5 years after needlestick law

We’re safer, but not safe enough

Market data show gaps in adoption

Five years after the Needlestick Safety and Prevention Act became law, hospitals have made a dramatic shift to safety devices, bringing about a decline of one-third to one-half in the rate of needlesticks among health care workers.

But amid this sea change toward a safer workplace, serious problems still exist. Virtually no operating rooms use blunt suture needles, a technology that has improved and is in widespread use in Japan. Some specialty areas, such as anesthesia and allergy, continue to resist the use of safety products. And cost and convenience continue to play a role, as with the use of conventional devices in pre-packaged kits and trays.

"It’s the first law in the world mandating safety devices. There’s no doubt it’s had a huge impact," says Janine Jagger, PhD, MPH, a pioneer in sharps safety who is director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville. Yet, she adds, "there are areas where the compliance has not been as good."

Jagger and other sharps safety experts have turned their attention toward promoting sharps safety in these " residual areas." They focus on education, better training, evaluation and selection of new technologies, and even influencing manufacturers to improve their device offerings.

"People aren’t really using systematic evaluation," says June Fisher, MD, director of the TDICT Project (Training for the Development of Innovative Control Technologies), which provides tools and training to health care facilities for sharps safety devices. She also is associate clinical professor of medicine at the University of California at San Francisco. "I’m hoping that people will be upgrading [devices] on an ongoing basis."

Conventional devices still used

There’s plenty of room for improvement. Market data reveal the progress as well as the gaps in safer device implementation.

In acute care facilities, virtually all peripheral IV catheters (95%), which are attached to needle-less IV systems, are safety-engineered devices, according to market conversion data compiled by the Healthcare Products Information Services in San Jose, CA, and provided to HEH by Becton, Dickinson & Co. (BD) in Franklin Lakes, NJ. Yet in other health care settings, such as doctor’s offices, clinics or surgery centers, about 18% still are conventional devices.

Syringes and blood collection devices were a prime target of safety programs as the problem of needlesticks emerged in the 1990s. But an estimated 21% of core hypodermic needles and syringes used in acute care hospitals still are conventional devices, according to projected FY 2005 data. Some may be used for pharmaceutical or other activities that don’t involve the risk of bloodborne exposures. But in alternate care sites, less than half (45%) of the needles and syringes used are safety-engineered — a clear indication that sharps safety is lagging. (See charts below.)

Market Penetration of Safety Devices

 

Blood Collection Devices

Some medical specialties have been particularly unwilling to adopt safety devices. For example, in hospitals, only 59% of syringes and needles used in insulin administration and only 26% in allergy treatment were safety-engineered.

"The conversion to safety is highly dependent on behavior change," says Amber Hogan, MPH, manager of safety and health policy at BD, and some specialists have been more resistant to that change.

Hospitals should make sure that clinicians who work in multiple facilities do not bring conventional devices with them, says Hogan. For example, some anesthesiologists still will use a conventional needle to access a needleless IV system, overriding the safety feature. If an employee is stuck, the hospital will be liable for any costs associated with post-exposure prophylaxis or seroconversion, she notes.

"Hospitals need to establish and enforce rigorous internal protocol," says Hogan, who previously worked with the Occupational Safety and Health Administration (OSHA) compliance division.

Disparities also are evident in blood collection, according to the market data. In acute care, the use of safety devices rose from 74% in FY 2002 to an estimated 83% in FY 2005. Yet in alternate care sites, only an estimated 57% of blood collection devices are safety-engineered. "Safety adoption is highly dependent on the type of facility in which [providers] practice," says Hogan.

In fact, the earliest sharps safety efficacy studies focused on phlebotomy devices, demonstrating the benefits of the technology, says Gina Pugliese, RN, MS, vice president of the Premier Safety Institute. "Phlebotomy poses one of the greatest risks of transmission of bloodborne pathogens," she says. "We have plenty of devices on the market. This should be 100% [adoption]. We should have crossed the finish line on this one."

The Service Employees International Union and advocacy group Public Citizen asked the Food and Drug Administration (FDA) to ban devices that don’t meet safety criteria and to ban glass capillary tubes, which have been associated with bloodborne pathogen exposures.

In a Sept. 8 Federal Register notice, the FDA said the agency didn’t have a "legal basis" for banning the devices. Instead, the notice said the agency would promote education, assist other organizations with voluntary " consensus" standards, and provide swift clearance of safer technologies.

"By allowing considerably more dangerous devices to stay on the market when equally effective, safer alternatives are available, the FDA has endangered the lives of hundreds of thousands of health care workers in this country," contended Peter Lurie, MD, deputy director of Public Citizen’s Health Research Group, in a statement.

