Sr.Manager, Prod Management, Pre-filled S&D
March 14, 2019
Prefilled glass and polymer syringes fulfill the requirements of major therapeutic areas for patient care and continue to grow thanks to ease of use. Compared with drugs offered in vials, the use of the prefilled syringes (PFS) with attached needles reduces administration steps but may increase the potential for needle stick injuries.
To ensure prefilled syringes are safe for caregivers and patients, many countries have implemented safety laws. The most recent directive is a World Health Organization (WHO) guideline request for a “smart “syringe by 2020. Improved patient outcomes along with needlestick legislation is driving growth in the global market for syringes with a safety system.
Manufacturers must complete usability testing of their safety system to validate the product's suitability for its intended use. The main advantage of usability testing is that the use of the device is more realistic, and the results of the process are more representative than results obtained through other approaches. Summative usability testing differs from formative usability testing in terms of its timing and purpose. Developers might perform several formative usability tests during the product development process to identify opportunities for design improvement.
Usability testing must be integrated and completed during development to identify potential use-related hazards so that they can be addressed with design improvements prior to product freeze. The requirement helps to reduce risk to caregivers and patients by ensuring that the medical device reflects good human factors engineering practices.
West offers a variety of safety systems, including the NovaGuard® SA Pro safety system, which helps protect healthcare workers and patients from accidental needlestick injury. Visit the NovaGuard SA Pro safety system page or contact us for more information.
NovaGuard® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.