When will safer needles offer better designs?
April 1, 2002
When will safer needles offer better designs?
Manufacturers respond to design complaints
If you are frustrated with your choices of safer sharps devices, consider this: Last year, dozens of patents were issued for safety syringes alone. The number of manufacturers has risen to more than 100, and the variety of safety products continues to grow.
This rapid escalation in needlestick prevention technology creates confusion in the short term — but offers promise for devices that are easier to use and lead to fewer needlesticks. Employee health professionals report that poor design is a major stumbling block as they seek to replace all sharps with safety devices.
"A lot of these devices still have problems with them," agrees June Fisher, MD, director of the Training for Development of Innovative Control Technology Project of the Trauma Foundation at San Francisco General Hospital, a collaboration of frontline health workers, industrial hygienists, and product designers. "I would like to see much closer cooperation of manufacturers dealing with frontline workers for input. They all tell me they get a lot of input. I doubt it because they wouldn’t be making some of the mistakes they’re making."
Complaints include:
• Safety devices have to be attached before use. (Many health care workers won’t bother.)
• Syringes don’t eject all the contents. (The hospital gets fewer doses from expensive medications.)
• Sharps are not sharp enough. (Patients are uncomfortable, and IV starts require more than one stick.)
These concerns point out the importance of continually screening new technology and getting input from frontline health care workers at every stage of the selection process, needle safety experts say. At the same time, complaints don’t necessarily mean a device is bad, notes Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the Univer-sity of Virginia in Charlottesville.
"There can be legitimate reasons for wildly different opinions on the same device," she says. "The fact that health care workers in one setting don’t like a device is not necessarily a condemnation of that device.
"At the same time, we need to be listening now more than ever to feedback from health care workers," she says. "This is a new generation of devices. The advances are going to be continuing at a very high rate. Now is the time for health care workers to convey their opinions."
Positive changes are apparent as new devices emerge. For some procedures, hospitals now have needleless alternatives. Safety features have become more refined. In the latest guidebook from ECRI, a technology assessment firm in Plymouth Meeting, PA, more than 30 of the 66 devices were evaluated for the first time. ECRI also covered 13 product groups. In Sharps Safety and Needlestick Prevention, ECRI rated safety scalpels, blunted sutures, arterial blood gas syringes, and protec-tive lancets for the first time. And as technology changes, some devices that were considered acceptable in earlier assessments are now rated unacceptable. (See editor’s note for more information on the guide, at the end of this article.)
Robyn Silverman, ECRI senior project officer, notes that manufacturers are gradually improving designs. "There is a lot more attention being paid to devices that would be easier for the health care worker to use without learning a lot of new techniques," she says. "The best thing is for a device to come in and not cause a big training and learning curve. That’s what manufacturers are looking for now."
ECRI has been criticized for conducting its device testing in a laboratory environment. Silverman notes that ECRI also solicits input from device users. But she acknowledges that a device recommended by the firm might not be the best one for a particular hospital or unit.
"When we rate a device preferred, this is based on the fact that people find it easy to use and they like it," Silverman says.
"The most important thing is for your personnel to like the device so they’ll feel comfortable using it. If they don’t, that’s not the device for you."
Safety device design is much more advanced in some product categories than in others. "The products that have the highest volume use are becoming fairly sophisticated with several different design options in each category," notes Jane Perry, MA, communications director for the International Health Care Worker Safety Center.
"Now manufacturers are starting to take on the issue of smaller niche products." Allergy shots and pre-filled syringes are just two areas where new items have recently become available, she notes.
IV catheter systems are an example of a highly evolved market, Jagger says. "That product category is at a very high compliance rate right now. The technology keeps on getting better, more refined, and simpler to use, and it’s very, very effective in reducing needlestick rates," she says. "That’s one of the shining lights in this transition to safer technology."
How do you cope with the onrush of new products and designs? As a first step, you should screen two or three samples of every product available on the market in a given category, Fisher advises.
"You go through them quickly," she says. "You probably will discard the majority of them. There are still a lot of bad devices out there."
Frontline health care workers should be a part of this early screening, Fisher says. The user should guide the process, she says. "Making a pre-selection [of safer needle devices] and then showing it to people is not [a way to involve frontline workers]."
Health care workers in different units may reach very different conclusions about the merits of new products, Fisher notes. Your screening and selection process should allow for those differences. "Your device needs change for different work environments," she says.
The San Francisco General emergency department (ED) has more in common with the ED at Bellevue Hospital in New York City than it does with its own neonatal unit, Fisher points out.
Marshfield (WI) Clinic offers flexibility even within units by purchasing two or three different products in the same category. For example, nurses may give intramuscular injections with a retractable or sliding sheath syringe or a needleless injector, says Bruce Cunha, RN, MS, manager of employee health and safety.
"We felt it was best to give employees the choice of what product they wanted to use," he says.
As much as possible, Marshfield Clinic tries to buy passive products — those that are activated during use and don’t require extra steps from the health care worker. If it requires activation, the design should be as similar as possible to the conventional technique, Cunha says. But even if products don’t have an ideal design, they are still vastly better than conventional needles, and they are reducing needlesticks. In the first year of using a "snap cap" style device, in which the user flips a cap over the needle, the clinic’s laboratory had no reported needlesticks. The only needlestick that has occurred happened when a patient moved, jarring the needle and exposing the worker.
"In general, the market is definitely moving to one-handed operation for safety devices," says Peter Allen, spokesman for Becton Dickinson, the Franklin Lakes, NJ, company that is the nation’s largest manufacturer of needle devices.
"We’ve got some technologies in development that are more passive than our current technologies," he says. "The issue of passivity is a tricky one because very often there’s a trade-off between how passive the device is and how much control the user has in the procedure." A variety of factors impact the acceptability of products, he says. "The key criteria should be clinical acceptance and whether or not the project is effective in reducing accidental needlesticks."
Some complaints about safer needle devices stem from discomfort with change. But gradually, the employees are getting used to the new devices, Cunha says. "Most people are comfortable with the fact that we are going with devices that will reduce their chance for injury," he says. "Most people understand this is really for their safety."
[Editor’s note: Sharps Safety and Needlestick Prevention ($295) is available from ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462. Telephone: (610) 825-6000. Fax: (610) 834-1275. Web site: www.ecri.org. Lists of available safety devices are maintained by the International Health Care Worker Safety Center at the University of Virginia at www.med.virginia.edu/medcntr/centers/epinet/ and the occupational health branch of the California Department of Health Services at www.dhs.ca.gov/ohb/.]
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