Inviro Medical - Makers of InviroSNAP! Safety SyringeInviro Medical - Makers of InviroSNAP! Safety Syringe
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  PRODUCTS » SNAP! Safety Syringe » Regulatory Compliance

The InviroSNAP! Offers Sharps Injury Prevention

In August, 2005, the Food and Drug Administration (FDA) issued a document, "Guidance for Industry and FDA Staff - Medical Devices with Sharps Injury Prevention Features" to clarify important performance characteristics of medical devices that contain a sharps injury prevention feature. We’ve summarized the relevant performance recommendations below and compared them to the InviroSNAP! Safety Syringe.

FDA Performance Recommendations InviroSNAP! Safety Syringe
The user should be able to easily tell whether the sharps injury prevention feature is activated.
Yes. The needle retracts into the barrel of the syringe with a visual and audible representation.
Once activated, the sharps injury prevention feature cannot be deactivated and should remain protective through disposal.
Yes. Once the plunger is broken off the InviroSNAP!, the syringe is permanently disabled.
It should be possible to activate the feature with a single-handed technique, allowing the user's hands to remain behind the exposed sharp.
Yes. InviroSNAP! can be activated by single-handed technique, and the clinicians hands remain behind the exposed needle at all times.
The sharp should be fully retracted within the housing of the device.
Yes. The needle is completely retracted into the barrel of the syringe when the safety mechanism is activated.
The use of color should achieve a specific purpose, (e.g., differentiate device models or sizes) and conform with user conventions, (e.g., orange hubs and needle covers for insulin syringes).
Yes. The hub of the InviroSNAP! Safety Syringe complies with industry standard needle gauge color configurations.

With the addition of the InviroSTRIPE to the full range of manually retractable InviroSNAP! Safety Syringes, the InviroSNAP! with InviroSTRIPE also helps address the Joint Commissions's labeling requirements.

From the Joint Commission's 2008 National Patient Safety Goals: Does InviroSTRIPE assist
in addressing this goal?
» 3D: Label all medications, medication containers (for example, syringes, medicine cups, basins), or other solutions on and off the sterile field.
Yes, the InviroSTRIPE allows for the healthcare professional to document syringe contents, thus conforming with JCAHO 3D.

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