Member states of the European Union are now expected to pass national legislation aimed at preventing sharps injuries. EU Council Directive (2010/32/EU), which took effect May 11, 2013, aims “to achieve the safest possible working environment by preventing injuries to workers caused by all medical sharps (including needle-sticks),” reads the document. In other words, hospitals as well as other workplaces where healthcare services are provided are expected to take steps to protect employees from needle sticks.
EU’s effort largely resembles the U.S.’s Needlestick Safety and Prevention Act (NSPA), which became law in November 2000. That act modified the Occupational Safety & Health Administration’s Bloodborne Pathogens Standard “to set forth in greater detail (and make more specific) OSHA’s requirement for employers to identify, evaluate, and implement safer medical devices,” OSHA reports.
“The EU has used the United States as their benchmark for their own directive,” says Alan Shortall, founder and CEO of Unilife Corp. “The differences will likely come as each EU member state turns this directive into law at the national level, and how vigorously they direct their occupational safety and health agencies to enforce the mandatory use of needlestick prevention products.”
Trapping the Needle
Schreiner MediPharm reports that its Needle-Trap device for trapping needles after injection meets the new EU Council Directive and has also been awarded FDA 510(k) clearance for marketing in the United States. The system's safety mechanism is integrated as a component of the self-adhesive syringe label.
“Needle-Trap has been mainly designed for use with prefilled syringes with staked in needles,” reports Gene Dul, President of Schreiner MediPharm U.S. “These are ready to use and easy to handle in healthcare environments. Needle-Trap is adaptable to all standard syringe dimensions, for instance, 1 ml standard, 0.5 ml long, as well as 1 ml long.” The safety mechanism can be operated by healthcare personnel in a controlled, single-handed fashion, he explains. “After the needle has locked into the plastic trap–an action clearly perceptible by a clicking sound–it is irreversibly protected.”
Dul says feedback that Schreiner has received “from user studies has been very positive and shows a high level of acceptance." For instance, 92% of survey respondents found the device easy and obvious to operate, and 82% reported that the safety device does not impact their injection technique. For details and a video, visit www.needle-trap.com/3/needle-trap-user/user-survey/.
Dul says that Needle-Trap’s design offers some benefits compared with passive needle protection systems. "While Needle-Trap is applied to standard syringes like a normal label, passive devices are more complex and voluminous, thus usually requiring major changes to the packaging and resulting in significant additional costs. Needle-Trap requires no such changes, making it a particularly cost-efficient solution that can be processed on conventional dispensing systems using standard secondary packaging. Due to its compact design it saves storage space and reduces the amount of waste."
And the system doesn't "change the presentation of the product, [so] the syringe equipped with Needle-Trap is preserved in its original form and familiar to the user, while maintaining the consistency of the brand’s design," Dul says.
Needle-Trap has been used on millions of syringes produced by multi-national pharmaceutical companies, Dul reports.
For instance, Germany has just updated its laws in response to the EU Directive, reports Alex Jaksch, Director, Marketing & Commercial Development, Safety, for BD Medical – Pharmaceutical Systems. “In addition to updated requirements for hospitals, the very broad law also includes elderly care facilities and laboratories.” Jaksch also expects future legislation to materialize in South America, Russia, India, and Asia.
Because of the OSHA requirement, U.S. hospitals and other sharps users have sought safety devices for prefilled syringes and other sharps-containing products. The U.S. act has made a difference, and so should the EU directive, says Ron Stoker, executive director of the International Sharps Injury Prevention Society (ISIPS). (He promotes the use of safety products and has served as a consultant to many medical device companies.) “In 12 years, we’ve seen a decrease in injuries, and we have seen a decline in some infections,” he says. “The EU directive is very much appreciated by healthcare.” For instance, a group of doctors writing to the New England Journal of Medicine in February 2012 point to “evidence that the NSPA contributed to the decline in percutaneous injuries among U.S. hospital workers.”
But some argue that risks still persist. According to Safe In Common, a group consisting of healthcare personnel, “5.6 million healthcare personnel in the U.S lack access to safety-engineered medical devices that can fully protect them from occupational exposure to bloodborne pathogens such as HIV and Hepatitis C,” reads their Web site. Starting in 2012 and throughout 2013, the group is touring the United States to promote the Safe in Common pledge, posted here from Facebook: “I pledge to support Safe in Common in its campaign to promote and strengthen the Federal Needlestick Safety and Prevention Act, raise awareness of needlestick safety, and utilize safer engineering controls to protect me and my fellow healthcare personnel from unnecessary needlestick injuries.”
Unilife’s Shortall also sees challenges. “In most cases, healthcare facilities have done a tremendous job in adopting measures that comply with needlestick prevention laws. Conversion to safety-engineered medical devices has been very strong in acute-care facilities. Secondary care sites have been a little slower to convert to safety products, perhaps due to a lower level of focus by OSHA. [But] despite strong rates of conversion, the reported number of needlestick injuries has not reduced since 2000 across several high-risk categories such as needles and syringes or suture needles. Alarmingly, safety-engineered products now account for the majority of injuries in many device categories.”
