CE Mark for ECA Medical’s Surgical Instruments, Kits

ECA Medical Instruments, Newbury Park, Calif., received the CE Mark designation. Earning the CE Mark allows the company’s single-procedure precision surgical instruments and kits to be more easily adopted for use by customers across the EU medical device market.

CE Mark or Conformité Européenne marking certificate was earned by ECA following comprehensive audit of the company’s quality management systems, processes, and validations by auditor and registrar G-Med North America a division of LNE/G-Med in France. Earning the CE Mark follows ECA’s January 2013 registration with the U.S. FDA as a Class 1 medical device company.

The CE designation underscores ECA’s commitment to meeting requirements of its EU based medical implant device customers. ECA makes single-procedure instruments and kits for the cardiac rhythm management (CRM), cardiovascular, neuromodulation, and orthopaedic implant markets.

“Achieving the CE Mark will accelerate adoption of our single-procedure instruments and procedural kits across the EU medical implant community,” states John Nino, ECA’s president and CEO. “Our EU based CRM and Neuro customers have added assurance we meet EU wide directives while our existing and new orthopaedic implant customers will gain access to new ECA instruments and kits tailored for their medical devices and surgical procedures.”

ECA’s products are in high demand as device makers, hospitals and surgeons work to solve current safety and financial challenges posed by using reusable instrument sets, which have expensive purchase price and have high life cycle costs including heavy use of chemicals and utilities for cleaning and large carbon footprints for logistics.

Surgeons and hospitals in the EU now have a viable and cost effective alternative to existing instruments which may not be in proper torque calibration, sterility is not always assured and the life cycle cost to support and inventory these tools is spiraling placing increased surgical risk and financial burden on both national and EU wide healthcare system. Conversely ECA’s torque instruments are 100% calibrated, are delivered sterile ready or sterile packed and the single-use designation eliminates any chance of contracting surgical site infections.

ECA makes a complete portfolio of disposable torque-limiting and fixed-driver surgical instruments and multi-instrument surgical kits used to secure screws, fasteners and connectors used for CRM, neuromodulation, cardiovascular and orthopaedic implants. The company is a principal supplier to major medical implant manufacturers worldwide including developers of pacemakers, defibrillators, ventricle assist devices and essentially every type of orthopaedic implant including spine, small bone, extremities, trauma, cranial-maxillofacial, knee, hip, shoulder and general reconstruction products.

ECA Medical Instruments provides off-the-shelf as well as modified standard and full custom instruments and surgical kits. The firm’s Rapid Instrument Customization (RIC) program allows OEM implant makers to work in full collaboration with ECA’s design and new product introduction team to quickly create unique instruments and also convert existing reusable instruments and designs to contemporary and cost effective disposable products. Major surgical instrument product lines are:

• Precision torque-limiting instruments from 2oz./” to 10Nm (90 lb./”)
• Fixed-Driver instruments including new Wick Away technology products
• Surgical procedure kits for orthopaedic implants
• Sterile-ready and sterile-pack solutions
• Specialty products including inserters, cannulas, kerrisons, and cavity carvers and more