K-Pack Surshield™ has its own regulatory status (CE-marking), subsequently the pharmaceutical industry does not have to invest in and validate additional assembly operations. This minimizes resources and limits regulatory hurdles to implement sharp protection features along with the parenteral drugs that are placed into the market.
With K-Pack Surshield™, Terumo offers the pharmaceutical industry an optimal technological solution to become compliant with the European Council Directive 2010/32/EU concerning the prevention of sharps injuries. Terumo plans to expand the regulatory approval status beyond CE Marking so that the product will be available for other regions in the near future.
Designed in particular for subcutaneous and intra-muscular injections, a route of administration for many parenteral pharmaceutical and biopharmaceuticals drugs, K-Pack Surshield™ is a hypodermic needle with passive sharps protection. This prevents needle sticks and hence minimizes the risk of transmission of blood-borne pathogens from needle sticks.
The encapsulating protection feature is integrated with the needle and so the needle is never exposed, not before, not during, not after injection.
As a truly passive system, the protection mechanism is 'armed' during needle insertion, thus the protection system cannot be bypassed. The needle fits to 6% luer slip and luer lock (pre)-filled syringes.
K-Pack Surshield™ is individually packed in a rigid packaging with a tamper-evident and colour-coded label. It provides the user with Terumo's well renowned high quality needle for minimal patient trauma.
K-Pack Surshield™ will be shown at the 10th Pharmapack congress & exhibition in Paris on 23rd and 24th February – booth N° 454.
Terumo is a global medical technology company dedicated to the development, manufacturing and marketing of quality medical products and services used in a wide range of therapeutic applications.
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