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By Kathy Dix
No matter how many times we are told how dangeroussharps can be, injuries still persist. But healthcare workers, the federalgovernment, accreditation organizations and manufacturers are all gettinginvolved 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 sharpssafety. In documenting its recommendations, JCAHO references guidelines releasedby the National Institute for Occupational Safety and Health (NIOSH),recommending that healthcare facilities should ensure that healthcare workersare 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 arefamiliar with the Needlestick Safety and Prevention Act, and whether any actionbeing taken to comply includes staff that use sharps and needles and aretherefore at risk for injury, according to a Sentinel Event Alert released byJCAHO in August 2001. The law requires that these healthcare workers andother staff be included in the review of safer devices as well as in makingrecommendations for replacement devices. JCAHO began including compliancewith 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 becompliant by OSHA may be faced with fines for failure to comply, the JCAHOpublication reads. During the on-site survey of accredited organizations,JCAHO surveyors assess the organizations familiarity with and use of SentinelEvent 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 areasonable explanation for not implementing relevant changes.
An Oct. 15, 2003, OSHA information bulletin has been a recent development insharps safety. The bulletin deals with the disposal of contaminated needles andblood tube holders used for phlebotomy; it explains the national policyregarding the disposal of such devices. This document addresses theprohibition against the removal of contaminated needles from medical devicesunless no feasible alternative exists or it is necessary for a specific medicalor dental procedure, as stated in OSHAs Bloodborne Pathogens Standard [29 CFR1910.1030(d)(2)(vii)(A)]. This includes a prohibition against the removal ofcontaminated needles from blood tube holders following a blood drawingprocedure, 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, infact, this is a requirement.
When a tube of blood is drawn from a patient, a plastic barrel is used tocollect the blood; the barrel is attached to a screw-on safety needle. OSHAexpects you to throw out both the plastic tube holder and safety needle, whichhas been activated at this point, minimizing a stick from the front and a stickfrom the back, Dunn explains. Inside, the plastic tube is covered with arubber sheet, but theres a needle under there. OSHAs point is that you mayget stuck from behind or stuck from the front.
It has been common practice in many healthcare settings to use a sharpsdisposal container with a click-off top that removes the needle and allowsthe reuse of the blood collection tube, she says. Thats been commonpractice across the country. Now OSHA is telling them they need to discard thewhole thing, and people are saying, Wait a minute! We dont think this isreally necessary.
OSHA can clearly cite them for noncompliance, says Joe Laco, MS, EH, aregulatory specialist at Quality America, Inc. Its in the code for thebloodborne pathogens standard. It states very clearly under the engineeringcontrol section that you cannot remove the needle once its been used.
However, manufacturers still make available these containers that assist withthe removal of the needle from the collection device. The end user asks, Whydo the companies make something that is clearly against the law? One reasonwhy people havent switched is because they figure if the product is on themarket, it is ok to use. They assume the FDA would never allow something to beon the market that was noncompliant, Dunn adds.
Its tremendously cost effective to just discard the needle and reusethe tube holder up to one hundred times, observes Laco. You can save a lotof bucks that way. Also, when you have to throw away the tube holder and theneedle, its big and its bulky and it takes up a lot of space in thosesharps containers. Theyll fill up fast. These medical facilities arediscarding many more sharps containers that they have to pay for by volume andby weight.
Youve got two costs there, Dunn says. You have the cost to hauloff the excess waste, and the cost to buy a new needle holder for every singlevenipuncture and every single blood collection.
Sharps containers can range in size from around a quart to many gallons. Thelargest ones sometimes are open at the top; this, Dunn says, is one reason whythe tube holder needs to remain attached to the needle. The back end of thatneedle is a sharp, and if you throw it away with the tube holder on it, itsimpossible to get stuck on the back end of that needle. If you take the tubeoff, that could be sticking out of the sharps container; I could inadvertentlyput 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 matterwhat the cost.
Although some facilities did begin complying with the law in 2001, not allhave made the transition yet, Dunn says. I dont think theres anyfacility in the United States thats 100 percent converted yet. Everyone should have been in compliance in 2001, but for the most part, Ithink 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, somefacilities may not be aware of the General Duty Clause of the Safety and HealthAct. Ask everybody what the level of compliance is. I was at mydentists last week and theyve never heard of safety needles, Lacooffers.
Even though it seems all gloom and doom, and scary and expensive, thereare lots of options out there, observes Laco. There are a lot ofmanufacturers out there that make sharps products, and there are lots ofproducts available so that every facility could find something their employeescould be comfortable with. The process to go through and switch to safety sharpsrequires that you use front-line employees. That has a lot of benefits as well, because they get to do somethingdifferent, they get to be involved, and they feel empowered in helping with thedecision process.
The other advantage is employees will be less likely to file complaintswith OSHA, so from a risk management standpoint, although youre spending moremoney for these safety needles, its going to end up probably saving money inthe long run, because youre going to avoid OSHA fines and citations andneedlestick follow-up.
