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Description:
Risk of infection associated with Huber needles is expected to hamper growth of the market. During the use of Huber needles, the caregiver repetitively needs to access the implanted port and pierce a silicon septum with non-corning Huber needle. The Huber needles pose high risk of needle stick injuries during the removal of needle.
Market Trends/Key Takeaways
Increasing focus on reducing needle stick injuries has led companies to develop and introduce various needles with enhanced safety features in the market. Products with advanced features such as self-retracting needles and needles with safety locking are gaining traction among healthcare professionals and patients.
Increasing prevalence of end-stage renal disease is expected to boost growth of the global Huber needles market. For instance, according to November 2019 data of National Center for Biotechnology Information, the prevalence of end-stage renal disease is rising at a stable number of about 20,000 cases per year.


Regulations:

U.S.

The U.S. FDA authorizes the use of Huber needles for long term medication infusion and blood withdrawal
Huber needles are type of safety vascular access needles that fall under class II with special controls. However, companies need a premarket approval before commercializing the device.
FDA mandates performance tests for stiffness, bending breakage, corrosive resistance and elasticity of Huber needles
Huber needle manufacturers are expected to submit performance tests in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of Huber needles. These devices require a premarket approval (PMA) application before marketing and commercialization.
According to FDA, the basic structure of Huber needle contains needle, needle cap and needle hub. These needles are either straight type available in gauges 19, 20, and 22, and length 1’’ to 1-1/2’’ or bent 90 degree angle available in gauges 19, 20, and 22, and length 1’’ to 1-1/2’’
FDA has set few standard guideline in order to meet the safety requirement. These devices falls under the category of class II devices (Special Controls) or Class III (PMA).


Global Huber Needles Market: Competitive Landscape

Major players operating in the global Huber Needles market include, Baxter International Inc., B. Braun Medical Inc., Smiths Medical, NIPRO Medical Corporation, AngioDynamics, Inc., and C. R. Bard, Inc.


Global Huber Needles Market: Key Developments

Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in February 2019, B. Braun Medical Inc. acquired Medisystems Streamline Bloodlines business that includes the Streamline Bloodline for the Dialog+ hemodialysis system, Streamline Bloodline for the Fresenius Medical Care hemodialysis system, and Streamline Bloodline Long for the Fresenius Medical Care hemodialysis system.


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