Infection Control Today - 01/2004: Clinical Update

The Truth About Sharps Safety:
Back to the Basics

By Kathy Dix

No matter how many times we are told how dangerous sharps can be, injuries still persist. But healthcare workers, the federal government, accreditation organizations and manufacturers are all getting involved in the prevention of needlesticks.

The Letter of the Law

Even the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), a purely accrediting body, ensures that its members are aware of sharps safety. In documenting its recommendations, JCAHO references guidelines released by the National Institute for Occupational Safety and Health (NIOSH), recommending that healthcare facilities should ensure that healthcare workers are properly trained in the safe use and disposal of needles and sharps.

In July 2001, the Needlestick Safety and Prevention Act took effect; JCAHO surveyors are now asking if healthcare organization leaders are familiar with the Needlestick Safety and Prevention Act, and whether any action being taken to comply includes staff that use sharps and needles and are therefore at risk for injury, according to a Sentinel Event Alert released by JCAHO in August 2001. The law requires that these healthcare workers and other staff be included in the review of safer devices as well as in making recommendations for replacement devices. JCAHO began including compliance with this recommendation as part of its scoring in January 2002.

In April 2002, the Occupational Safety and Health Administration (OSHA) will begin enforcing the new law and organizations that are not found to be compliant by OSHA may be faced with fines for failure to comply, the JCAHO publication reads. During the on-site survey of accredited organizations, JCAHO surveyors assess the organizations familiarity with and use of Sentinel Event Alert information. Organizations are expected to (1) review each Sentinel Event Alert, (2) consider the suggestions, as appropriate to the organizations services, and (3) implement the suggestions, or reasonable alternatives, or provide a reasonable explanation for not implementing relevant changes.

An Oct. 15, 2003, OSHA information bulletin has been a recent development in sharps safety. The bulletin deals with the disposal of contaminated needles and blood tube holders used for phlebotomy; it explains the national policy regarding the disposal of such devices. This document addresses the prohibition against the removal of contaminated needles from medical devices unless no feasible alternative exists or it is necessary for a specific medical or dental procedure, as stated in OSHAs Bloodborne Pathogens Standard [29 CFR 1910.1030(d)(2)(vii)(A)]. This includes a prohibition against the removal of contaminated needles from blood tube holders following a blood drawing procedure, says the document.

OSHA has clarified this twice before, points out Sheila Dunn, DA, president and CEO of Quality America, Inc. Apparently, no one believed them, so they came out with another compliance bulletin, to reiterate that, yes, in fact, this is a requirement.

When a tube of blood is drawn from a patient, a plastic barrel is used to collect the blood; the barrel is attached to a screw-on safety needle. OSHA expects you to throw out both the plastic tube holder and safety needle, which has been activated at this point, minimizing a stick from the front and a stick from the back, Dunn explains. Inside, the plastic tube is covered with a rubber sheet, but theres a needle under there. OSHAs point is that you may get stuck from behind or stuck from the front.

It has been common practice in many healthcare settings to use a sharps disposal container with a click-off top that removes the needle and allows the reuse of the blood collection tube, she says. Thats been common practice across the country. Now OSHA is telling them they need to discard the whole thing, and people are saying, Wait a minute! We dont think this is really necessary.

OSHA can clearly cite them for noncompliance, says Joe Laco, MS, EH, a regulatory specialist at Quality America, Inc. Its in the code for the bloodborne pathogens standard. It states very clearly under the engineering control section that you cannot remove the needle once its been used.

However, manufacturers still make available these containers that assist with the removal of the needle from the collection device. The end user asks, Why do the companies make something that is clearly against the law? One reason why people havent switched is because they figure if the product is on the market, it is ok to use. They assume the FDA would never allow something to be on the market that was noncompliant, Dunn adds.

Its tremendously cost effective to just discard the needle and reuse the tube holder up to one hundred times, observes Laco. You can save a lot of bucks that way. Also, when you have to throw away the tube holder and the needle, its big and its bulky and it takes up a lot of space in those sharps containers. Theyll fill up fast. These medical facilities are discarding many more sharps containers that they have to pay for by volume and by weight.

Youve got two costs there, Dunn says. You have the cost to haul off the excess waste, and the cost to buy a new needle holder for every single venipuncture and every single blood collection.

Sharps containers can range in size from around a quart to many gallons. The largest ones sometimes are open at the top; this, Dunn says, is one reason why the tube holder needs to remain attached to the needle. The back end of that needle is a sharp, and if you throw it away with the tube holder on it, its impossible to get stuck on the back end of that needle. If you take the tube off, that could be sticking out of the sharps container; I could inadvertently put my hand on it and get a needlestick. Thats OSHAs point.

When asked about all the added waste that following the law will generate, Laco responds, OSHA couldnt care less about the cost of safety equipment, or the cost of disposal. They only care about protecting employees, no matter what the cost.

Although some facilities did begin complying with the law in 2001, not all have made the transition yet, Dunn says. I dont think theres any facility in the United States thats 100 percent converted yet. Everyone should have been in compliance in 2001, but for the most part, I think ambulatory medical facilities are about 50 percent compliant; Id say hospitals are about 75 percent compliant.

Despite the widespread knowledge that sharps can spread pathogens, some facilities may not be aware of the General Duty Clause of the Safety and Health Act. Ask everybody what the level of compliance is. I was at my dentists last week and theyve never heard of safety needles, Laco offers.

