DropSafeTM SicuraTM has obtained the FDA 510K clearance

13 January 2023

The leading medical device company MTD Group has announced yesterday the FDA 510K clearance obtained for the innovative device DropSafeTM SicuraTM passive safety needle for the intramuscular and subcutaneous injection.

Needlestick injuries are the most common hazard among healthcare workers worldwide. At least 20 different pathogens can be transmitted by NSIs such as Human immunodeficiency virus, Hepatitis B and C viruses. According to the European Agency for Safety and Health at Work and the Center for Disease Control and Prevention in the US, more than one million NSIs cases are reported every year in Europe and the US. In this context, MTD Group – one of the world’s leading medical device companies – have developed the DropSafeTM SicuraTM, a sterile single-use passive safety injection needle. Used in combination with a PFS or a filled syringe for subcutaneous and intramuscular injection of drugs, the device is equipped with a shield that protects the needle before, during and after injection to prevent needle stick injuries (the needle length is shorter than the shield).

The device features an automatic safety activation mechanism that locks the needle in the shield after the injection. Moreover, a needle use indicator, white before the injection, turns red just after use and the needle is lock in the safety shield. DropSafeTM SicuraTM is compatible with luer-slip and luer-lock connectors, and is available in 8 sizes with different the colors of the connectors depending on the gauge and needle length.