Hypodermic needle for safe drug delivery receives FDA clearance
MTD Group announced the FDA clearance obtained by its affiliate Pikdare S.p.A. for DropSafe Sicura passive safety needle, an innovative injection needle with a fully passive mechanism that can be used for the intramuscular and subcutaneous injection of vaccines and other drugs.
Key highlights:
- It is estimated that more than 2 million occupational needlestick injuries still occur each year, despite the introduction of safety regulations.
- DropSafe Sicura passive safety needle is designed to eliminate needlestick injuries among HCPs 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.
Safety injection needles are widely used by healthcare professionals (HCPs) in order to avoid the risk of needlestick injuries (NSIs) when injecting drugs to patients. NSIs can lead to occupational exposure to bloodborne and infectious disease. Injury and infection can incur significant distress to staff, as well as substantial costs to healthcare systems and result in disruption of patient treatment workflow.
Despite broad introduction of safety regulations over the last several decades, it is estimated that more than 2 million occupational needlestick injuries 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,” said Amber Mitchell, DrPH, MPH, CPH, president and executive director of the International Safety Center.
DropSafe Sicura passive safety needle is designed to eliminate needlestick injuries among healthcare professionals providing a fully safe injection experience before, during and after drug administration. The needle is protected by a transparent shield which automatically locks after injection, requiring no incremental activation step by the HCP post-injection.
Passive safety engineered devices are shown to be most effective for needlestick injury prevention since the HCP is less likely exposed to bloodborne pathogen post-use through the elimination of active motion for safety feature activation.