In February 2015, the World Health Organization (WHO) announced a new policy urging the use of “smart” syringes to promote injection safety. “Transmission of infection through an unsafe injection occurs all over the world,” the WHO states on its Web site. As one example, it cites the 2007 hepatitis C outbreak in Nevada, which was reportedly prompted by a doctor who used a syringe to deliver an anesthetic to a hepatitis C-infected patient and then using the same syringe withdrew additional doses from the same vial used for injecting other patients.
WHO describes “smart” syringes as those that prevent reuse. The organization is “urging countries to transition, by 2020, to the exclusive use of the new ‘smart’ syringes, except in a few circumstances in which a syringe that blocks after a single use would interfere with the procedure,” it reports. WHO is also calling for training and safety programs to protect health workers during injection procedures.
Graham Reynolds, Vice President, Marketing and Communications, West Pharmaceutical Services says “ ‘smart’ could refer to ensuring safety around needlesticks as well as to an autodisabling system that prevents reuse.”
To prevent reuse and to promote safety, “passive systems are needed,” Reynolds tells PMP News. “OSHA guidance pertaining to needle stick prevention here in the United States defines the preferred safety system as something that doesn’t require any effort or user step to activate the safety feature,” he explains. “I believe that, in a totally 'passive' system, there should be an immediate and automatic covering of the needle upon the withdrawal to prevent contamination through a needlestick.”
To meet WHO recommendations, Reynolds says that West Pharmaceutical Services offers a range options intended to be simple to use and to produce. “In addition to conventional “add-on” systems, we are developing a passive safety system preassembled to a conventional prefilled syringe, that is compatible with current filling lines so there are no secondary processes required,” he says.
Late last year West’s NovaGuard SA (Staked-needle Automatic) Safety System received 510(k) clearance from the U.S. FDA. According to the company, the NovaGuard SA safety system helps reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use. The system features a tamper-evident needle shield and a safety mechanism that prevents pre-activation of the system.
Also, West is currently developing a passive system that will be fully integrated into a syringe. “It is designed to be compatible with established prefilled syringes so it doesn’t require new technology that may impact the container closure integrity,” Reynolds says. “The form factor also reduces the system’s footprint throughout the cold chain and supply chain.
“Part of our development is to work with filling companies and partner with glass companies that carry out part of the assembly process to ensure compatibility with our customers’ needs,” he continues. “And we work closely with our customers to understand their challenges.”
West is actively working with pharmaceutical manufacturers on preliminary evaluations, design evaluation studies, and user research and studies, he says. “Customers have different needs. Not only do we have products today, we will continue to innovate.”
To date, West Pharmaceutical Services has shipped more than 1.5 billion needle safety systems, Reynolds says.