FDA approval for DropSafe Sicura

An innovative safety needle with fully passive mechanism.

Sterile, single-use passive safety injection needle to be used in combination with a (pre)-filled syringe for subcutaneous and intramuscular injection.
https://dropsafe.info/

MTD Group obtained FDA clearance by its affiliate Pikdare S.p.A. for DropSafe Sicura passive safety needle for the intramuscular and subcutaneous injection of vaccines and other drugs.

Safety needles are widely used by healthcare professionals (HCPs) to avoid the risk of needlestick injuries (NSIs) when injecting drugs to patients. Despite broad introduction of safety regulations over the last decades, it is estimated that more than 2 million NSIs still occur each year.

"Moving towards safer medical device technology –and especially evolving sharps with injury prevention features to a more passive design– promises to reduce needlestick injuries. Safety device designs that require a user to actively do something can result in injury during activation, or failure to activate the safety feature at all. Truly passive designs can not only protect the user, but those downstream who may encounter that contaminated device as well" says Amber Mitchell, DrPH, MPH, CPH, president and executive director of the International Safety Center.

DropSafe Sicura is designed to eliminate needlestick injuries providing a fully safe injection experience. The needle is protected by a transparent shield which automatically locks after injection, requiring no incremental activation step by the HCP post-injection.

The safety of HCPs has always been the top priority for the MTD Group, and the criticality of our mission has been further amplified in recent years with the spread of SARS-COV-2.

"Since the COVID pandemic began, vaccination effectiveness is a key global focus. A fully passive injection device such as the DropSafe Sicura, fulfills an unmet need of our customers in the US for increased safety. We will immediately start to make the product available to pharmacy chains and the other practices that are fully focused in delivering care throughout the US", concludes Carl Ward, general manager of HTL Inc., the MTD Group company in North America.

This device is CE certification pending.

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