Syringe Testing and Needle Testing
With the increased emphasis on reducing needlestick injuries in recent years have come regulations requiring the use of safety devices wherever they are feasible. These regulations have, in turn, led to the development of many new safety syringes, needles, and other devices. CITECH testing has helped companies with these devices get clearance or approval to market their new safety devices.
Consider safety syringes as an example of these new devices that help protect the user against sharps injuries. To market a new safety syringe, the manufacturer must first demonstrate that the new device meets all the requirements for a conventional syringe.
For a syringe, this would include ISO 7886-1, Sterile hypodermic syringes for single use—Part 1: Syringes for manual use (ISO 8537 for insulin syringes). Most conventional syringes (i.e., those without safety features) have male Luer fittings for the attachment of standard hypodermic needles. Where a safety syringe includes a Luer fitting, the fitting should be tested according to ISO 594-1 and/or ISO 594-2 (click here for more information). But what if the safety syringe doesn’t have a Luer fitting?
The safety feature on many syringes involves drawing the needle back into the syringe barrel after it is used. Often, a Luer fitting would be too large to fit into the syringe barrel, and the syringe is designed with a different connector for use with proprietary needles (often pre-assembled). These special fittings cannot be tested against ISO 594-1 and ISO 594-2 because they do not meet the dimensional requirements of those standards, and some of the tests might be inapplicable. CITECH is skilled in examining the safety device against the intent of the ISO standards and developing suitable test methodology to demonstrate compliance with that intent.
Beyond demonstrating that a safety syringe meets all requirements for a conventional syringe, testing must also show that the safety feature works reliably and is not unduly burdensome to use. Otherwise, users might ignore the safety feature or choose a competitive product. Worse, the device might never gain FDA marketing clearance. FDA has issued a document, Guidance for industry and FDA staff: Medical devices with sharps injury prevention features (August 9, 2005); it may be found at http://www.fda.gov/cdrh/ode/guidance/934.html. This document outlines the simulated clinical use testing that should be done on these devices. CITECH is experienced in conducting this testing, as well as the physical testing of the safety device.
When preparing a 510(k) for a safety device, it is necessary to specify a predicate device, preferably one with a similar safety feature. Because the 510(k) submission should demonstrate that the new device is substantially equivalent to the predicate in safety and effectiveness, limited testing of predicate samples is usually helpful. CITECH can help companies determine what tests are appropriate.
If you are considering marketing a new needlestick prevention device, contact CITECH to learn how we can help.
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