Adds Graham Reynolds, vice president, marketing and innovation, West Pharmaceutical Services: “While the industry has seen improvement, there needs to be ongoing development to create safer systems and practices. Systems that incorporate a safety mechanism can lower the risk of accidental needlesticks significantly and reduce costs. The CDC estimates that using safer medical devices could prevent anywhere from 60-88% of sharps injuries in hospitals. Device companies need to strive for safer systems, and authorities need to ensure that the policies and funding support are in place.”
Safety device manufacturers and the drug manufacturers that are implementing such devices are doing “good work,” says Stoker of ISPIS, but he would like all manufacturers to “make sure safety is integrated into each product,” rather than left up to the hospitals to add on. “Clinicians can struggle with add-on technologies.”
Reynolds believes “drug manufacturers must take responsibility for providing end-users of their products with systems that ensure safe and effective delivery of the medication, but also provide safety to the nurse, caregiver, or patient as it relates to needlestick prevention,” he says. “If the system contains a needle—whether for direct injection or reconstitution/transfer—then the drug company should consider the addition of a safety system. In many cases when pharmaceutical companies supply, for example, a prefilled syringe with a luer lock, they place the burden of affixing a safe needle on the healthcare worker. There may be safety benefits by providing administration systems with either an integrated needle safety system, or with a safety needle provided within the kit.”
Jaksch from BD says that safety solutions that come prepackaged with the prefilled syringe (in the blister package, for example) and allow a one-handed use enable the nurses to work more efficiently and more safely. “Nurses must work very fast, and time is critical. Any step that can be saved increases safety.”
A Range of Solutions
BD Medical – Pharmaceutical Systems offers needle safety devices and shielding systems ranging from manual to active to passsive or automatic solutions. For instance, the active BD Preventis features a shield for prefilled BD Hypak syringes with an attached needle that can be activated with one hand, while the BD UltraSafe PLUS Passive Needle Guard features new passive needle guard technology.
The BD UltraSafe PLUS Passive Needle Guard just received 510(k) clearance as an antineedlestick safety device, BD reported earlier this year. The device features extended built-in finger flanges and an enhanced plunger head for improved injection support and stability, it reported. In a recent focus group with patients suffering from rheumatoid arthritis and multiple sclerosis, BD found that “subjects reported the BD UltraSafe PLUS Passive Needle Guard provided ease of use with 100% of injections executed successfully.” The product was developed by Safety Syringes Inc., which was acquired by BD in December 2012.
Alex Jaksch, Director, Marketing & Commercial Development, BD Medical–Pharmaceutical Systems, Safety, says ergonomic features can be built into safety devices and shielding systems “to make injection more comfortable, either for the professional or the patient. The trend more and more is for patients to inject themselves, and little changes can be made to make them easier to use, like making smaller or easier to grip devices.”
Shortall argues that “one of the big problems is the continued use of products that require the user to manually activate the safety mechanism only after the non-sterile sharp has been removed from the body. There is now a groundswell of support for the strengthening of the laws to require the use of products with passive, or automatic, safety mechanisms that virtually eliminate the risk of needlestick injury and do not require a change to normal procedures.”
Reynolds says that “on the whole, safety devices will reduce risk; however, systems that can minimize changes to drug administration practices and eliminate extra activation steps should be preferred.
“Research—as well as legislation—has shown a preference for passive systems as opposed to active systems where the user has to employ an extra step to engage a safety feature,” Reynolds continues. “The ideal passive system should ensure that needle protection is triggered automatically at any point after the needle is inserted into the body, and before completion of the full dose. This would ensure protection even if the dose is partially administered in circumstances where, for example, a patient struggles so the needle is removed and healthcare workers are exposed to a contaminated sharp in a dangerous situation. Active systems are used extensively, and work must continue to ensure that passive systems are adopted and optimized to help ensure safety.”
Safety solutions may also require some customization to fit product and procedure. “Bulky safety shields could obstruct healthcare practitioner view during procedures such as epidurals and present risks to patients,” says Stoker. “And safety devices are often complex medical devices themselves that can present needlestick risks.”
Finally, safety devices may not be readily available for some products. “Unfortunately, the whole market has not switched, and OSHA allows the use of certain products if safety devices are not available,” says Stoker.
Stoker would especially like to see passive safety features fully integrated into single-use prefilled syringes. “There are so many benefits with prefilled syringes—dosing accuracy, convenience, single use minimizing risks of cross contamination, and sterilization assurance,” he says.
Cost may be a deterrent for some potential users, but Jaksch from BD says that safety features are “worth the investment, given the tremendous cost associated with needlesticks.” Stoker agrees: “The costs for safety devices are higher, but the costs of clinician exposure and treatment after needlesticks need to be considered, too.”
Lower-cost devices may be in demand in certain developing markets, Jaksch says, but he has seen drug companies market “safety as a differentiator.” And many safety devices can be automatically assembled, applied, and packaged in high-volume operations, he says.
Reynolds says that “the addition of a system to a prefilled syringe most likely will result in an additional assembly step. It may also require extra volume for a drug package and extra regulatory work to gain approval for the assembled system. All of these challenges can be overcome by close collaboration between the device manufacturer and the pharmaceutical company. The ultimate benefit of increased safety should justify any investment necessary.”
And Stoker says he’d like to see safety solutions in place that protect healthcare practitioners in every situation: “Passive safety products activate automatically. The safety feature should protect a clinician even if the patient kicks or convulses—the needle shouldn’t hurt anyone.”