Designing Syringes for Needle Safety: Partnership is a Must

Administering an injection to a patient is a routine task for many healthcare workers. Each year, more than 16 billion injections are administered worldwide.¹ Most of the time, this is a quick and safe process for both the healthcare professional and the patient. But if the patient moves, the clinician’s hand is bumped or the syringe slips, there is potential for an accidental needlestick, and possible infection of a serious disease.

The most common causes of needlestick injury include two-handed recapping and the unsafe collection and disposal of sharps. At least 2 million healthcare workers suffer accidental needlestick injury each year.² Given the serious risk and frequency of accidental needlesticks, the World Health Organization (WHO) is calling for the use of “smart” syringes to reduce the risk of needlestick injury as part of a new guideline aimed at protecting healthcare workers and patients from illnesses such as HIV and hepatitis B and C.

Announced in February, WHO’s global health initiative recommends the use of safety-engineered, smart syringe devices to help reduce sharps injuries and to promote injection safety for patients and healthcare workers. Under the new guideline, WHO is urging the healthcare industry to transition to the exclusive use of “new smart syringes” by 2020.

According to WHO officials, the surest way to protect against unsafe injections is to use devices for injections that have been engineered so they cannot be re-used and don’t lead to accidental needle stick injuries among healthcare workers.

Smart refers to a mechanism on a syringe that is engineered for safety. Examples include an auto-disabling system that prevents reuse of the needle; a needle-shielding device that immediately and automatically covers the needle upon withdrawal; and a tamper-evident needle to help prevent contamination or accidental needlestick.

With increased scrutiny and regulation to prevent the spread of bloodborne infectious diseases, there is an urgent need to develop and implement safer injection systems such as these to better prevent needlestick injuries across the entire healthcare ecosystem.

Designing Safety-Engineered Systems
Drug companies and their delivery device manufacturer partners are encouraged to lead the way in safety innovation by evaluating and designing new options for syringe systems. Injectable drug delivery systems that incorporate a safety mechanism, whether user-controlled or triggered automatically, can significantly reduce the risk of accidental needlestick injuries. The Centers for Disease Control and Prevention estimates that using safer medical devices could prevent 60-88 percent of sharps injuries in hospitals.³

One of the first steps toward preventing needlestick injury is having a safety mindset when designing an injectable drug delivery device. This should incorporate a thorough understanding not only of the drug and its packaging and delivery system, but also the interactions between the delivery system and the patient and healthcare worker. Usability and safety should be considered together—and equally—as they both are critical to needlestick prevention.

For any drug delivery system that contains a needle (whether for direct injection, reconstitution or transfer), the manufacturers should consider the addition of a safety system. In many cases, when drug companies supply, for example, a prefilled syringe with a luer lock, they place the burden of safety 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 drug administration kit. These systems often work by preventing exposure to needles before and after injection, avoiding the need to recap needles, and/or eliminating unprotected disposal.

Prefillable syringe systems remain the container of choice for many injectable drugs and, in many cases, the drug manufacturer may look to several formats for the delivery system that are all based on the same primary container in order to support a drug product throughout its life cycle.

There are two main design types for prefillable safety syringes: active and passive systems.

• Passive safety systems require no activation steps, allowing healthcare workers to administer injections without any change in technique. Safety features are built in as an integral part of the syringe system and cannot be removed, and those safety features remain in effect before, during and after an injection.
• Active safety systems require the user to take additional steps to activate the safety feature during the injection process, such as manually flipping a guard over the needle. Proper use by healthcare workers is the primary factor in the effectiveness of active systems. Failure to activate the safety feature can leave both clinicians and their patients unprotected. 

Active and passive systems can be safe, effective drug delivery devices. When selecting a delivery device, it’s important for manufacturers to consider how patients, healthcare workers and the drug will interact with the delivery device. This holistic picture of integrated drug delivery should be the guiding principle when choosing the appropriate device.

Partnering for Needle Safety
The addition of a safety system to a prefilled syringe is an ideal way to reduce the risk of accidental needlestick injury, however, there are a few considerations for manufacturers to keep in mind. Adding a safety system may result in an extra assembly step. It also may require extra volume for a drug product and extra regulatory work to gain approval for the assembled system. All of these challenges can easily be overcome by close collaboration between the device manufacturer and the pharmaceutical company. And the ultimate benefit of increased safety should justify the necessary investments.

Packaging an injectable drug in a prefillable syringe with a needlestick prevention feature can provide additional protection for healthcare workers and patients, but it requires specialized knowledge and production capabilities. It’s essential to select a manufacturing partner with deep expertise in needlestick prevention, experience producing safety-engineered products and a thorough knowledge of integrated drug delivery. Close collaboration with such a partner in the early stages of a drug’s development can help anticipate administration needs and design a safe, effective drug delivery system that can support a particular drug product throughout its life cycle while helping to ensure the safety of patients and healthcare workers.

The WHO’s new guideline puts a spotlight on the serious issue of needle safety and places the burden of responsibility on drug manufacturers and their device development partners. The directive is clear: Drug manufacturers must take responsibility for providing end users with systems that ensure effective delivery of injectable medication, but they also must make strides to prevent accidental needlestick injury in order to keep healthcare workers and patients safe. 

References

1. World Health Organization. Making All Injections Safe. Available at: www.who.int/injection_safety/global-campaign/injection-safety_brochure.pdf. 2015.
2. Wilburn SQ, Eijkemans G. Preventing Needlestick Injuries among healthcare workers: A WHO–ICN collaboration. International Journal of Occupational and Environmental Health, 2004;10:451-456.
3. Centers for Disease Control and Prevention. (1997b). Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures—Minneapolis-St. Paul, New York City, and San Francisco, 1993-1995. MMWR, 46(2):21-25; Jagger, J. (1996). Reducing occupational exposure to bloodborne pathogens: where do we stand a decade later? Infection Control Hospital Epidemiology, 17(9), 573-575.

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Brian Kenny is director of business development, safety systems, for West Pharmaceutical Services Inc., an Exton, Pa.-based designer and manufacturer of pharmaceutical packaging and delivery systems.