By Jonathan Briggs
Government regulations prompt a higher demand for needle-safety and sharp-safety devices
With white powder-filled envelopes wreaking havoc on our postal system, many recent safety discussions among healthcare personnel have focused on anthrax. But as real as they are, the dangers posed by anthrax pale in comparison to the threat presented by exposure to bloodborne pathogens such as HIV, and hepatitis B and C.
Nearly 8 million people work in healthcare-related jobs and so are at risk of exposure to bloodborne pathogens, according to the U.S. Occupational Safety and Health Administration. Of that 8 million, the National Institute of Occupational Safety estimates some 600,000 to 800,000 suffer needlestick or sharp object injuries each year. EPINet, a database of sharps injuries maintained at the University of Virginia in Charlottesville reports that of out of 3,180 injuries reported by 52 hospitals, laboratorians and phlebotomists each suffer about 4 percent of the needlestick and sharps injuries. In 1998, for example, 125 clinical lab workers and 137 phlebotomist /IV team members were stuck by a needle-bearing device.
Before the rise of HIV and hepatitis infection, needlesticks were considered a slightly painful but largely insignificant occupational hazard. Today, the cost of that pain is much higher for all concerned.
Although an individual’s risk of infection after a needlestick is still small, the number of healthcare workers and the incidence of accidental skin punctures quickly swell those numbers. The risk of infection after a single needle stick with a contaminated object is 0.3% for HIV, 6% to 30% for hepatitis B and 0.5% for hepatitis C. With so many workers at risk for such severe consequences, something had to be done.
In 1997-98, a coalition of California healthcare workers began lobbying Sacramento for the regulation of needles and sharps, according to David Betit, of Trilogy Connection, a marketing and advertising agency specializing in biomedical and technology products. Baltimore-based Trilogy represents Greiner Bio-One, the world’s largest manufacturer of plastic blood collection containers. In 1999, OSHA issued an enforcement directive concerning sharps safety and blood borne pathogens. In November 2000, President Clinton signed into law the Needlestick Safety and Prevention Act, and OSHA issued new compliance directives in keeping with the changes mandated in the bloodborne pathogen standard of the Occupational Safety and Health Act of 1970.
The standards now require frontline workers to provide input on device evaluation and selection and that most employers maintain a log of injuries caused by contaminated sharps.
At first glance, it might seem easy to follow these guidelines and meet the OSHA standards. After all, over the past 15 years, more than 1,000 U.S. patents have been issued for medical devices designed to prevent injuries. It is possible that the use of these devices could prevent more than 80 percent of needlestick and sharps injuries. However, studies on which devices are safest do not exist, nor are they likely to be done, according to Gina Pugliese, vice president for safety at Premier and director of the Premier Safety Institute. Premier, a healthcare alliance, which is owned by its member hospitals, has offices in Charlotte, NC, Chicago and San Diego. “The incidence of events is so low for the number of procedures done that a study would have to include millions of procedures to reach statistical significance,” Pugliese noted. Moreover, no device can completely eliminate the risk of an injury. And because workers’ experience and comfort with a device directly affect its effectiveness, the selection of such devices must involve worker preference. That’s why OSHA requires that frontline workers be involved in device evaluation and selection.
Cost is an issue
To manufacture a typical syringe costs about a dime. To manufacture a typical needle-safety syringe costs about a quarter, more than twice as much. On the flip side, there’s the cost of not playing it safe. In one 1997 case, a jury awarded $12.2 million to a woman who became infected with HIV after receiving a needlestick injury at Yale-New Haven hospital.
Two approaches to sharps safety
There are two approaches to sharps safety. “The primary means is to eliminate the sharp object and the secondary means is to render a sharp object safe after is has been used,” said Brad Poulos, a representative of the National Alliance for the Primary Prevention of Sharps Injuries (NAPPSI).
