Given the tough stance the Occupational Safety & Health Administration is taking on sharps safety compliance as part of the revised Bloodborne Pathogen standard of 2001, it’s little wonder many facilities are scrambling to ensure that their exposure control plans are in place.

At the same time, it’s also little wonder why so many are challenged and confused by the hundreds of different sharps safety devices on the market. In the operating room, those choices can range from safety syringes, scalpels and needleless IV insertion and connection devices to anti-suturing devices, bladeless laser devices and safety blood-draw sets. Couple that with the broad range of companies offering their own versions of each and it becomes clear how staff can become hamstrung by the product evaluation and selection process.

“There’s also the issue of product selection being based on preference and habit, when it should actually be based on evidence,” said Steven Bierman, M.D., president of the National Alliance for the Primary Prevention of Sharps Injuries (NAPPSI), Carlsbad, CA.

Poor product designs are also impeding the development of successful sharps safety programs. A number of devices that were created to reduce sharps injuries have proven to be even more dangerous than their predecessors in light of difficult-to-operate features and those that can be easily disabled by frontline caregivers.

The good news is, the market is flooded with a range of sharps safety devices that are user-friendly, highly effective and inexpensive. There’s also a wealth of information available to help healthcare providers better understand the different types of safety devices on the market, and offer guidance on product evaluation and selection.

Primary or secondary protection?
When evaluating the available sharps safety devices, healthcare workers will quickly discover that they aren’t all created equal.

There are at least four categories of safety device features. These devices may include: passive safety features, which remain in effect before, during and after use, and do not require the user to activate the safety feature; active devices, which require the operator to activate the safety mechanism (failure to do so will leave the user unprotected); an integrated safety design whereby the safety feature is included into its design and cannot be removed or inactivated; and an accessory device, which is a safety feature external to the device itself and must be fixed to the device at the point of use.

As guidance, the U.S. Food and Drug Administration has recommended that sharps safety devices have the following characteristics: provide a barrier between the operator’s hands and the needle after use; will allow the operator’s hands to remain behind the needle/sharp at all times; be an integral component of the device rather than an accessory; provide protection before, during and after use, and after disposal; and be simple and self-evident to all operators and require little training and no particular expertise.

While Bierman stressed that no device—regardless of its safety features—is perfect, “because it is operated by humans who are not perfect,” he did note that healthcare workers can up their chance for success by implementing devices that offer both primary and secondary prevention. The term “primary prevention” refers to healthcare technologies and practices that reduce or eliminate the use of sharp implements by replacing them with safer technologies and practices, such as catheter securement devices, NAPPSI noted. Secondary prevention, on the other hand, offers protection, but still requires use of a potentially dangerous sharp (i.e., retractable needles). According to NAPPSI, studies show that injuries still frequently occur with secondary prevention, with possible causes including clinicians’ failure to activate safety features, failure of the safety features to operate as intended, design problems that make the safety features difficult to operate, and post-usage accidents that occur while the devices are in the waste stream.

“NAPPSI advises the use of both primary and secondary protection. Primary prevention is the most direct way to prevent injuries because when you eliminate the sharp, you essentially eliminate the risk,” explained Bierman. “Of course, it isn’t possible to do away with the [sharp] in all devices, which is why secondary protection is also critical.”

The manufacturers and designers of sharps safety devices who comprise part of NAPPSI’s membership have developed primary prevention technologies as a response to the high rate of bloodborne infections caused by sharps injuries. More than 600,000 healthcare workers in the US are accidentally injured by sharps each year; approximately 2,500 of these cases lead to the development of hepatitis B or C, or HIV.

Improved device engineering
Two devices appear to be capturing significant attention in the realm of sharps safety: catheter securement devices, which prevent needlesticks by replacing tape and suture needles, and by reducing unplanned catheter restarts, and safety scalpels.

If not properly secured, a catheter can be dangerous to both patient and caregiver. Neither tape nor suture were designed to secure catheters; both allow catheter micromovements that can lead to phlebitis, infiltration, extravasation, dislodgement, disconnections and infection. Such complications make unscheduled catheter restarts necessary, exposing workers to blood-filled stylets and needles.

Some companies such as San Diego, CA-based Venetec International, Inc. have been successful in developing effective primary prevention devices to eliminate such risks. Venetec’s StatLock products are proven to reduce catheter movement and the need for unscheduled catheter restarts. The products have also been found to significantly improve patient safety and nursing productivity during a clinical trial at Veterans Administration Puget Sound Health System in Seattle and Tacoma, WA. Specifically, the StatLock IV Ultra reduced total complications related to short peripheral IV devices by 42% and unscheduled restarts by 63%.

“Complications related to short peripheral IV catheters are adverse events in a patient safety context because they are avoidable,” noted Timothy Royer, nurse manager of the IV team/diagnostic services at VA PSHCS, in a press release. “Our study suggests there’s no reason to tolerate high complication and restart rates from taping catheters because a safer, more efficient alternative is available.”

Bierman, who founded Venetec International, stressed that he considers himself an “anti-suture advocate, in general,” and not just an advocate of StatLock.

Operating room personnel who have been interested in safer surgical scalpels, but disappointed by their lighter weight, will be pleased to know they have other options. Sandel Medical Industries LLC, Chatsworth, CA, has introduced a weighted safety scalpel that gives the surgeon the feel of a heavier reusable scalpel.

“In the past, the problem with safety scalpels was that they were made of plastic and were very lightweight. The acceptance level was very low because no surgeon wanted to use a light scalpel,” said Dan Sandel, chief executive officer of Sandel Medical Industries.

Sandel became the first company to offer a weighted, totally disposable scalpel for the OR—a development that was initiated at the request of nurses. “They told us what they needed and we designed it.” He acknowledged, however, that the safety scalpel may not be appropriate for all surgical procedures, such as those where there is a need to scrape bone.

Both Bierman and Sandel also acknowledged that facilities will likely battle resistance from frontline caregivers, regardless of the effectiveness of today’s safety devices. Part of the blame, they say, lies with the physicians who disregard the safety of themselves and others because of product preference and misconceptions. But they aren’t alone. Nurses may also fail to push for the acceptance of safety devices because they don’t want to rock the boat, said Sandel.
“There is a tremendous level of resistance from physicians, which I believe is totally unacceptable. The problem is, nurses are letting them get away with it,” he said. “I tell them that they are really the ones in the driver’s seat.”
Bierman stressed again that the OSHA requirements should be driving the product evaluation and selection process—not the physicians who feel they have the power to veto any devices that are different from those they have always used.

“The regulations require that healthcare workers protect themselves as they do their patients. When you get right down to it, it’s a very simple request that just so happens to be mandatory.”

Resources:
For more information on sharps safety, or for help developing a comprehensive sharps safety program, log on to the follow web sites:
• National Association for the Primary Prevention of Sharps Injuries (www.nappsi.org)
• Association for Professionals in Infection Control and Epidemiology Inc. (www.apic.org)
• Centers for Disease Control and Prevention (www.cdc.gov/sharpssafety/)
• Occupational Safety and Health Administration (www.osha.gov)
• ECRI (www.ecri.org/sharpssafety)
• International HealthCare Worker Safety Center at the University of Virginia (home of EPINet)
• Premier Safety Institute (www.premiersafetyinstitute.org)