Saturday, January 28, 2023

DropSafe Sicura, An Innovative Hypodermic Needle with a Transparent Safety Shield and Fully Automated Safety Mechanism, Received US FDA 510(k) Clearance

MTD Group – a global leader in medical devices– today 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.

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[1]. 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[2].

“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.

DropSafeTM SicuraTM 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[3].

“The device is based on intellectual property developed at MTD Engineering, our innovation hub connected to the technology behind all MTD’s medical sharps, resulting in over 300 currently active patents.”, stated Alberto Munzone, Chief Technology Officer at MTD; “A passive solution incorporated into the safety needle has been designed aiming to deliver a safe and easy to use mechanism that would not disrupt current injection procedures”.

 

The safety of healthcare professionals 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.

Carl Ward, General Manager of HTL Inc., the MTD Group company in North America. concluded…

“Since the COVID pandemic began, vaccination effectiveness is a key global focus. A fully passive injection device such as the DropSafeTM SicuraTM, that automatically locks the needle after injection in the safety shield slider with no additional step required, 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”.

DropSafeTM SicuraTM is fully manufactured by MTD’s affiliate PIKDARE S.p.A. at its plant located near Milan, Italy where a brand-new production line for this innovative device has been built with the purpose of serving global markets.

This device is CE certification pending.

[1] Mannocci A, De Carli G, Di Bari V, et al. How Much do Needlestick Injuries Cost? A Systematic Review of the Economic Evaluations of Needlestick and Sharps Injuries Among Healthcare Personnel. Infect Control Hosp Epidemiol. 2016;37(6):635-646.

[2] Bouya S, Balouchi A et al. Global Prevalence and Device Related Causes of Needle Stick Injuries among Health Care Workers: A Systematic Review and Meta-Analysis. 2020; 86(1): 35

[3] W. Tosini, et al., Needlestick Injury Rates According to Different Types of Safety-Engineered Devices: Results of a French Multicenter Study, Infection control and hospital epidemiology, April 2010, vol. 31, no. 4

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