Examples of what NAPSSI calls “Primary Prevention Devices” include:
- Catheter securement devices
- Non-sharp surgical instruments
- Laser technologies
- Needle-free infusion devices
- Non-needle wound closure technologies
- Non-needle drug delivery systems
Early efforts to reduce accidental skin punctures focused on re-sheathing a needle and placing it in a hard plastic biohazard disposal container after use, rather than device design. It wasn’t until the late ‘80s that the concept of designing safety features into products took hold in the medical device industry.
The lion’s share of the worldwide market in both needle-bearing and needle-safety technology belongs to Becton Dickenson (BD) of Franklin Lakes, N.J. In fact, BD’s market share is so large that the company is currently the defendant in a federal antitrust suit. Not surprisingly, it prefers to keep its market share numbers close to the vest. However, industry insiders estimate that BD owns no less than 90 percent of the worldwide market for needle-bearing and safety-needle technology in every country except Japan. That means everyone else gets to fight it out for that remaining 5 to 10 percent.
In 1989, BD debuted its Safety-Lok syringe with a protective plastic tube. It was not the first safety-needle technology on the market, but it was the first one from BD. Once Safety-Lok is removed from the patient, the user slides the tube forward to lock it into place to cover the needle. Unfortunately, this action requires two hands at a time when the user only has one hand available. Furthermore, the addition of Safety-Lok meant safety-promoting hospitals would have to carry both systems in their supply inventories.
The company’s second-generation safety product was an add-on to standard needles that is operated with one hand. SafetyGlide consisted of a hinged plastic piece that snaps shut over the needle when the user pushes it with a thumb, while the rest of the hand still holds the needle.
Many other companies also sell devices to replace needles and other sharp devices or new versions of traditional devices that include safety features.
Laser technology, such as the Cell-Robotic’s Lasette, uses a laser rather than a needle to make a very small hole in the finger for
capillary blood draws. The Lasette is FDA-cleared for blood screening tests and for home use in monitoring glucose levels.
Abbott Laboratories of Abbott Park, Ill., is also a player in the needlestick safety market with its needlestick prevention system that includes the Clave Connector, the LifeShield Prepierced Reseal and Blunt Cannula System and the LifeShield Luer Activated Valve. This system allows hospitals to provide needle-free IV pathogens. The safety features in the system are activated before disassembly and after disposal.
Still another approach to reducing sharps injuries is the StickSafe container. This individually-wrapped, 120mL sterile specimen container features a needle entry port and a laboratory safe access port. The cap’s safety grommet reduces the amount of sharps manipulation when a specimen is introduced into the container but also maintains the sterile environment. The laboratory access port also eliminates the need to remove the cap thus reducing the likelihood of exposure to potentially biohazardous specimens.
Perhaps one of the best means of reducing sharps injuries in the laboratory is to use only plastic and handle specimen containers as little as possible. Betit estimates that the number of sharps injuries from broken glass test tubes outnumbers needlesticks by ten-fold. And while it’s mandatory for a healthcare institution to report all needlesticks, there is no similar requirement for reporting on broken blood collection tubes.
Beckman Coulter has made inroads on safety with its LX20 Synchron Pro, the only analyzer on the market right now with closed tube sampling. When asked if the safety features alone were enough to justify purchasing the LX20, Leonard Dunikoski, Ph.D., director of clinical laboratories at Raritan Bay Medical Center in New Jersey replied, “The safety advantage made the difference for us. I’d like to think that most laboratorians are as safety-conscious as we are. After all, if two instruments are similar, why wouldn’t you choose the one that’s safe and more efficient? We haven’t done a formal time study, but in addition to safety, our techs — especially those on the evening and midnight shifts — like the fact that they can just take samples out of the centrifuge and put them on the instrument without having to remove stoppers.”
In 2000, ECRI, a non-profit organization that has been called the “Consumer Reports” for medical devices, published its Needlestick Prevention Device Selection Guide as a resource for healthcare professionals looking for help in choosing needleless systems and complying with safer needle regulations.
In a world that seems to be offering less in the way of safety and security, freedom from the fear of accidental needle-sticks doesn’t seem like too much to ask for.
Jonathan Briggs is a freelance writer in Tijeras, NM.