSHA directive document may allow too much subjective judgment by inspectors. The section in question notes that if an OSHA inspector finds that an employer is using an engineering control "but believes another device would be clearly more effective than the one in use, the compliance officer should document how the device was being used and how the employer and/or employee selected it." The inspector should consult with the OSHA regional bloodborne pathogens coordinator to determine if a violation exists, the directive states.

"That is a subjective decision that the OSHA inspector is allowed to make, and I worry about the implications of that," Grant says. "The bottom line is, there is always going to be something better, because the technology is always changing."

Asked about Grant’s concern, Sands noted that the section doesn’t say a citation will be issued, emphasizing that OSHA intentionally added another level of review by bringing in the regional compliance bloodborne coordinator. "The decision is not left to the individual compliance officer, but will be made in or after consultation with the regional coordinator, the regional solicitor, and, if necessary, the national office," Sands says. "The agency purposely added the higher review [so] that compliance officers will have higher-level discussions before determining if a violation exists on this particular issue."

Nevertheless, the Washington, DC-based Service Employees International Union (SEIU), which represents some 650,000 health care workers, plans to push OSHA on that very point to ensure only the best safety devices are implemented. Independent evaluations show that some devices are poorly designed or require too much activation on the part of the worker, notes Bill Borwegen, director of the occupational health and safety program at the SEIU. "The language in the compliance directive is actually very impressive," he says. "It says not only do you have to buy safety needles, but also, you have to continually evaluate these things to make sure you are buying the best. We’re going to start flooding OSHA with complaints. All safety needles are not created equal."

While welcoming the NIOSH and OSHA actions, the SEIU will continue to push for a formal amendment of the bloodborne pathogen standard to require the devices, he adds. "This [compliance directive] does not codify anything. All this is is an interpretation by OSHA on how the 1991 rule should apply. They need to amend the rule." OSHA previously announced it may formally amend the bloodborne pathogen standard, and there also have been state laws passed and federal initiatives proposed to require use of the devices. Indeed, the actions make it appear to be a foregone conclusion that safety devices are becoming the standard in the nation’s health care settings. State legislation is proceeding, with laws passed in California, Tennessee, and Texas, and bills under discussion in some 20 other states. (See Hospital Infection Control, July 1999, pp. 85-91.) In the interim, OSHA will weigh the effectiveness of the compliance directive changes in determining whether to pursue a formal amendment to the standard, Sands says.

"We have answered many congressional correspondences by saying that we believe that our standard right now requires these things to be done because of the way it is written," Sands says. "Certainly, the intent of these [compliance revisions] was to try to get to the bottom line without changing those requirements." Employee complaints can prompt an inspection, but there is no targeted inspection plan aimed at health care at this point, Sands says. Still, serious violations can be cited up to $7,000 each, and "willful" or repeated violations can be cited up to $70,000 each.

"ICPs who have the support of their key managers and who are doing the right thing will not be affected by this," says Grant. "The institutions that are sitting back and saying I’m not doing it until [OSHA amends the] standard have had a rude awakening. I know that I can go back and show an OSHA inspector fairly confidently that we are evaluating our occupational exposure incidents and we have implemented improvements. We will continue to do that every year."

[Editor’s note: The directive can be accessed on the Internet at the OSHA home page at Copies can also be obtained from the agency’s publications office by calling (202) 693-1888. The NIOSH alert is available on the web at Free copies of the alert are available by writing NIOSH Publications Dissemination, 4676 Columbia Parkway, Cincinnati, OH 45226-1998. Telephone: (800) 35-NIOSH.]


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.

2. National Institute for Occupational Safety and Health. "NIOSH Alert: Preventing Needlestick Injuries in Health Care Settings. DHHS NIOSH Publication No. 2000-108." Washington, DC: November 1999.