OSHA has long held that the practice of removing needles in virtuallyevery application is not considered the safest practice, so even though itsdone and there are some times where perhaps it is appropriate, but usuallywith clean needles for the most part, the products are designed to notencourage 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 wereonly disposing of the needle by denotching, the size of the collectors wassmall; it usually would fit in a phlebotomy tray and the like. The consequencenow is that the smaller containers may not be sufficient to contain the volumenecessary to dispose of these holders, he says.
What were finding in patient rooms is that the counterbalanced doorproducts will accommodate the disposal of those holders without any particularproblem, he adds. Thats what we encourage the most, is that at thepoint of use, the healthcare worker can dispose of the holder and the needleimmediately.
When asked about educating customers in the proper disposal of these bloodcollection devices, Taylor points out, Weve been doing that for manyyears, in terms of overall denotching (from traditional hypodermic syringes),but as I mentioned earlier, it has been an accepted practice for many years, inthe blood drawing side, for them to be denotched. Thats the reason why OSHA came out with new guidelines, in recognition ofthe fact that it was widespread practice.
The blood collection containers are not the only recent item of interest insharps safety. One other thing thats relatively new in the market is theNIOSH guidelines for safe sharps disposal, says James Shaw, director ofmarketing for Becton Dickinson Sharps Disposal. While some of those itemshave been common sense for a long time, the first generations of sharpscontainers didnt really reflect much of the safe disposal guidelines thatNIOSH calls for.
Creating disposal containers that follow NIOSH guidelines and promote a saferenvironment is his companys goal, Shaw says. Thats what were allabout right now trying to get the message out to healthcare facilities thateven if theyre using a sharps collector now, there are ways to look at thosesystems and find safer products and practices to further reduce needlestickrisk. 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 findsafer and safer alternatives. NIOSH has specifically described alternatives thatthey ought to be looking at and considering as they look at their disposalsystems. The NIOSH set of guidelines has become a rallying cry for the disposalend of the industry, he adds.
NIOSH categorizes design elements and work practices around four basiccategories: functionality, accessibility, visibility and accommodation, saysShaw. From there, we get into specific thought about what a collector shouldlook like and how it should behave and where they should be placed in afacility. The first generation of sharps collectors that were placed on wallsdidnt have the benefit of being designed in light of what NIOSH has to say.
Visibility, one of the four NIOSH pillars of good sharps disposaldesign, is a recent focus. In the early days, everybody thought they needed to make themaesthetically pleasing and hide the nasty contents within, Shaw relates. NIOSHresearch indicates that visibility is very important. People need to visualizethe fill level so they can avoid overfilling the collectors. They need to beable 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 earliergenerations that promoted just aesthetics.
The first attempt at sharps collectors disguised their true intent, andthere were some companies that made pastel colors, he adds. More recently,people started to make collectors red exclusively, but even a dark redcollector, especially in low light, prohibits people from visualizing filllevels. More recently, one of the trends has been to create systems that useclearer collectors and cabinetry to allow people to avoid overfill byvisualizing better.
A counterbalanced door at the top of the sharps collection device isanother advance. The previous generations were open-top designs, and that isto say there was really nothing between the contents inside and the outsideworld, Shaw says. Those were according to NIOSH easier tooverfill, and intuitively much more easy to abuse, if somebody were to try tooverfill, or for some reason try to put their hands inside.
Some facilities have not designated specifically whose role it is to monitorand empty sharps disposal containers; NIOSH has suggested the assignment of aspecific individual to that responsibility in each department or on each floor.What we find in practice is its not something thats generallywell-defined, says Shaw. Some do, but some dont, and its almost ashared responsibility and it ends up sometimes being by default either ahousekeeping person or nurse, whoever happens upon a filled collector.
You can appreciate that nurses would prefer not to have to change outsharps collectors, because they have so many other duties, Taylor offers. Theywould probably think that is something done by someone perhaps fromhousekeeping, but housekeeping staff are not readily available throughout theday and night. So there are some practical issues.
Other options to increase the safety of sharps disposal include followingNIOSH guidelines for the height of the wall-mounted collector; NIOSH recommends that the opening of the collector be placed 52 to 56 inchesfrom the floor. Any height above that can add to the needlestick risk.
A further option includes hands-free opening of sharps collectors that resideon the floor or on a trolley. Large first-generation collectors kept on thefloor often are designed to be kept open between uses, and it can becatastrophic 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 temporaryclosure that can be opened with the use of a foot pedal, so the healthcareworker with full hands can open the collection device with less risk.
Ultimately, the goal is patient and employee safety, exemplified by the OSHAand NIOSH recommendations.
For more information on sharps safety and evaluation, visitwww.quality-america.com, which offers free sharps evaluation forms and a freesharps injury log.