Still, needle safety has led to changes in market forces and inspired voluntary actions. BD has removed a couple of conventional devices from the market, including a reusable blood tube holder (OSHA requires single-use holders) and a dose-sparing syringe that used a conventional needle attached to the syringe. Premier, a Charlotte, NC-based health care alliance that provides group purchasing, no longer offers any conventional phlebotomy devices or IV catheters, Pugliese says.

The operating room has been the most impervious to the adoption of safer technology. Few reusable scalpels (less than 5%) incorporate safety features to protect the blade, and only 59% of disposable scalpels in use are designed with safety, according to the market conversion data. (Most surgeons use the heavier, reusable scalpels.)

Less than 1% of all suture needles used in the United States use blunt technology that allows the penetration of muscle and fascia but not skin, says Brian Luscombe, group director of marketing for Syneture, a division of U.S. Surgical based in Norwalk, CT. In fact, suture needle manufacturers have historically promoted their sharpness.

Changes in blunt suture needle technology, including a special coating that improves their performance, could change their acceptability, he notes.

"We have just launched an initiative to promote blunt needle usage," Luscombe says. "There’s definitely a recognition at this point that blunt needles can contribute to reduction in the incidence of needlestick injuries."

Meanwhile, some other safety products haven’t even been developed for certain applications. For example, there are no safety-engineered arterial catheters or biopsy needles.

"More intuitive products are needed, more products that operate like their standard counterparts, to maximize use," says Cathie Gosnell, RN, MBA, clinical consultant of Premier Safety Institute.

Pre-packaged kits often contain conventional devices, including conventional syringes, violating the hospital’s own policies about selection and use of safety devices. These may have been chosen by surgeons or anesthesiologists who are not well educated on safety, says Hogan. They are provided by medical supply companies that specialize in kit-packing, not by device manufacturers.

"Kits and trays are not standardized," says Hogan. "They’re customized based on what the customer requests."

Are you likely to get an OSHA inspection or citation from these gaps in safety? That depends on where your hospital is located and whether your practices generate complaints from employees.

In the past five years, various federal OSHA regions and state OSHA programs have had special emphasis programs targeting the bloodborne pathogens standard. For example, in FY 2005, more than a third of the 97 federal OSHA citations were issued in Region 3, which encompasses Pennsylvania, West Virginia, Delaware, and the District of Columbia. (Virginia and Maryland, also in the region, run their own OSHA-approved programs.)

The number of " programmed," or planned, federal OSHA inspections related to bloodborne pathogens exposure in hospitals rose after the revision of the standard in 2001 — from three in FY 2001 to 34 in FY 2002. (See chart below.)

OSHA Bloodborne Pathogen Inspections and Citations

Complaints actually have declined. In FY 2005, there were only eight inspections of hospitals based on complaints to federal OSHA related to the bloodborne pathogens standard. In FY 2001, there were 21.

Yet concern about sharps safety and exposures has not waned — and isn’t likely to, says Dionne Williams, MPH, an OSHA senior industrial hygienist who focuses on bloodborne pathogen issues.

"We have a hotline that answers calls on compliance issues. Bloodborne continues to be the No. 1 [standard] that people ask about," she reports. "It’s the top of our health standard, one of the top issues."

The most frequent cause of a citation: Failure to use a safety-engineered device. Citations also are often issued for failure to update exposure control plans annually or to receive input from nonmanagerial employees. (See chart below.)

Percutaneous Injuries by Device Type*

Thousands of health care workers continue to suffer needlesticks annually. With underreporting and a lack of uniform national surveillance, it’s impossible to know the full breadth of the problem.

But it’s clear that while needlesticks have declined, they still pose a substantial workplace risk. An on-line survey published in Nursing2004 found that one-quarter of nurses said they had at least one needlestick in the past year, but 42% said they did not report their needlesticks. About 40% of nurses said they used conventional devices at least some of the time.2

In September, the Centers for Disease Control and Prevention (CDC) in Atlanta held a conference with sharps safety experts to develop an "action plan" on sharps safety. Reducing needlesticks is one of the seven health care safety challenges of CDC’s Division of Healthcare Quality and Promotion. It also is a goal of HealthyPeople 2010.

The meeting adjourned with the creation of smaller "working groups" on subtopics and a decision to meet again. There was no clear game plan for tackling the remaining barriers to implementation of sharps safety.

Perhaps the challenge of redirecting a workplace culture was exemplified by the design on the cover of the binders for the National Sharps Injury Prevention Meeting. It offered the maxim, "Sharps safety begins with you." The picture showed a conventional needle.

References

1. Food and Drug Administration. Needle-bearing devices; Withdrawal of advance notice of proposed rulemaking. 70 Fed Reg 53,326-53,328 (Sept. 8, 2005).

2. Perry J, Robinson ES, Jagger J. Nursing2004 needle-stick and sharps-safety survey: Getting to the point about preventable injuries. Nursing2004 2004; 34:43-47.