MedPro Safety Products, Inc., a developer of transformational technologies that enable safer medication delivery and blood collection, announces that its passive safety winged blood collection set has received 510(k) market clearance from the Food and Drug Administration (FDA).
The passive safety winged blood collection set, commonly referred to as a butterfly collection and infusion device, is the first collection set with a passive safety feature that activates through normal occupational use and without an extra procedural step. The needle becomes fully encapsulated as it is removed from the patient, thus reducing the risk of a needlestick injury. It can also be used as a single patient infusion set, allowing for venous access for blood collection in addition to infusion procedures. It features a familiar look and feel for the healthcare worker.
The product will be manufactured and distributed globally under an exclusive distribution agreement by an international manufacturer and supplier of medical devices and pre-analytic products.
This clearance marks an important milestone toward MedPros objective to meet market demand for safer blood collection and infusion products, says Craig Turner, chairman and CEO of MedPro. We expect our passive butterfly device to meet regulatory requirements set out by the Federal Needlestick Safety & Prevention Act, and help reduce the healthcare costs associated with needle stick injuries. According to the American Hospital Association, a single serious infection by a bloodborne pathogen caused by a needlestick injury can exceed $1 million in expenditures for testing, follow-up, lost time, treatment and disability payments.