Even though it seems all gloom and doom, and scary and expensive, there are lots of options out there, observes Laco. There are a lot of manufacturers out there that make sharps products, and there are lots of products available so that every facility could find something their employees could be comfortable with. The process to go through and switch to safety sharps requires that you use front-line employees. That has a lot of benefits as well, because they get to do something different, they get to be involved, and they feel empowered in helping with the decision process.

The other advantage is employees will be less likely to file complaints with OSHA, so from a risk management standpoint, although youre spending more money for these safety needles, its going to end up probably saving money in the long run, because youre going to avoid OSHA fines and citations and needlestick follow-up.

Product Advances

OSHA has long held that the practice of removing needles in virtually every application is not considered the safest practice, so even though its done and there are some times where perhaps it is appropriate, but usually with clean needles for the most part, the products are designed to not encourage that practice except in those rare cases where it is appropriate, says Joseph Taylor, general manager of Becton Dickinson Sharps Disposal.

The impact (of the OSHA bulletin) is that in the past, since they were only disposing of the needle by denotching, the size of the collectors was small; it usually would fit in a phlebotomy tray and the like. The consequence now is that the smaller containers may not be sufficient to contain the volume necessary to dispose of these holders, he says.

What were finding in patient rooms is that the counterbalanced door products will accommodate the disposal of those holders without any particular problem, he adds. Thats what we encourage the most, is that at the point of use, the healthcare worker can dispose of the holder and the needle immediately.

When asked about educating customers in the proper disposal of these blood collection devices, Taylor points out, Weve been doing that for many years, in terms of overall denotching (from traditional hypodermic syringes), but as I mentioned earlier, it has been an accepted practice for many years, in the blood drawing side, for them to be denotched. Thats the reason why OSHA came out with new guidelines, in recognition of the fact that it was widespread practice.

The blood collection containers are not the only recent item of interest in sharps safety. One other thing thats relatively new in the market is the NIOSH guidelines for safe sharps disposal, says James Shaw, director of marketing for Becton Dickinson Sharps Disposal. While some of those items have been common sense for a long time, the first generations of sharps containers didnt really reflect much of the safe disposal guidelines that NIOSH calls for.

Creating disposal containers that follow NIOSH guidelines and promote a safer environment is his companys goal, Shaw says. Thats what were all about right now trying to get the message out to healthcare facilities that even if theyre using a sharps collector now, there are ways to look at those systems and find safer products and practices to further reduce needlestick risk. Thats still part of our primary message to the healthcare industry, even if you have collectors on the walls and the floors now, to continue to find safer and safer alternatives. NIOSH has specifically described alternatives that they ought to be looking at and considering as they look at their disposal systems. The NIOSH set of guidelines has become a rallying cry for the disposal end of the industry, he adds.

NIOSH categorizes design elements and work practices around four basic categories: functionality, accessibility, visibility and accommodation, says Shaw. From there, we get into specific thought about what a collector should look like and how it should behave and where they should be placed in a facility. The first generation of sharps collectors that were placed on walls didnt have the benefit of being designed in light of what NIOSH has to say.

Visibility, one of the four NIOSH pillars of good sharps disposal design, is a recent focus. In the early days, everybody thought they needed to make them aesthetically pleasing and hide the nasty contents within, Shaw relates. NIOSH research indicates that visibility is very important. People need to visualize the fill level so they can avoid overfilling the collectors. They need to be able to identify any hazards that might be there as they go to use that device. More recent designs really promote visibility, as opposed to the earlier generations that promoted just aesthetics.

The first attempt at sharps collectors disguised their true intent, and there were some companies that made pastel colors, he adds. More recently, people started to make collectors red exclusively, but even a dark red collector, especially in low light, prohibits people from visualizing fill levels. More recently, one of the trends has been to create systems that use clearer collectors and cabinetry to allow people to avoid overfill by visualizing better.

A counterbalanced door at the top of the sharps collection device is another advance. The previous generations were open-top designs, and that is to say there was really nothing between the contents inside and the outside world, Shaw says. Those were according to NIOSH easier to overfill, and intuitively much more easy to abuse, if somebody were to try to overfill, or for some reason try to put their hands inside.

Some facilities have not designated specifically whose role it is to monitor and empty sharps disposal containers; NIOSH has suggested the assignment of a specific individual to that responsibility in each department or on each floor. What we find in practice is its not something thats generally well-defined, says Shaw. Some do, but some dont, and its almost a shared responsibility and it ends up sometimes being by default either a housekeeping person or nurse, whoever happens upon a filled collector.

You can appreciate that nurses would prefer not to have to change out sharps collectors, because they have so many other duties, Taylor offers. They would probably think that is something done by someone perhaps from housekeeping, but housekeeping staff are not readily available throughout the day and night. So there are some practical issues.

Other options to increase the safety of sharps disposal include following NIOSH guidelines for the height of the wall-mounted collector; NIOSH recommends that the opening of the collector be placed 52 to 56 inches from the floor. Any height above that can add to the needlestick risk.

A further option includes hands-free opening of sharps collectors that reside on the floor or on a trolley. Large first-generation collectors kept on the floor often are designed to be kept open between uses, and it can be catastrophic if they tip over. And they have a very high center of gravity, so theyre prone to that, says Shaw. The solution to that is a temporary closure that can be opened with the use of a foot pedal, so the healthcare worker with full hands can open the collection device with less risk.

Ultimately, the goal is patient and employee safety, exemplified by the OSHA and NIOSH recommendations.


Resources

For more information on sharps safety and evaluation, visit www.quality-america.com, which offers free sharps evaluation forms and a free sharps injury log.

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