ECRI rates performance of safer needle devices

Some unacceptable’ devices still stop needlesticks

How well do needlestick prevention devices work? A newly released Consumer Reports-style review gives the pros and cons of different safety technologies. But the report by ECRI, a technology assessment firm in Plymouth Meeting, PA, also has drawn criticism for its judgment of some injury-prevention devices as "unacceptable."

ECRI’s ratings aren’t based on how well the devices actually reduce needlesticks in clinical use. Few data are currently available to compare technologies in a clinical setting. Rather, ECRI based its evaluations on simulations in a laboratory environment, as well as input from clinical advisors who have used the products.

"The main issue here is the lack of performance data," says Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville and a leading expert on needlestick prevention. "They can be declaring a device unacceptable that can show good performance in use."

ECRI released its "Needlestick-Prevention Device Selection Guide" in February, just as many hospitals were responding to the updated needle safety directive issued by the U.S. Occupational Safety and Health Administration last fall. (See Hospital Employee Health, January 2000, pp. 1-4.) Several state legislatures also have passed or are considering stronger laws on the use of safety sharps devices.

ECRI wanted to fill an information gap and immediately had strong interest in compiling the special report, says Jim Keller, MS, director of ECRI’s health devices group.

Technologies differ in effectiveness

Designs for safety devices can vary significantly, with implications for ease of use and needlestick prevention. For example, safer phlebotomy devices use one of several technologies to reduce injuries. They may blunt the needle before it is removed from the patient, shield it with an external sheath, or use spring-loaded needle retraction.

In a study by the Centers for Disease Control and Prevention in Atlanta, researchers found that all three types of devices reduced needlestick injuries. Although the needlestick reduction ranged from 23% (winged steel needles) to 76% (bluntable vacuum-tube blood collection needles), researchers noted that the study wasn’t designed to compare the technologies.1

Perhaps more importantly, the study highlighted the need for health care workers to be comfortable with the new technologies. In 20% of the cases in which needlesticks occurred with the safer devices, health care workers had not activated the safety feature.

In a survey portion of the study, only 44% of health care workers said they preferred the safety device to conventional ones.

That concern about ease of activation was reflected in the ECRI evaluations, says Keller.

"We have a 30-year history of doing comparative evaluation of a wide range of medical products," says Keller. "The staff we have on board are trained in looking at ways a device can fail."

Tom Sutton, executive vice president of marketing and administration for Bio-Plexus, a Vernon, CT-based manufacturer of safety devices, says he respects ECRI’s method of evaluation. Bio-Plexus’ blunting needle products fared well in the ratings.

"In general, we applaud their consistency and how systematic the evaluation is," he says. "They seem to emphasize key safety features first and foremost, and that’s very important. They emphasized [the importance of] activation during the use of the needle or as close as possible."

Unacceptable’ is better than conventional

Even so, ECRI ratings of some products as "not recommended" or "unacceptable" shouldn’t lead employee health professionals to believe they are better off with conventional needles, Keller says.

"We have rated some products unacceptable that would reduce the risk of needlestick injuries, but there are products in our judgment that would better reduce the risk of needlesticks," he says. "We weren’t attempting to imply that an unacceptable’ needlestick prevention product is worse than not using any needlestick prevention product."

That is what concerns Janine Jagger. Health care workers need to decide which product they are most comfortable using, and more clinical data are needed to compare safety devices.

"The issue of evaluating and judging safety devices is a very tricky business," she says. "It’s one that everyone involved in this field has been struggling with.

"The problem is that you can get very different answers from different institutions. You can have one institution showing very good efficacy [with a product] and another institution not showing good efficacy," she says.

The bottom line, says Jagger, is that "from my view, no device is unacceptable if it reduces injury."

[Editor’s note: The "Needlestick-Prevention Device Selection Guide" ($295) is available from ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000. Fax: (610) 834-1275. Web site: www.ecri.org. A list of manufacturers of safety devices also is available free of charge on the Web site of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville: www. med.virginia.edu/~epinet.]

Reference

1. Centers for Disease Control and Prevention. Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures. MMWR 1997; 46:21-25.